title: 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.
authors.affiliation: Dow Europe GmbH , Horgen , Switzerland .
authors.forename: Nigel P
authors.initials: NP
authors.lastname: Moore
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Boogaard
authors.forename: Susanne
authors.initials: S
authors.lastname: Bremer
authors.forename: Roland
authors.initials: R
authors.lastname: Buesen
authors.forename: James
authors.initials: J
authors.lastname: Edwards
authors.forename: Benoit
authors.initials: B
authors.lastname: Fraysse
authors.forename: Nina
authors.initials: N
authors.lastname: Hallmark
authors.forename: Helena
authors.initials: H
authors.lastname: Hemming
authors.forename: Carole
authors.initials: C
authors.lastname: Langrand-Lerche
authors.forename: Richard H
authors.initials: RH
authors.lastname: McKee
authors.forename: Marie-Louise
authors.initials: ML
authors.lastname: Meisters
authors.forename: Paul
authors.initials: P
authors.lastname: Parsons
authors.forename: Valerie
authors.initials: V
authors.lastname: Politano
authors.forename: Stuart
authors.initials: S
authors.lastname: Reader
authors.forename: Peter
authors.initials: P
authors.lastname: Ridgway
authors.forename: Christa
authors.initials: C
authors.lastname: Hennes
mesh_terms: D000818:Animals; D002070:Butadienes / Q000145:classification / Q000633:toxicity; D004983:Ethanolamines / Q000145:classification / Q000633:toxicity; D005260:Female; D017408:Guidelines as Topic; D015386:Hazardous Substances / Q000145:classification* / Q000633:toxicity*; D038622:Internationality; D008297:Male; D009578:Nitrobenzenes / Q000145:classification / Q000633:toxicity; D010795:Phthalic Acids / Q000145:classification / Q000633:toxicity; D011356:Product Labeling; D012098:Reproduction / Q000187:drug effects*; D018675:Toxicity Tests
chemical_list: D002070:Butadienes; D004983:Ethanolamines; D015386:Hazardous Substances; D009578:Nitrobenzenes; D010795:Phthalic Acids; C001335:hexachlorobutadiene; C036077:nitrobenzene; C035835:N-(2-hydroxyethyl)ethylenediamine