The test chemical selection procedure of the European Centre for the Validation of Alternative Methods for the EU Project ReProTect.
The selection of reference compounds is crucial for a successful in vitro test development in order to proof the relevance of the test system. This publication describes the criteria and the selection strategy leading to a list of more than 130 chemicals suitable for test development within the ReProTect project. The presented chemical inventory aimed to support the development and optimization of in vitro tests that seek to fulfill ECVAM's criteria for entering into the prevalidation. In order to select appropriate substances, a primary database was established compiling information from existing databases. In a second step, predefined selection criteria have been applied to obtain a comprehensive list ready to undergo a peer review process from independent experts with industrial, academic and regulatory background. Finally, a peer reviewed chemical list containing 13 substances challenging endocrine disrupter tests, additional 50 substances serving as reference chemicals for various tests evaluating effects on male and female fertility, and finally 61 substances were identified as known to provoke effects on the early development of mammalian offspring. The final list aims to cover relevant and specific mode/site of actions as they are known to be relevant for various substance classes. However, the recommended list should not be interpreted as a list of reproductive toxicants, because such a description requires proven associations with adverse effects of mammalian reproduction, which are subject of regulatory decisions done by involved competent authorities.
Pazos
Patricia
P
Institute for Health and Consumer Protection, European Commission, Joint Research Centre, Ispra (VA), Italy. patricia.pazos@jrc.ec.europa.eu
Pellizzer
Cristian
C
Stummann
Tina C
TC
Hareng
Lars
L
Bremer
Susanne
S
D000826:Animal Testing Alternatives / Q000379:methods / Q000592:standards; D016208:Databases, Factual; D052244:Endocrine Disruptors / Q000145:classification / Q000592:standards / Q000633:toxicity; D005062:European Union; D005260:Female; D005298:Fertility / Q000187:drug effects*; D006801:Humans; D008297:Male; D012016:Reference Values
D052244:Endocrine Disruptors