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1.
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GENERAL INTRODUCTION
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Chemical substances and products must be assessed in respect of their quality (classifications), cf. § § 4 and 5. This Annex resides the requirements for this classification. For the purposes of this Annex, chemical substances and products of this Annex are also understood to be the plant protection products and biocidal products, unless otherwise stated in the text.
The purpose of the classification of chemical substances and products is to identify all non-resident physico-chemical, toxicological and ecotoxicological properties which may give rise to risks during normal handling or use. It takes account of all the possible dangers which may be exposed to normal handling and use of dangerous substances and products when they are in the form in which they are placed on the market, but not necessarily in other forms of use, such as, for example, diluted.
Criteria for the classification of substances and products are in section 2-4. The classification includes location of the staging classes, the assignment of risk phrases (R-phrases) that specify the risks to the substance or product. In addition, danger symbols and indications of danger shall be assigned, cf. Section 2-4, as well as safety phrases (S-phrases), which provide instructions for necessary precautions, cf. Section 5.
Where a substance or product is classified as hazardous, it must be labelled with the indication of the danger to protect users, the public and the environment, cf. § 13, nr. 7. Detailed rules for this labelling are listed in Annex 2, Section 1.
The classification shall reflect all the dangerous properties of a substance or product. To that end, it is necessary to take account of the criteria in each of the paragraphs 2 and 4 of paragraphs 2 to 4. For example, classification is subject to section 3.2.1.1. not that, for example, section 3.2.1.2., 3.2.1.3. or 3.2.2.
Chemical substances shall be classified on the basis of the criteria set out in 2.2. (Fire and Explosion), 3.2. (Health Danger), and 4.2. (environmental effects). The classification shall be based on all available data on the substance.
An attempt to make use of substances within the framework of this notice shall be carried out in accordance with the requirements of Article 13 of Regulation (EC) No 2 of the European Parliament and of the Council. 1907/2006 on the registration, assessment and approval, as well as restrictions on chemicals (REACH).
In the case of substances, the information set out in Annexes VI, VII and VIII to Regulation (EC) No 2 of the European Parliament and of the Council is required. 1907/2006 on the registration, assessment and approval of, and restrictions on chemicals (REACH), most of the necessary data for classification and labelling are available in the base set. The classification and labelling must, where necessary, be reviewed when further information is available (Annex IX and X to Regulation (EC) No 2. 1907/2006). The data necessary for the classification of other substances shall be obtained from the following sources, in particular :
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-WHAT?
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the results of the examination of the substance ;
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-WHAT?
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the information required under international rules on the transport of dangerous goods ;
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-WHAT?
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information from the reference plants and the literature ;
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-WHAT?
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information stemming from practical experience,
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-WHAT?
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the results from structure / activity relationships and expert assessments.
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The criteria referred to in Section 2.2, 3.2 and 4.2 shall apply for direct use when the relevant data has been obtained by means of investigation corresponding to the indicated in Annex 12. In other cases, the available data must be evaluated by comparing the methods used and the results of studies with the methods referred to in Annex 12 and the criteria referred to in point 2.2, 3.2 and 4.2., for the purpose of determination of the appropriate classification criteria.
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In some cases, there may be some doubt as to the criteria set out in 2.2, 3.2 and 4.2. must be used, particularly when they require the use of expert opinion. In such cases, the manufacturer or importer shall classify the substance on the basis of a competent person's evaluation of the documentation. For approval products such as plant protection products and biocidal products, the classification shall be carried out by the competent authority.
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Where an expert opinion is based on the classification of the substance, where there is fear of the possible inconsistent application of the criteria referred to in 2.2, 3.2 and 4.2, the relevant scientific data on which it is based is due ; the communication referred to in section 7 (3). 1, to the Environmental Management Board at its request. The same procedure shall be used when information is available which may raise doubts about the accuracy of the classification of a substance in the list of hazardous substances.
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If, for a given characteristic, there are several sets of data, the data that results in the most stringent classification shall be used unless they have been obtained on the basis of studies that are scientifically incorrect.
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Chemical products shall be classified for the fire and explosion hazard according to the same criteria as substances (point 2.2), cf. however item 2.3. As far as plant protection products are concerned, look at the point. 2.1.
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In the case of a health hazard (toxicological properties) other than carcinogenic, mutagenic and toxic effects, chemical products shall be classified according to the same criteria as substances, cf. section 3.2.1. to 3.2.6, and / or using the methods described in 3.3. (calculation methods). For plant protection products, look at it. 3.1. As far as the R65 is concerned, the criterion is used in item 3.2.1.3.
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For carcinogenic, mutagenic and toxic effects must chemical products are classified according to the methods described in 3.3.6.
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In the case of environmental hazology (ecotoxicological properties), chemical products for toxicity in the aquatic environment shall be classified according to the same criteria as for substances or by using the methods laid down in Point 4.3. (method of calculation). For plant protection products, see section 4.1.
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A product is classified for its ability to bioaccumulation and degradability according to the methods described in Point 4.3. (The calculation rules). The rules on calculation must also be applied in the classification of a product as dangerous for the ozone layer.
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The data used to classify a chemical product using fact-finding data on the product shall be obtained by using the methods referred to in Annex 12. They shall be carried out in accordance with the principles of good laboratory practice in accordance with the rules applicable to the Security Management Board at any time. However, this does not apply to studies for physico / chemical properties for chemical products. If laboratory tests are carried out by a laboratory outside Denmark as a responsible laboratory, this must be subject to the supervision of the GLP authority of the country concerned, in accordance with the rules of the OECD, or otherwise ; documentation that GLP principles have been followed.
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2.
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CLASSIFICATION OF FIRE AND EXPLOSION RISKS
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2.1.
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Introduction
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Substances and products shall be classified for explosive, oxidising of oxidising (oxidising) and flammable properties according to the criteria specified in this section. The criteria are directly indicated in the test methods set out in Annex 12, where such are specified.
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The plant protection products covered by Chapter 7 of the law on chemical substances and products shall be classified according to the criteria laid down in this Title. These properties shall be determined by means of the methods set out in Appendix 12 unless other internationally accepted methods are acceptable in accordance with the publication of the control measures laid down in Annex 5.1.
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Where there is sufficient evidence in practice that the physico-chemical properties of substances and products (other than organic peroxides) differ from those to show the test methods in Annex 12, such substances and products shall be classified as appropriate ; in accordance with the possible hazard they present to persons who consort with these substances and products, or to other persons.
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The criteria contained in this section apply to both substances and products. If none of the content substances of a product are to be classified according to the criteria laid down in this Title, and the producer or importer has information, indicating that it is likely that the product involves the dangers of it in this section However, it is not necessary to examine whether the product is to be classified according to the criteria laid down in this Title.
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The same applies if there is scientific evidence to assume that a new risk assessment in the event of a change to the well-known composition of a product will not lead to a change in classification. In the case of pesticides, studies must be carried out in accordance with the publication of the control measures laid down in Annex 5.1.
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Specific rules have been laid down for certain gas mike products in item 2.3.
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2.2.
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Criteria for classification
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2.2.1.
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Explosive
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In the case of explosive substances and products, fixed, liquid, gainous or gelatinous substances and products which, without the supply of oxygen, can react rapidly to heat-developers with rapid acceleration and which are detonated by the test conditions ; rapidly deflares or at a partial containment explodes or, at a time of heating, explode. Substances and products shall be classified as explosive and assigned the symbol " T" and the indication of danger ' in accordance with the results of the tests given in Annex 12, if the substances and products are explosive in the form they are concerned ; is marketed.
A R-statement is mandatory and it is selected on the basis of :
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R2
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Explosive for shock, friction, fire, or other sources of ignition
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All explosive substances and products, including organic peroxides, except the above mentioned below.
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R3
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Highlight explosive for shock, friction, fire, or other sources of ignition.
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Especially sensitive substances and products, such as the salts of picrinic acid, pentaerythritoltetranitrate (PETN).
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2.2.2.
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Brandnourishing
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In the case of oxidising substances and products, substances and products which, in contact with other substances, especially flambates, react highly thermal developers. Substances and products shall be classified as oxidising and assigned the symbol " O " and the indication of danger ' Brandnourishing ` in accordance with the results of the studies referred to in Annex 12 (hereinafter referred to as ' Oxidizing properties ').
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A R-statement is mandatory and is selected on the basis of the results of the survey, but in accordance with the following :
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R7
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Can cause fire
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Organic peroxides, which are flammable even if they are not in contact with other combustiable materials.
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R8
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Brandfarlig on contact with flammable substances
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Other oxidising substances or products, including inorganic peroxides, which may cause fire or increase the fire hazard of contact with combustiable substances.
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R9
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Explosive when mixing with flammable substances
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Other substances and products, including inorganic peroxides, which are explosive when mixed with combustible substances, such as certain chlorates.
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2.2.2.1.
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Comments concerning peroxides
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Organic peroxides combines a fire-nutrient and properties of a combustible substance in a molecule : when an organic peroxide is degraded, the oxidising part of the molecule is reacting to the oxidized part of the combustible parts of the fire hydrant (oxiderable) part.
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As far as explosive properties are concerned, organic peroxides or products thereof are classified in the form in which they are placed on the market according to the criteria referred to in 2.2.1 on the basis of the tests carried out in accordance with the methods laid down in Annex 12.
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As far as the oxidising properties are concerned, the existing methods can be used, cf. Annex 12 is not used on organic peroxides.
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What? substances in the case of the classification of organic peroxides which are not already classified as explosive, which are dangerous on the basis of their structure (e.g. R-O-O-H, R, 1 -O-O-R 2 ).
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Products not already classified as explosive shall be classified by applying the calculation method based on the percentage of active oxygen.
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The active oxygen content (%) in a product with organic peroxide is determined by the formula :
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16 x. (n). i x c i /m i ()
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where :
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n i = number of peroxic groups per molecule organic peroxide i
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c i = concentration (weight percentage) of organic peroxide i
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m i = molecular weight of organic peroxide i
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Organic peroxides or products thereof which are not already classified as explosive shall be classified as oxidizing, if the peroxide or product contains :
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more than 5% of organic peroxides, or
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more than 0,5% active oxygen from the organic peroxides and not more than 5% of hydrogenperoxide.
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2.2.3.
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Highly flammable
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Substances and products shall be classified as highly flammable and shall be assigned the symbol ' Exterior flammable `, in accordance with the results of the studies indicated in Annex 12.
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The R-statement shall be assigned in accordance with the following criteria :
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R12
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Highly flammable
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Liquid substances and products which have flamethroid lower than 0 ° C and oiling point (at the range of boiling range) lower than or equal to 35 ° C.
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Gas-mike substances and products that can be ignanted at normal temperature and normal pressure.
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2.2.4.
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Very flammable.
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Substances and products shall be classified as highly flammable and shall be assigned the symbol " Extreme dangerous " in accordance with the results of the studies indicated in Annex 12.
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R-phrases are assigned according to the following criteria :
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R11
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Very flammable.
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Fixed substances and products which are readily flammable by means of a source of ignition and which, following its removal, continue to burn or glow.
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Liquid substances and products which have flamethroid lower than 21 ° C, but are not highly flammable.
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R15
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Reacts with water during the formation of highly flammable gases
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Substances and products which, in contact with water or damp air, develop highly flammable gases in dangerous quantities, i.e. at least 1 litres per kilograms. per Hour.
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R17
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Self-combustible in air
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Substances and products, which are at normal temperature and without power supply at the impact of the air, develop heat and then ign-ign-ignition.
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2.2.5.
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Flammable
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Substances and products shall be classified as flammable in accordance with the results of the studies referred to in Annex 12. The R-statement shall be assigned in accordance with the following criteria :
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R10
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Flammable
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Liquid substances and products which have flamepoint equal to or higher than 21 ° C and lower than or equal to 55 ° C.
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However, a product which has flamelight equal to or higher than 21 ° C and lower than or equal to 55 ° C does not have to be classified as flammable if it cannot in any way be given a fire, and there is no reason to fear that it will lead to danger ; for persons handling it, or for other people.
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2.2.6.
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Other physico-chemical properties
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Substances and products that are already classified according to section 2.2.1 to 2.2.5., 2.3. or in accordance with paragraphs 3 or 4, additional R phrases shall be assigned in accordance with the following criteria :
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R1
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Explosive in dry mode
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Explosive substances and products placed on the market or in a moisture form, such as nitrocellulose, with a content of more than 12.6% nitrogen.
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R4
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Danner very sensitive explosive metal compounds
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Substances and products capable of forming sensitive, explosive metallic derivatives, e.g. pic acid, styphninlic acid.
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R5
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Explosive for heating
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Thermal unstable substances and products that are not classified as explosive, e.g. perchloric acid above 50%
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R6
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Explosive on and without contact with air
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Substances and products which are unstable at room temperature, such as acetylene.
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R7
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Can cause fire
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Reactive substances and products, such as fluoride, sodium hydrogensulphite.
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R14
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Reacts violently with water
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Substances and products which react violently with water, such as acetylchloride, alkaline metals, titanium trachloride.
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R16
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Explosion hazardous when mixing with oxidising substances
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Substances and products that react explosively with oxidizing funds, for example, red phosphorus.
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R18
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In use, fireable fumes / explosive steam-air mixtures are formed
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Products not classified as flammable but which contain volatile components that are flammable in the air.
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R19
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Can create explosive peroxides
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Substances and products which may constitute explosive peroxides during storage, e.g. diethyl ether, 1,4-dioxan.
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R30
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Can become very flammable when using
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Products that are not themselves classified as flammable but which may be flammable due to the loss of non-flammable, volatile components.
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R44
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Explosive during containment of warm-up
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Substances and products not themselves classified as explosive in accordance with point 2.2.1, but nevertheless exhibited explosive properties in practice if they are heated during sufficient containment. For example, certain substances may explode at a time of heating in a steel surge but not by heating in less solid containers.
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Other additional R-phrases are listed in section 3.2.8.
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2.3
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Gas-mixing products (gas mixtures)
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Gas mimige products shall be classified according to the criteria referred to in paragraph 2.2, with the following exceptions being applicable.
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2.3.1.
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Fire Farliness
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In cases where gaseous products are produced on order in small quantities, the fire-risk of these gas mixtures may be evaluated according to the following calculation method :
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The expression for the gaseous mixture
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A 1 F 1 +. + A i F i +. A n F n + B 1 I 1 +. + B i I i +. B p I p
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where :
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A i and B i is an Moldovan
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F i flammable gas,
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I i inert gas
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n number of flammable gases,
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p number of inert gases
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can be rewritten into a form where all you i (inert gases) expressed in a nitrogen equivalent during the use of a coefficient K, i , and where the equivalent content of the dangerous gas A ' i is expressed as follows :
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By using the value for the maximum content of flammable gases, which in a mixture of nitrogen, a mixture that is not flammable in air (Tci) can be achieved :
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. i 'A' i /Tci ≤ 1
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The gas mixture is flammable if the value of the above expression is greater than 1 and the product is classified as highly flammable. Moreover, the R12 statement is assigned.
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Equivalencoefficients (R i ()
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The value of the equivalence K i between the inert gases and nitrogen and the values of the maximum flammable gases (Tci) can be found in Tables 1 and 2 of ISO standard ISO/DIS 10156.
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Maximum content of flammable gases (Tci)
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The value of the maximum content of flammable gases (Tci) can be found in Table 2 of the ISO standard ISO/DIS 10156.
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When a Tci-value for a flammable gas does not exist in the above standard, the corresponding lower explosive limit (LEL) shall be used. If no LEL value is found, the TEL value is set to 1% by volume.
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Remarks
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-WHAT?
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The above expression may be used to obtain a fair labelling of gaseous products, but it should not be regarded as a method of substituting for the purpose of the determination of the technical safety parameters.
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-WHAT?
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Furthermore, this expression does not provide any information about whether a mixture containing oxidizing gases may be treated safely. The evaluation of the fire risk shall not be taken into account for these oxidizing gases.
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-WHAT?
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The above expressions provide reliable results only if the flammable gases do not affect each other in relation to their fire haziness. This has to be taken into account, for example, by halogenated hydrocarbons.
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2.3.2.
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Oxidising properties
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As the directives listed in Annex 12 do not contain any method of determining the oxidizing properties of the gaseous mixers (oxidising) properties, these properties must be evaluated in accordance with the following method.
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The principle of the method is based on a comparison between the oxidizing ability of the gases in a mixture and the oxidising capacity of the oxygen in air. The concentration of gases in the mixture is expressed in volume percentage.
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The gases mixture are considered as oxidizing or more oxidizing than air if the following condition is met :
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. i x i C i 2121
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where
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x i concentration of gas in% by volume and
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C i is the equivalence coefficient,
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In this case, the product shall be classified as oxidising and assigned the R8 R8.
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Coefficient of equivalence between oxidising gases and oxygen
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The following coefficients are used in the calculation of the oxidizing ability of certain gases in a mixture compared with the oxidising capacity of oxygen in air, calculated in paragraph 5.2. in ISO standard ISO/DIS 10156 :
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O 2 : 1
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N 2 O : 0,6
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When no value for C i the coefficient exists for a gas in the specified standard, the coefficient shall be attributed to a value of 40.
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3.
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HEALTH HAZARD CLASSIFICATION
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3.1.
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Introduction
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The classification of health concerns both acute effects and long-term effects of substances and products, whether they come from a single, repeated or long-term impact.
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If, in the case of epidemiological studies, scientifically justified case studies as specified in this section or by statistical underused experience, so as to assess data from poisonous information lesions or from occupational diseases, be shown that the toxicological effects on humans are different from the effects of the methods used for the use of methods of animal testing or the use of the calculation method in 3.3. effects on humans. However, studies on humans must not be used and should not normally be used to refute positive data from animal testing.
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In the case of several dangerous properties, there are authenticated in vitro methods in Annex 12, and these tests should be used where appropriate.
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Where classification is carried out from the results of tests, studies from methodologies which reflect the risks that are relevant to the human being should be used in a suitable manner.
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Classification of substances be carried out on the basis of the survey data available, in accordance with the criteria referred to in 3.2. The scope of these effects shall be taken into account.
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For products classification shall be classified as a health hazard :
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(a) On the basis of the classification of the incoming substances, using the calculation methods in 3.3.
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b) according to the criteria referred to in 3.2. The properties shall be determined by means of the methods set out in Annex 12, with less for plant protection products other internationally accepted methods, in accordance with the publication of the control measures laid down in Annex 5.1.
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Except for plant protection products to comply with the requirements of Annex 5.1, the methods laid down in paragraph (b) may be used only when the person responsible for marketing, scientifically, can prove that the product is : toxicological properties may not be calculated correctly according to the calculation methods in 3.3 or on the basis of existing animal tests. The test methods must also be justified or separately authorized in accordance with Article 12 of Directive 86 /609/EEC.
