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EC number: 946-615-6
CAS number: -
- Ames Test (OECD 471, GLP, K, rel. 1): non
mutagenic up to limit or cytotoxic concentration in S. typhimurium TA
1535, TA 1537, TA 98, TA 100 & E.coli WP2uvrA.
Cf Tables of results in attached background
In a reverse gene mutation assay performed
according to the OECD test guideline No. 471 and in compliance with GLP,
Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and
Escherichia coli strain WP2uvrA were treated with the test item diluted
in acetone both in the presence and absence of metabolic activation
system (10% liver S9 in standard co-factors) using the Ames
pre‑incubation methods in Experiment 1 and 2.
The dose range for Experiment 1 was
predetermined and was 1.5 to 5000 mg/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). The experiment was repeated on a separate day using fresh
cultures of the bacterial strains and fresh test item formulations. the
same maximum dose level was used as the maximum dose in the first
mutation test (5000 µg/plate). Up to six test item concentrations were
selected in Experiment 2 in order to achieve both four non‑toxic dose
levels and the toxic limit of the test item.
The vehicle (tetrahydrofuran) control plates
gave counts of revertant colonies within the normal range. All of the
positive control chemicals used in the test induced marked increases in
the frequency of revertant colonies, both with or without metabolic
activation. Thus, the sensitivity of the assay and the efficacy of the
S9-mix were validated.
In Experiment 1, there were no 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. In Experiment 2, similarly, there were any
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.
No test item precipitate was observed on the
plates at any of the doses tested in either the presence or absence of
S9-mix in both experiments.
Under the test condition, the test material
is not mutagenic with and without metabolic activation in S. typhimurium
(strains TA1535, TA1537, TA98 and TA100) and E.coli WP2 uvrA.
This study is considered as acceptable and
satisfies the requirement for reverse gene mutation endpoint.
7.6/1: Summary of genotoxicity tests
Test / Guideline
K, rel. 1
E. coli WP2uvrA
Up to limit concentration
-S9 : non mutagenic
+S9 : non mutagenic
Gene mutation Assays (Tests n° 1):
Bacterial Reverse mutation Assay (Ames test) was performed according to
OECD guideline No. 471 with the substance (Test n°1, see Table 7.6/1).
No significant increases in the frequency of revertant colonies were
recorded for any of the bacterial strains under the test condition, with
any dose of the substance, either in the presence or absence of
metabolic activation. The substance does not induce gene mutations in
bacteria whereas all positive control chemicals (with and without
metabolic activation) induced significant increase of colonies. The
substance is therefore considered as non-mutagenic according to the Ames
test material has no harmonized classification for human health
according to the Regulation (EC) No. 1272/2008.
on the available data, no additional classification is proposed
regarding germ cell mutagenicity according to the Regulation (EC) No.
1272/2008 (CLP) and to the
Globally Harmonised System of classification and labelling of chemicals
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