请教做过乌克兰登记的朋友们,关于报告的要求如何处理,比如:
1. active ingredient subchronical toxicity, 28 days, 90 days rodents, 90 days other animals(own research transactions)
2. active ingredient chronic toxicity (own research transactions)有效成分慢性
3. active ingredient mutagenicity (own research transactions)有效成分诱变性
4. active ingredient reproductive toxicity (own research transactions)有效成分生殖毒性
5. active ingredient teratogenicity (own research transactions)有效成分致畸性
6. active ingredient neurotoxicity (own research transactions)有效成分神经毒性
7. metabolite and other decay product and additives toxicity (own research transactions)代谢物、其他衰变产物及添加剂的毒性
8. carcinogenicity (own research transactions)有效成分致癌性
9. hygienic evaluation of the application conditions (own research transactions)使用条件的卫生学评估
a) hygienic specialties while application使用时的特殊卫生学条件
b) hygienic measurement data (permissible daily dose, soil mesurement data, water mesurement data, fish pool mesurement data, working zone air mesurement data, air mesurement data, foods mesurement data, hygienic regulations of safe application)卫生学测量值(ADI,土壤、水、鱼塘、工作区空气、空气、食物等的测量值,安全使用的卫生学规范
10. toxicity for people (other companies’ research transactions possible)对人的毒性
11. impact on the non-purpose objects (other companies’ research transactions possible)对非靶标生物的影响(1.蜜蜂饲料中的最大允许量、在蜜蜂植物上使用的管理; 2.对鱼的急慢性毒性,对鱼卵的慢性毒性,鱼苗的慢性毒性,对鱼卵、鱼苗、市场销售鱼种的生殖毒性,鱼的生物富集,对水蚤的急性毒性及生殖毒性,对海藻的生长抑制,对有益生物的影响;3. 对鸟的急性毒性;4. 在土壤和水中的降解和转化)
a) safety for the insects pollinators (maximum allowable concentration in the fodder for bees, regulations for application on the bee plants)
b) other toxicological information (acute toxicity for fish; chronical toxicity for fish; chronical toxicity for spawn; chronical toxicity for young fish; reproductive research on fish (spawn, young fish, marketable fish); bioaccumulation; acute toxicity for daphnies; reproductive research on daphnies; algae growth inhibition; influence on useful insects; acute toxicity for birds; influence on game)
c) degradation and transformation in water and soil
还有好多,要求的这些“research transactions”都需要是实验室出的报告的形式吗?还是只要概括一下就可以了呢?这么多报告也太折磨人了吧!请高人指点。