GHS Classification Criteria For Reproductive Toxicity

GHS Classification Criteria for Reproductive Toxicity

Little Pro on 2018-04-09

Reproductive toxicity refers to adverse effects of a chemical substance/mixture on sexual function and fertility in adult males and females, as well as developmental toxicity in the offspring. Developmental toxicity pertains to adverse toxic effects to the developing embryo or fetus.

GHS Classification Criteria for Reproductive Toxicity

There are 3 hazard categories for reproductive toxicity under GHS.

Category	Criteria
Category 1A	Known human reproductive toxicants Based on evidence from humans.
Category 1B	Presumed human reproductive toxicants - largely based on animal studies. Clear evidence of adverse effects on sexual function and fertility or on development in absense of other toxic effects has been identified; or If occuring with other toxic effects, the reproductive toxicity is not considered to be a second non-specific consequence of the other toxic effects. If there is mechanistic information that raises doubt about the relevance of the effects for humans, category 2 is more appropriate.
Category 2	Suspected human reproductive toxicant - Evidence from animal and/or human studies is limited There is some evidence supplemented with other info and the evidence is not sufficiently convincing to place the substance in category 1. For example, bad quality of studies.
Effects on via lactation	Effects on via lactation Toxicants which may interfere with lactation or which may be present in breast milk and may cause harm to breast-fed children

Testing Guidelines for Reproductive/Developmental Toxicity

The following studies can provide evidence for GHS classification.

• Reproductive/Developmental Toxicity Screening Assay (OECD TG 421)
• Prenatal developmental toxicity test (OECD TG 414)
• Two-generation reproduction toxicity study (OECD TG 416)
• Extended one-generation reproductive toxicity study (EOGRTS; OECD TG 443)

Reproductive Toxicity Classification for Mixture

The picture below shows you the concentration limit of a reproductive toxicant triggering the reproductive toxicity classification of a mixture.

Note: Different authorities may have adopted different concentration limits. More info can be found below.

• Comparison of concentration limits for reproductive toxicity

References and More Reading

• GHS classification criteria in a single page
• UN GHS purple book - health hazards
• GHS classification criteria - acute toxicity
• GHS classification criteria - skin irritation and corrosion
• GHS classification criteria - eye irritation and corrosion
• GHS classification criteria - skin sensitization
• GHS classification criteria - specific target organ toxicity (STOT)
• GHS classification criteria - germ cell mutagenicity
• GHS classification criteria - reproductive toxicity
• GHS classification criteria - carcinogenicity
• M-factor and GHS Classification Criteria for Aquatic Environment

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Tags: Topics - GHS, GHS Classification