User Guide to Thresholds and Classification - Environmental ...

248User Guide for Thresholds and ClassificationsAppendix 16B: Comparison of Globally Harmonized System ofClassification and Labelling of Chemicals and HSNO Actreproductive or developmental toxicity hazard classificationTable 16B.1 displays the reproductive or developmental categories from the Globally Harmonized System ofClassification and Labelling of Chemicals (United Nations, 2007) and the Hazardous Substances and NewOrganisms Act 1996 (HSNO Act) equivalent.Table 16B.1: Comparison of Globally Harmonized System of Classification and Labelling of Chemicals and HSNOAct reproductive or developmental toxicity hazard classificationGHS reproductive or development toxicity classificationCategory 1: Known or presumed human reproductive toxicantThis category includes substances that are known to have produced an adverse effect on sexualfunction and fertility or on development in humans, or for which there is evidence from animalstudies, possibly supplemented with other information, to provide a strong presumption that thesubstance has the capacity to interfere with reproduction in humans. For regulatory purposes, asubstance can be further distinguished on the basis of whether the evidence for classification isprimarily from human data (category 1A) or from animal data (category 1B).HSNO Actequivalentcategory *Category 1A: Known human reproductive toxicantThe placing of the substance in this category is largely based on evidence from humans.6.8ACategory 1B: Presumed human reproductive toxicantThe placing of the substance in this category is largely based on evidence from experimentalanimals. Data from animal studies should provide clear evidence of an adverse effect on sexualfunction and fertility or on development in the absence of other toxic effects, or, if occurringtogether with other toxic effects, the adverse effect on reproduction is considered not to be asecondary non-specific consequence of other toxic effects. However, when there is mechanisticinformation that raises doubt about the relevance of the effect for humans, classification incategory 2 may be more appropriate.Category 2: Suspected human reproductive toxicantThis category includes substances for which there is some evidence from humans or experimentalanimals, possibly supplemented with other information, of an adverse effect on sexual functionand fertility, or on development, in the absence of other toxic effects, or, if occurring together withother toxic effects, the adverse effect on reproduction is considered not to be a secondary nonspecificconsequence of the other toxic effects, and where the evidence is not sufficientlyconvincing to place the substance in category 1. For instance, deficiencies in the study may makethe quality of evidence less convincing, so category 2 could be the more appropriate classification.6.8BReferencesUnited Nations 2007. The Globally Harmonized System of Classification and Labelling of Chemicals (GHS),2nd revised edition. United Nations, Geneva.January 2012 EPA0109