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Is there a rationale for direct dosing of chemicals to nursing pups in the EOGRTS (OECD 443)?
Regulatory Toxicology and Pharmacology ( IF 3.0 ) Pub Date : 2020-03-09 , DOI: 10.1016/j.yrtph.2020.104641
Josje Arts 1 , Manon Beekhuijzen 2
Affiliation  

In OECD guideline 443 - Extended One Generation Reproductive Toxicity Study (EOGRTS) - to be used for testing industrial and agrochemicals, it has been indicated that careful consideration of benefits and disadvantages should be made prior to conducting direct-dosing studies in nursing pups. Nursing pups will not be directly dosed in dietary and drinking water studies whereas in oral gavage studies this possibility exists. Besides the risk of intubation trauma and overdosing due to direct exposure and exposure via the mother's milk, direct dosing could lead to a different hazard assessment of chemicals depending on the choice of the route of administration. In addition, in case of industrial and agrochemicals used in industrial or professional settings only, there will never be direct exposure of newborns. Moreover, direct dosing of nursing pups is an artificial, non-physiological, route of exposure and as such it would hamper risk assessment. It should therefore only be considered in exceptional cases and justified on a case-by-case approach.

中文翻译:

在EOGRTS(OECD 443)中是否有向护理幼犬直接配药的理由?

在用于测试工业和农用化学品的经合组织准则443(扩展的一代生殖毒性研究(EOGRTS))中,已经表明在对护理幼崽进行直接剂量研究之前,应仔细考虑其利弊。在饮食和饮用水研究中,不会直接给幼崽喂食,而在管饲法研究中,这种可能性是存在的。除了因直接暴露和通过母乳暴露而引起的插管创伤和用药过量的风险外,根据给药途径的选择,直接用药可能会导致对化学品的不同危害评估。此外,仅在工业或专业环境中使用工业和农用化学品时,绝对不会直接接触新生儿。此外,幼犬的直接给药是一种人为的,非生理的接触途径,因此会妨碍风险评估。因此,仅在特殊情况下才应考虑该问题,并应根据具体情况进行论证。
更新日期:2020-03-09
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