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EC number: 614-523-2
CAS number: 68475-37-6
Plate incorporation method
Manual counts were performed at 5000
µg/plate due to the presence of a test film and also on other plates
where there were spreading of revertant colonies, thus distorting the
actual plate count.
The result was deemed negative.
Master strains were checked for
characteristics, viability and spontaneous reversion rate and were all
found to be satisfactory.
Animo acid supplemented top agar, the S9
-mix and test substance formulation were shown to be sterile.
data is being read across from the source study that tested Resin acids
and Rosin acids, esters with trimethylolpropane based oncategory
read across that is explained in the category justification document
attached in Section 13 of the dossier.
The mutagenicity of the test substance,
Resin acids and Rosin acids, esters with trimethylolpropane, was
determined in Salmonella Typhimurium (S. Typhimurium)
TA98, TA100, TA1535 and TA1537 strains and E.coli Wp2uvrA strain,
in a method compatible with the following guidelines: OECD No. 471
'Bacterial Reverse Mutation Test', Method B13/14 of Commission
Regulation (EC) number 440/2008 of 30 May 2008, the USA EPA OPPTS
870.5100 - Bacterial Reverse Mutation Test and the Japanese Regulatory
Authorities including METI, MHLW and MAFF.
The bacteria were treated with the test
substance using both the Ames plate incorporation (Experiment 1) and the
pre-incubation method (Experiment 2) at eight dose levels, testing in
triplicate with and without the addition of a rat liver homogenate
metabolising system (10% liver S9 in standard co-factors). The dose
range for Experiment 1 was pre-determined to be 1.5 -5000 µg/plate,
based on the General Study Plan. The result of Experiment 1 was deemed
negative and so the test was repeated using the pre-incubation method
over the dose range of 15 -5000 µg/plate, based on results from
Experiment 1. Six test substance concentrations were chosen in
Experiment 2 in order to achieve four non-toxic dose levels and the
potential toxic limit of the test substance following the change in
methodology. The vehicle control used was acetone. The negative
untreated controls were employed in order to assess the spontaneous
revertant colony rate. The positive controls used were
N-ethyl-N'-nitro-N-nitrosoguanidine (ENNG), 9 -Aminoacridine (9AA), 4
-Nitroquinoline-1 -oxide (4NQO), 2 -Aminoanthracene (2AA) and
The maximum dose levels of the test
substance in Experiment 1 was selected as the maximum recommended dose
level of 5000 µg/plate. In both Experiment 1 and 2, there was no visible
reduction in the growth of the bacterial background lawn in any of the
doses tested in the presence and absence of the S9 -mix. At 1500
µg/plate, there was a cream-coloured test substance film observed, but
it did not inhibit the scoring of the revertant colonies. There were
also no toxicologically significant increases observed in the frequency
of revertant colonies for any of the bacterial strains at any of the
doses tested, both with and without the S9 -mix.
The vehicle (acetone) control produced
counts of revertant colonies falling within the normal range and all of
the positive control chemicals induced marked increases in the frequency
of revertant colonies, both with and without metabolic activation. All
of the evaluation and acceptability criteria were, therefore this
validated the sensitivity of the assay and the efficacy of the S9 -mix.
Based on the results of the study and in
accordance with the evaluation criteria, the test substance, Resin acids
and Rosin acids, esters with trimethylolpropane, was considered to be
non-mutagenic to the bacterial strains testsed under the conditions of
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