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EC number: 946-188-6
CAS number: -
The substance was not mutagenic/genotoxic in three in vitro GLP
- Ames test in bacteria (Salmonella typhimurium strains TA98, TA100,
TA1535 and TA1537 and Escherichia coli WP2 uvrA; OECD TG 471);
- Micronucleus test in human lymphocytes (the substance was
non-clastogenic and non-aneugenic) (OECD TG 487);
- HPRT test in hamster V79 lung fibroblasts (OECD TG 476).
A GLP Ames test was performed in accordance with current OECD, EU, and
EPA testing guidelines. The maximum dose level of the test item in the
first experiment was selected as the maximum recommended dose level of
5000 μg/plate. There was no visible reduction in the growth of the
bacterial background lawn at any dose level, either in the presence or
absence of metabolic activation (S9-mix), in the first mutation test
(plate incorporation method). Consequently, the same maximum dose level
was used as the maximum concentration in the second mutation test.
Similarly, there was no visible reduction in the growth of the bacterial
background lawn at any dose level, either in the presence or absence of
metabolic activation (S9-mix), in the second mutation test
(pre-incubation method). No test item precipitate was observed on the
plates at any of the doses tested in either the presence or absence of
S9-mix. There were no significant increases in the frequency of
revertant colonies recorded for any of the bacterial strains, with any
dose of the test item, either with or without metabolic
activation (S9-mix) in Experiment 1 (plate incorporation method).
Similarly, no significant increases in the frequency of revertant
colonies were recorded for any of the bacterial strains, with any dose
of the test item, either with or without metabolic activation (S9-mix)
in Experiment 2 (pre-incubation method). The positive controls were
An in vitro micronucleus test was conducted in human lymphocytes in
accordance with the OECD guideline and under GLP conditions.
All vehicle (Minimal Essential Medium) controls had frequencies of cells
with micronuclei within the range expected for normal human lymphocytes.
The positive control items induced statistically significant increases
in the frequency of cells with micronuclei. Thus, the sensitivity of the
assay and the efficacy of the S9-mix were validated.
The test item did not induce any statistically significant increases in
the frequency of binucleate cells with micronuclei in the 4-hour
exposure groups in the presence and absence of S9 using a dose range
that included a dose level that was the lowest precipitating dose level.
The 24-hour exposure group did demonstrate statistically significant
increases in the frequency of binucleate cells with micronuclei but the
increases were only marginally greater than the upper limit of the
historical control range for a vehicle and were set against a low
vehicle control value and were therefore considered to be of no
toxicological significance. The upper dose level for the scoring of the
24-hour hour exposure was limited to the lowest precipitating dose level.
A GLP in vitro gene mutation study in V79 hamster fibroblasts was
performed in accordance with the currrent OECD test guideline 475. The
test substance did not induce any toxicologically significant or
concentration-related increases in the mutant frequency at any of the
concentration levels in the main test including the dose level at the
onset of test item precipitate in both the absence and presence of
metabolic activation. Both of the exposure groups met the requirements
recommended by the OECD 476 guideline.
The vehicle (MEM) controls gave mutant frequencies within the range
expected of V79 cells at the HPRT locus.
The positive control substances induced marked increases in the mutant
frequency, sufficient to indicate the satisfactory performance of the
test and of the activity of the metabolizing system.
Based on the available data, the test substance does not require
classification for mutagenicity according to the CLP Regulation (EC) No
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