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SECTION 11: Toxicological information

Informations are provided from COMMISSION REGULATION (EU) No 453/2010 of 20 May 2010 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

This section of the safety data sheet is meant for use primarily by medical professionals, occupational health and safety professionals and toxicologists. A concise but complete and comprehensible description of the various toxicological (health) effects and the available data used to identify those effects shall be provided, including where appropriate information on toxicokinetics, metabolism and distribution. The information in this section shall be consistent with the information provided in the registration and/or in the chemical safety report where required, and with the classification of the substance or mixture.

11.1. Information on toxicological effects

11.1.1. Substances The relevant hazard classes for which information shall be provided, are:
(a) acute toxicity;
(b) skin corrosion/irritation;
(c) serious eye damage/irritation;
(d) respiratory or skin sensitisation;
(e) germ cell mutagenicity;
(f) carcinogenicity;
(g) reproductive toxicity;
(h) STOT-single exposure;
(i) STOT-repeated exposure;
(j) aspiration hazard. For substances subject to registration, brief summaries of the information derived from the application of Annexes VII to XI shall be given, including, where appropriate, a reference to the test methods used. For substances subject to registration, the information shall also include the result of the comparison of the available data with the criteria given in Regulation (EC) No 1272/2008 for CMR, categories 1A and 1B, following point 1.3.1 of Annex I to this Regulation.

11.1.2. Mixtures The relevant effects, for which information shall be provided, are:
(a) acute toxicity;
(b) irritation;
(c) corrosivity;
(d) sensitisation;
(e) repeated dose toxicity;
(f) carcinogenicity;
(g) mutagenicity;
(h) toxicity for reproduction. For the health effects of carcinogenicity, mutagenicity and toxicity for reproduction, classification for a given health effect based on the conventional method outlined in Article 6(1)(a) of Directive 1999/45/EC, and relevant information for the substances listed under Section 3 shall be provided. For other health effects, if a mixture has not been tested as a whole for a given health effect, information relevant to that health effect relating to substances listed under Section 3 shall be provided, if relevant.

11.1.3. Information shall be provided for each hazard class, differentiation or effect. If it is stated that the substance or mixture is not classified for a particular hazard class, differentiation or effect, the safety data sheet shall clearly state whether this is due to lack of data, technical impossibility to obtain the data, inconclusive data or data which are conclusive although insufficient for classification; in the latter case the safety data sheet shall specify “based on available data, the classification criteria are not met”.

11.1.4. The data included in this subsection shall apply to the substance or mixture as placed on the market. If available, the relevant toxicological properties of the hazardous substances in a mixture shall also be provided, such as the LD50, acute toxicity estimates or LC50.

11.1.5. Where there is a substantial amount of test data on the substance or mixture, it may be necessary to summarise results of the critical studies used, for example, by route of exposure.

11.1.6. Where the classification criteria for a particular hazard class are not met, information supporting this conclusion shall be provided.

11.1.7. Information on likely routes of exposure
Information shall be provided on likely routes of exposure and the effects of the substance or mixture via each possible route of exposure, that is, through ingestion (swallowing), inhalation or skin/eye exposure. If health effects are not known, this shall be stated.

11.1.8. Symptoms related to the physical, chemical and toxicological characteristics
Potential adverse health effects and symptoms associated with exposure to the substance or mixture and its ingredients or known by-products shall be described. Available information shall be provided on the symptoms related to the physical, chemical, and toxicological characteristics of the substance or mixture following exposure. The first symptoms at low exposures through to the consequences of severe exposure shall be described, such as “headaches and dizziness may occur, proceeding to fainting or unconsciousness; large doses may result in coma and death”.

11.1.9. Delayed and immediate effects as well as chronic effects from short and long-term exposure
Information shall be provided on whether delayed or immediate effects can be expected after short or long- term exposure. Information on acute and chronic health effects relating to human exposure to the substance or mixture shall also be provided. Where human data are not available, animal data shall be summarised and the species clearly identified. It shall be indicated whether toxicological data is based on human or animal data.

11.1.10. Interactive effects
Information on interactions shall be included if relevant and available.

11.1.11. Absence of specific data
It may not always be possible to obtain information on the hazards of a substance or mixture. In cases where data on the specific substance or mixture are not available, data on similar substances or mixtures, if appropriate, may be used, provided the relevant similar substance or mixture is identified. Where specific data are not used, or where data are not available, this shall be clearly stated.

11.1.12. Mixture versus substance information The substances in a mixture may interact with each other in the body resulting in different rates of absorption, metabolism and excretion. As a result, the toxic actions may be altered and the overall toxicity of the mixture may be different from that of the substances in it. This shall be taken into account when providing toxicological information in this section of the safety data sheet. Classification of mixtures as having effects of carcinogenicity, mutagenicity or toxicity for reproduction must be calculated from available information regarding substances in the mixture. For other health effects, it is necessary to consider whether the concentration of each substance is sufficient to contribute to the overall health effects of the mixture. The information on toxic effects shall be presented for each substance, except for the following cases:

(a) if the information is duplicated, it shall be listed only once for the mixture overall, such as when two substances both cause vomiting and diarrhoea;
(b) if it is unlikely that these effects will occur at the concentrations present, such as when a mild irritant is diluted to below a certain concentration in a non-irritant solution;
(c) where information on interactions between substances in a mixture is not available, assumptions shall not be made and instead the health effects of each substance shall be listed separately.

11.1.13. Other information
Other relevant information on adverse health effects shall be included even when not required by the classification criteria.


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