User Guide to Thresholds and Classification - Environmental ...

235User Guide for Thresholds and Classifications16. Reproductive and Developmental Effects – Subclass 6.816.1. General considerations16.1.1. Reproductive and developmental effects overviewSee section 9.6 in chapter 9 for definitions of the key terms used in this chapter.This classification subclass considers:adverse effects on sexual function and fertility (that is, reproductive effects); andadverse effects on the development of offspring (that is, developmental effects).Some reproductive toxic effects cannot be clearly assigned to either impairment of sexual function andfertility or to developmental toxicity. Nonetheless, chemicals with these effects would be classified asreproductive/developmental toxicants.For classification purposes, the known induction of genetically based inheritable effects in the offspring isaddressed in mutagenicity (subclass 6.6 – see chapter 14), since in the present classification system it isconsidered more appropriate to address such effects under the separate hazard class of mutagenicity.16.1.2. Weight-of-evidence approachThe best quality data should be used as the fundamental basis for classification. Classification shouldpreferably be based on primary data sources. It is essential that test conditions be clearly and completelyarticulated.Data from internationally harmonised test methods are preferred for classification under this subclass. Datashould preferably be derived using Organisation for Economic Co-operation and Development (OECD) TestGuidelines or equivalent according to the principles of Good Laboratory Practice. When such data are notavailable, classification should be based on the best available data using a weight-of-evidence approach.See section 1.3 in chapter 1 above for information about assessing data quality.See Appendix 16A below for a detailed list of acceptable test methods for reproductive and developmentaltoxicity.16.2. Reproductive or developmental effects hazard and classification criteria16.2.1. Reproductive or developmental effects threshold criteriaSchedule 4 of the threshold criteria defined in the Hazardous Substances (Minimum Degrees of Hazard)Regulations 2001 state:2 Minimum degrees of hazard(1) A substance with toxic properties is not hazardous for the purposes of the Act unless—…January 2012 EPA0109