Safety Data Sheet Layout Guide
(according to GHS rev. 3)
SECTION 11: Toxicological information
11.1 Toxicological effects
[This section is used 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, should be provided. Under GHS classification, the relevant hazards, for which data should be provided, are:
(a) acute toxicity;
(b) skin corrosion/irritation;
(c) serious eye damage/irritation;
(d) respiratory or skin sensitization;
(e) germ cell mutagenicity;
(g) reproductive toxicity;
(h) STOT-single exposure;
(i) STOT-repeated exposure; and
(j) aspiration hazard.
If data for any of these hazards is not available, they should still be listed on the SDS with a statement that data is not available.
The data included in this sub-section should apply to the substance or mixture as used. The toxicological data should describe the mixture. If that information is not available, the classification under GHS and the toxicological properties of the hazardous ingredients should be provided.
The health effects included in the SDS should be consistent with those described in the studies used for the classification of the substance or mixture.
General statements such as “Toxic” with no supporting data or “Safe if properly used” are not acceptable as they may be misleading and do not provide a description of health effects. Phrases such as “not applicable”, “not relevant”, or leaving blank spaces in the health effects section can lead to confusion and misunderstanding and should not be used. For health effects where information is not available, this should be clearly stated. Health effects should be described accurately and relevant distinctions made. For example, allergic contact dermatitis and irritant contact dermatitis should be distinguished from each other.
Where there is a substantial amount of test data on the substance or mixture, it may be desirable to summarize results e.g. by route of exposure.
Also provide information on the relevant negative data. Information to support negative test results should be provided (e.g. “carcinogenicity studies in the rat have shown no significant increase in the incidence of cancer”)
Provide information on the dose, concentration or conditions of exposure that may cause adverse health effects. Where appropriate, doses should be linked to symptoms and effects, including the period of exposure likely to cause harm.
Information on interactive effects should be included if relevant and readily 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 the chemical class, if appropriate, may be used. Where generic data are used or where data are not available, this should be stated clearly in the SDS.
If a mixture has not been tested for its health effects as a whole then information on each ingredient listed should be provided and the mixture should be classified using the processes that are described in the GHS.
Mixture versus ingredient information:
Ingredients 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 its ingredients.
It is necessary to consider whether the concentration of each ingredient is sufficient to contribute to the overall health effects of the mixture. The information on toxic effects should be presented for each ingredient, except:
(a) if the information is duplicated, it is not necessary to list this more than once. For example, if two ingredients both cause vomiting and diarrhoea, it is not necessary to list this twice. Overall, the mixture is described as causing vomiting and diarrhoea;
(b) if it is unlikely that these effects will occur at the concentrations present. For example, when a mild irritant is diluted in a non-irritating solution, there comes a point where the overall mixture would be unlikely to cause irritation;
(c) Predicting the interactions between ingredients is extremely difficult, and where information on interactions is not available, assumptions should not be made and instead the health effects of each ingredient should be listed separately.]
11.2 Information on the likely routes of exposure
[Provide information on the 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. A statement should be made if health effects are not known]
11.3 Symptoms related to the physical, chemical and toxicological characteristics
[Describe the potential adverse health effects and symptoms associated with exposure to the substance or mixture and its ingredients or known by-products. Provide information on the symptoms related to the physical, chemical and toxicological characteristics of the substance or mixture following exposure related to the intended uses. Describe the first symptoms at the lowest exposures through to the consequences of severe exposure; for example, “headaches and dizziness may occur, proceeding to fainting or unconsciousness; large doses may result in coma and death”]
11.4 Delayed and immediate effects and also chronic effects from short and long term exposure
[Provide information on whether delayed or immediate effects can be expected after short or long term exposure. Also provide information on acute and chronic health effects relating to human exposure to the substance or mixture. Where human data are not available, animal data should be summarized and the species clearly identified. It should be indicated in the SDS whether toxicological data is based on human or animal data]
11.5 Conditions to avoid
[List conditions such as heat, pressure, shock, static discharge, vibrations or other physical
stresses that might result in a hazardous situation]
11.6 Other Information
[Other relevant information on adverse health effects should be included even when not required by the GHS classification criteria]