OECD 一代繁殖 毒理学标准.pdfVIP

1 1 Merged draft version 4, 2008-06-18 2 3 Text highlighted in yellow raises particular discussion points 4 5 Preliminary statement: 6 7 This project is developed by a team of 3 lead countries, the USA, 8 Germany and the Netherlands. The present draft TG reflects the 9 consensus of the 3 lead countries for many issues but NOT for all of 10 them. Some of the comments that have been inserted in the draft focus 11 on these issues, still debated within the lead countries. 12 13 14 15 DRAFT Extended One-Generation 16 Reproductive Toxicity TEST GUIDELINE 17 18 19 OECD/OCDE XXX 20 21 OECD GUIDELINE FOR THE TESTING OF CHEMICALS 22 23 24 INTRODUCTION 25 1. This Test Guideline has been designed to meet different regulatory needs and to address the 26 common goal of reduced/refined animal testing for toxicity to reproduction and offspring 27 development. The TG is largely based on the International Life Science Institute (ILSI)-Health 28 and Environmental Sciences Institute (HESI), Agricultural Chemical Safety Assessment (ACSA) 29 Technical Committee proposal for a life stage F1 extended study published in Cooper et al., 2006 30 [1]. Several improvements and clarifications have been made to the study design to provide 31 flexibility and a more efficient testing approach by stressing the importance of starting with 32 existing knowledge and using in-life observations to guide and tailor the testing. Depending on 33 the information available and the data required for regulatory purposes, this test can serve as an 34 alternative to other protocols intended to examine r