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- W4200178039 abstract "In 2018, the risk assessment for tebufenozide in light of confirmatory data requested following approval in accordance with Article 6(1) of Directive 91/414/EEC and Article 6(f) of Regulation (EC) No 1107/2009 concluded that based on the submitted data, the metabolite RH-2651 has to be considered as a relevant groundwater metabolite since the absence of genotoxic potential in vivo was not fully demonstrated. Following further considerations during the decision-making process, the European Commission asked EFSA on 14 July 2021 to provide its scientific view on the genotoxic potential of the metabolite RH-2651 following consideration of new experimental data submitted by the applicant under Article 21(2) of Regulation (EC) No 1107/2009. Based on the available data, it is concluded that metabolite RH-2651 does not have genotoxic potential and therefore is not automatically considered a relevant groundwater metabolite." @default.
- W4200178039 created "2021-12-31" @default.
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- W4200178039 date "2021-11-01" @default.
- W4200178039 modified "2023-09-27" @default.
- W4200178039 title "Statement on the relevance of the groundwater metabolite RH‐2651 in the assessment of confirmatory data on the active substance tebufenozide" @default.
- W4200178039 cites W4205810581 @default.
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- W4200178039 doi "https://doi.org/10.2903/j.efsa.2021.6920" @default.
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