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If a toxicological property is determined both based on the rules of a (a) and (b), the result obtained from point (b) is used for the classification of the product, with the exception of carcinogenic, mutagenic and reproduction properties, where the calculation methods in point 3.3 are calculated. must be used.
|
|
| |
|
Irrespective of the method used to assess the risks of a product, account must be taken of all the dangerous health effects referred to in this Title. For example, classification is subject to section 3.2.1.1. not that, for example, section 3.2.1.2., 3.2.1.3. or 3.2.2.
|
|
| |
|
If one or more toxicological properties of a product of known composition is assessed on the basis of fact-finding data, a new assessment shall be carried out, either on the basis of fact-finding data or using the calculation methods, in the following cases :
|
|
| |
|
1)
|
if changes are made to the composition of the product, by replacing or inserting one or more substances, whether these substances are to be classified as dangerous or not,
|
|
| |
|
2)
|
the concentration of one of the content substances classified for human health is changed. However, no further assessment needs to be made if the concentration of the concentration does not exceed the following limits :
|
|
| |
|
|
|
| |
Interval of the initial concentration of the substance
|
Allowed variation in the initial concentration of the substance (as a percentage of the initial concentration)
|
|
| |
konc. ≤ 2.5%
|
± 30%
|
|
| |
2,5% < konc. ≤ 10%
|
± 20%
|
|
| |
10% < konc. ≤ 25%
|
± 10%
|
|
| |
25% < konc. ≤ 100%
|
± 5%
|
|
| |
|
|
|
| |
|
The new assessment will be valid unless there are scientific reasons to assume that a new hazard assessment will not result in a change of classification.
|
|
| |
|
Where impurities, additives or individual constituents of substances have been identified, account shall be taken of this where their concentration is greater than or equal to the following concentration limits :
|
|
| |
|
-WHAT?
|
0,1% for substances classified as highly toxic, toxic or as carcinogenic, mutagenic or toxic to reproduction in category 1 or 2, or for the environment (assigned symbol N for its waters for the aquatic environment or the ozone layer),
|
|
| |
|
-WHAT?
|
1% for substances classified as harmful, corrosive, irritant, sensitizing or as carcinogenic, mutagenic or toxic to reproduction in category 3, or dangerous to the environment (not assigned the symbol N, d.v.s. organisms living in water and / or may cause long-term adverse effects in the aquatic environment,
|
|
| |
|
unless lower values are specified in the list of hazardous substances.
|
|
| |
|
In the case of impurities, additives or individual components of the classification of a substance, the rules applicable to the classification of products shall be taken into account when the classification of products is to be classified.
|
|
| |
|
Substances containing asbestos must not, however, be assessed in accordance with the rules for products before a concentration limit has been set in the list of hazardous substances.
|
|
| |
|
|
|
| |
3.2.
|
Criteria for classification based on survey data
|
|
| |
|
|
|
| |
3.2.1.
|
Acute lethal effects
|
|
| |
|
Where classification is carried out from the results of tests, the results of methods which reflect the risks that are relevant to man should be used in an appropriate manner.
|
|
| |
|
Acute toxicity to the oral administration of substances or products may be determined by means of a method which makes it possible to assess the LD 50 -the value, or by determining the critical dose (fastdosis-method) or by determining the exposure interval where mortality is expected (acute toxicity method).
|
|
| |
|
The critical dose is the dose that results in clear signs of toxicity, but no fatalities, and shall be one of the four levels of dose specified in the method indicated in Annex 12 (5, 50, 500 or 2000 mg/kg body weight).
|
|
| |
|
The term ' clear indication of toxicity ` shall be used as a description of toxic effects after exposure of the substance or product so serious that exposure to the next higher dose is likely to cause deaths.
|
|
| |
|
The results of the examination at a particular dose after the dose dose method may be either :
|
|
| |
|
-WHAT?
|
less than 100% survival,
|
|
| |
|
-WHAT?
|
100% survival, but clear signs of toxicity,
|
|
| |
|
-WHAT?
|
100% survival, no obvious signs of toxicity,
|
|
| |
|
In certain cases, the fixed dose method requires that the substance or product be re-examined with a higher or lower dose if it has not already been examined at the appropriate level of dose. See also the evaluation table in test method B1 bis listed in Annex 12.
|
|
| |
|
In the criteria referred to in 3.2.1.1., 3.2.1.2 and 3.2.1.3, only the final survey result is available. The dose of 2000 mg/kg shall above all be used to obtain information on the toxic effects of substances and products that display low acute toxicity and are not classed on the basis of acute toxicity.
|
|
| |
|
The exposure interval, where mortality is expected, can be found on whether there are related deaths or not by the acute toxicity class method. In the first attempt, one of the three fixed initial doses (25, 200 or 2000 mg/kg body weight) is used.
|
|
| |
|
The method of acute toxicity class requires, in certain cases, that the substance is re-examined with higher or lower doses, if it has not already been examined at the appropriate level of dose. See also the evaluation form in test method B. 1 ter in Appendix 12.
|
|
| |
|
|
|
| |
3.2.1.1.
|
Meget giftig
|
|
| |
|
Substances and products are classified according to the following criteria as highly toxic and awarded the symbol Tx, the indication of danger ' Very Giftig ` and one or more of the following R-phrases :
|
|
| |
|
|
|
| |
|
R28
|
Meget giftig at indtagelse
|
|
| |
|
|
acute toxicity,
|
|
| |
|
|
-WHAT?
|
LD 50 oral, rat : ≤ 25 mg/kg, or
|
|
| |
|
|
-WHAT?
|
Fastdose method : less than 100% survival at 5 mg/kg, oral, rat, or
|
|
| |
|
|
-WHAT?
|
High mortality at dose ≤ 25 mg/kg oral, rat, by the acute toxicity class method (with regard to interpretation of test results, refer to the diagrams in Annex 2 for test method B. 1 ter in Appendix 12.).
|
|
| |
|
|
|
|
| |
|
R27
|
Meget giftig for hudkontakt
|
|
| |
|
|
acute toxicity,
|
|
| |
|
|
-WHAT?
|
LD 50 dermal, rat or rabbit : ≤ 50 mg/kg
|
|
| |
|
|
|
|
| |
|
R26
|
Meget giftig on inhalation
|
|
| |
|
|
acute toxicity,
|
|
| |
|
|
-WHAT?
|
LC 50 inhalation, rat, for aerosols and particulates : ≤ 0,25 mg/l/ 4 hours
|
|
| |
|
|
-WHAT?
|
LC 50 inhalation, rat, for gases and vapours : ≤ 0,5 mg/1/4 hours
|
|
| |
|
|
|
|
| |
3.2.1.2.
|
Giftig
|
|
| |
|
Substances and products shall be classified according to the following criteria as toxic and awarded the symbol " T ", the indication of danger ' Toxic ` and one or more of the following R-phrases :
|
|
| |
|
|
|
|
| |
|
R25
|
Giftig on indtagelse
|
|
| |
|
|
acute toxicity,
|
|
| |
|
|
-WHAT?
|
LD 50 oral, rat : 25 mg/kg < LD 50 ≤ 200 mg/kg, or
|
|
| |
|
|
-WHAT?
|
Fastdose method : Critical dosage, oral, rat, 5 mg/kg : 100% survival, but clear signs of toxicity or
|
|
| |
|
|
-WHAT?
|
High mortality in dosiarea > 25 to ≤ 200 mg/kg oral, rat, by the acute toxicity class method (with regard to interpretation of test results, refer to the diagrams in Annex 2 for test method B. 1 ter in Appendix 12.).
|
|
| |
|
|
|
|
| |
|
R24
|
Toxic to hudkontakt
|
|
| |
|
|
acute toxicity,
|
|
| |
|
|
-WHAT?
|
LD 50 dermal, rat or rabbit : 50 mg/kg < LD 50 ≤ 400 mg/kg
|
|
| |
|
|
|
|
| |
|
R23
|
Giftig by inhalation
|
|
| |
|
|
acute toxicity,
|
|
| |
|
|
-WHAT?
|
LC 50 inhalation, rat, for aerosols and particulates : 0,25 mg/1/4 hours < LC 50 ≤ 1 mg/1/4 hours
|
|
| |
|
|
-WHAT?
|
LC 50 inhalation, rat, for gases and vapours : 0,5 mg/1/4 hours < LC 50 ≤ 2 mg/l/4 hours
|
|
| |
|
|
|
|
| |
3.2.1.3.
|
Harmful
|
|
| |
|
Substances and products are classified according to the following criteria as harmful and assigned the symbol " Xn ", the indication of danger ' harmful to health `, and one or more of the following R-phrases :
|
|
| |
|
|
|
|
| |
|
R22
|
Hazable on intake
|
|
| |
|
|
acute toxicity,
|
|
| |
|
|
-WHAT?
|
LD 50 oral, rat : 200 mg/kg < LD 50 ≤ 2000 mg/kg, or
|
|
| |
|
|
-WHAT?
|
Fastdose method : Critical dosage, oral, rat, 50 mg/kg : 100% survival, but clear signs of toxicity, or less than 100% survival at 500 mg/kg, oral, rat, see the evaluation table in test method B1 bis listed in Annex 12 or
|
|
| |
|
|
-WHAT?
|
High mortality in dosiarea > 200 to ≤ 2000 mg/kg oral, rat, by the acute toxicity class method (with regard to interpretation of test results, refer to the diagrams in Annex 2 for test method B. 1 ter in Appendix 12.).
|
|
| |
|
|
|
|
| |
|
R21
|
Farlig on hudkontakt
|
|
| |
|
|
acute toxicity,
|
|
| |
|
|
-WHAT?
|
LD 50 dermal, rat or rabbit : 400 mg/kg < LD 50 ≤ 2000 mg/kg
|
|
| |
|
|
|
|
| |
|
R20
|
Farlig on inhalation
|
|
| |
|
|
acute toxicity,
|
|
| |
|
|
-WHAT?
|
LC 50 inhalation, rat, for aerosols and particulates : 1 mg/l/4 hours < LC 50 ≤ 5 mg / l / 4 hours
|
|
| |
|
|
-WHAT?
|
LC 50 inhalation, rat, for gases and vapours : 2 mg/l/4 hours < LC 50 ≤ 20 mg/l/4 hours
|
|
| |
|
|
|
|
| |
|
R65
|
Farlig : may cause lung damage when ingestion
|
|
| |
|
|
Liquid substances and products which, because of their low viscosity, constitute an aspirational hazard to humans :
|
|
| |
|
a)
|
Substances and products which contain the aliphatic, alicyclic and aromatic hydrocarbons of a total concentration of 10% or more and which have either have
|
|
| |
|
|
-WHAT?
|
an expiration time of less than 30 seconds. in a 3 mm ISO cup in accordance with ISO 2431 (the day of April 1996 /July 1999) relating to the "Paints and varnishes-Determination of flow time" " (paints and varnishes-determination of expiration time with the use of the expiry dates), or
|
|
| |
|
|
-WHAT?
|
a kinematic viscosity measured by a calibrated glass capillary in accordance with ISO 3104/3105, in less than 7 x 10, -6 m 2 / sec. at 40 ° C, (ISO 3104, 1994-Release, concerning "Petroleum products-Transparent and opaque liquids-Determination of kinematic viscosity and calculation of dynamic viscosity" (oil products-transparent and opaque liquids-determination of kinematic viscosity and computation of dynamic viscosity) ISO 3105, 1994-Edition, regarding "Glass capillary kinematic viscometers-Specifications and related instructions" (kinematic glass capsumethree specifications and instructions)), or
|
|
| |
|
|
-WHAT?
|
a kinematic viscosity, calculated on the basis of measurements by means of rotation in accordance with ISO 3219, in less than 7 x 10, -6 m 2 / sec. at 40 ° C. (ISO3219, 1993-Release, concerning "Plastics-Polymers / resins in the liquid state or as emulsions or dispersions-Determination of viscosity using a rotational viscomets with defined shear rate" (plastics-polymers / harpiks in floating state, or as emulsions or dispersions-determination of the viscosity by means of a rotational range, with a fixed offset speed)).
|
|
| |
|
|
However, the classification of substances and products satisfying these criteria may be omitted if their average surface voltage is more than 33 mN/m at 25 ° C measured at the Nuoy tensiometer or by the measuring methods laid down in Part A. 5 of the conditions set out in Annex 12 ; mentioned testing methods.
|
|
| |
|
b)
|
Other substances and products in the case of practical experience of human beings.
|
|
| |
|
|
|
|
| |
3.2.2.
|
Non-lethal, but irreversible effects after a single exposure
|
|
| |
|
|
|
| |
3.2.2.1.
|
Meget giftig
|
|
| |
|
Substances and products must, according to the following criteria, be classified as highly toxic and awarded the symbol Tx, the indication of danger "Very toxic" and the R-statement :
|
|
| |
|
|
|
| |
|
R39 2)
|
Hazard for varig alvorlig skade på Health
|
|
| |
|
-WHAT?
|
greater likelihood that, in addition to the effects referred to in 3.2.7, irreversible damage is caused by a single influence in a given way, generally at doses of the magnitude referred to in section 3.2.1.1.
|
|
| |
|
|
|
|
| |
3.2.2.2.
|
Giftig
|
|
| |
|
Substances and products must, according to the following criteria, be classified as toxic and awarded the symbol " T ", the indication of danger ' Toxic ` and the R-statement :
|
|
| |
|
|
|
|
| |
|
R39 3)
|
Hazard for varig alvorlig skade på Health
|
|
| |
|
-WHAT?
|
greater likelihood that, in addition to the effects referred to in 3.2.7, irreversible damage to a single influence is likely to be damaged in a given way, in general by doses of the magnitude referred to in section 3.2.1.2.
|
|
| |
|
|
|
|
| |
3.2.2.3.
|
Harmful
|
|
| |
|
Substances and products must, according to the following criteria, be classified as harmful and assigned the symbol " Xn ", the indication of danger ' health-harmful ` and the R-statement :
|
|
| |
|
|
|
| |
|
R68 4)
|
Mutability for varig skade in Health
|
|
| |
|
-WHAT?
|
greater likelihood that, in addition to the effects referred to in 3.2.7, irreversible damage to a single influence is likely to be damaged in a given way, in general by doses of the magnitude referred to in Item 3.2.1.3.
|
|
| |
|
|
|
|
| |
3.2.3.
|
Serious adverse effects on repeated or prolonged exposure
|
|
| |
|
Substances and products must, according to the following criteria, be classified as toxic or harmful and assigned the symbol " T " or Xn, the indication of danger ' Toxic ` or ' Sundance `, and the R-statement :
|
|
| |
|
|
|
| |
|
R48 5)
|
Serious health hazard on longer exposure
|
|
| |
|
-WHAT?
|
likely to cause severe damage to the repeated or sustained impact of a given application method (obvious dysfunction or morphological modification of toxicological importance).
|
|
| |
|
|
Substances and products are classified at least as toxic when these effects are observed at dose levels, which are a size lower (that is to say. 10 times lower) than those listed below.
|
|
| |
|
|
Substances and products are classified at least as harmful when these effects are observed at dose levels of the following magnitude :
|
|
| |
|
-WHAT?
|
oral, rat : ≤ 50 mg/kg (bodyweight) /day
|
|
| |
|
-WHAT?
|
dermal, rat or rabbit : ≤ 100 mg/kg (bodyweight) /day
|
|
| |
|
-WHAT?
|
inhalation, rat : ≤ 0,25 mg/l, 6 hours / day
|
|
| |
|
|
These indicative values may be used immediately when, in the case of subchronic toxicity (90 days), serious damage has been observed. In interpretation of the results of the subakut test (28-day) toxicity, these values should be approximately Three times bigger. In the case of chronic toxicity studies (2 years), an evaluation should be carried out on a case-case-case basis.
|
|
| |
|
|
If results of studies of different duration are available, the results of the study of the longest duration standard should be used.
|
|
| |
|
|
|
| |
|
Comments regarding the use of R48
|
|
| |
|
This R-statement is used to refer to particular biological effects of the kind described in the below. For the purpose of applying this R statement, serious injury shall be deemed to include death, clear function disturbances or morphological changes to toxicological significance. It is particularly important to use it when these changes are irreversible. It is also important that serious changes are not taken into account not only in a single body or biological system, but also to general changes of less serious nature in several bodies or serious changes in the general ; state of health.
|
|
| |
|
When assessing whether there is any evidence of such effects, it should be reviewed according to the following guidelines.
|
|
| |
|
1.
|
Characters of R48 should be used :
|
|
| |
|
|
a)
|
Freed deaths
|
|
| |
|
|
b)
|
i)
|
Major functional changes in the central nervous system or in the peripheral nervous system, including surveys, hearing and smelling, assessed in clinical observations or other appropriate methods (e.g. electrophysiology).
|
|
| |
|
|
|
(ii)
|
Greater functional changes in other organ systems (e.g. in the lungs).
|
|
| |
|
|
c)
|
Any persistent changes in parameters of clinical biochemistry, haematology or urethra, indicating severe malfunction in one or more bodies. Hematological disorders are considered to be of particular importance if there are signs that they are due to the reduction of bone marrow production of blood cells.
|
|
| |
|
|
d)
|
Serious organ damage detected by microscopic studies of tissue after autopsi :
|
|
| |
|
|
|
i)
|
Exhibit or severe formation of necrosis, fibrosis or granuloma in vitals with regenerative capacity (e.g. liver).
|
|
| |
|
|
|
(ii)
|
Serious morphological changes that are potentially reversible, but clearly indicative of significant malfunctions (e.g. serious change in the liver's obesity, severe acute tubular nefrosis in kidney, ulcerous gastritis).
|
|
| |
|
|
|
(iii)
|
Signs of significant cell death in vitals which cannot regenerate (e.g. fibrosis in the heart of the cardiac or the inclination of a nerve) or in stem cell populations (e.g. aplasia or hypoplasia in the bone marrow).
|
|
| |
|
|
The above evidence will usually be obtained from animal testing. Where data from practical experience are used, special attention should be paid to dose levels.
|
|
| |
|
2.
|
Characters of R48 should not be used :
|
|
| |
|
|
The use of this R statement is limited to ' serious health hazard for longer exposure '. A number of drug-related effects can be observed, both with people and animals who do not justify the use of R48. These effects are relevant when trying to determine a level in which a chemical substance does not have any effect. As examples of well-documented changes which do not normally justify the classification of R48, irrespective of their statistical significance, the following may be mentioned :
|
|
| |
|
|
a)
|
Clinical observations or changes in bodily increases, food or water intake, which may have a certain toxicological meaning but which are not in themselves any 'serious health hazard'.
|
|
| |
|
|
b)
|
Minor changes in clinical biochemistry, haematology or urine analysis, which are of dubious or negligible toxicological significance.
|
|
| |
|
|
c)
|
Changes to the body ' s weight without signs of malfunction in the bodies concerned.
|
|
| |
|
|
d)
|
Customization responses (e.g., immigration of macros in the pulmonary tissue, liver hypertrophy and enzyme reduction, hyperplastic reactions to irritant substances). Local reactions to the skin due to repeated dermal use of a substance which is better classified by R38 "Irritating to Skin."
|
|
| |
|
|
(e)
|
Where there is a certain species-specific toxicity mechanism (e.g. through specific metabolic pathways).
|
|
| |
|
|
|
| |
3.2.4.
|
Remarks for very volatile substances
|
|
| |
|
In particular substances in respect of which the concentration of saturated vapors is high, there may be indications of effects which cause concern. Such substances may not be classified according to the criteria for health impact in this Annex (section 3.2.1.3., 3.2.2.3 and 3.2.3), or are not covered by item 3.2.8. However, where there is sufficient evidence that such substances may give rise to risks during normal handling and use, it may be necessary to classify them by individual assessment and to include them in the list of hazardous substances.
|
|
| |
|
|
|
| |
3.2.5.
|
Agrating and irritant effects
|
|
| |
|
|
|
| |
3.2.5.1.
|
Ate
|
|
| |
|
The substance or product shall be classified as corrosive and assigned the symbol " C " and the indication of danger " corrosive ` shall be classified according to the following criteria :
|
|
| |
|
-WHAT?
|
A substance or product shall be deemed to be corrosive when, on an animal's undamaged skin, the death of at least one animal shall be produced in at least one animal in the test for skin irritation referred to in Annex 12, or under an equivalent method ;
|
|
| |
|
-WHAT?
|
The classification can be based on results from authenticated in vitro tests to which those referred to in Annex V (B). 40. Skin corrosion : measure of transcutaneous electrical resistance (TER) in pigskin and a test where a human skin model is used.)
|
|
| |
|
-WHAT?
