©2019 by productSDS Global SDS Authoring Center

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;      
(f) carcinogenicity;      
(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.

Mixtures:

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]