Testing for prenatal developmental toxicity (PNDT) is a requirement under the EU REACH and Biocidal Products Regulations. The preferred species are the rat and the rabbit, and testing in two species is often required.
However, rabbits are known to be susceptible to gastrointestinal (GI) imbalances and therefore may be an inappropriate species for the testing of some substances like antibiotics and poorly absorbed materials.
Hence, there is a concern that, for certain substances, testing in rabbits may not provide relevant information for risk assessment, due to species sensitivity to gastrointestinal effects.
This questionnaire survey is aimed at CROs, MS CA experts and consultants involved in the performance and/or evaluation of PNDT studies.
Completing the questionnaire should take between 10-15 minutes. Your participation is highly valued and appreciated.
The project aims to conclude on the human relevance of rabbit PNDT studies for hazard identification where GI toxicity was observed.
This project is being conducted by a consortium of EcoMole, VUOS and ReachSpektrum following a tender launched by the European Chemicals Agency (ECHA).
The project is funded by the European Chemicals Agency (ECHA) based on the procurement procedure No. ECHA/2017/256
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