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EC number: 234-974-5
CAS number: 12047-11-9
Two different in vitro studies were performed to evaluate the
mutagenicity of barium hexaferrite. In Salmonella and E.coli the
substance did not shown mutagenic activity, while some positive results
were observed in vitro micronucleus test performed on V79 and CHO cell
lines. During the preliminary citotoxicity test (performed in order to
evaluate the most suitable concentrations of test substance for both CHO
and V79 cells), an unexpected, marked citotoxicity was observed in CHO
cells not exposed to the substance but treated with metabolic activator
S9. For this reason, CHO cells were tested with the substance only in
absence of S9 activation, while V79 cells were exposed to barium
hexaferrite both with and without S9. Positive results were observed at
the highest concentration levels tested for both CHO and V79 cells; in
V79 cells the mutagen activity was observed only in presence of
metabolic system. Overall, the results are unclear. The citotoxicity due
to S9 in CHO cells and the different results observed in the two cell
lines 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 further test was performed.
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