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EC number: 271-080-4
CAS number: 68515-39-9
A complex combination of hydrocarbons produced by the esterification of phthalic anhydride with tridecyl alcohol. It consists predominantly of C13 primary aliphatic alcohols, C11-13 paraffins and saturated and unsaturated C26 ethers and boiling in the range of approximately 120°C to 280°C (248°F to 536°F).
This study was performed to investigate the potential of the study substance to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
Strain TA 100: 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
The remaining strains: 33; 100; 333; 1000; 2500; and 5000 μg/plate
The test item precipitated in the overlay agar in the test tubes from 1000 to 5000 μg/plate with and without S9 mix in both experiments. Precipitation of the test item in the overlay agar on the incubated agar plates was observed at 5000 μg/plate without S9 mix and from 1000 to 5000 μg/plate with S9 mix. The undissolved particles had no influence on the data recording.
The plates incubated with the study substance showed reduced background growth in experiment I in strains TA 1537 and TA 100 with and without S9 mix, and in experiment II in all strains with S9 mix and in strains TA 1537 and TA 100 without S9 mix.
Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), were observed in strain TA 100 in experiment I at 5000 μg/plate without S9 mix and from 1000 to 5000 μg/plate with S9 mix, and in experiment II at 5000 μg/plate with and without S9 mix. In the remaining strains no toxic effects were observed, neither in the presence nor absence of metabolic activation
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the study substance at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
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