Guidance on classification for reproductive toxicity under the globally harmonized system of classification and labelling of chemicals (GHS)

Abstract

The Globally Harmonised System of Classification (GHS) is a framework within which the intrinsic hazards of substances may be determined and communicated. It is not a legislative instrument per se, but is enacted into national legislation with the appropriate legislative instruments. GHS covers many aspects of effects upon health and the environment, including adverse effects upon sexual function and fertility or on development. Classification for these effects is based upon observations in humans or from properly designed experiments in animals, although only the latter is covered herein. The decision to classify a substance based upon experimental data, and the category of classification ascribed, is determined by the level of evidence that is available for an adverse effect on sexual function and fertility or on development that does not arise as a secondary non-specific consequence of other toxic effect. This document offers guidance on the determination of level of concern as a measure of adversity, and the level of evidence to ascribe classification based on data from tests in laboratory animals.

• Classification
• globally harmonised system of classification and labelling of chemicals (GHS)
• hazard
• mode of action
• toxicity to reproduction

4 Acknowledgements

The authors are grateful to members of the ECETOC Scientific Committee, and in particular the stewards, Dr. David Owen (Shell) and Prof. Dr. med. Helmut Greim (Technische Universität München), for careful review of this report; Drs Heinrich Bürgin (F. Hoffmann-La Roche), Samia Khalil (Syngenta), and Richard Lewis (Syngenta) for their earlier work cited in Appendix; external reviewers whose comments were helpful in improving the guidance; and Drs. Robert Ellis-Hutchings, Sue Marty, and Reza Rasoulpour (Dow Chemical) for early technical contributions.

5 Declaration of interest

This paper was prepared by a Task Force of the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC). ECETOC is a scientific, non-profit making, non-commercial association with a mission to act as an independent, credible, peer-reviewed technical resource to all concerned with the assessment of health effects and environmental impact of chemicals. It is financed by its membership, which comprises some 43 of the leading companies with interests in the manufacture and use of chemicals. For this Task Force, ECETOC invited two scientists from regulatory research organisations to participate; no honorarium was paid and no reimbursement for travel expenses related to participating in the Task Force. All other authors participated in the Task Force during the normal course of their employment affiliation as shown on the cover page. The employers that are commercial entities produce and market products that are subject to regulation by National and International authorities that may consider the Guidance proposed in this paper. The authors have sole responsibility for the writing and contents of the paper.

Notes

¹Further investigations into the MOA and the relevance of these findings to humans, which are ongoing at the time of writing, may lead to an alternative conclusion on classification and labelling.