|
A substance or product should be considered to be corrosive if the result is possible to predict, for example, from a strong acid or alkali reaction (measured pH of 2 or less or 11,5 or above). However, where extreme pH values form the basis for the classification, account may also be taken of the base or the acid reserve. J.R. Young, M.J. How, A.P. Walker and W.M.H. Worth (1988 'Classification as corrosive or irritant to skin of preparations containing acidic or alkaline substances, without testing on animals' Toxic. In Vitro 2 (1) : 19-26). If the basic or acid appraisal of the reserve is estimated that the substance or preparation is not corrosive, further testing should be carried out at any time by the use of an appropriate validated validation ; in vitro Attempto. The evaluation of the basic or acid reserve should not be used alone to exclude substances or preparations from classification as corrosive.
|
|
| |
|
R-phrases are assigned according to the following criteria :
|
|
| |
|
|
|
| |
|
R35
|
Severe corrosion
|
|
| |
|
-WHAT?
|
if there is no more than three minutes of exposure to an animal's undamaged skin, or this result may be predicted.
|
|
| |
|
|
|
|
| |
|
R34
|
Ectsdanger
|
|
| |
|
-WHAT?
|
if there are not more than four hours of exposure, deep-range tissue death in an animal's undamaged skin, or this result may be predicted.
|
|
| |
|
-WHAT?
|
organic hydroperoxides, unless documentation is available for the contrary.
|
|
| |
|
|
|
|
| |
|
Remarks :
|
|
| |
|
Is the classification based on results from an authenticated in vitro attempts, used R35 or R34, depending on the possibilities of the test method, to distinguish between these.
|
|
| |
|
If the classification is based only on an extreme pH value, R35 should be used.
|
|
| |
|
|
|
| |
3.2.5.2.
|
Locator
|
|
| |
|
Substances and products shall be classified as irritant and shall be assigned the symbol " Rotating " and one or more of the following R-phrases in accordance with the following criteria.
|
|
| |
|
|
|
|
| |
|
1.
|
Inflammation of the skin
|
|
| |
|
|
|
|
| |
|
R38
|
Irritating to skin
|
|
| |
|
|
-WHAT?
|
Substances and products which cause significant inflammation of the skin, which after an impact time of not more than four hours, performs at least 24 hours, intended for rabbits in accordance with the skin irritation test shown in Annex 12.
|
|
| |
|
|
The inflammation is significant
|
|
| |
|
|
-WHAT?
|
where the mean of the scores obtained for either blushing and crust or liquid collection, intended for all animal testing, is 2 or more ;
|
|
| |
|
|
-WHAT?
|
or, where the sample referred to in Annex 12 is carried out on three animals, if the mean value of either blushing and crust or liquid collection, calculated for each animal, two or more animals equal to 2 or more.
|
|
| |
|
|
In both cases, each of the scores (24, 48 and 72 hours) each of which is obtained in the calculation of the respective middle values.
|
|
| |
|
|
The inflammation of the skin shall also be significant if it relates to at least two animals until the end of the observation period. Special effects such as, for example, swelling, scales, discoloration, cracks, crusts, crusts and hairs must be taken into account.
|
|
| |
|
|
The relevant data may also be obtained from non-acute animal testing (see the explanatory notes to R48, paragraph 2 (d). These are considered to be significant if the visible effects correspond to the described above.
|
|
| |
|
|
-WHAT?
|
Substances and products which cause significant inflammation of the skin, on the basis of practical observations in human beings, immediately, longer or repeated contact.
|
|
| |
|
|
-WHAT?
|
Organic peroxides, unless evidence is available for the contrary.
|
|
| |
|
|
| |
|
|
Paresthesia
|
|
| |
|
|
Paresthesia, which arises in people's skin contact with pyrethroid pesticides, is not considered to be an irritating effect, which is gracified as Xi ; R38. However, S-sentence S24 should be used for substances which may produce this effect.
|
|
| |
|
|
|
| |
2.
|
Eye damage
|
|
| |
|
|
|
| |
R36
|
Irritating to eyes
|
|
| |
|
-WHAT?
|
Substances and products which, according to the application in the eye of the experimental animal, cause significant eye damage to be shown in the course of 72 hours after the impact, and which will remain at least 24 hours.
|
|
| |
|
|
Ecular damage is significant if the mean value of the scores obtained under the eye irritation test given in Annex 12 corresponds to one of the following values :
|
|
| |
|
|
-WHAT?
|
or more ambiguity in the cornea hinden of 2 or more, but less than 3 ;
|
|
| |
|
|
-WHAT?
|
irrigor damage to 1 or more, but not more than 1,5,
|
|
| |
|
|
-WHAT?
|
Redcoating the hyphenated in 2,5 or more
|
|
| |
|
|
-WHAT?
|
the hyphenation in the hyphenum (chemosis) of 2 or more,
|
|
| |
|
|
or, when the test referred to in Annex 12 has been carried out on three animals if the damage to at least two animals corresponds to one of the above levels other than in irany damage which must be greater than 1 but less than 2, and the value of the red-forming part of the hyphenal value ; must be either 2.5 or more.
|
|
| |
|
|
In both cases, all of the loading dates (24, 48 and 72 hours) are taken into account in the calculation of the respective middle values.
|
|
| |
|
|
-WHAT?
|
Substances and products which cause significant eye damage, on the basis of practical observations in human beings.
|
|
| |
|
|
-WHAT?
|
Organic peroxides, unless evidence is available for the contrary.
|
|
| |
|
|
|
| |
R41
|
Risk of severe eye injury
|
|
| |
|
-WHAT?
|
Substances and products which, according to the application in the eye of the experimental animal, are causing serious damage to the eye injuries during the course of 72 hours after the impact, which shall be at least 24 hours after the introduction of the test material.
|
|
| |
|
|
Eyelisions are serious if the average value of the scores obtained under the eye irritation test specified in Annex 12 corresponds to one of the following values :
|
|
| |
|
|
-WHAT?
|
ambiguity in the cornea of 3 or more ;
|
|
| |
|
|
-WHAT?
|
irris; or more than 1,5 or more.
|
|
| |
|
|
|
The same applies if the test has been carried out on three animals and the damage to at least two animals is at one of the following values :
|
|
| |
|
|
-WHAT?
|
ambiguity in the cornea of 3 or more ;
|
|
| |
|
|
-WHAT?
|
iris damage to 2.
|
|
| |
|
|
In both cases, all of the loading dates (24, 48 and 72 hours) are taken into account in the calculation of the respective middle values.
|
|
| |
|
|
Eyewitness damage is also serious if they are still present after the end of the observation period.
|
|
| |
|
|
Eyelisions are also serious if the substance or product causes a durable approach.
|
|
| |
|
-WHAT?
|
Substances and products that cause serious damage to eye injuries, on the basis of practical observations in human beings.
|
|
| |
|
|
|
| |
|
Note :
|
|
| |
|
The classification of a substance or product as corrosive to the R34 or R35 phrases shall also be considered to pose a risk of serious injury to the cause, and therefore R41 is not included on the label.
|
|
| |
|
|
|
| |
|
3.
|
Irritation of the respiratory system
|
|
| |
|
|
|
|
| |
|
R37
|
Irriterer respirators
|
|
| |
|
|
Substances or products which may cause severe irritation of the respiratory system, on the basis of :
|
|
| |
|
|
-WHAT?
|
practical observing of human beings,
|
|
| |
|
|
-WHAT?
|
positive results from appropriate animal testing.
|
|
| |
|
|
|
|
| |
|
Comments regarding the application of R37
|
|
| |
|
In the interpretation of practical observations in people, they must carefully distinguish between effects that lead to classification with R48 (see furtive. 3.2.3), and effects which lead to classification with R37. The conditions normally leading to classification with R37 are reversible and usually limited to the upper airways.
|
|
| |
|
Positive results from appropriate animal testing may include data obtained by a general toxicity study involving histopathological data from the respiratory system. Data from measurements of experimental bradylatitude (short-spirited) may also be used for the assessment of airway sirarity.
|
|
| |
|
|
|
| |
3.2.6.
|
Sensitizing effects
|
|
| |
|
|
|
| |
3.2.6.1.
|
Sensitivity by inhalation
|
|
| |
|
Substances and products must, according to the following criteria, be classified as sensitizing and assigned the symbol " Xn ", the indication of danger ' to the danger ' and the R-statement :
|
|
| |
|
|
|
|
| |
|
R42
|
Can cause sensitization by inhalation
|
|
| |
|
|
-WHAT?
|
if there is evidence that the substance or product may cause specific sensitisation by inhalation ;
|
|
| |
|
|
-WHAT?
|
if there are positive results from appropriate animal tests,
|
|
| |
|
|
-WHAT?
|
where the substance is an isocyanate, unless there is evidence that the substance does not cause sensitisation by inhalation.
|
|
| |
|
|
|
|
| |
|
Comments regarding the use of R 42 :
|
|
| |
|
|
|
| |
|
Documentation from humans
|
|
| |
|
Proof that the substance or product may cause specific sensitisation by inhalation will normally be based on experience from humans. In this context, sensibility is seen as asthma, but other sensitivity reactions like rhinitis and alvepolicies also take into account. The condition has a clinical nature of an allergic reaction. However, it is not necessary to demonstrate immunological mechanisms.
|
|
| |
|
In the examination of evidence from exposure to humans, the decision to classify it must, in addition to the documented cases, take into account :
|
|
| |
|
-WHAT?
|
the size of the exposed population,
|
|
| |
|
-WHAT?
|
the extent of exposure.
|
|
| |
|
|
|
| |
|
The documentation referred to above may be :
|
|
| |
|
-WHAT?
|
clinical history and data from appropriate pulmonary function tests placed in relation to exposure to the substance, confirmed by other supporting documents which may include :
|
|
| |
|
|
-WHAT?
|
a similar chemical structure such as the substances known to cause sensitisation by inhalation ;
|
|
| |
|
|
-WHAT?
|
in vivo immunological tests (e.g., a priktest)
|
|
| |
|
|
-WHAT?
|
in vitro immunological tests (e.g. serological analyses),
|
|
| |
|
|
-WHAT?
|
studies to show other specific but non-immunological action mechanisms, such as the repeated faint irritation and pharmacological induction ;
|
|
| |
|
|
-WHAT?
|
data from positive bronchial provocation tests with the substance, carried out in accordance with accepted guidelines for the determination of a specific sensitivity reaction.
|
|
| |
|
|
Clinical cover story should cover both medical and professional history to detect a causal relationship between exposure to a particular substance or product and development of sensitisation by inhalation. Relevant information encomplicates worsening factors, both at home and in the workplace, the beginning and development of the disease and the family history and medical history of the patient concerned. The medical history should also include allergic diseases or respiratory diseases from childhood, and smoking habits.
|
|
| |
|
|
The results of positive bronchial provocation tests are considered to be sufficient evidence to classify as sensitising. It must be recognised, however, that many of the studies mentioned above in practice will already be carried out at an earlier stage.
|
|
| |
|
|
Substances which only induction asthma symptoms to irritation in persons with bronchial hyperreactivity should not be required for the R-42 statement to be specified.
|
|
| |
|
|
|
|
|
| |
|
|
Animal trials
|
|
| |
|
|
Data from tests to indicate that a substance or product may cause sensitisation by inhalation of human beings may include :
|
|
| |
|
|
-WHAT?
|
IgE measurements (e.g. in mice)
|
|
| |
|
|
-WHAT?
|
specific pulmongers for guinea pigs.
|
|
| |
|
|
|
| |
3.2.6.2.
|
Sensitivity on skin contact
|
|
| |
|
Substances and products shall be classified as sensitizing and assigned the symbol " Xi ", the indication of danger ' Rotating ` and the R-statement :
|
|
| |
|
|
|
| |
|
R43
|
Can cause sensitisation by contact with the skin
|
|
| |
|
|
-whose practical experience shows that the substances and products cause sensitisation by a significant number of persons in contact with skin contact,
|
|
| |
|
|
-on the basis of positive results from an appropriate animal study ;
|
|
| |
|
|
|
|
| |
|
Comments regarding the application of R 43 :
|
|
| |
|
|
|
| |
|
Documentation from humans
|
|
| |
|
The following documentation (practical experience) is sufficient to classify a substance with R43 :
|
|
| |
|
|
-positive data from appropriate cargo samples, normally from more than one dermatological clinic, or
|
|
| |
|
|
-epidemiological studies which show that the substance or product has caused allergic contact dermatitis. Situations in which a high percentage of exposed persons show characteristic symptoms must be considered to be particularly serious, even though the number of cases is low, or
|
|
| |
|
|
-positive data from experimental studies on human beings (see, however, furtive. 3.1).
|
|
| |
|
The following shall be sufficient to classify a substance with R43 when supporting documentation is provided :
|
|
| |
|
|
-isolated cases of allergic contact dermatitis, or
|
|
| |
|
|
-epidemiological studies, where cases, systematic errors (bias) or unhandled contexts (confounders) have not been completely excluded.
|
|
| |
|
|
Supporting supporting documents may include :
|
|
| |
|
|
-data from animal testing carried out according to the applicable guidelines, with a result that does not satisfy the criteria laid down in the section on animal studies, but which are sufficiently close to the border to be considered significant, or
|
|
| |
|
|
-data from non-standardized methods, or
|
|
| |
|
|
-relevant relationships between structure and activity.
|
|
| |
|
|
|
|
| |
|
Animal studies
|
|
| |
|
As positive results from appropriate animal experiments are considered :
|
|
| |
|
|
-a response of at least 30% of the test animals if the test method of the adjuqueal type of the skin sensitisation is referred to in Annex 12 or other test methods of the adjusting type of adjuvolous type.
|
|
| |
|
|
-For all other fact-finding methods, a response to at least 15% of the test animals is considered to be positive.
|
|
| |
|
|
|
|
| |
3.2.6.3
|
Immunological contact ticeria (non-oedefect)
|
|
| |
|
Some substances and products which meet the criteria for R 42 may also cause immunological contact-aria. In such cases, information on contact turticaria should be included in the use of suitable S-phrases, usually S 24, and S 36/37, and in the supplier instructions.
|
|
| |
|
For substances and products showing signs of immunological contact-aria, but which do not meet the criteria for R42, the classification with R 43 should be considered.
|
|
| |
|
There is no such thing as a recognised animal model to identify substances that cause immunological contact-aria. The classification will, therefore, normally have to be based on documentation of people who correspond to the rules of sensitisation by skin contact (R 43).
|
|
| |
|
|
|
| |
3.2.7.
|
Carcinogens, mutagenic and toxic effects
|
|
| |
|
|
|
| |
3.2.7.1.
|
Carcinogens
|
|
| |
|
For the classification, these substances shall be divided into account, taking into account the current knowledge of three categories :
|
|
| |
|
|
|
| |
|
Carcinogenic Category 1 (category Carc1) :
|
|
| |
|
Substances known to provoke cancer in human beings. There is sufficient evidence for a causal relationship between human exposure to the substance and the development of cancer.
|
|
| |
|
|
|
| |
|
Carcinogenic Category 2 (category Carc2) :
|
|
| |
|
Substances which should be regarded as provoking cancer in human beings. There is sufficient evidence to provide strong grounds for the effect that the effects of the substance in human beings may cause cancer, generally on the basis of :
|
|
| |
|
-WHAT?
|
appropriate long-term animal testing,
|
|
| |
|
-WHAT?
|
other relevant information.
|
|
| |
|
|
|
| |
|
Carcinogenic Category 3 (category Carc3) :
|
|
| |
|
Substances which give cause for concern, as they may be able to provoke cancer in human beings, but for which there is insufficient information to carry out a satisfactory assessment. There we are. s see signs from relevant animal tests, but these are insufficient to place them in category 2.
|
|
| |
|
|
|
| |
3.2.7.1.1.
|
The following danger symbols and R-phrases shall apply :
|
|
| |
|
|
|
| |
|
Categories Carc1 and Carc2 :
|
|
| |
|
T ; R45 : May cause cancer
|
|
| |
|
For substances and products which only involve the hazards of inhalation, such as dust, ponds or smoke (whereas other influavenues such as intake or skin contact do not involve any risk to cancer), the following symbol and R-phrase should be used :
|
|
| |
|
T, R49 : Can inducer cancer by inhalation
|
|
| |
|
|
|
| |
|
Category Carc3 :
|
|
| |
|
Xn ; R40 : Possibility of carcinogenic effect
|
|
| |
|
|
|
| |
3.2.7.1.2.
|
Detailed criteria for the classification of carcinogenic substances
|
|
| |
|
The location of a substance in category Carc1 shall be carried out on the basis of epidemiological data ; the location in category Carc2 and Carc3 is based mainly on the basis of animal tests.
|
|
| |
|
For classification as a carcinogen in category Carc2, either positive results from two animal species or clearly positive effects from an animal species supported by, among other things, genotoxic data, metabolic or biochemical studies, the presence of good tumors, structural similarities with other carcinogenic substances or data from epidemiological studies, which indicate a connection.
|
|
| |
|
Category Carc3 includes two sub-categories :
|
|
| |
|
a)
|
substances which have been thoroughly investigated, but where the documentation for the tugenous effects is insufficient for classification in category 2, further attempts are not expected to produce additional information that may be relevant for : the classification.
|
|
| |
|
b)
|
substances which are not sufficiently investigated. The data that are available are inadequate, but it gives cause for concern for man. This classification is provisional ; further attempts are necessary before a final decision can be taken.
|
|
| |
|
In the case of Category Carc2 and Carc3, the following arguments are relevant, reducing the importance of experimental tumors for the possible human exposure possible. These arguments will, in particular, when combined, in most cases lead to classification category Carc3, even if the tumors have been produced in animals :
|
|
| |
|
-WHAT?
|
only the carcinogenic effects of very high dose levels exceeding the maximum tolerated dose `. The maximum tolerated dose is characterized by toxic effects which, although not reducing the life of the animal, are accompanied by physical changes, such as 10% reduced growth,
|
|
| |
|
-WHAT?
|
Tumorous occurrences, in particular at high levels of dose, which are only occurring in certain animal species in certain animal species, which are known to be particularly inclined to show comprehensive spontaneous tumoration,
|
|
| |
|
-WHAT?
|
in the case of an application site in very sensitive test systems (e.g., application under the skin or within the bughul of certain local active connections) if the particular target body is not relevant to humans ;
|
|
| |
|
-WHAT?
|
the absence of genotoxicity in short-term studies in vivo and in vitro,
|
|
| |
|
-WHAT?
|
presence of a secondary mechanism, which in practice means that there is a threshold at a certain dose level (e.g. hormonal effects in the target organs or on physiological regulatory mechanisms and chronic stimulus of the cell division),
|
|
| |
|
-WHAT?
|
presence of a species-specific tumoration mechanism (e.g. through specific metabolic mechanisms) that are not applicable to man.
|
|
| |
|
|
|
| |
|
In the case of Category Carc3 and non-classified substances, such arguments are relevant, which exclude concern for human beings :
|
|
| |
|
-WHAT?
|
A substance shall not be classified in any of the categories if the mechanism responsible for the tumoreformation during the tests is clearly identified and there is good evidence that this process cannot be extrapolated to humans.
|
|
| |
|
-WHAT?
|
If the only cryo-data that exists is the liver tumours in certain sensitive clams, without any other supporting documentation, this substance cannot be classified in any of the categories.
|
|
| |
|
-WHAT?
|
Special attention must be given to cases where the only cryo-data that exists is related to the presence of neoplasm in places and in breeds, where it is well known that they often occur spontaneously with a high frequency.
|
|
| |
|
|
|
| |
3.2.7.2.
|
Mutagenic substances
|
|
| |
|
For the classification, these substances shall be divided into account, taking into account the current knowledge of three categories :
|
|
| |
|
|
|
| |
|
Mutagen category 1 (category Mut1) :
|
|
| |
|
Substances which are known to have mutagenic effects on man.
|
|
| |
|
There is sufficient evidence of a causal link between the impact of the substance on human and heredic damage to the genetic material.
