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EC number: 234-974-5
CAS number: 12047-11-9
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
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