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Description

The OECD TG 414 (Prenatal Developmental Toxicity Study) provides information on adverse effects on prenatal development and is part of the standard information requirements in various regulatory frameworks (under REACH for substances registered for more than 100 tonnes/year, as well as for plant protection products and biocides) to generate information for risk assessment of chemicals.
OECD TG 414 is included in Level 4 of the OECD conceptual framework. It involves repeated dosing of pregnant females and therefore potential exposure of the developing foetus. The assay includes some endpoints that may detect effects of endocrine disrupters (e.g. abnormalities of male and female genitalia) (OECD GD 150, 2012). However, an update in relation to inclusion of more endpoints relevant for endocrine disruption would increase the possibility for detecting effects of endocrine disrupting substances.
Assessment of testosterone levels and anogenital distance (AGD) in male foetuses has been used in several published studies and appear as sensitive endpoints for detecting effects of endocrine disrupters with anti-androgenic properties. Thus, inclusion of these endpoints in TG 414 in GD 21 foetuses at the time of caesarean section could be a significant enhancement with regards to detection of effects of endocrine disrupting substances. Also, an enhancement with some additional text giving guidance on evaluation of abnormalities of male and female genitalia is relevant.
Short titleTG 414
StatusFinished
Effective start/end date01/01/201631/12/2018
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