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EC number: 411-370-1
CAS number: 82857-68-9
GM 102 E
reverse gene mutation assay in bacteria, performed according to the OECD
No.471 guideline and in compliance with GLP, GM102E diluted in DMSO was
tested in S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100 in
the presence and the absence of mammalian metabolic activation (S9).
Four known mutagens (Sodium azide; 2-Aminoanthracene; 2-nitrofluorene
and 9-aminoacridine), dissolved in dimethylsulfoxide (except for sodium
azide which was dissolved in sterile distilled water), were used to
check the sensitivity of the test system.
preliminary study (one plate/concentration) was performed in order to
determine the appropriate concentrations for the two independent main
studies (3 plates/concentration). In the preliminary study, the
bacterial strain TA100 was exposed to the test substance at the
following concentrations: 33 µg, 100 µg, 333 µg, 1 mg, 3.3 mg and 10 mg
per plate. Cytotoxicity, assessed by the decrease in the number of
revertants and/or the thinning of the bacterial lawn, was observed from
a concentration of 3.3 mg/plate in the presence of S9-mix (a moderate to
strong toxicity was noted at 10 mg/plate) and from 1 mg/plate in the
absence of S9-mix (a strong toxicity was noted at dose-levels ≥ 3.3
In the main
studies GM102E was tested with and without S9 mix at 10, 33, 100, 333,
1000, 3300 µg/plate for the TA 1535, TA 1537, TA 1538, TA 98 and TA 100
strains in both experiments. The results of the two main tests showed
that toxicity was observed in the presence of S9-mix in strains TA 1535
and TA 1538 at the top dose tested of 3.3 mg/plate. In the absence of
S9-mix, toxicity was noted from 333 µg/plate in strain TA 1535, from 1
mg/plate in strain TA 1538 and at 3.3 mg/plate in strains 1537, TA 98
and TA100. The number of revertants for the vehicle and positive
controls met the acceptance criteria. The study was therefore considered
to be valid. The test item did not induce any noteworthy or biologically
relevant increase in the number of revertants, in any of the other
test conditions, GM102E did not show any mutagenic activity in the
bacterial reverse mutation test using Salmonella typhimurium. This study
is considered as acceptable as it satisfied the criteria of the OECD
Guideline No. 471.
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