|
|
| |
|
|
|
| |
|
Mutagen Category 2 (category Mut2) :
|
|
| |
|
Substances which should be regarded as having mutagenic effects on the human person.
|
|
| |
|
There are sufficient evidence to provide strong grounds for the effect that the human exposure of the substance may result in heredial damage to the genetic material, generally on the basis of :
|
|
| |
|
-WHAT?
|
appropriate animal testing,
|
|
| |
|
-WHAT?
|
other relevant information.
|
|
| |
|
|
|
| |
|
Mutation Category 3 (category Mut3) :
|
|
| |
|
Substances which give cause for concern, as they may have mutagenic effects. Evidence is available from mutagenicity studies, but it is insufficient to place the substance into category 2.
|
|
| |
|
|
|
| |
3.2.7.2.1.
|
The following danger symbols and R-phrases shall apply :
|
|
| |
|
|
|
| |
|
Category Mut1 :
|
|
| |
|
T ; R46 : May cause heredial genetic damage
|
|
| |
|
|
|
| |
|
Category Mut2 :
|
|
| |
|
T ; R46 : May cause heredial genetic damage
|
|
| |
|
|
|
| |
|
Category Mut3 :
|
|
| |
|
Xn ; R68 : Possibility of permanent damage to health
|
|
| |
|
|
|
| |
3.2.7.2.2.
|
Detailed criteria for the classification of mutagenic substances
|
|
| |
|
|
|
| |
|
Expression Definition :
|
|
| |
|
A mutation is a permanent change in the genetic material or structure of the genetic material of an organism which results in a change in the phenotypic properties of the organism. The changes may cover a single gen, a regroup or a whole chromosome. Effects that include a single gene can be a result of effects on individual DNA bases (point mutations) or large changes, including the deletion of the gene within the gene. Effects on whole chromosomes may include structural or numerical changes. A mutation in the germ cells of organisms with gender propagation can be disinherited to the offspring. A mutagen is a substance that raises or increases the number of mutations.
|
|
| |
|
Substances shall be classified as mutagenic, with particular reference to genetic damage to heredic genetic damage. It should be noted that the kind of results that lead to the classification of substances in category Mut3 : 'the emergenation of genetic relevant events in somatic cells' is generally considered as a warning of possible carcinogenic activity.
|
|
| |
|
The development of methods for mutagenicity studies is an ongoing process. For many new methods, there are no standardised protocols and evaluation criteria. The evaluation of mutagenicity data must be considered on the quality of the conduct of the study and the extent of the validation of the method must be assessed.
|
|
| |
|
|
|
| |
|
Category Mut1 :
|
|
| |
|
In order to place a substance in category Mut1, positive evidence from epidemiological studies on human mutation is a positive one. Examples of such substances are not known to date. It is extremely difficult to obtain reliable information from studies on the effects of mutations in human populations, or whether greater mutation frequency may be increased.
|
|
| |
|
|
|
| |
|
Category Mut2 :
|
|
| |
|
In order to place a substance in category Mut2, positive results are needed from studies showing :
|
|
| |
|
2 (a)
|
mutagenic effects,
|
|
| |
|
2 (b)
|
other cellular interactions in relation to mutagenicity in mammalian cells in vivo, or
|
|
| |
|
2 (c)
|
mutagenic effects in mammal somatic cells in vivo combined with clear evidence that the substance or the relevant metabolit reaches the holding cells.
|
|
| |
|
|
|
| |
|
For the purposes of category Mut2, the following methods are currently appropriate :
|
|
| |
|
Ad 2a)
|
In vivo mutagenicity studies on germ cells :
|
|
| |
|
|
-WHAT?
|
the method of detection of mutation within a particular locus,
|
|
| |
|
|
-WHAT?
|
method of detection of hereditary translocation,
|
|
| |
|
|
-WHAT?
|
method of detecting dominant fatso,
|
|
| |
|
These studies show, in fact, the presence of affected offspring or a defect in an embryo in development.
|
|
| |
|
by 2 b)
|
In vivo studies, which show relevant interaction with germ cells (usually DNA) :
|
|
| |
|
|
-WHAT?
|
method of detecting chromosomes, as demonstrated by cytogenic analyses, including aneidi, caused by incorrectly splitting of chromosomes ;
|
|
| |
|
|
-WHAT?
|
method of detecting sisterling exchange exchanges (SCE),
|
|
| |
|
|
-WHAT?
|
detection of non-replanting DNA-synthesis (UDS),
|
|
| |
|
|
-WHAT?
|
the method of showing (covalent) binding of the mutagen to cell-DNA
|
|
| |
|
|
-WHAT?
|
method of detecting other forms of DNA damage,
|
|
| |
|
These studies give more or less indirect evidence. Positive results from these investigations will normally be supported by positive results from in vivo mutagenicity studies on somatic cells, in mammals or in people (see no. 3, preferred methods as No 3 (a).
|
|
| |
|
by 2 c)
|
In vivo studies, which show mutagenic effects in mammals in somatic cells (see No, 3 (a), combined with two ksiko-kinetic methods or other methods which may show that the substance or the relevant metabolit reaches the holding cells.
|
|
| |
|
|
For 2 (b) and (2) (c), it may be considered to use positive results from the host-mediated studies or the detection of clear effects in in-vitro studies as supplementary documentation.
|
|
| |
|
|
|
|
| |
|
Category Mut3 :
|
|
| |
|
In order to place a substance into category Mut3, there is a need for positive results from studies showing
|
|
| |
|
3 (a)
|
mutagenic effects, or
|
|
| |
|
3 (b)
|
other cellular interactions that are relevant to mutagenicity in somatic cells in mammals in vivo.
|
|
| |
|
In particular, the latter would normally be supported by positive results from in vitromutagenicity studies.
|
|
| |
|
|
|
| |
|
For the effects of somatic cells in vivo, the following methods are currently appropriate :
|
|
| |
|
by 3 (a),
|
In vivo studies concerning mutagenicity in somatic cells
|
|
| |
|
|
-WHAT?
|
bone marrow micronucleus test or metaphased analysis ;
|
|
| |
|
|
-WHAT?
|
metaphases analysis in peripheral lymphocytes
|
|
| |
|
|
-WHAT?
|
mouse spot test (colour stains on mouse skin)
|
|
| |
|
ad 3 (b)
|
In vivo studies concerning the DNA interactions in somatic cells :
|
|
| |
|
|
-WHAT?
|
method of detecting cuttinage exchange exchanges (SCE) in somatic cells ;
|
|
| |
|
|
-WHAT?
|
method of detection of non-replanting DNA-synthesis (UDS) in somatic cells ;
|
|
| |
|
|
-WHAT?
|
the method of showing (covalent) binding of mutagen to DNA in somatic cells,
|
|
| |
|
|
-WHAT?
|
method of detecting DNA injuries, for example in the Baseline of somatic elution, in somatic cells.
|
|
| |
|
|
Substances which show only positive results in one or more in vitro mutagenicity studies should normally not be classified. However, it is highly recommended to carry out further studies with in vivo studies. In exceptional cases, for example, by a substance which shows strong reactions in several in vitro studies and in which relevant in vivo data are not available, and which also exhibit similarities with known mutagenic / carcinogens, can classification in category Mut3 are considered.
|
|
| |
|
|
|
| |
3.2.7.3.
|
Toxic to reproduction
|
|
| |
|
For the classification, these substances shall be divided into account, taking into account the current knowledge of three categories :
|
|
| |
|
|
|
| |
|
Reproductive Toxic Category 1 (category Rep1)
|
|
| |
|
Substances that are known to dephate people's reproductive abilities. There is sufficient evidence for a causal relationship between the exposure of human exposure to the substance and phoned reproductive efficiency.
|
|
| |
|
Substances known to cause damage to people's offspring. There is sufficient evidence for a causal relationship between the exposure of human exposure to the substance and subsequent damage to the offspring.
|
|
| |
|
|
|
| |
|
Reproductive Toxic Category 2 (Category Rep2)
|
|
| |
|
Substances which should be considered to prejudice the reproductive ability of humans. The existence of sufficient evidence to ensure that human exposure to the substance may lead to reproductive efficiency, in general, on the basis of :
|
|
| |
|
-WHAT?
|
clear evidence from animal testing to premediate reproductive capability without simultaneous toxic effects, or proof of abdication of reproductive ability to occur around the same dose level as other toxic effects, without being a secondary ; non-specific result of the other toxic effects ;
|
|
| |
|
-WHAT?
|
other relevant information.
|
|
| |
|
Substances which should be regarded as causing harm to offspring. There are sufficient evidence to ensure that the exposure of human exposure to the substance may result in damage to the offspring generally on the basis of :
|
|
| |
|
-WHAT?
|
clear results from appropriate animal tests, where there have been observed injuries at a dose level without at the same time significant maternel toxicity, or at a dose level, causing other toxic effects, but where the damage is done ; the offspring is not a secondary, non-specific consequence of such other toxic effects ;
|
|
| |
|
-WHAT?
|
other relevant information.
|
|
| |
|
|
|
| |
|
Reproductive Toxic Category 3 (Category Rep3)
|
|
| |
|
Substances which give rise to concern in terms of human reproductive ability , generally on the basis of :
|
|
| |
|
-WHAT?
|
results from appropriate animal tests, which provide sufficient evidence to feed strong reproductive performance in the absence of other simultaneous toxic effects or of deteriorating reproductive capacity, or at the dose level, which causes other toxic effects where the phoned reproductive ability is not a secondary, non-specific result of such other toxic effects, but where the documentation is not sufficient to place the substance in category 2 ;
|
|
| |
|
-WHAT?
|
other relevant information.
|
|
| |
|
Substances which give rise to concern about damage to human offspring in general on the basis of :
|
|
| |
|
-WHAT?
|
results from appropriate animal tests, which provide sufficient evidence to sustain a dose of damage to the offspring at a dose level without at the same time significant maternel toxicity, or at a dose level, causing other toxic levels ; effects, but where the damage to the offspring is not a secondary, non-specific result of other toxic effects, but where the documentation is not sufficient to place the substance in category 2 ;
|
|
| |
|
-WHAT?
|
other relevant information.
|
|
| |
|
|
|
| |
3.2.7.3.1.
|
The following danger symbols and R-phrases shall apply :
|
|
| |
|
|
|
| |
|
Category Rep1 :
|
|
| |
|
For substances which prejudice the reproductive ability of humans :
|
|
| |
|
T ; R60 : Can damage reproductive sleep
|
|
| |
|
For substances causing damage to offspring :
|
|
| |
|
T ; R61 : May harm the child during pregnancy
|
|
| |
|
|
|
| |
|
Category Rep2 :
|
|
| |
|
For substances which should be regarded as to prejudice the reproductive ability of humans :
|
|
| |
|
T, R60 : Can damage reproductive sleep
|
|
| |
|
For substances which should be considered to cause damage to human beings :
|
|
| |
|
T ; R61 : May harm the child during pregnancy
|
|
| |
|
|
|
| |
|
Category Rep3 :
|
|
| |
|
For substances giving rise to concern regarding the reproductive ability of humans :
|
|
| |
|
Xn ; R62 : Possibility of prejudice to reproductive function
|
|
| |
|
For substances which cause concern for the damage to human offspring :
|
|
| |
|
Xn ; R63 : Possibility of the damage to the child during pregnancy
|
|
| |
|
|
|
| |
3.2.7.3.2.
|
Detailed criteria for the classification of toxic to reproduction
|
|
| |
|
Reproductive toxicity shall include the deterioration in the reproductive function or ability of men and women and the resulting non-inheritance harmful effects of the offspring. There is the possibility of classifying two main groups : 1) the effects on the reproductive ability of men and women and of 2) damage to the offspring.
|
|
| |
|
1)
|
Effects on the reproductive ability of men and women, includes harmful effects on libido, sexual behaviour, all aspects of spermatogeneses or oogeneses or hormonal activity or physiological responses which may interfere with reproductive function, the reproductive system itself or the development of it ; fertilised eggs up to and including the implantation.
|
|
| |
|
2)
|
Damage to the offspring, in its broadest sense, all effects that interfere with the normal course of development, both within and after birth. It shall include both effects caused or show prior to the birth of an effect that is first to be expressed after birth. This includes embryo toxic / phototoxic effects such as reduced body weight, growth and development deceleration, organ toxicity, death, abortion, structural defects (teratogenic effects), functional defects, peri and postnatal defects ; and hauled postnatal mental or physical development to and including normal puberty development.
|
|
| |
|
|
The classification of chemical substances as toxic to reproduction is intended for chemical substances which have an inherent or specific property that provoke such toxic effects. Chemical substances should not be classified as toxic to reproduction if these effects only arise as a non-specific secondary consequence of other toxic effects. The chemical substances that give rise to most concern are substances which are toxic to reproduction at exposure levels, which do not cause any other signs of toxicity.
|
|
| |
|
|
The location of a chemical substance in category Rep1 for effects on reproductive performance and / or damage to the offspring shall be based on epidemiological data. The position in Category Rep2 or Rep3 is based mainly on data from animal testing. Data from in vitro studies or studies from bird eggs shall be considered as 'supporting evidence' and will only lead exceptionally to the classifications in the absence of in vivo data.
|
|
| |
|
|
As is the case for most other types of toxic effects, substances that display reproduction toxicity are suspected of having a threshold below which does not cause harmful effects. Even where significant effects are apparent during animal experiments, the meaning of human beings may be doubtful due to the doses used, for example where the effects have only shown in high doses or where there are two-ksikinetic differences ; or the application method is not applicable. These or similar reasons may cause the substance to be classified in Category Rep3 or, if any, are not at all classified.
|
|
| |
|
|
In the methods set out in Annex 12, a limit test for substances with low toxicity is specified. If a dose level of at least 1000 mg/kg at oral reproduction does not give any indication of reproduction effects, then attempts at other dose levels may be considered superfluous. If data are available from studies carried out with higher levels of dose than the above limit dose, then these data shall be evaluated together with other relevant data.
|
|
| |
|
|
Under normal circumstances, effects which are only at higher doses other than the limit doses may not necessarily be classified as reproduction toxicity.
|
|
| |
|
|
|
|
| |
|
Effects on reproductive ability
|
|
| |
|
In order to classify a substance in category Rep2 for phyphyphyphyreproduction, a clear evidence of such effects must normally be available in an animal species with supporting evidence of an effective mechanism or point of attack or chemical, similarities with other known reproductive substances or other information from humans, which may conclude that such effects are likely to occur in humans. Where there are only studies of an animal species without other relevant supporting documents, classifications in Category Rep3 may be appropriate.
|
|
| |
|
Since reproductive capability may appear as a non-specific knockdown effect of severe general toxicity or where there is serious collection, classification in Category Rep2 should be classified only if there is evidence of some degree of specific toxicity to the reproductive operation. If it has been demonstrated that reproductive efficiency in animal testing is due to dizzying parring, it will normally be necessary for the classification in Category Rep2 to have evidence of the reaction mechanism in question in order to be able to : interpret whether it is likely that any harmful effects, such as changes in the hormone balance, will also be held in people's places.
|
|
| |
|
|
|
| |
|
Development toxicity
|
|
| |
|
In order to classify a substance in category Rep2, documentation must clearly indicate harmful effects from well-organised experiments with one or more animal species. Since harmful effects during pregnancy or after birth can be caused by secondary effects of maternel toxicity, the consumption of food or water, the stress of the mother animal, the shortage of juveninal care, specific deficiencies in the feed, poor breeding conditions, adjacent infections and so on, it is important that the observed effects appear during well-organised tests and at dose levels that are not associated with significant maternel toxicity. The method of application is also important. In particular, the intraperitonic venom of localising substances may cause local damage to the uterus and its contents, and the results of such investigations may be interpreted with prudence and would normally not only be able to lead to classification.
|
|
| |
|
Classification in Category Rep3 based on similar criteria as for Category Rep2 but can be used where there are certain deficiencies in the design of the study, which may make the conclusions less convincing, or the possibility of the effects may be caused by : non-specific influences, such as general toxicity, cannot be excluded.
|
|
| |
|
Generally speaking, classification is used in Category Rep3 or no category on an ad hoc basis, where the only observed effects are minor changes in the frequency of spontaneous defects, minor changes to the frequency of commonly occurring ; any variants observed in skeletal studies or small differences noted in the assessment of post-natal developments.
|
|
| |
|
|
|
| |
|
Effects during amusing
|
|
| |
|
Substances which are classified as toxic to reproduction and which also give cause for concern as to their effects on the feeding must also be assigned to R64 (see the criteria in section 3.2.8).
|
|
| |
|
In the case of the classification, toxic effects will be exclusively as a result of exposure to the milk or toxic effects that are one ; directly the exposure of children to the substance shall not be considered as 'toxic to reproduction', unless the effects result in the inhibited development of the offspring.
|
|
| |
|
Substances which are not classified as toxic to reproduction but which cause concerns as a result of toxicity when transferred to infants under the ammex period must be marked with R64 (see criteria of 3.2.8.). This R-phrase may also be used for substances which affect the quantity or quality of the milk.
|
|
| |
|
R64 is normally used on the basis of :
|
|
| |
|
a)
|
toxicokinetic studies indicating that the substance may be present in possible toxic quantities in breast milk and / or
|
|
| |
|
b)
|
on the basis of results from one or two-generation experiments involving animals indicating harmful effects of offspring resulting from transmission by the milk ; and / or
|
|
| |
|
c)
|
on the basis of evidence from people who are indicative of a threat to infants in the framework of the ammetime.
|
|
| |
|
Substances on which it is known that they accumulate in the body, and which can then be transmitted with milk under aamation, can be assigned to R33 and R64.
|
|
| |
|
|
|
| |
3.2.8.
|
Other toxicological properties
|
|
| |
|
Substances and products classified according to section 2.2.1 to 3.2.7 or 3.3.1 to 3.3.6. or in accordance with section 4, additional R-phrases shall be assigned in accordance with the following criteria :
|
|
| |
|
|
|
| |
|
R29
|
Developer giftig gas when contact with water
|
|
| |
|
|
Substances and products which, in contact with water or damp air, develop very toxic or toxic gases in potentially dangerous quantities, such as aluminium phosphid, phosphorous phosphate.
|
|
| |
|
|
|
|
| |
|
R31
|
Developer giftig gas when contact with acid
|
|
| |
|
|
Substances and products that react with acid in the development of toxic gases in dangerous quantities, such as sodium hypochlorite, bariumpolysulphides. For substances for private use, S50 should not be mixed........ (if specified by the manufacturer)).
|
|
| |
|
|
|
|
| |
|
R32
|
Developer highly toxic gas when contact with acid
|
|
| |
|
|
Substances and products which react with acid in the development of very toxic gases in dangerous quantities, e.g. salts of hydrogen cyanide, sodium oxide. For substances for private use, S50 should not be confused......... (if specified by the manufacturer)).
|
|
| |
|
|
|
|
| |
|
R33
|
Can accumulate in the body after repeated use
|
|
| |
|
|
Substances and products likely to be accumulated in the human body and where this accumulation may cause concern, but not so much that it is justified to use R48.
|
|
| |
|
|
On products containing substances with R33, see section 3.3.7.
|
|
| |
|
|
|
|
| |
|
R64
|
Can harm children in the sucka period
|
|
| |
|
|
For substances and products which are collected by women and which may affect the breast or may be present (including metabolites) in the breast milk in sufficient quantities to be harmful to breast children.
|
|
| |
|
|
With regard to comments on the application of this R-phrase (and in certain cases R33), reference is made to section 3.2.7.3.2.
|
|
| |
|
|
On products containing substances with R64, see section 3.3.7.
|
|
| |
|
|
|
|
| |
|
R66
|
Repeated exposure may cause dry or cracked skin.
