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EC number: 417-790-1
CAS number: 78418-01-6
Table 1: group means for
animals sacrificed at 24 h
Table 2: group means for
animals sacrificed at 48 h
Table 3: group means for animals sacrificed at 72 h
In an in vivo micronucleus test similar to
OECD guideline 474 and in compliance with GLP, mice were exposed to
Mexoryl SAB. In a range finding assay, pairs of male mice were orally
exposed to Mexoryl SAB at concentrations of 50, 320 and 1000 mg/kg
without any critical sign of toxicity. Then, 5 animals/sex/dose/time of
sacrifice were given single dose of 250, 500 and 1000 mg/kg of Mexoryl
SAB by oral gavage and were sacrificed at 24, 48 and 72 h after dosing.
Then bone marrow cells were harvested, stained with Giemsa and analysed
Positive controls (mitomycin C at 4 mg/kg
intraperitoneally) induced an appropriate increase in the number of
polychromatic erythrocytes. Micronuclei were not induced at any tested
concentrations and at any time of sacrifice in control and in Meroxyl
SAB-treated mice despite a decrease in polychromatic
erythrocytes/normochromatic erythrocytes for 1000 mg/kg at 24 h.
Under the test conditions, Mexoryl SAB was
found not to be clastogenic in vivo in mice.
In a reverse gene mutation assay in
bacteria, performed similarly to the OECD guideline 471, in compliance
with GLP, MEXORYL SAB was not mutagenic in S. typhimurium (TA 1535, TA
1537, TA 1538, TA 100 and TA 98) and one Escherichia coli strain (WP2
In an in vitro chromosome aberration test
performed in Chinese Hamster Ovary (CHO) cells according to OECD
guideline 473 and in compliance with GLP, MEXORYL SAB induced an
increase in chromosome aberrations only in presence of metabolic
In an in vivo micronucleus test performed in
mice, similar to OECD guideline 474 and in compliance with GLP,
micronuclei were not induced at any tested concentrations and at any
time of sacrifice in control and in MEXORYL SAB-treated mice despite a
decrease in polychromatic erythrocytes/normochromatic erythrocytes for
1000 mg/kg at 24 h.
Also, in a GLP study conducted in compliance
with OECD guideline 486, MEXORYL SAB did not induce unscheduled DNA
synthesis in primary rat hepatocytes after in vivo treatment up to 2000
Despite an induction of chromosome
aberrations in presence of metabolic activation, MEXORYL SAB was
negative in two in vivo tests (micronulceus test in mice and UDS in rats
hepatocytesafter in vivo treatment) and was not mutagenic in several
bacterial strains. Therefore, MEXORYL SAB is not classified as
mutagenic according to Directive 67/548/EEC and in CLP Regulation.
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