Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 947-655-7
CAS number: -
typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli
strain WP2uvrA were treated with the test item using both the Ames plate
incorporation and pre-incubation methods at up to eight dose levels, in
triplicate, both with and without the addition of a rat liver homogenate
metabolizing system (10% liver S9 in standard co-factors). The dose
range for Experiment 1 was predetermined and was 1.5 to 5000 µg/plate.
The experiment was repeated on a separate day (pre-incubation method)
using fresh cultures of the bacterial strains and fresh test item
formulations. The dose range was amended following the results of
Experiment 1 and was 5 to 5000 µg/plate.
test item dose levels were selected in Experiment 2 in order to achieve
both a minimum of four non-toxic dose levels and the toxic limit of the
test item following the change in test methodology.
vehicle (sterile distilled water) 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.
maximum dose level of the test item in the first experiment was selected
as the maximum recommended dose level of 5000 µg/plate. In the first
mutation test (plate incorporation method) the test item induced a
visible reduction in the growth of the bacterial background lawn of
Salmonella strain TA100 at 5000 µg/plate in the absence of metabolic
activation (S9-mix). Reductions in revertant colony frequency (without a
significant weakening of the bacterial background lawns) were also noted
from 1500 µg/plate to TA1537 and TA1535 dosed in the absence of S9-mix
and to TA1537 and TA100 at 5000 µg/plate dosed in the presence of
S9-mix. These results were not indicative of toxicity sufficiently
severe enough to prevent the test item being tested up to the maximum
recommended dose level of 5000 µg/plate in the second mutation test. The
test item induced a stronger toxic response after employing the
pre-incubation method in Experiment 2 with weakened bacterial background
lawns noted in the absence of S9-mix from 1500 µg/plate (TA100 and
TA1535) and at 5000 µg/plate (TA98 and TA1537). In the presence of
S9-mix, weakened lawns were noted to TA100 at and above 1500 µg/plate
with substantial reductions in TA1537 revertant colony frequency noted
at 5000 µg/plate. The sensitivity of the bacterial tester strains to the
toxicity of the test item varied both between strain type, exposures
with and without S9-mix and experimental methodology. 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
unsaturated fatty acids, reaction products with 1-aminopropan-2-ol,
maleic anhydride and sodium bisulfite was considered to be non-mutagenic
under the conditions of this test.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again