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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.

GHS Classification Reproductive Toxicity

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

References and More Reading

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