|
|
| |
|
|
For substances and products that may cause concern because the skin is dry, scales of or cracks but which do not meet the criteria for R38 and shall be assigned either on the basis of :
|
|
| |
|
|
a)
|
practical observing for normal handling and use, or
|
|
| |
|
|
b)
|
relevant evidence concerning their prefixed effects on the skin.
|
|
| |
|
|
The results from structure / activity relationships can also justify the allocation of the R66.
|
|
| |
|
|
|
|
| |
|
R67
|
Vacus can cause clockiness and dizziness.
|
|
| |
|
|
For volatile substances and products containing clear symptoms of the weakening of the central nervous system during inhalation and which are not already classified with acute inhalation toxicity (R20, R23, R26, R68/20, R39/23 or R39/26)
|
|
| |
|
|
The following documentation may be used
|
|
| |
|
|
a)
|
Data on animal testing, which shows clear signs of weakening of the central nervous system, as narcotic effects, letariangi, failing coordination (including loss of 'wealth reflex', that is, the case of 'rigidity'. the reflex that leads the animal back to the creation of a position) and ataksi, either :
|
|
| |
|
|
|
-WHAT?
|
at concentrations / exposure times of not more than 20 mg/l/4h, or,
|
|
| |
|
|
|
-WHAT?
|
where the ratio between up to 4 hours and saturated steam concentration (SVC) at 20 ºC is less than or equal to 1/10.
|
|
| |
|
|
b)
|
Practical experiences of human beings (e.g. narcosis, mortality, reduced attention, failing reflexes, vertigo coordination, vertigo) from well-documented reports under exposure conditions comparable to those specified above effects on animals.
|
|
| |
|
|
Results from structure / activity relationships can also justify the allocation of R67.
|
|
| |
|
|
Other additional R phrases are set out in 2.2.6.
|
|
| |
|
|
For products containing one or more R67 substances, see section 3.3.7.
|
|
| |
|
|
|
|
| |
3.3.
|
Classification of products based on the classification of the incoming substances (calculation methods)
|
|
| |
|
The classification of health-risk products for the calculation based on the classification of the incoming substances must be taken into account all the substances which are to be classified for health hazinas referred to in point 3.2, even if they are to : presence in the form of impurities, constituents or additives.
|
|
| |
|
Without prejudice to lower concentration limits for the classification of the hazard, however, no account shall be taken of the substances present in a product in concentrations ;
|
|
| |
|
|
|
| |
Haunting of the substance
|
Concentration
|
| |
|
gaseous gaseous
products
% vol / vol
|
others
products
% Weight / Weight
|
| |
Meget giftig
|
0,02
|
0.0.1
|
| |
Giftig
|
0,02
|
0.0.1
|
| |
Carcinogenic Category 1 and 2
|
0,02
|
0.0.1
|
| |
Mutagen Category 1 and 2
|
0,02
|
0.0.1
|
| |
Toxic Categories 1 and 2
|
0,02
|
0.0.1
|
| |
Harmful
|
0,2
|
≥ 1
|
| |
Ate
|
0,02
|
≥ 1
|
| |
Locator
|
0,2
|
≥ 1
|
| |
Sensibilising
|
0,2
|
≥ 1
|
| |
Carcinogenic Category 3
|
0,2
|
≥ 1
|
| |
Mutagen Category 3
|
0,2
|
≥ 1
|
| |
Toxic category 3
|
0,2
|
≥ 1
|
| |
|
|
|
| |
|
The concentration of a substance in a product is calculated for non-gaseous products as a percentage by weight and by gaseous products as a volume percentage.
|
|
| |
|
The calculation methods are specified in 3.3.1. to 3.3.7, as well as for gaseous products listed in 3.3.8.
|
|
| |
|
When it can be established that calculation methods, because of effects such as potensation or antagonism, lead to an under-or overvaluing of the health risks of the product, these effects must be taken into account when the product classification is. This is true that the substances which cause that effect should be classified as dangerous or not.
|
|
| |
|
|
|
| |
3.3.1.
|
Acute lethal effects
|
|
| |
|
In calculating the classification of products due to their acute lethal effects, the content substances that meet the classification criteria as highly toxic or toxic or harmful due to such effects are taken into account, cf. item 3.2.1. However, this does not apply to the content substances that are classified as harmful to R65. On the classification of products such as hazardous to health, due to their ability to induce chemical pneumonia, see the criterion for R65, item 3.2.1.3.
|
|
| |
|
|
|
| |
3.3.1.1.
|
If only such a substance, in the product, the classification of the product is shown in the following table. 8)
|
|
| |
|
The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances is set out other concentration limits.
|
|
| |
|
The product shall be assigned the hazard symbol, the indication of danger and the phrase (s) of the R (s) corresponding to the classification.
|
|
| |
|
The applicable phrase (s) of the product shall correspond to the R-statement of the substance (s) of the substance.
|
|
| |
|
|
|
| |
Classification of the substance
|
Tx with R26,
|
T with R23,
|
Xn with R20,
|
|
| |
Concentration
(weight percentage) of the substance in the product
|
R27 and / or R28
|
R24 and / or R25
|
R21 and / or R22
|
|
| |
0% ≤ konc. < 0,1%
|
|
|
|
|
| |
0,1% ≤ conc. < 1%
|
Xn with R20, R21 and / or R22
|
|
|
|
| |
1% ≤ conc. < 3%
|
T with R23, R24 and / or R25
|
|
|
|
| |
3% ≤ konc. < 7%
|
|
Xn with R20, R21 and / or R22
|
|
|
| |
7% ≤ konc. < 25%
|
Tx with R26, R27 and / or R28
|
|
|
|
| |
25% ≤ konc.
|
|
T with R23, R24 and / or R25
|
Xn with R20, R21 and / or R22
|
|
| |
|
|
|
|
|
| |
3.3.1.2.
|
If, in the product, more than one substance, classified according to section 3.2.1, the classification of the product shall be calculated according to the following criteria : the product is assigned the hazard symbol, the indication of danger and the phrase (s) of the phrase (s) corresponding to the classification of the product.
|
|
| |
|
In the case of the route of entry, R-phrases shall reflect the dangers of the product on the classification of the incoming substances. Where one or more substances are included in a concentration which in itself would lead to classification according to section 3.3.1.1, the product must be given at least R-Phrase (s) which shall correspond to the classification of this product or the classification of the substances.
|
|
| |
|
|
|
| |
3.3.1.2.1.
|
Product is classified as highly poisonous if the sum of the figures resulting from the concentration of each highly toxic substance in the product with the concentration limit for this substance for the classification as highly toxic is greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
P Tx the concentration of each highly toxic substance in the product, and
|
|
| |
|
L Tx the concentration limit for the product classification as highly toxic for each highly toxic substance in the product.
|
|
| |
|
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as highly toxic is used the following value : 8) :
|
|
| |
|
L Tx : 7%
|
|
| |
|
|
|
| |
3.3.1.2.2.
|
Product is classified as giftig if the sum of the figures resulting from the concentration of each highly toxic or toxic substance in the product with the concentration limit for this substance for the classification as toxic, is greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
P Tx and P T is the concentration of each of the toxic and toxic substances in the product, and
L TxT and L T-T the concentration limit for the classification of the product as toxic for each of the toxic and toxic substances in the product is toxic.
|
|
| |
|
Unless, for a substance in the list of hazardous substances, a different classification limit for classification is fixed as toxic is used the following values : 8) :
|
|
| |
|
L TxT : 1%
|
|
| |
|
L T-T : 25%
|
|
| |
|
|
|
| |
3.3.1.2.3.
|
Product is classified as harmful to health, if the sum of the figures resulting from the concentration of each very toxic, toxic or harmful substances-with the exception of substances awarded to the R65-in the product, with the exception of this substance for the concentration limit for this substance, the amount of the substances which have been allocated for the concentration limit for this substance shall be subject to : classification as harmful to health, is greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
P Tx , P T and P Xn the concentration of each of the toxic, toxic and harmful substances in the product is used, and
|
|
| |
|
L Tx-Xn YOU'RE NOT T-Xn and L Xn-Xn the concentration limits for the classification of the product are harmful to the health damage of each of the toxic, toxic and harmful substances, except for the R65, with the R65 substances, in the product.
|
|
| |
|
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as harmful to health is subject to the following values : 8) :
|
|
| |
|
L Tx-Xn : 0,1%
|
|
| |
|
L T-Xn : 3%
|
|
| |
|
L Xn-Xn : 25%
|
|
| |
|
|
|
| |
3.3.2.
|
Non-lethal, but irreversible damage after a single exposure.
|
|
| |
|
For the purposes of calculating the classification of products on account of their non-lethal, but irreversible effects after a single exposure, the substance is taken into consideration which meets the criteria for classification as a result of such exposure ; effects, cf. item 3.2.2.
|
|
| |
|
The classification of the product is apparent from the following schema 8) , since each substance is to be considered.
|
|
| |
|
The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances has been set at a different concentration limit.
|
|
| |
|
The product shall be assigned the symbol of danger, the indication of danger and the phrase of the R-statement corresponding to the classification. In order to specify the injections / impact, combinations of R-phrases shall be used in accordance with the requirements referred to in section 3.2.2. specified.
|
|
| |
|
|
|
| |
Classification of the substance
|
Tx with R39
|
T with R39
|
Xn with R68
|
|
| |
Concentration (weight percent) of the substance in the product
|
|
|
|
|
| |
0% ≤ konc. < 0,1%
|
|
|
|
|
| |
0,1% ≤ conc. < 1%
|
Xn with R68
|
|
|
|
| |
1% ≤ conc. < 10%
|
T with R39
|
Xn with R68
|
|
|
| |
10% ≤ konc.
|
Tx with R39
|
T with R39
|
Xn with R68
|
|
| |
|
|
|
|
|
| |
3.3.3.
|
Serious adverse effects on repeated or prolonged exposure.
|
|
| |
|
For the purposes of calculating the classification of products due to their serious adverse effects on repeated or prolonged exposure, the content substances that meet the classification criteria as a result of such effects, cf. item 3.2.3.
|
|
| |
|
The classification of the product is apparent from the following schema 8) , since each substance is to be considered.
|
|
| |
|
The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances has been set at a different concentration limit.
|
|
| |
|
The product shall be assigned the symbol of danger, the indication of danger and the phrase of the R-statement corresponding to the classification. To specify the injectable / impact method combinations of R-phrases are used in accordance with the procedure laid down in 3.2.3. specified.
|
|
| |
|
|
|
| |
Classification of the substance
|
T with R48
|
Xn with R48
|
|
| |
Concentration (weight percent) of the substance in the product
|
|
|
|
| |
0% ≤ konc. < 1%
|
|
|
|
| |
1% ≤ conc. < 10%
|
Xn with R48
|
|
|
| |
10% ≤ konc.
|
T with R48
|
Xn with R48
|
|
| |
|
|
|
| |
3.3.4.
|
Agrating and irritant effects
|
|
| |
|
For the purposes of calculating the classification of products on the basis of their corrosive and irritant effects, the content substances that meet the classification criteria as a result of such effects shall be taken into account as defined in the case of such effects, cf. item 3.2.5.
|
|
| |
|
For the classification according to calculation rules, the recommendations shall be taken into account in section 3.2.5.1, 3. point and section 3.3 for potent and antagonism.
|
|
| |
|
|
|
| |
3.3.4.1.
|
If there is only such a substance, in the product, the classification of the following table shows : 8) :
|
|
| |
|
The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances has been set at a different concentration limit.
|
|
| |
|
The product shall be assigned the symbol of danger, the indication of danger and the phrase of the R-statement corresponding to the classification.
|
|
| |
|
|
|
| |
Classification of the substance
|
C with R35
|
C with R34
|
Xi with R41
|
Xi with R36,
|
|
| |
Concentration (weight percent) of the substance in the product
|
|
|
|
R37 and / or R38
|
|
| |
0% ≤ konc. < 1%
|
|
|
|
|
|
| |
1% ≤ conc. < 5%
|
Xi with R36/38
|
|
|
|
|
| |
5% ≤ konc. < 10%
|
C with R34
|
Xi with R36/38
|
Xi with R36
|
|
|
| |
10% ≤ konc. < 20%
|
C with R35
|
C with R34
|
Xi with R41
|
|
|
| |
20% ≤ konc.
|
|
|
|
Xi with R36, R37 and / or R38
|
|
| |
|
|
|
|
|
|
| |
3.3.4.2.
|
If, in the product, more than one substance, have been classified according to section 3.2.5, the classification of the product according to the following criteria, given the danger symbol, the indication of danger and the phrase (s) of the phrase (s) corresponding to the classification.
|
|
| |
|
|
|
| |
3.3.4.2.1.
|
Product is classified as corrosive to R35, if the sum of the figures resulting from the concentration of each substance in the product that is classified as corrosive to the concentration limit for the classification as corrosive to that substance as corrosive to R35 is greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
P R35 is the concentration of each substance in the product that is classified as corrosive to R35, and
|
|
| |
|
L R35 the concentration limits for the product classification as corrosive to each substance in the product, which is classified as corrosive to R35, is the concentration limit.
|
|
| |
|
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as corrosive to R35 shall be the following value : 8) :
|
|
| |
|
L R35 : 10%
|
|
| |
|
|
|
| |
3.3.4.2.2.
|
Product is classified as corrosive to R34, if the sum of the figures resulting from the concentration of each substance in the product that is classified as corrosive to R35 or corrosive to R34 with the concentration for this substance for the classification as corrosive to R34 shall be so as corroborated ; is greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
P R35 and P R34 the concentration of each substance in the product, which is classified as corrosive to R35 and corrosive to R34, and
|
|
| |
|
L R35-R34 and L R34-R34 the concentration limit for the product classification as corrosive to R34 for each substance in the product, which is classified as corrosive to R35 and corrosive, is equivalent to R34 and corrosive.
|
|
| |
|
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as corrosive to R34 shall be used for the following values : 8) :
|
|
| |
|
L R35-R34 : 5%
|
|
| |
|
L R34-R34 : 10%
|
|
| |
|
|
|
| |
3.3.4.2.3.
|
Product is classified as irritant to R41, if the sum of the figures resulting from the concentration of each substance in the product that is classified as irritant with R41 or as corrosive, with the concentration limit for this substance for the classification as defined as " the ", irritant with R41, is greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
P R35 , P R34 and P R41 is the concentration of each substance in the product that is classified as corrosive to R35, corrosive to R34 and irritant to R41, and
|
|
| |
|
L R35-R41 , and L R34-R41 and L R41-R41 the concentration limit for the product classification as a irritant to R41 for each substance in the product, which is classified as corrosive to R35, corrosive to R34 and irritant with R41.
|
|
| |
|
Unless, for a substance in the list of dangerous substances, a different classification limit for classification as irritant with R41 is the following values : 8) :
|
|
| |
|
L R35-R41 : 5%
|
|
| |
|
L R34-R41 : 10%
|
|
| |
|
L R41-R41 : 10%
|
|
| |
|
|
|
| |
3.3.4.2.4.
|
Product is classified as irritant with R38 9) , if the sum of the figures resulting from the concentration of each substance in the product that is classified as corrosive to R35, corrosive to R34 or irritant with R38 with the concentration limit for this substance for the concentration of the substance, classification as irritant with R38, is greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
P R35 , P R34 and P R38 is the concentration of each substance in the product that is classified as corrosive to R35, corrosive to R34 and irritant with R38 and
|
|
| |
|
L R35-R38 YOU'RE NOT R34-R38 and L R38-R38 the concentration limit for the product classification as irritant with R38 for each substance in the product, which is classified as corrosive to R35, corrosive to R34 and irritant with R38. Unless, for a substance in the list of hazardous substances, a different classification limit for classification as irritant with R38 is used for the following values : 8) :
|
|
| |
|
L R35-R38 : 1%
|
|
| |
|
L R34-R38 : 5%
|
|
| |
|
L R38-R38 : 20%
|
|
| |
|
|
|
| |
3.3.4.2.5.
|
The product shall be classified as irritant to R36 if the sum of the figures resulting from the concentration of each substance in the product that is classified as irritant with R41 or irritant with R36 or as corrosive to the product ; the concentration limit for this substance for classification as irritant with R36 is greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
PR35, PR34, PR41, and PR36 are the concentration of each substance in the product that is classified as corrosive to R35, corrosive to R34, irritant with R41 and irritant with R36, and
|
|
| |
|
LR35-R36, LR34-R36, LR41-R36 and LR36-R36 are the concentration limits for the product classification as irritant with R36 for each substance classified as corrosive to R35, corrosive to R34, irritant with R41 and irritating with R36.
|
|
| |
|
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as irritant with R36 is used as the following values8) :
|
|
| |
|
LR35-R36 : 1%
|
|
| |
|
LR34-R36 : 5%
|
|
| |
|
LR41-R36 : 5%
|
|
| |
|
LR36-R36 : 20%
|
|
| |
|
|
|
| |
3.3.4.2.6.
|
The product shall be classified as irritant to R37 if the sum of the figures resulting from the concentration of each substance in the product that is classified as irritant with R37, with the applicable for this substance, the rating limit for classification as irritant with R37 is greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
PR37 is the concentration of each substance in the product that is classified as irritant with R37 and
|
|
| |
|
LR37 is the concentration limits of the product classification as irritant to R37 for each substance in the product that is classified as irritant to R37.
|
|
| |
|
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as irritant with R37 shall be used as the following value 8 (8)) :
|
|
| |
|
LR37 : 20%
|
|
| |
|
|
|
| |
3.3.4.2.7.
|
A gaseous product shall be classified as irritant with R37 if the sum of the figures resulting from the concentration of each substance in the product that is classified as corrosive to R35, corrosive to R34 or irritant with R37 is corrosive ; the concentration limit for this substance for classification as irritant with R37 shall be greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
PR35, PR34 and PR37 are the concentration of each substance in the product that is classified as corrosive to R35, corrosive to R34 and irritant with R37 and
|
|
| |
|
LR35-R37, LR34-R37 and LR37-R37 are the concentration limits for the product classification as irritant with R37 for each substance, classified as corrosive to R35, corrosive to R34 and irritant with R37. Unless, for a substance in the list of hazardous substances, a different classification limit for classification as irritant with R37 shall be used as follows :
|
|
| |
|
LR35-R37 : 0,02%
|
|
| |
|
LR34-R37 : 0,5%
|
|
| |
|
LR37-R37 : 5%
|
|
| |
|
|
|
| |
3.3.5.
|
Sensitizing effects
|
|
| |
|
For the purposes of calculating the classification of products due to their sensitizing effects, the content substances that meet the classification criteria for such effects shall be taken into account, cf. item 3.2.6. The classification of the product is apparent from the following table 8), since each substance is to be considered to be.
|
|
| |
|
The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances has been set at a different concentration limit.
|
|
| |
|
The product shall be assigned the symbol of danger, the indication of danger and the phrase of the R-statement corresponding to the classification.
|
|
| |
|
If the product is both to be classified with R42 and R43, the combination of R42/43 is used.
|
|
| |
|
|
|
| |
Classification of the substance
|
Sensitizing with R42
|
Sensitizing with R43
|
|
| |
Concentration (weight percent) of the substance in the product
|
|
|
|
| |
0% ≤ konc. < 1%
|
|
|
|
| |
1% ≤ conc.
|
Sensitizing with R42 (This hazard symbol and
-designation Xn
|
Sensitizing with R43 (hazard symbol and
-designation Xi
|
|
| |
|
|
|
|
| |
3.3.6.
|
Carcinogens, mutagenic and toxic effects
|
|
| |
|
If a chemical product contains one or more substances that meet the classification criteria as carcinogenic, mutagen or reproductive toxicity, cf. in section 3.2.7, the product has to be classified in the same way as the substance (substances), where the concentration of the substance (substances) is greater than or equal to the concentration limits of the below. 5) .
|
|
| |
|
Each substance and every property to which the substance is classified shall be considered to be.
