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EC number: 430-150-6
CAS number: -
In a reverse gene mutation assay performed
according to the OECD test guideline No. 471 and No. 472 and in
compliance with GLP, S. typhimurium strains TA1535, TA1537, TA98, TA100
and E. coli strains WP2(pKM101) and WP2uvrA(pKM101) were exposed to the
test material diluted in DMSO both in the presence and absence of
metabolic activation system using the plate incorporation method. The
dose range was determined in a preliminary toxicity assay and ranged
between 1.5-150 µg/plate (without S9-mix) and 5- 500 µg/plate (with
S9-mix). In a complementary assay with S9-mix in TA1537 strain, dose
range was between 5-500 µg/plate. Mutagenicity test was repeated using
dose range between 1.5-150 µg/plate in all strains without S9-mix using
direct plate incorporation method and with S9-mix using pre-incubation
Vehicle (DMSO) and positive control groups
were also included in mutagenicity tests.
A significant increase in the number of
revertants was observed in the presence of reference positive
substances. Thus, the sensitivity of the assay and the efficacy of the
S9-mix were validated. The frequency of spontaneous revertants (solvent
controls) in each strain was within the limits of historical controls.
Toxic effects were noted at 5000, 1500 and 500 µg/plate (without S9-mix)
and at 5000 and 1500 µg/plate (with S9-mix) in all the tested strains.
In the absence of metabolic activation, in
two independant assays, no significant increase in the number of
revertants was noted in the presence of the test compound.
In the first assay in the presence of
metabolic activation without pre-incubation, a slight increase (3 times
the number of spontaneous revertants) at the limit of biological
significance was noted at 50 µg/plate in TA1537 strain. However, in an
independent complementary assay performed under the same operating
conditions, no significant increase in the number of revertants was
observed in this strain. Therefore, the effect observed in the first
assay was not reproducible. In addition, it was not dose-related, not
statistically significant and cannot be attributed to a significant
mutagenic activity of the test compound. Furthermore, in the same first
assay with metabolic activation, no significant increase in the number
of revertants was seen in other bacterial strains.
In the second assay in the presence of
metabolic activation using pre-incubation method, no significant
increase in the number of revertants was observed in all the bacterial
It is noted that in the first assay in the
presence of metabolic activation without pre-incubation in strains TA98
and WP2(pKM101) at the highest dose tested of 500 µg/plate and in the
second assay with pre-incubation in all the strains tested at the
maximum dose or at two first highest doses of 150 and 50 µg/plate, a
statistically significant decrease in the number of revertants was
found. However, this effect which was due to the toxic activity of the
test compound at high doses, had no meaning in terms of mutagenic
Under the test condition, the test material
is not mutagenic with and without metabolic activation to S. typhimurium
strains TA1535, TA1537, TA98,TA100 and E. coli strains WP2(pKM101) and
WP2uvrA(pKM101) according to the criteria of the Annex VI of the of the
Regulation (EC) No.1272/2008 (CLP) and according to the GHS.
This study is considered as acceptable and
satisfies the requirement for reverse gene mutation endpoint.
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