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EC number: 205-031-5
CAS number: 131-57-7
Oxybenzone was found negative for inducing gene mutations in four in
vitro studies (two Ames tests according to OECD 471, Mammalian
Chromosome Aberration test according to OECD 473 and Mammalian Cells
Gene Mutation test according to OECD 476), all conducted in the presence
and absence of metabolic activation. The key Ames test studied five
mutant strains of Salmonella typhimurium (TA1535, TA1537, TA 1538, TA98,
and TA100) with and without liver homogenate (S9) as well as E. coli WP2
with and without liver homogenate (S9) in test concentrations up to 1250
µg per plate. No increase in revertant colony numbers of any of the
tester strains was observed following treatment with oxybenzone at any
dose level, neither in the presence nor absence of metabolic activation
(S9 mix). The second supporting Ames test was performed using four
strains of Salmonella typhimurium (TA1535, TA1537, TA98, and TA100) with
and without liver homogenate (S9) as well as E. coli WP2 with and
without liver homogenate (S9) in test concentrations up to 5000 µg per
plate. In both studies there was no tendency of higher mutation rates
with increasing concentrations in the range below the generally
acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls in both
studies and showed a distinct increase of induced revertant colonies.
In conclusion, these results indicated that test article was not
mutagenic to Salmonella typhimurium strains TA1535,TA1537, TA 1538,
TA98, and TA100 or to E. coli WP2 in the absence and presence of a
The third in vitro study was performed to evaluate the potential to
induce structural chromosomal aberrations in V79 Chinese Hamster cells
in the absence and the presence of artificial sunlight (with and without
metabolic activation) in two independent experiments according to OECD
guideline 473. The test article was applied up to 75 µM. In the assay,
based on the results given in this study, oxybenzone, was found not to
induce structural chromosome aberrations in the absence or presence of
artificial sunlight in V79 Chinese Hamster cells. Therefore, the test
article was shown to be non-clastogenic in this chromosomal aberration
photomutagenicity test when tested up to cytotoxic concentrations.
The third in vitro study was performed to investigate the potential of
oxybenzone to induce gene mutations at the HPRT locus in V79 cells of
the Chinese hamster according to OECD guideline 476.The test article was
applied up to 2283 µg/ml in the pre-test and up to 160 µg/ml in the two
main tests. No substantial and reproducible dose dependent increase of
the mutation frequency was observed in either of the main experiments.
Thus, the test item did not induce gene mutation effects at the HPRT
locus in V79 cells.
As all available in vitro tests were negative, in vivo data are not
does not have to be classified for mutagenicity according to the
criteria laid down in the EU Dangerous Substances Directive (67/548/EEC)
and in the EU Classification Labelling and Packaging Regulation
(1272/2008/EC) because it did not reveal any mutagenic effect in the
bacterial reverse mutation assay in the presence or absence of metabolic
activation, in the mammalian cell gene (HPRT) mutation test in V79 cells
or in an in vitro chromosomal aberration test.
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