Carcinogenic chemical products in category Carc3 shall not be marked with R40 if the R45 has already been assigned. If the product is to be allocated both R49 and R40, then both R-phrases must be specified because R40 does not take up the exposure route, while R49 applies only in case of inhalation.
Mutagenical chemical products in category Mut3 shall not be labelled with R68 if R46 has already been allocated.
Toxic chemical products in Category Rep3 must not be labelled with R63, if R61 has already been allocated.
|
|
| |
|
|
|
| |
Concentration limits for the classification of products as carcinogenic, mutagenic and toxic to reproduction :
|
|
| |
Classification of the substance
|
Concentration Limit (% weight by weight)
|
|
| |
carcinogenic, category Carc1 and Carc2
(T with R45 or R49)
|
0,1%
|
|
| |
carcinogenic, category Carc3 ;
(Xn with R40)
|
1%
|
|
| |
mutagen, category Mut1 and Mut2 ;
(T with R46)
|
0,1%
|
|
| |
mutagen, category Mut3 (Xn with R68)
|
1%
|
|
| |
reproduction toxicity, category Rep1 and Rep2 (T with R60 and / or R61)
|
0.5%
|
|
| |
reproduction toxicity, category Rep3 (Xn with R62 and / or R63)
|
5%
|
|
| |
|
|
|
| |
|
These concentration limits shall apply, except where the substance in question in the list of hazardous substances has been set at a different concentration limit for the effect in question.
The product shall be assigned the hazard symbol, the indication of danger and the phrase (s) of the R (s) corresponding to the classification.
|
|
| |
|
|
|
| |
3.3.7.
|
Other toxicological properties
|
|
| |
|
It must be assessed in accordance with the criteria set out in section 3.2.8, whether a product should be allocated to the additional R-phrases R29, R31, R32 and R66.
|
|
| |
|
For products classified in accordance with the above points 2.2.1. -3.2.7. or 3.3.1. -3.3.6 and which contain one or more substances classified with R33 or R64 the product is classified by R33, respectively R64, if the substance of the product is included in the product in a concentration of 1% or more, unless there is set a different concentration limit in the list of hazardous substances.
|
|
| |
|
|
|
| |
3.3.8.
|
Gas-mixing products (gas mixtures)
|
|
| |
|
In the case of gaseous products, the classification limits for classification other than those specified in section 3.3.1 are applicable to 3.3.6. Instead of the scheme, item 3.3.1.1. the following applies :
|
|
| |
|
|
|
| |
Classification of the substance
|
Tx with R26, R27
|
T with R23, R24
|
Xn with R20, R21
|
|
| |
Concentration (Volume Percent) of the substance in the product
|
and R28
|
and R25
|
and R22
|
|
| |
0% ≤ konc. < 0,02%
|
|
|
|
|
| |
0.02% ≤ conc. < 0,2%
|
Xn with R20, R21 and / or R22
|
|
|
|
| |
0,2% ≤ conc. < 0,5%
|
T with R23, R24 and / or R25
|
|
|
|
| |
0.5% ≤ conc. < 1%
|
|
Xn with R20, R21 and / or R22
|
|
|
| |
1% ≤ conc. < 5%
|
Tx with R26, R27 and / or R28
|
|
|
|
| |
5% ≤ konc.
|
|
T with R23, R24 and / or R25
|
Xn with R20, R21 and / or R22
|
|
| |
|
|
|
|
|
| |
|
Instead of the limits that exist in item 3.3.1.2. the following applies :
|
|
| |
|
L Tx : 1%
|
|
| |
|
L TxT : 0,2%
|
|
| |
|
L T-T : 5%
|
|
| |
|
L Tx-Xn : 0,02%
|
|
| |
|
L T-Xn : 0.5%
|
|
| |
|
L Xn-Xn : 5%
|
|
| |
|
|
|
| |
|
Instead of the scheme, section 3.3.2 shall be as follows :
|
|
| |
Classification of the substance
|
Tx with R39
|
T with R39
|
Xn with R68
|
|
| |
Concentration (Volume Percent) of the substance in the product
|
|
|
|
|
| |
0% ≤ konc. < 0,02%
|
|
|
|
|
| |
0.02% ≤ conc. < 0,2%
|
Xn with R68
|
|
|
|
| |
0,2% ≤ conc. < 0,5%
|
T with R39
|
|
|
|
| |
0.5% ≤ conc. < 1%
|
|
Xn with R68
|
|
|
| |
1% ≤ conc. < 5%
|
Tx with R39
|
|
|
|
| |
5% ≤ konc.
|
|
T with R39
|
Xn with R68
|
|
| |
|
|
|
|
|
| |
|
Instead of the scheme, item 3.3.3. the following applies :
|
|
| |
Classification of the substance
|
T with R48
|
Xn with R48
|
|
| |
Concentration (Volume Percent) of the substance in the product
|
|
|
|
| |
0% ≤ konc. < 0,5%
|
|
|
|
| |
0.5% ≤ conc. < 5%
|
Xn with R48
|
|
|
| |
5% ≤ konc.
|
T with R48
|
Xn with R48
|
|
| |
|
|
|
|
| |
|
Instead of the scheme, item 3.3.4.1. the following applies :
|
|
| |
Classification of the substance
|
C with R35
|
C with R34
|
Xi with R41
|
Xi with R36, R37
|
|
| |
Concentration (Volume Percent) of the substance in the product
|
|
|
|
and / or 38
|
|
| |
0% ≤ konc. < 0,02%
|
|
|
|
|
|
| |
0.02% ≤ conc. < 0,2%
|
Xi with R36, R37 and / or R38
|
|
|
|
|
| |
0,2% ≤ conc. < 0,5%
|
C with R34
|
|
|
|
|
| |
0.5% ≤ conc. < 1%
|
|
Xi with R36,
|
Xi with R36
|
|
|
| |
|
|
R37 and / or R38
|
|
|
|
| |
1% ≤ conc. < 5%
|
|
|
|
Xi with R36,
|
|
| |
5% ≤ konc.
|
C with R35
|
C with R34
|
Xi with R41
|
R37 and / or R38
|
|
| |
|
|
|
|
|
|
| |
|
Instead of the limits that exist in item 3.3.4.2. the following applies :
|
|
| |
|
L R35 : 1%
|
|
| |
|
L R35-R34 : 0,2%
|
|
| |
|
L R34-R34 : 5%
|
|
| |
|
L R35-R41 : 0,2%
|
|
| |
|
L R34-R41 : 5%
|
|
| |
|
L R41-R41 : 5%
|
|
| |
|
L R35-R38 : 0,02%
|
|
| |
|
L R34-R38 : 0.5%
|
|
| |
|
L R38-R38 : 5%
|
|
| |
|
L R35-R36 : 0,02%
|
|
| |
|
L R34-R36 : 0.5%
|
|
| |
|
L R41-R36 : 0.5%
|
|
| |
|
L R36-R36 : 5%
|
|
| |
|
L R37 : 5%
|
|
| |
|
|
|
| |
|
Instead of the scheme, section 3.3.5. the following applies :
|
|
| |
|
|
|
| |
Classification of the substance
|
Sensitizing with R42
|
Sensitizing with R43
|
|
| |
Concentration (Volume Percent) of the substance in the product
|
|
|
|
| |
0% ≤ konc. < 0,2%
|
|
|
|
| |
0,2% ≤ conc.
|
Sensitizing with R42 (This hazard symbol and description Xn)
|
Sensitizing with R43 (hazard symbol and description Xi)
|
|
| |
|
|
|
|
| |
|
Instead of the scheme, section 3.3.6 shall be as follows :
|
|
| |
|
|
|
| |
Classification of the substance
|
Concentration Limit (Volume Percent)
|
|
| |
carcinogenic, category Carc1 and Carc2
(T with R45 or R49)
|
0,1%
|
|
| |
carcinogenic, category Carc3 ;
(Xn with R40)
|
1%
|
|
| |
mutagen, category Mut1 and Mut2 ;
(T with R46)
|
0,1%
|
|
| |
mutagen, category Mut3
(Xn with R68)
|
1%
|
|
| |
reproduction toxicity, category Rep1 and Rep2 ;
(T with R60 and / or R61)
|
0.2%
|
|
| |
reproduction toxicity, category Rep3
(Xn with R62 and / or R63)
|
1%
|
|
| |
|
|
|
| |
4.
|
CLASSIFICATION FOR ENVIRONMENTAL EFFECTS
|
|
| |
|
|
|
| |
4.1.
|
Introduction
|
|
| |
|
The main purpose of classifying substances dangerous to the environment is to warn the user against the dangers that these substances pose to the ecosystems. The current criteria are mainly referring to the aquatic environment, but some substances may at the same time or, instead, have effects on other ecosystems with populations that can extend from the soil microphases of the soil and microfauna to mammals. The criteria set out below shall be followed directly by Commission Regulation (EC) No 2. 440/2008 of 30. May 2008 laying down experimental methods in accordance with Regulation (EC) No 2 of the European Parliament and of the Council. 1907/2006 on the registration, assessment and approval, as well as restrictions on chemicals (REACH), to the extent that they have been mentioned. The test methods for the base set referred to in Annexes VII and VIII to Regulation (EC) No (EC) No 1907/2006 is limited, and the information from here may be insufficient for the appropriate classification. A classification may require additional data on the basis of Annexes IX and X to Regulation (EC) No 2. 1907/2006 or other similar studies. Classifications may also be re-examined in the light of new knowledge.
|
|
| |
|
For the purposes of classification, the criteria on the basis of the present knowledge in two groups shall be either after the acute and / or long-term effects of the substances in the aquatic environment or the acute and / or long-term effects of the substances in other ecosystems.
|
|
| |
|
Substances shall be classified on the basis of the fact-finding data available in accordance with the criteria referred to in 4.2.
|
|
| |
|
For products, classification shall be classified as follows :
|
|
| |
|
For acute aquatic toxicity :
|
|
| |
|
a)
|
on the basis of the classification of the incoming substances, by using the calculation methods in Point 4.3.
|
|
| |
|
b)
|
according to the criteria referred to in 4.2. The properties are determined by means of the methods set out in Annex 12 with less for plant protection products other internationally accepted methods are acceptable in accordance with the publication of the control measures laid down in Annex 5.1. At the same time, for plant protection products, the test requirements must comply with Annex 5.1. in the fight against the mean publication.
|
|
| |
|
If a toxicological property is determined both from the rules of a (a) and (b), the results of point (b) shall be used for the classification of the product, with the exception of undesirable long-term effects and hazards for the ozone layer, where the calculation methods laid down in Point 4.3 must be taken ; used.
|
|
| |
|
Where the methods of paragraph (b) apply, the quality criteria for the methods set out in Annex 12 must be complied with The samples must also be carried out on all three species groups in accordance with the criteria referred to in 4.2. (algae, daphnia and fish), unless the product has been assigned the highest peril of exposure to the aquatic environment after testing on one of the species, or a result of the test already existed before this notice ; entered into force unless special rules are applied to plant protection products.
|
|
| |
|
If one or more dangerous environmental properties of a product of known composition are evaluated based on fact-finding data, other than plant protection products must take a new evaluation, either based on the examination data or by using the calculation method in the following cases :
|
|
| |
|
1. If changes are made to the composition of the product by replacing or inserting one or more substances, whether these substances are to be classified as dangerous or not,
|
|
| |
|
2. the concentration of one of the substances classified as classified for the environment is changed. However, a new assessment does not need to be re-evaluated if the concentration of the concentration does not exceed the following limits :
|
|
| |
|
|
|
| |
Interval of the initial concentration of the substance
|
Allowed variation in the initial concentration of the substance (as a percentage of the initial concentration)
|
|
| |
2.2.5%,
|
± 30%
|
|
| |
> 2.510%, 10%
|
± 20%
|
|
| |
> 10 25%
|
± 10%
|
|
| |
> 25 100% 100%
|
± 5%
|
|
| |
|
|
|
| |
|
The new assessment shall be valid unless there are scientific reasons to assume that a review of the danger is not going to result in a change of classification.
|
|
| |
|
|
|
| |
4.2.
|
Criteria for classification based on survey data
|
|
| |
|
|
|
| |
4.2.1.
|
Aquatic environment
|
|
| |
|
|
|
| |
4.2.1.1.
|
Substances shall be classified as dangerous for the environment and assigned the symbol " N ", the indication of danger as " dangerous to the environment " as well as R-phrases according to the following criteria :
|
|
| |
|
|
|
| |
4.2.1.1.1.
|
Both the following R phrases :
|
|
| |
|
|
|
| |
|
R50 Very toxic to organisms living in water
|
|
| |
|
and
|
|
| |
|
R53 May cause undesirable long-term effects in the aquatic environment
|
|
| |
|
Acute Toxicity :
|
|
| |
|
96 hours LC 50 (for fish) ≤ 1 mg/l or
|
|
| |
|
48 Hours EC 50 (for Daphnia) ≤ l / l or
|
|
| |
|
72 hours EC 50 (foralgae) ≤ 1 mg/l,
|
|
| |
|
and
|
|
| |
|
the substance is not readily biodegradable or log P ow. (log octanol / water partition coefficient), 3,0 (unless the experimental bioconcentration factor (BCF) ≤ 100) is not used.
|
|
| |
|
|
|
| |
4.2.1.1.2.
|
Both of the following R phrases
|
|
| |
|
|
|
| |
|
R51 Toxic to organisms living in water
|
|
| |
|
and
|
|
| |
|
R53 May cause undesirable long-term effects in the aquatic environment
|
|
| |
|
Acute Toxicity :
|
|
| |
|
96 hours LC 50 (for fish) 1 mg/l < LC 50 ≤ 10 mg/l or
|
|
| |
|
48 Hours EC 50 (for Daphnia) I mg/1 < EC 50 ≤ 10 mg/l or
|
|
| |
|
72 hours EC 50 (for algae) l mg / l < IC 50 ≤ 10 mg/l
|
|
| |
|
and
|
|
| |
|
the substance is not readily biodegradable or log P ow. (log octanol / water partition coefficient), 3,0 (unless the experimental bioconcentration factor (BCF) ≤ 100) is not used.
|
|
| |
|
|
|
| |
4.2.1.1.3.
|
Substances and products are classified as dangerous to the environment and assigned the symbol " N ", the indication of danger as " dangerous goods " and the R-sentence according to the following criteria :
|
|
| |
|
|
|
| |
|
R50 Very toxic to organisms living in water
|
|
| |
|
Acute Toxicity :
|
|
| |
|
96 hours LC 50 (for fish) ≤ 1 mg/l or
|
|
| |
|
48 Hours EC 50 (for dnia) ≤ l mg/1 or
|
|
| |
|
72 hours EC 50 (for algae) ≤ l mg/l,
|
|
| |
|
|
|
| |
4.2.1.2.
|
Substances shall also be classified as environmentally hazardous and assigned R-phrases according to the following criteria :
|
|
| |
|
|
|
| |
4.2.1.2.1.
|
Both of the following R phrases
|
|
| |
|
|
|
| |
|
R52 Harmful for organisms living in water
|
|
| |
|
and
|
|
| |
|
R53 May cause undesirable long-term effects in the aquatic environment
|
|
| |
|
Acute Toxicity :
|
|
| |
|
96 hours LC 50 (for fish) 10 mg/l < LC 50 ≤ 100 mg/l or
|
|
| |
|
48 Hours EC 50 (for daphnia) l0 mg/1 < EC 50 ≤ 100 mg/l or
|
|
| |
|
72 hours EC 50 (for algae) l0 mg/l < IC 50 ≤ 100 mg/l
|
|
| |
|
and
|
|
| |
|
the substance is not readily biodegradable.
|
|
| |
|
|
|
| |
|
This criterion shall apply unless there is sufficient scientific evidence of the degradation and / or toxicity of the substance to with reasonable certainty that neither the substance nor its degradation products constitute any potential ; long-term and / or delayed environmental haz-risk.
|
|
| |
|
Such additional scientific evidence should normally be based on studies required in accordance with Annex IX to Regulation (EC) No 2 of the European Parliament and of the Council. 1907/2006 on the registration, assessment and approval of and restrictions on chemicals (REACH) or studies of equivalent value and could include :
|
|
| |
|
i)
|
a proven possibility of rapid decomposition in the aquatic environment ;
|
|
| |
|
(ii)
|
lack of chronic toxic effects at a concentration of 1,0 mg/l, e.g. no observed effect at concentrations of 1,0 mg/l determined by prolonged toxicity study with fish or daphnia.
|
|
| |
|
|
|
| |
4.2.1.2.2.
|
R53 May cause undesirable long-term effects in the aquatic environment
|
|
| |
|
Substances which do not fall within the criteria referred to in points 4.2.1.1 and 4.2.1.2, but which, on the basis of the evidence available for their persistence, accumulation potential and their foreseen or observed fate and behaviour in the environment, may, however, constitute an immediate or long-term and / or delayed hazard of the structure and / or function of the ecosystem systems.
|
|
| |
|
For example, substances with low water solubility, d.v.s. substances with a solubility of less than 1 mg/l shall be subject to this criterion if :
|
|
| |
|
a)
|
they are not easily degradable and
|
|
| |
|
b)
|
log P ow. (log octanol / water partition coefficient), 3,0 (unless the experimental bioconcentration factor (BCF) ≤ 100) is not used.
|
|
| |
|
This criterion shall apply unless there is sufficient scientific evidence of the degradation and / or toxicity of the substance to with reasonable certainty that neither the substance nor its degradation products constitute any potential ; long-term and / or delayed environmental haz-risk.
|
|
| |
|
Such additional scientific evidence should normally be based on studies required in accordance with Annex IX to Regulation (EC) No 2 of the European Parliament and of the Council. 1907/2006 on the registration, assessment and approval of and restrictions on chemicals (REACH) or studies of equivalent value and could include :
|
|
| |
|
i)
|
a proven possibility of rapid decomposition in the aquatic environment ;
|
|
| |
|
(ii)
|
lack of chronic toxic effects at a concentration of 1,0 mg/l, e.g. no observed effect at concentrations of 1,0 mg/l determined by prolonged toxicity study with fish or daphnia.
|
|
| |
|
|
|
| |
4.2.1.3.
|
Substances and products are also classified as dangerous for the environment and assigned the R-statement according to the following criteria :
|
|
| |
|
|
|
| |
|
R52 Harmful for organisms living in water
|
|
| |
|
Substances which do not fall within the criteria referred to in points 4.2.1.1 and 4.2.1.2, and products not to be classified as highly toxic or toxic to the aquatic environment, but which on the basis of the evidence available for their toxicity, may nevertheless constitute a hazard to the structure and / or function of the water ecosystem.
|
|
| |
|
|
|
| |
4.2.1.4.
|
For the purpose of applying the criteria set out in Section 4.2.1.1 to 4.2.1.3 :
|
|
| |
|
Where it is demonstrated in the case of highly coloured substances or products, that the algeal growth is prevented solely from limited lymph intensity, the classification base should not be 72 hours of EC ; 50 algae.
|
|
| |
|
Substances shall be deemed to be readily degradable where the following criteria are met :
|
|
| |
|
a)
|
If biodegradability studies more than 28 days are obtained, the following degradation levels are obtained :
|
|
| |
|
|
-in studies based on dissolved carbon : 70%,
|
|
| |
|
|
-in studies based on oxygenre consumption or production of carbon dioxide : 60% of the theoretical maximum.
|
|
| |
|
These biodegradation levels shall be attained within 10 days from the start of decomposition, at which time is calculated at the time 10% of the substance has been broken ; or
|
|
| |
|
b)
|
Provided only COD or BOD is available ; 5 -data when the BOD/COD ratio is greater than or equal to 0,5, or
|
|
| |
|
c)
|
In the case of other compelling scientific evidence that the substance can be degraded (biodegradability and / or otherwise) in the aquatic environment to a level of over 70% over a period of 28 days.
