Registration Dossier

Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
genetic toxicity in vivo, other
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Conclusions:
The uncertainties, which are arisen from the in vitro test results, would make desirable a verification by means of an in vivo test, as it is foreseen by the Regulation EC 1907/2006. However, toxicokinetics evidences do not support the adsorption (after oral administration) and the subsequently reaching of the target tissue by the substance, making non reliable the validated in vivo mutagenicity tests. Indeed, B.11 (In Vivo Mammalian Bone Marrow Chromosome Aberration Test) and B.12 (In Vivo Mammalian Erythrocyte Micronucleus Test) sections of the Regulation CE 440/2008 reports that: "If there is evidence that the test substance, or a reactive metabolite, will not reach the target tissue, it is not appropriate to use this test". In light of above issue, no in vivo test was performed.
Executive summary:

The uncertainties, which are arisen from the in vitro test results, would make desirable a verification by means of an in vivo test, as it is foreseen by the Regulation EC 1907/2006. However, toxicokinetics evidences do not support the adsorption (after oral administration) and the subsequently reaching of the target tissue by the substance, making non reliable the validated in vivo mutagenicity tests. Indeed, B.11 (In Vivo Mammalian Bone Marrow Chromosome Aberration Test) and B.12 (In Vivo Mammalian Erythrocyte Micronucleus Test) sections of the Regulation CE 440/2008 reports that: "If there is evidence that the test substance, or a reactive metabolite, will not reach the target tissue, it is not appropriate to use this test". In light of above issue, no in vivo test was performed.