Section 11
Toxicological information
Information Elements
- Information on the likely routes of exposure (inhalation, ingestion, skin and eye contact)
- Symptoms related to the physical, chemical and toxicological characteristics;
- Delayed and immediate effects, and chronic effects from short-term and long-term exposure
- Numerical measures of toxicity, including ATEs
Most common non-compliances
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Routes of exposure are missing.
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Numerical measures of toxicity (the acute toxicity estimate, LD50 / LC50 values etc.) are missing, when available.
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Information on the symptoms related to the physical, chemical and toxicological characteristics, is not disclosed on the ingredients when information on the mixture as a whole is not available.
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Hazard statements are used to identify the symptoms related to the physical, chemical and toxicological characteristics.
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Symptoms are not specified for all classifications, or are reported for some and not for others.
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Information on the delayed or immediate effects after exposure to the product is not listed.
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Information on chronic effects is not disclosed.
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The Acute Toxicity Estimate (ATE) is not disclosed.
Tips
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Toxicological Information
Relevant human (case reports and/or results of population-based studies) and animal (test or study results) evidence should be disclosed.
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In vitro data for accepted tests (e.g., skin corrosion tests, mutagenicity tests) should be disclosed.
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Information on the toxicological properties of the mixture must be disclosed, if available. Otherwise, information on the toxicological properties of the hazardous ingredients, with an indication as to which ingredient(s) the provided information applies must be disclosed.
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Professional judgment should be used to determine the extent and nature of health hazard disclosure, particularly where the data are extensive, conflicting or contradictory.
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Likely routes of exposure
Information on the likely routes of exposure (ingestion, inhalation or skin and eye contact) must be presented.
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Symptoms
The symptoms related to the physical, chemical and toxicological characteristics of the substance, mixture or product must be disclosed.
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They should be disclosed in sequential order, beginning with the first symptoms occurring at low exposures and progressing through to the consequences of severe exposure.
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Effects
Information on both the delayed and immediate effects after both short-term and long-term exposure must be disclosed.
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Numerical Measures of Toxicity
The numerical measures of toxicity that are available must be disclosed on the safety data sheet (SDS).
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For example, the acute toxicity estimate of the hazardous product.
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The acute toxicity estimate (ATE) for a mixture must be disclosed, indicating the specific route of exposure to which the estimate was calculated (oral, dermal, inhalation).