|
|
| |
|
|
|
| |
4.2.2.
|
Other ecosystems other than the aquatic environment
|
|
| |
|
|
|
| |
4.2.2.1.
|
Substances shall be classified as dangerous for the environment and assigned the symbol " N ", the indication of danger as " dangerous to the environment ", and at least one of the following R phrases according to the following criteria :
|
|
| |
|
|
|
| |
|
R54 Toxic to plants
|
|
| |
|
|
|
| |
|
R55 Toxic to animals
|
|
| |
|
|
|
| |
|
R56 Toxic to grounders in soil
|
|
| |
|
|
|
| |
|
R57 Toxic to bees
|
|
| |
|
|
|
| |
|
R58 May cause undesirable long-term effects in the environment
|
|
| |
|
Substances which, on the basis of the present evidence of their properties, persistence, accumulation potential and their foreseen or observed fate and behaviour in the environment, may constitute an immediate or long-term and / or delayed danger ; the structure and / or function of other natural ecosystems other than those covered by point 4.2.1. (Whether or not these substances are classified according to 4.2.1). Detailed criteria will be drawn up later.
|
|
| |
|
|
|
| |
4.2.2.1
|
The ozone layer
|
|
| |
|
Substances shall be classified as dangerous for the environment and assigned the symbol " N ", the indication of danger as " Dangerous Dangerous ' and R-phrases according to the following criteria :
|
|
| |
|
|
|
| |
|
R59 Dangerous for the ozone layer
|
|
| |
|
Substances which, on the basis of the present evidence of their properties and their foreseen or observed fate and behaviour in the environment, may constitute a danger to the structure and / or function of the ozone layer in the stratosphere. This includes substances listed in Annex I of Council Regulation (EC) No 2. 2037/2000 on substances that deplet the ozone layer (FT-L 244 of 29.9.2000, p. 1) with subsequent amendments.
|
|
| |
4.3.
|
Classification of products based on the classification of the incoming substances (the calculation method)
|
|
| |
|
For the classification of environmental haz-risk products, account must be taken of all the content substances which are to be classified for environmental risk in accordance with point 4.2, even if they are present in the the form of impurities, constituents or additives.
|
|
| |
|
Without prejudice to lower concentration limits for the classification of the hazard, however, no account shall be taken of the substances present in a product in concentrations ;
|
|
| |
|
|
|
| |
Haunting of the substance
|
Concentration
|
|
| |
|
Gasformige% vol ./vol.
|
Other% Weight / Weight
|
|
| |
Dangerous, N
|
|
0,1%
|
|
| |
Dangerous, ozone
|
0,1%
|
0,1%
|
|
| |
Environmental Dangerous
|
|
1%
|
|
| |
|
|
|
| |
|
The calculation methods are specified in 4.3.1 to 4.3.5.1.
|
|
| |
|
|
|
| |
4.3.1.
|
Acute toxicity and adverse long-term effects on the aquatic environment
|
|
| |
|
For the purposes of calculating the classification of products, due to their acute toxicity and long-term adverse effects on the aquatic environment, the content substances which meet the criteria for the classification of such effects shall be taken into consideration.
|
|
| |
|
|
|
| |
4.3.1.1.
|
If only one such substance in the product, the classification of the product is shown in the following table.
|
|
| |
|
The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances is set out other concentration limits.
|
|
| |
|
The product shall be assigned the hazard symbol, the indication of danger and the phrase (s) of the R (s) corresponding to the classification.
|
|
| |
Classification of the substance
|
N with R51/53
|
R52/53
|
|
| |
Concentration
(weight percentage)
the substance of the product,
|
|
|
|
| |
0% ≤ konc. < 2,5%
|
|
|
|
| |
2,5 %≤ konc. < 25%
|
R52/53
|
|
|
| |
25% ≤ konc.
|
N with R51/53
|
R52/53
|
|
| |
|
|
|
| |
4.3.1.2.
|
If only one such substance classified as N with R50/53 of the product, is shown in the classification of the product by the following schema.
Concentration limits (C n () in the scheme, except where the substance in the list of hazardous substances in the list is specified, other concentration limits have been set. For products containing a LC 50 -value or EC 50 -value less than 0,00001 mg/l, the concentration limits are calculated in a similar manner (at a factor of 10 intervals).
The product shall be assigned the hazard symbol, the indication of danger and the phrase (s) of the R (s) corresponding to the classification.
|
|
| |
|
|
|
|
LC 50 -or EC 50 -value
|
Classification of the product
|
|
|
(L (E) C 50 () for substance classified
|
N, R50/53
|
N, R51/53
|
R52/53
|
|
|
as N, R50/53 (mg/l)
|
|
|
|
|
|
0.1 < L (E) C 50 ≤ 1
|
C n 250%
|
2,5% ≤ C n < 25%
|
0.25% ≤ C n < 2,5%
|
|
|
0,01 < L (E) C 50 ≤ 0,1
|
C n 2,5%
|
0.25% ≤ C n < 2,5%
|
0.025% ≤ C n < 0,25%
|
|
|
0,001 < L (E) C 50 ≤ 0,01
|
C n ECU 0.25%
|
0.025% ≤ C n < 0,25%
|
0.0025% ≤ C n < 0,025%
|
|
|
0,0001 < L (E) C 50 ≤ 0,001
|
C n ECU 0.025%
|
0.0025% ≤ C n < 0,025%
|
0,00025% ≤ C n < 0,0025%
|
|
|
0.00001 < L (E) C 50 ≤ 0,0001
|
C n ECU 0.0025%
|
0,00025% ≤ C n < 0,0025%
|
0.000025% ≤ C n < 0,00025%
|
|
| |
|
|
|
| |
4.3.1.3.
|
If, in the product, more than one substance where the product is classified according to section 4.2, the classification of the product shall be calculated according to the following criteria, given the danger symbol, the indication of danger and the phrase (s) which correspond to the classification of the product.
|
|
| |
|
|
|
| |
4.3.1.3.1.
|
The product shall be classified as dangerous for the environment, with the danger symbol N and R50/53 if the sum of the figures resulting from the concentration of each N, R50/53 substance in the product with the concentration limit laid down for this substance for the classification as defined as : environmental hazard with N, R50/53 is greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
P N, R50/53 the concentration of each substance in the product with N, R50/53, and L, N, R50/53 the concentration limit for classification as environmentally hazardous to N, R50/53 for each such substance in the product.
|
|
| |
|
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as environmentally hazardous to N, R50/53 is the following value :
|
|
| |
|
L N, R50/53 : the concentration limit which, on the basis of the LC of the substance, is : 50 -or EC 50 -classification as N, R50/53 is set out in Section 4.3.1.2.
|
|
| |
|
|
|
| |
4.3.1.3.2.
|
The product is classified as environmentally hazardous to N, R51/53, if the sum of the figures resulting from the concentration of each N, R50/53 or N, R51/53 substances in the product with the concentration limit for the classification as defined for this substance, N, R51/53, is greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
P N, R50/53 and P N, R51/53 the concentration of each of N, R50/53 and N, R51/53 substances in the product, and
|
|
| |
|
L N, R50/53-N, R51/53 and L N, R51/53-N, R51/53 the concentration limits for the classification of the product as environmentally hazardous to N, R51 for each substance in the product, classified as environmental hazardous to N, R50/53 and N, R51/53 shall be classified as respectively.
|
|
| |
|
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as environmentally hazardous to N, R51/53 is the following :
|
|
| |
|
L N, R50/53-N, R51/53 : the concentration limit which, on the basis of the LC of the substance, is : 50 -or EC 50 -classification as N, R51/53 is set out in Section 4.3.1.2.
|
|
| |
|
L N, R51/53-N, R51/53 : 25%
|
|
| |
|
|
|
| |
4.3.1.3.3.
|
The product shall be classified as environmentally hazardous to R52/53 if the sum of the figures resulting from the concentration of each N, R5 0 / 53, N, R51/53 or R52/53 substances in the product with the concentration limit for the classification of this substance for the classification of the product on the substance, as R52/53, greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
P N, R50/53 , P N, R51/53 and P R52/53 the concentration of each of N, R5 0 / 53, N, R51/53 and R52/53 substances in the product, and
|
|
| |
|
L N, R50/53-R52/53 YOU'RE NOT N, R51/53R52/53 and L R52/53R52/53 the concentration limits for classification as environmentally hazardous to R52/53 for each substance in the product, classified as environmentally hazardous to N, R5 0 / 53, N, R51/53 and R52/53 shall be classified.
|
|
| |
|
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as environmentally hazardous to R52/53 is used as the following value :
|
|
| |
|
L N, R50/53-R52/53 : the concentration limit which, on the basis of the LC of the substance, is : 50 -or EC 50 -the classification as R52/53 is set out in Section 4.3.1.2.
|
|
| |
|
L N, R51/53R52/53 : 2,5%
|
|
| |
|
L R52/53R52/53 : 25%
|
|
| |
|
|
|
| |
4.3.2.
|
Acute aquatic toxicity
|
|
| |
|
For the purposes of calculating the classification of products, due to their acute toxicity to the aquatic environment, the content substances that meet the classification criteria as a result of such effects shall be taken into account.
|
|
| |
|
|
|
| |
4.3.2.1.
|
If only one such substance classified as N with R50 in the product, classifies the classification of the product by the following schema.
Concentration limits (C n () in the scheme, except where the substance in the list of hazardous substances in the list is specified, other concentration limits have been set. For products containing a LC 50 -value or EC 50 -value less than 0,00001 mg/l, the concentration limits are calculated in a similar manner (at a factor of 10 intervals).
The product shall be assigned the hazard symbol, the indication of danger and the phrase (s) of the R (s) corresponding to the classification.
|
|
| |
|
|
|
| |
|
LC 50 -or EC 50 -value (L (E) C 50 () for substance classified as N, R50 (mg/l),
|
Classification of the product N, R50
|
|
| |
|
0.1 < L (E) C 50 ≤ 1
|
C n 250%
|
|
| |
|
0,01 < L (E) C 50 ≤ 0,1
|
C n 2,5%
|
|
| |
|
0,001 < L (E) C 50 ≤ 0,01
|
C n ECU 0.25%
|
|
| |
|
0,0001 < L (E) C 50 ≤ 0,001
|
C n ECU 0.025%
|
|
| |
|
0.00001 < L (E) C 50 ≤ 0,0001
|
C n ECU 0.0025%
|
|
| |
|
|
|
| |
4.3.2.2.
|
If only one such substance classified as R52 in the product, the following table shows the classification of the product of the following table. The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances is set out other concentration limits.
The product shall be assigned the hazard symbol, the indication of danger and the phrase (s) of the R (s) corresponding to the classification.
|
|
| |
|
|
|
| |
|
Classification of the substance
|
R52
|
|
|
| |
|
Concentration
(weight percentage)
the substance of the product,
|
|
|
|
| |
|
0% ≤ konc. < 25%
|
|
|
|
| |
|
25% ≤ konc.
|
R52
|
|
|
| |
|
|
|
| |
4.3.2.3.
|
If, in the product, more than one substance where the product is classified according to section 4.2, the classification of the product shall be calculated according to the following criteria, given the danger symbol, the indication of danger and the phrase (s) which correspond to the classification of the product.
|
|
| |
|
|
|
| |
4.3.2.3.1.
|
The product shall be classified as dangerous for the environment at the risk symbol N and R50 if the sum of the figures resulting from the concentration of each N, the R50 substance in the product with the concentration limit for the classification as defined for this substance, shall be classified as : environmental hazard with N, R50, is greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
P N, R50 is the concentration of each substance in the product with N, R50, and
|
|
| |
|
L N, R50 the concentration limit for the product classification as environmentally hazardous to N, R50 for each such substance in the product.
|
|
| |
|
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as environmentally hazardous to N, R50 is the following value :
|
|
| |
|
L N, R50 : the concentration limit which, on the basis of the LC of the substance, is : 50 -or EC 50 -classification as N, R50 has been set under point 4.3.2.1.
|
|
| |
|
|
|
| |
4.3.2.3.2.
|
The product shall be classified as environmentally hazardous with N, R50 if the sum of the figures resulting from the concentration of each N, R50 or N, R50/53 substance in the product with the concentration limit for the classification as defined for this substance for the classification as such environmental hazard with N, R50, is greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
P N, R50 and P N, R50/53 the concentration of each of N, R50 and N, R50/53 substances in the product, and
|
|
| |
|
L N, R50-N, R50 and L N, R50/53-N, R50 the concentration limits for the classification of the product as environmentally hazardous to N, R50 for each substance in the product, classified as environmentally hazardous to R50 and environmentally hazardous with R50/53 shall be classified as appropriate.
|
|
| |
|
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as environmentally hazardous to N, R50 is the following value :
|
|
| |
|
L N, R50-N, R50 : the concentration limit which, on the basis of the LC of the substance, is : 50 -or EC 50 -classification as N, R50 has been set under point 4.3.2.1.
|
|
| |
|
L N, R50/53-N, R50 : the concentration limit which, on the basis of the LC of the substance, is : 50 -or EC 50 -classification as N, R50 is determined under item 4.3.1.2.
|
|
| |
|
|
|
| |
4.3.2.3.3.
|
The product shall be classified as environmentally hazardous to R52 if the sum of the figures resulting from the concentration of each substance in the product that is classified with R52 with the concentration limit for the classification as defined in the product, Environmental Dangerous with R52 is greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
P R52 the concentration of each substance in the product that is classified as environmentally hazardous to R52 and
|
|
| |
|
L R52 the concentration limits for the classification of the product as environmentally hazardous to R52 for each substance in the product classified as environmentally hazardous to R52 is classified.
|
|
| |
|
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as environmentally hazardous to R52 is the following value :
|
|
| |
|
L R52 : 25%
|
|
| |
|
|
|
| |
4.3.3.
|
Unwanted long-term effects in the aquatic environment
|
|
| |
|
In calculating the classification of products because of their long-term adverse effects in the aquatic environment, the content substances which meet the criteria for classification due to such effects are taken into consideration.
|
|
| |
|
|
|
| |
4.3.3.1.
|
If there is only such a substance, the classification of the following table shall be shown in the product.
|
|
| |
|
The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances is set out other concentration limits.
|
|
| |
|
The product shall be assigned the hazard symbol, the indication of danger and the phrase (s) of the R (s) corresponding to the classification.
|
|
| |
|
|
|
| |
Classification of the substance
|
R53
|
|
| |
Concentration (weight percent) of the substance in the product
|
|
|
| |
0% ≤ konc. < 25%
|
|
|
| |
25% ≤ konc.
|
R53
|
|
| |
|
|
|
| |
4.3.3.2.
|
If, in the product, more than one substance which is classified according to section 4.2.1, the classification of the product shall be calculated according to the following criteria : the product is assigned the hazard symbol, the indication of danger and the phrase (s) of the phrase (s) corresponding to the classification of the product.
|
|
| |
|
|
|
| |
4.3.3.3.
|
The product shall be classified as environmentally hazardous to R53 if the sum of the figures resulting from the concentration of each substance in the product that is classified with R53 with the concentration limit for the classification as defined for this substance, environmental hazard with R53 is greater than or equal to 1, i.e. :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
|
|
| |
|
P R53 the concentration of each substance in the product that is classified as environmentally hazardous to R53 and
|
|
| |
|
L R53 the concentration limit for the classification of the product as environmentally hazardous to R53 for each substance in the product, classified as environmentally hazardous to R53.
|
|
| |
|
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as environmentally hazardous to R53 is used as the following value :
|
|
| |
|
L R53 : 25%
|
|
| |
|
|
|
| |
4.3.3.4.
|
The product shall be classified as environmentally hazardous to R53 if the sum of the figures resulting from the concentration of each substance in the product, classified as R53, N, R50/53, N, R51/53 or R52/53 with the applicable for this substance for this substance, the classification limit for classification as R52/53 is greater than or equal to 1, in other words :
|
|
| |
|
|
|
| |
|
|
|
| |
|
|
|
| |
|
where
P R53 , P N, R50/53 , P N, R51/53 and P R52/53 is the concentration of each substance in the product that is classified as respectively R53, N, R50/53, N, R51/53 and R52/53 and
|
|
| |
|
L R53-R53 YOU'RE NOT N, R50/53-R53 YOU'RE NOT N, R51/53-R53 and L R52/53-R53 the concentration limits for the classification of the product as environmentally hazardous to R53 for each substance in the product, classified as environmentally hazardous to R53, N, R50/53, N, R51/53 and R52/53 shall be classified as " dangerous " for each substance.
|
|
| |
|
Unless, for a substance in the list of hazardous substances, a different classification limit for classification as dangerous to the environment is dangerous with R53 is the following value :
|
|
| |
|
L R53-R53 : 25%
|
|
| |
|
L N, R50/53-R53 : 25%
|
|
| |
|
L N, R51/53-R53 : 25%
|
|
| |
|
L R52/53-R53 : 25%
|
|
| |
|
|
|
| |
4.3.4.
|
Other ecosystems other than the aquatic environment
|
|
| |
|
The terrestrial environment
|
|
| |
|
Classification of products using the following risk phrases shall be carried out when detailed criteria for the use of these sentences have been drawn up.
|
|
| |
|
|
|
| |
|
R54 Toxic to plants
|
|
| |
|
|
|
| |
|
R55 Toxic to animals
|
|
| |
|
|
|
| |
|
R56 Toxic to grounders in soil
|
|
| |
|
|
|
| |
|
R57 Toxic to bees
|
|
| |
|
|
|
| |
|
R58 May cause undesirable long-term effects in the environment
|
|
| |
|
|
|
| |
4.3.5.
|
The ozone layer
|
|
| |
|
For the purposes of calculating the classification of products on account of their dangerous effect on the ozone layer, the content substances that meet the classification criteria as a result of such effects shall be taken into account in the ozone layer, cf. item 4.2.2.1.
|
|
| |
|
|
|
| |
4.3.5.1.
|
If at least one such substance is included in the product, the classification of the following table shall be classified.
|
|
| |
|
The concentration limits of the scheme shall apply unless the substance of the substance in question in the list of hazardous substances is set out other concentration limits.
|
|
| |
|
The product shall be assigned the hazard symbol, the indication of danger and the phrase (s) of the R (s) corresponding to the classification.
|
|
| |
|
|
|
| |
Classification of the substance
|
N with R59
|
|
| |
Concentration (weight percent) of the substance in the product
|
|
|
| |
0.0.1%
|
N, R59
|
|
| |
|
|
|
| |
5.
|
VALG OF SIKKERHEDSSARY (S-phrases)
|
|
| |
|
|
|
| |
|
Safety phrases (S-phrases) must be allocated to substances and products in accordance with the following general criteria. In the case of certain products, the safety requirements set out in Annex 2 are also mandatory.
|
|
| |
|
In all parts of paragraph 5 where the word manufacturer is mentioned, the manufacturer or importer who is responsible for the placing on the market of the substance or the product is believed to be the manufacturer or the product.
|
|
| |
|
|
|
|
| |
|
S1
|
Store under lock
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
very toxic, toxic and corrosive substances and products ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for very toxic, toxic and corrosive substances and products if they are sold for private use.
|
|
| |
|
|
|
|
| |
|
S2
|
Keep out of reach of children
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
all dangerous substances and products,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for all dangerous substances and products where they are sold for private use, except those products and products which are only environmentally hazardous.
|
|
| |
|
|
|
|
| |
|
S3
|
Store Queue
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
organic peroxides
|
|
| |
|
|
-WHAT?
|
other dangerous substances and products with a boiling point ≤ 40 ° C,
|
|
| |
|
|
use criteria,
|
|
| |
|
|
-WHAT?
|
obligatory for organic peroxides unless S47 is used ;
|
|
| |
|
|
-WHAT?
|
recommended for other dangerous substances and products with a code of < 40 ° C,
|
|
| |
|
|
|
|
| |
|
S4
|
Do not be stored in proximity to inhabitation
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
very toxic and toxic substances and products,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
normally limited to very toxic and toxic substances and products if S13 should be supplemented, for example, when inhaling, and the substance or product should not be stored in the vicination of inhabitation. The S statement does not preclube the use of the substance or of the product in the vicinal of inhabitation when applied in the right way.
|
|
| |
|
|
|
|
| |
|
S5
|
Stay under there. (a suitable liquid indicated by the manufacturer)
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
spontaneous fixed substances and products,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
normally limited to special cases, such as sodium, potassium and white phosphorus.
|
|
| |
|
|
|
|
| |
|
S6
|
Stay under there. (inactive gas, as indicated by the manufacturer)
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
dangerous substances and products to be kept under an inert atmosphere ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
normally limited to special cases, f. Exes. organo-metallic compounds.
|
|
| |
|
|
|
|
| |
|
S7
|
Packaging must be kept close to closed.
