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Is there a rationale for direct dosing of chemicals to nursing pups in the EOGRTS (OECD 443)?
Josje Arts1, Manon Beekhuijzen2
1Nouryon Chemicals BV, Velperweg 76, 6824 BM, Arnhem, Netherlands.
Abstract:
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.
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