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Editorial Information
X1Substituted by Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Official Journal of the European Union L 396 of 30 December 2006).
Textual Amendments
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.
The relevant hazard classes, for which information shall be provided, are:
acute toxicity;
skin corrosion/irritation;
serious eye damage/irritation;
respiratory or skin sensitisation;
germ cell mutagenicity;
carcinogenicity;
reproductive toxicity;
STOT-single exposure;
STOT-repeated exposure;
aspiration hazard.
These hazards shall always be listed on the safety data sheet.
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.
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.
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 ’ .
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.
Information on interactions shall be included if relevant and available.
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.
For a given health effect, if a mixture has not been tested for its health effects as a whole, relevant information on relevant substances listed under Section 3 shall be provided.
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;
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;
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.
Other relevant information on adverse health effects shall be included even when not required by the classification criteria.] ]