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
organic peroxides
|
|
| |
|
|
-WHAT?
|
substances and products which may place very toxic, toxic, harmful or extremely flammable fumes,
|
|
| |
|
|
-WHAT?
|
substances and products which emitting extremely flammable gases in contact with moisture,
|
|
| |
|
|
-WHAT?
|
highly flammable solids and products,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for organic peroxides,
|
|
| |
|
|
-WHAT?
|
recommended for the other applications referred to above.
|
|
| |
|
|
|
|
| |
|
S8
|
Emballagen must be kept dry
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
substances and products which react violently with water ;
|
|
| |
|
|
-WHAT?
|
substances and products which, in the case of contact with water, develop highly flammable gases ;
|
|
| |
|
|
-WHAT?
|
substances and products which, in the case of contact with water, develop very toxic or toxic gases,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
normally limited to the scope of application referred to above, when necessary to tighten up the warnings given in particular with R14 and R15 as well as with R29.
|
|
| |
|
|
|
|
| |
|
S9
|
Emballagen must be stored in a good ventilated location
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
volatile substances and products which may place very toxic, toxic or harmful fumes ;
|
|
| |
|
|
-WHAT?
|
extremely flammable and highly flammable liquids and highly flammable gases,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
recommended for volatile substances and products which can develop very toxic, toxic or harmful vapours ;
|
|
| |
|
|
-WHAT?
|
recommended for highly flammable and highly flammable fluids and highly flammable gases.
|
|
| |
|
|
|
|
| |
|
S12
|
Packaging must not be closed close
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
substances and products which, by means of the production of gases or vapours, could be detonate ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
normally limited to the above special cases.
|
|
| |
|
|
|
|
| |
|
S13
|
Do not be stored with food, beverages and feedingstuffs
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
very toxic, toxic and harmful substances and products ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
recommended, if it is likely that the substances and products concerned will be used in private.
|
|
| |
|
|
|
|
| |
|
S14
|
Keep away from it. (inequitable substances specified by the manufacturer)
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
organic peroxides
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for and normally limited to organic peroxides. May also be used in exceptional cases when the uneventness of the substance may present a special risk.
|
|
| |
|
|
|
|
| |
|
S15
|
Do not be exposed to heat
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
substances and products which can be spelessed or spontaneously in heat effects ;
|
|
| |
|
|
suiskrit e rier :
|
|
| |
|
|
-WHAT?
|
normally limited to special cases, such as monomers, but not prescribed if R-phrases R2, R3 and / or R5 have already been used.
|
|
| |
|
|
|
|
| |
|
S16
|
Stay away from sources of ignition-Smoking prohibited
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
extremely flammable and highly flammable liquids and highly flammable gases,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
recommended for the abovementioned substances and products, but not prescribed if R-phrases R2, R3 and / or R5 have already been used.
|
|
| |
|
|
|
|
| |
|
S17
|
Keep away from branded drugs
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
substances and products which may develop explosive or spontaneous mixtures with flammable material ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
are used in exceptional cases, e.g. for R8 and R9 underscores.
|
|
| |
|
|
|
|
| |
|
S18
|
Emballagen must be treated and opened with care
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
substances and products with a propensity to produce excess pressure in the packaging ;
|
|
| |
|
|
-WHAT?
|
substances and products which may develop explosive peroxides ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
normally limited to the above cases when there is a risk of eye damage, and / or if it is likely that the substances or products will be used in private.
|
|
| |
|
|
|
|
| |
|
S20
|
The use must not be eaten or drickled under the use
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
very toxic, toxic and corrosive substances and products ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
normally limited to special cases (e.g. arsenic and arsenic compounds, fluoracetates), in particular where it is likely that they will be used in private.
|
|
| |
|
|
|
|
| |
|
S21
|
The use must not be allowed to be moved.
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
substances and products which produce toxic combustion products,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
normally limited to special cases (e.g. halogenated compounds) ;
|
|
| |
|
|
|
|
| |
|
S22
|
To avoid inhalation of dust
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
all fixed substances and products dangerous to health,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for the abovementioned substances and products for which R42 has been provided ;
|
|
| |
|
|
-WHAT?
|
recommended for the substances and products referred to above, provided that they are delivered in the form of dust that can be inhaled and the possible health hazards are not known to breathe.
|
|
| |
|
|
|
|
| |
|
S23
|
Avoid inhalation of gas / smoke / vapour / vap/aerosols (or denomined by the manufacturer).
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
all liquid and gaseous substances and products which are dangerous to health ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for those substances and products mentioned above for which R42 has been provided ;
|
|
| |
|
|
-WHAT?
|
obligatory for substances and products for spraying. In addition, a S38 or S51 shall be specified,
|
|
| |
|
|
-WHAT?
|
recommended when it is necessary to draw the attention of the user to the danger by inhalation which does not appear in the required R phrases.
|
|
| |
|
|
|
|
| |
|
S24
|
Avoid contact with skin
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
all substances and products dangerous to health,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for the abovementioned substances and products for which R43 has been provided, unless S36 is also required ;
|
|
| |
|
|
-WHAT?
|
recommended, if it is necessary to draw the attention of the user to the dangers of skin contact which do not appear in the required R phrases (e.g., Paresthesia) can also be used for the underscore of such R phrases.
|
|
| |
|
|
|
|
| |
|
S25
|
Avoid contact with eyes
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
all substances and products which are dangerous to health,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
recommended, where necessary, in order to draw the attention of users to the dangers of eye contact, which do not appear in the risk phrases specified in the prescribed risk phrases ; it may also be used to underscore such risk phrases.
|
|
| |
|
|
-WHAT?
|
recommended for substances for which R34, R35, R36 or R41 are provided, if it is likely that these substances will be used in private.
|
|
| |
|
|
|
|
| |
|
S26
|
If the drug comes into the eyes, the water and doctor will be contacted right away.
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
corrosive and irritant substances and products ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for corrosive substances and products, as well as for substances and products for which R41 has already been prescribed ;
|
|
| |
|
|
-WHAT?
|
recommended for irritant substances and products for which R36 has already been prescribed.
|
|
| |
|
|
|
|
| |
|
S27
|
Tilsmudset outfits shall be taken immediately
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
very toxic, toxic and corrosive substances and products ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for very toxic substances and products for which R27 is required if the use of these substances is likely to be used in private,
|
|
| |
|
|
-WHAT?
|
recommended for highly toxic substances and products for which R27 is required, and used in industry. However, this safety statement should not be used if S36 is required ;
|
|
| |
|
|
-WHAT?
|
recommended for toxic substances and products for which R24 is required, and corrosive substances and products, where it is likely that these substances and products are used privately.
|
|
| |
|
|
|
|
| |
|
S28
|
The substance on the skin is immediately washed with a large amount of it. (indicated by the manufacturer)
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
very toxic, toxic and corrosive substances and products ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for very toxic substances and products,
|
|
| |
|
|
-WHAT?
|
recommended for the abovementioned substances and products, in particular if water is not the most appropriate purification solution ;
|
|
| |
|
|
-WHAT?
|
recommended for corrosive substances and products, where it is likely that they will be used privately.
|
|
| |
|
|
|
|
| |
|
S29
|
Do not empty in sewage drain
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
extremely and highly flammable liquids that do not allow themselves to be mixed with water ;
|
|
| |
|
|
-WHAT?
|
very toxic and toxic substances and products,
|
|
| |
|
|
-WHAT?
|
dangerous substances and products,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for dangerous substances and products which have been assigned the symbol " N " if it is likely that these will be used privately unless they are directly intended for use in sewage drains ;
|
|
| |
|
|
-WHAT?
|
recommended for the substances and products referred to above, where it is likely that they will be used privately unless they are directly intended for use in the sewer drain.
|
|
| |
|
|
|
|
| |
|
S30
|
Do not pour water on or in the product
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
substances and products which react violently with water ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
normally limited to special cases (for example, sulphuric acid), but may, where appropriate, be used to make the information as clear as possible, either to underline R14 or as an alternative to R14 ;
|
|
| |
|
|
|
|
| |
|
S33
|
Tref measures against static electricity
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
extremely and highly flammable substances and products ;
|
|
| |
|
|
usability s Ecriteria :
|
|
| |
|
|
-WHAT?
|
recommended for industrial substances and products not absorbed moisture is not used in reality for substances and products placed on the market for private use.
|
|
| |
|
|
|
|
| |
|
S35
|
The material and its container must be disposed of in a safe manner.
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
all dangerous substances and products,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
recommended for substances and products in which special instructions are needed for safe disposal ;
|
|
| |
|
|
|
|
| |
|
S36
|
Use special work clothes
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
organic peroxides
|
|
| |
|
|
-WHAT?
|
very toxic, toxic and harmful substances and products ;
|
|
| |
|
|
-WHAT?
|
corrosive substances and products
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for very toxic and corrosive substances and products ;
|
|
| |
|
|
-WHAT?
|
obligatory for substances and products, where either R21 or R24 is required ;
|
|
| |
|
|
-WHAT?
|
obligatory for carcinogenic, mutagenic and toxic to reproductive substances and products in category 3 unless the effects are obtained exclusively by inhalation of the substance or the product ;
|
|
| |
|
|
-WHAT?
|
obligatory for organic peroxides,
|
|
| |
|
|
-WHAT?
|
recommended for toxic substances and products, if the LD 50 the dermal value is not known, but the substance or product is likely to be toxic by skin contact ;
|
|
| |
|
|
-WHAT?
|
recommended for industrial substances and products which could be harmful to the harmful effects of the environment.
|
|
| |
|
|
|
|
| |
|
S37
|
Use suitable protective gloves during work
|
|
| |
|
|
used for :
|
|
| |
|
|
-WHAT?
|
very toxic, toxic, harmful and corrosive substances and products ;
|
|
| |
|
|
-WHAT?
|
organic peroxides
|
|
| |
|
|
-WHAT?
|
substances and products which irritate the skin or may cause sensitisation by skin contact ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for very toxic and corrosive substances and products ;
|
|
| |
|
|
-WHAT?
|
obligatory for substances and products in which either R21, R24 or R43 has been specified ;
|
|
| |
|
|
-WHAT?
|
obligatory for carcinogenic, mutagenic and toxic to reproductive substances and products in category 3 unless the effects are obtained exclusively by inhalation of the substance or the product ;
|
|
| |
|
|
-WHAT?
|
obligatory for organic peroxides,
|
|
| |
|
|
-WHAT?
|
recommended for toxic substances and products, if the LD 50 the dermal value is not known, but the substance or the product is likely to be harmful to skin contact ;
|
|
| |
|
|
-WHAT?
|
recommended for substances and products which irritate the skin.
|
|
| |
|
|
|
|
| |
|
S38
|
Use appropriate respiratory tool if effective ventilation is not possible
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
very toxic and toxic substances and products,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
normally limited to special cases where very toxic and toxic substances and products are used in industry or agriculture.
|
|
| |
|
|
|
|
| |
|
S39
|
Use protective goggles / face screen during work
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
organic peroxides
|
|
| |
|
|
-WHAT?
|
corrosive and irritant substances and products which cause severe eye damage ;
|
|
| |
|
|
-WHAT?
|
very toxic and toxic substances and products,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for substances and products in which R34, R35 or R41 are required ;
|
|
| |
|
|
-WHAT?
|
obligatory for organic peroxides,
|
|
| |
|
|
-WHAT?
|
recommended where it is necessary to draw the attention of the user to the hazards of eye contact, which are not mentioned in the risk phrases prescribed ;
|
|
| |
|
|
-WHAT?
|
normally limited to very toxic and toxic substances and products in exceptional cases where there is a risk of spraying, and they are likely to be easily absorbed by the skin.
|
|
| |
|
|
|
|
| |
|
S40
|
The floor and the coated objects are cleansed. (the funds are provided by the manufacturer)
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
all dangerous substances and products,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
normally limited to dangerous substances and products for which water is not considered a suitable detergent (e.g. where it is necessary to be absorbed by pulver-shaped material, diluted with solvent, etc.) as well as the health and safety of the products ; and / or safety grounds are essential that the label is subject to a warning.
|
|
| |
|
|
|
|
| |
|
S41
|
Do not breathe smoke on fire or explosion
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
dangerous substances and products which, by incineration, emits very toxic and toxic gases,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
normally limited to special cases.
|
|
| |
|
|
|
|
| |
|
S42
|
Use suitable respiratory system (s) indicated by the manufacturer of the smoking / spraying (or the name of the manufacturer).
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
substances and products for this use, which are in danger of the health and safety of the user, unless the appropriate precautionary measures are taken.
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
normally limited to special cases.
|
|
| |
|
|
|
|
| |
|
S43
|
Use it. for fire extinguishing equipment (the exact type of fire-fighting equipment is indicated by the manufacturer. If water is not allowed to be added : 'Do not use water')
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
extremely flammable, highly flammable and flammable substances and products ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for substances and products which, in the case of contact with water or damp air, develop highly flammable gases ;
|
|
| |
|
|
-WHAT?
|
recommended for highly flammable, highly flammable and flammable substances and products, in particular if they are not intertwable with water.
|
|
| |
|
|
|
|
| |
|
S45
|
In case of accidental or accidental medical treatment, if possible, show the label if possible.
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
very toxic substances and products,
|
|
| |
|
|
-WHAT?
|
toxic and corrosive substances and products ;
|
|
| |
|
|
-WHAT?
|
substances and products which may give sensitisation by inhalation ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for the abovementioned substances and products.
|
|
| |
|
|
|
|
| |
|
S46
|
In the case of intake, contact immediately and show this vessel or label
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
all dangerous substances and products except very toxic, toxic, corrosive and environmentally dangerous ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for all dangerous substances and products listed above, where it is likely that they will be used in private, unless there is no reason to assume that they are dangerous to take in particular for children.
|
|
| |
|
|
|
|
| |
|
S47
|
Do not be stored at temperatures on over...... degrees C (indicated by the manufacturer)
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
substances and products which are unstable at a given temperature ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
normally limited to special cases (e.g., certain organic peroxides).
|
|
| |
|
|
|
|
| |
|
S48
|
Holdes beimed with. (appropriate means indicated by the manufacturer)
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
substances and products which may be extremely sensitive to sparks, friction and shock ;
|
|
| |
|
|
use, s criteria :
|
|
| |
|
|
-WHAT?
|
normally limited to special cases, such as nitrocellulose.
|
|
| |
|
|
|
|
| |
|
S49
|
May only be retained in the original packaging
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
substances and products which are readily decomposed in catalytic,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
substances and products which are readily decomposition catalytic (e.g., certain organic peroxides).
|
|
| |
|
|
|
|
| |
|
S50
|
Do not mix with.... (indicated by the manufacturer)
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
substances and products which may react with the specified product and develop very toxic and toxic gases,
|
|
| |
|
|
-WHAT?
|
organic peroxides
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for certain peroxides, which may react violently to accelerators and similar substances ;
|
|
| |
|
|
-WHAT?
|
recommended for the substances and products referred to above, where it is likely that they will be used privately if R31 or R32 is not a better alternative.
|
|
| |
|
|
|
|
| |
|
S51
|
May only be used in places with good ventilation
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
substances and products which may or may be designed to produce steam, powder, spray, gas, fog, etc. which may cause a hazard by inhalation, fire or explosion ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
recommended, if S38 should not be used ; it is therefore important if it is likely that these substances and products will be used in private.
|
|
| |
|
|
|
|
| |
|
S52
|
Should not be used for major surfaces in residential or accommoding spaces
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
volatile, very toxic, toxic and harmful substances and products containing such substances ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
recommended for substances and products resulting from evaporation from large treated surfaces in residential or residency rooms may result in a health hazard after a long delay in the case of these.
|
|
| |
|
|
|
|
| |
|
S53
|
Avoid any contact-Obtain special instructions before use
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
carcinogenic, mutagenic and / or reproduction substances and products ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for the abovementioned substances and products for which at least one of the following R phrases : R45, R46, R49, R60 or R61 shall be required.
|
|
| |
|
|
|
|
| |
|
S56
|
Deliver this material and its container to a collection place of hazardous waste and problem waste
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
all dangerous substances and products,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
recommended for all dangerous substances and products, where it is likely that they will be used in private, where special disposal is required.
|
|
| |
|
|
|
|
| |
|
S57
|
Must be indefensible in order to avoid environmental pollution ;
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
substances and products which have been assigned the symbol " N ",
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
normally limited to substances and products which are not intended for private use.
|
|
| |
|
|
|
|
| |
|
S59
|
Gain information about recovery / recycling at the manufacturer / supplier
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
all dangerous substances and products,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for substances and products dangerous for the ozone layer ;
|
|
| |
|
|
-WHAT?
|
recommended for other substances and products for which recovery / recycling is recommended.
|
|
| |
|
|
|
|
| |
|
S60
|
This material and its container must be disposed of as hazardous waste
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
all dangerous substances and products,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
recommended for substances and products, which will probably not be used in private and where S35 is not required.
|
|
| |
|
|
|
|
| |
|
S61
|
Avoid release to the environment. See particular road conduction / supplier instructions
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
dangerous substances and products,
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
are normally used for substances and products which have been assigned the symbol " N " ;
|
|
| |
|
|
-WHAT?
|
recommended for all substances and products classified as environmentally hazardous and which are not covered above.
|
|
| |
|
|
|
|
| |
|
S62
|
In the case of ingestion, avoid provoking vomiting : contact medically and show this container or label
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
substances and products classified as harmful to R65 in accordance with the criteria in section 3.2.1.3 ;
|
|
| |
|
|
-WHAT?
|
are not used for substances and products placed on the market in aerosol receptacles or containers equipped with a sealed spraying device ;
|
|
| |
|
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for the abovementioned substances and products, where they are sold to or intended for private use unless S45 or S46 are mandatory ;
|
|
| |
|
|
-WHAT?
|
recommended for the abovementioned substances and products when used in industry, unless S45 or S46 are mandatory.
|
|
| |
|
|
|
|
| |
|
S63
|
In case of accident by inhalation, casualty shall be injured in fresh air and kept in order ;
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
very toxic and toxic substances and products (gas, steam, particulates, volatile liquids),
|
|
| |
|
|
-WHAT?
|
substances and products which may cause sensitisation by inhalation ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
obligatory for substances and products for which R26, R23 or R42, where it is likely that these substances and products are likely to be used in private, in a manner which may result in inhalation.
|
|
| |
|
|
|
|
| |
|
S64
|
By ingestion, rinse your mouth with water (Only if the person is conscious)
|
|
| |
|
|
used for
|
|
| |
|
|
-WHAT?
|
corrosive or irritant substances and products ;
|
|
| |
|
|
use criteria :
|
|
| |
|
|
-WHAT?
|
recommended for the abovementioned substances and products, where it is likely that they will be used in private and where the above treatment is appropriate.
|
|
