SDS Section 11 (Tab "11.2 Toxicological")
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In this section/tab you enter brief but complete descriptions of germ cell mutagenicity, carcinogenicity, and reproductive toxicity.
· Describe delayed, immediate, and chronic effects from short-term and long-term exposure.
· Include available toxicological values, clearly distinguishing between values for individual ingredients and for the product as a whole. Provide available toxicological information on any hazardous by-products.
· Some toxicological data may be available by clicking on the Paste [t]oxicity items button, which will display a Toxicity items dialog. The dialog displays toxicity items from the Substances section of the program for the SDS components and (where available) the product itself.[1]
· Ensure the symptom descriptions are suitable for physicians and other medical professionals to identify.
· Symptoms should be arranged in order of increasing or decreasing exposure levels.
· Avoid general statements like "toxic", phrases such as “not applicable” or “not relevant”, or leaving entry areas blank.
· Ensure that the GHS health classifications/hazards on Tab "2 Hazards" are reflected/incorporated into the corresponding descriptions here.
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1. Germ cell mutagenicity — Indicate whether the product exhibits germ cell mutagenicity.
2. Carcinogenicity — Indicate whether the product or its components is/are listed in the National Toxicology Program Report on Carcinogens, International Agency for Research on Cancer Monographs, or by OSHA (29 CFR 1910 Subpart Z).
3. Reproductive toxicity — Indicate whether the product displays any toxic effects on reproduction.
4. Summary of the evaluation of the CMR (Carcinogen, mutagen, or reproductive toxicant) properties — Summarize the carcinogenic, mutagenic, and/or reproductive (CMR) toxicity properties of the product.
5. Next, click on the “11.3 Toxicological” tab.
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SDS Section 11 (Tab "11.2 Toxicological") — details
NOTE: The regulatory guidance information here is the same as in Tab 11.1.
Contents
A4.3.11 SECTION 11: Toxicological information
A4.3.11.7 Information on the likely routes of exposure
A4.3.11.8 Symptoms related to the physical, chemical and toxicological characteristics
A4.3.11.9 Delayed and immediate effects and also chronic effects from short and long term exposure
A4.3.11.10 Numerical measures of toxicity (such as acute toxicity estimates)
A4.3.11.11 Interactive effects
A4.3.11.12 Where specific chemical data are not available
A4.3.11.14 Mixture versus ingredient information
SECTION 11: Toxicological information
11.1 Information on toxicological effects
11.2 Information on other hazards
I. OSHA guidance
From: “OSHA Brief: Hazard Communication Standard: Safety Data Sheets”, https://www.osha.gov/Publications/OSHA3514.html.
This section identifies toxicological and health effects information or indicates that such data are not available. The required information consists of:
· Information on the likely routes of exposure (inhalation, ingestion, skin and eye contact). The SDS should indicate if the information is unknown.
· Description of the delayed, immediate, or chronic effects from short- and long-term exposure.
· The numerical measures of toxicity (e.g., acute toxicity estimates such as the LD50 (median lethal dose)) - the estimated amount [of a substance] expected to kill 50% of test animals in a single dose.
· Description of the symptoms. This description includes the symptoms associated with exposure to the chemical including symptoms from the lowest to the most severe exposure.
· Indication of whether the chemical is listed in the National Toxicology Program (NTP) Report on Carcinogens (latest edition) or has been found to be a potential carcinogen in the International Agency for Research on Cancer (IARC) Monographs (latest editions) or found to be a potential carcinogen by OSHA
II. UN guidance
From: United Nations (2017). Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Seventh Revised Edition. https://unece.org/ghs-rev7-2017. United Nations. Reprinted with permission.
A4.3.11 SECTION 11: Toxicological information
A4.3.11.1 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.
These hazards should always be listed on the SDS.
A4.3.11.2 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.
A4.3.11.3 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 (see A4.3.11.1).
A4.3.11.4 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.
A4.3.11.5 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.
A4.3.11.6 If data for any of these hazards are not available, they should still be listed on the SDS with a statement that data are not available. Also provide information on the relevant negative data (see A4.2.2.3). If data are available showing that the substance or mixture does not meet the criteria for classification, it should be stated on the SDS that the substance or mixture has been evaluated and based on available data, does not meet the classification criteria. Additionally, if a substance or mixture is found to be not classified for other reasons, for example, due to technical impossibility to obtain data, or inconclusive data, this should be clearly stated on the SDS.
A4.3.11.7 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.
A4.3.11.8 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”.
A4.3.11.9 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 summarised and the species clearly identified. It should be indicated in the SDS whether toxicological data is based on human or animal data.
A4.3.11.10 Numerical measures of toxicity (such as acute toxicity estimates)
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.
