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EC number: 629-732-4
CAS number: 1224966-13-5
The objective of this study was to evaluate
the potential of the test substance BASE 136 (batch No. AB771) to induce
reverse mutation inSalmonella typhimurium.
A preliminary toxicity test was
performed to define the dose-levels of BASE 136 to be used for the
mutagenicity study. The test substance was then tested in two
independent experiments with and three independent experiments without a
metabolic activation system, the S9 mix, prepared from a liver
microsomal fraction (S9 fraction) of rats induced with Aroclor 1254.
All experiments were performed
according to the direct plate incorporation method except for the second
test with S9 mix, which was performed according to the preincubation
method (60 minutes, 37°C).
Five strains of bacteriaSalmonella
typhimurium:TA 1535, TA 1537, TA 98, TA 100 and TA 102 were used.
Each strain was exposed to five dose-levels of the test substance (three
plates/dose-level). After 48 to 72 hours of incubation at 37°C, the
revertant colonies were scored.
The evaluation of the toxicity was
performed on the basis of the observation of the decrease in the number
of revertant colonies and/or a thinning of the bacterial lawn.
The test substance BASE 136 was
dissolved in dimethylsulfoxide (DMSO).
The dose-levels of the positive
controls were as follows:
Without S9 mix:
- 1 µg/plate of sodium azide (NaN3): TA 1535
and TA 100 strains,
- 50 µg/plate of 9-Aminoacridine (9AA): TA
- 0.5 µg/plate of 2-Nitrofluorene (2NF): TA
- 0.5 µg/plate of Mitomycin C (MMC): TA 102
- 2 µg/plate of2-Anthramine (2AM): TA 1535,
TA 1537, TA 98 and TA 100 strains,
- 10 µg/plate of2-Anthramine (2AM): TA 102
Since the test substance was toxic in the
preliminary test, the choice of the highest dose-level for the main test
was based on the level of toxicity, according to the criteria specified
in the international guidelines.
Experiments without S9 mix:
- 12.5,25,50, 100 and 200 µg/plate: for all
tester strains in the first experiment,
- 6.25, 12.5,25,50 and 100 µg/plate: for all
tester strains in the second experiment,
- 1.5625, 3.125, 6.25, 12.5 and 25 µg/plate:
for all tester strains in the third experiment.
A slight to marked toxicity was induced in
the tester strains, depending on the dose-levels.
In the three experiments, no noteworthy
increase in the number of revertants was observed in all the tested
Experiments with S9 mix:
- 12.5, 25, 50, 100 and 200 µg/plate: for
all tester strains in both experiments, except for the TA 1537 strain in
the second experiment,
- 6.25, 12.5,25,50 and 100 µg/plate: for the
TA 1537 strain in the second experiment.
A slight to moderate toxicity was induced,
depending on the tester strain, the dose-levels and the experimental
In both experiments, no noteworthy increase
in the number of revertants was observed in all the tested strains.
The number of revertants for the vehicle and
positive controls was as specified in the acceptance criteria. The study
was therefore considered valid.
This study on Fatty acids C16-18, C18 unsat
reaction products with tetraethylenepentamine is valid for the
evaluation of Tall oil fatty acids, reaction products with
All substances within the AAI group show the
same reactive groups, show similar composition of amide, imidazoline,
and some dimer structures of both, with the length of original EA amines
used for production as biggest difference. Inherent reactivity and
toxicity is not expected to differ much between these substances,
aspects which determine genotoxicty.
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.
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