Faithin Omaha eBook Collection

Download or read book How ECHA Identifies the Design for the Extended One-generation Reproductive Toxicity Study (EOGRTS) Under Dossier Evaluation written by and published by . This book was released on 2016 with total page 10 pages. Available in PDF, EPUB and Kindle. Book excerpt: The extended one-generation reproductive toxicity study (EOGRTS) is a modular test method where breeding and assessment of a second filial (F2) generation and testing for developmental neurotoxicity (DNT) and developmental immunotoxicity (DIT) are distinct and independent modules. The appropriate study design needs to be defined, justified and documented. Specification is required for the: - length of the premating exposure duration and dose level selection, - need to extend Cohort 1B to include the mating of F1 animals to produce a F2 generation, - need to include the DNT cohorts, and - need to include the DIT cohort. The information sources the Agency considers crucial for defining the EOGRTS design are discussed in this document in addition to aspects of triggering the study itself and its various designs.