A4.3.11.11 Interactive effects
Information on interactions should be included if relevant and readily available.
A4.3.11.12 Where specific chemical data are not 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.
A4.3.11.13 Mixtures
If a mixture has not been tested for its health effects as a whole then information on each ingredient listed under A4.3.3.2.1 should be provided and the mixture should be classified using the processes that are described in the GHS (Section 1.3.2.3 and subsequent chapters).
A4.3.11.14 Mixture versus ingredient information
A4.3.11.14.1 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.
A4.3.11.14.2 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.
A4.3.11.15 Other information
Other relevant information on adverse health effects should be included even when not required by the GHS classification criteria.
III. European Union guidance
From: "COMMISSION REGULATION (EU) 2020/878 of 18 June 2020, amending Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)”. Official Journal of the European Union, 26.6.2020.
SECTION 11: Toxicological information
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
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.
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.
11.1.1 Information shall be provided for each hazard class or differentiation. If it is stated that the substance or mixture is not classified for a particular hazard class or differentiation, 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”.
11.1.2 The data included in this subsection shall apply to the substance or mixture as placed on the market. In the case of a mixture, the data should describe the toxicological properties of the mixture as a whole, except if Article 6 (3) of Regulation (EC) No 1272/2008 applies. 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.
11.1.3 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.
11.1.4 Where the classification criteria for a particular hazard class are not met, information supporting this conclusion shall be provided.
11.1.5 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.
11.1.6 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”.
11.1.7 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, information on the experimental data shall be summarised, with details on either animal data and the species clearly identified or the in vitro tests and the cell types clearly identified. It shall be indicated whether toxicological data is based on human or animal data or on in vitro tests.
11.1.8 Interactive effects
Information on interactions shall be included if relevant and available.
11.1.9 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.
11.1.10 Mixtures
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.
11.1.11 Mixture versus substance information
11.1.11.1 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.
11.1.11.2 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.
11.2 Information on other hazards
11.2.1 Endocrine disrupting properties
Information on adverse health effects caused by endocrine disrupting properties shall be provided, where available, for the substances identified as having endocrine disrupting properties in Subsection 2.3. This information shall consist of brief summaries of the information derived from application of the assessment criteria laid down in the corresponding Regulations ((EC) No 1907/2006, (EU) 2017/2100, (EU) 2018/605), that is relevant to assess endocrine disrupting properties for human health.
11.2.2 Other information
Other relevant information on adverse health effects shall be included even when not required by the classification criteria.
IV. Health Canada guidance
From: "Technical Guidance on the Requirements of the Hazardous Products Act and the Hazardous Products Regulations, WHMIS 2015 Supplier Requirements", Cat.: H129-64/1-2016E-PDF. December 2016. ©2016, Her Majesty the Queen in Right of Canada, as represented by the Minister of Health. The acronym "HPR" refers to the Canadian Hazardous Products Regulations. The acronym "HCS 2012" refers to the (US) OSHA Hazard Communication Standard, as updated in 2012 for GHS compatibility.
This section provides a concise but complete description of the various health effects and the data used to identify those effects for either the material, substance or the mixture as whole or as hazardous ingredients. The required information includes:
· Information on likely routes of exposure (inhalation, ingestion, skin and eye contact)
· Description of the delayed and immediate effects
· Description of chronic effects from both short- and long-term exposure
· The numerical measures of toxicity, including acute toxicity estimates such as the LD50. Further guidance is provided in the discussion of the definition of Acute Toxicity Estimate (“ATE”) in both Part 1 and section 8.1 of the HPR
· Description of the symptoms following exposure. This description includes first symptoms at the lowest exposures through to the consequences of severe exposure to the hazardous product. For example, “Headaches and dizziness may occur, before/leading to fainting or unconsciousness: large doses may result in coma and death”
In the case of a mixture, the information provided under this heading must be the information that is available on the mixture as a whole, and if information is not available on the mixture as a whole, then it must be information that is available on the hazardous ingredients in the mixture. In the latter case, the chemical name of the hazardous ingredient to which the information applies must be clearly indicated.
Comparison to HCS 2012
Note that in the HCS 2012, under item 11(e) of Table D.1, there is a requirement to disclose whether the hazardous chemical is listed in the National Toxicology Program (NTP) Report on Carcinogens (latest edition) or has been found to be a potential carcinogen in the International Agency for Research on Cancer (IARC) Monographs (latest edition), or by OSHA. Schedule 1 of the HPR does not include this requirement; however, the information required by the HCS 2012 with regard to the disclosure of carcinogens may be added to section 11 of the SDS.
[rev. 4.9.2021]
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