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EC number: 947-313-7
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. The experiment was repeated
on a separate day using fresh cultures of the bacterial strains and
fresh test item formulations. The dose range was amended following the
results of Experiment 1 and ranged between 1.5 and 5000 µg/plate,
depending on bacterial strain type and presence or absence of S9-mix. Up
to seven test item concentrations were selected in Experiment 2 in order
to achieve both four non‑toxic dose levels and the toxic limit of the
The vehicle (acetone) 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 the first mutation test, the test item
caused a visible reduction in the growth of the bacterial background
lawns of all of the bacterial tester strains from 500 μg/plate (WP2uvrA
and TA1537), 1500 μg/plate (TA100) and 5000 μg/plate (TA1535 and TA98)
in the absence of S9-mix and to one bacterial strain (TA1537) at 5000
μg/plate in the presence S9-mix. Consequently, the toxic limit or the
maximum recommended dose (5000 μg/plate) of the test item was employed
as the maximum dose in the second mutation test, depending on bacterial
tester strain type and presence or absence of S9-mix. In the second
mutation test, the test item again induced a toxic response with
weakened bacterial background lawns noted in the absence of S9-mix from
1500 μg/plate (TA1535, WP2uvrA, TA98 and TA1537) and 5000 μg/plate
(TA100). In the presence S9-mix weakened bacterial background lawns were
noted to two of the bacterial tester strains from 3000 μg/plate (TA1535)
and at 5000 μg/plate (TA1537). The sensitivity of the bacterial tester
strains to the toxicity of the test item varied slightly between strain
type, exposures with or without S9-mix and experiment.
A test item precipitate (light and globular
in appearance) was noted at 5000 µg/plate, this observation did not
prevent the scoring of revertant colonies.
There were no biologically relevant
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. Similarly, no
biologically relevant 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. Small increases in TA1535 revertant colony frequency were
observed in the presence of S9‑mix at 1500 and 5000 µg/plate in
Experiment 1. These increases were considered to have no biological
relevance because there was no clear dose-response relationship (the
increases were very flat over the two dose levels) and the results could
not be reproduced in the second experiment which contained extra
intermediate test item concentration levels, in an attempt to qualify
the response. Furthermore, the test item exhibited variable toxicity
under certain circumstances (weakened bacterial background lawns were
noted at 3000 and 5000 μg/plate in Experiment 2) and although, weakened
lawns weren’t noted to the tester strain in Experiment1, the increases
noted at 1500 and 5000 μg/plate may have been an artefact resulting from
a modest level of toxicity to the tester strain at the upper test item
dose levels i.e. enough weakening of the background lawns (toxicity) to
induce a ‘false’ response.
Under the test condition, 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 or cytotoxic 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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