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EC number: 271-237-7
CAS number: 68526-89-6
A complex combination of hydrocarbons produced by the distillation of products from the hydrogenation of isononanal from the hydroformylation of octene. It consists predominantly of C9-10 primary aliphatic alcohols, C10-20 dimer alcohols, C>18 acetals and esters and C>18 acid sodium salts and boils in the range of approximately 200°C to 400°C (392°F to 752°F).
No relevant and reproducible increase in mutant colony numbers/1000000
cells was observed in the main experiments up to the maximal
concentration. The induction factor of three times the corresponding
solvent control was exceeded in experiment III, culture II with
metabolic activation at almost all of the concentrations. However, this
effect was not considered biologically relevant since it was not
reproduced in the parallel culture performed under identical
experimental conditions and was not dose dependent as indicated by the
lacking statistical significance. In fact, this increase is based on the
low corresponding solvent control of just 5.0 colonies per 1000000
cells. All of the mutation frequency values remained within the
historical range of solvent controls. An isolated but substantial
increase of the mutation frequency was noted in the second culture of
the second experiment at 20 μg/mL. However, no comparable increase
occurred in the parallel culture under identical conditions. Still, the
increase was statistically relevant so, the experiment was repeated to
verify this increase. No increase of the mutation frequency was observed
in the repeat experiment though the cytotoxic range of approximately
10-20% relative cloning efficiency I was covered.
A linear regression analysis (least squares) was performed to assess a
possible dose dependent increase of mutant frequencies using SYSTAT®11
statistics software. A significant dose dependent trend of the mutation
frequency indicated by a probability value of <0.05 was detected in the
second culture of the first experiment with metabolic activation. Since
the mutation frequency did not exceed the threshold of three times the
corresponding solvent control the statistical result was considered as
biologically irrelevant. Another significant trend was detected in the
second culture of the second experiment without metabolic activation.
This trend was relevant since the mutation frequency exceeded the
threshold as well and resulted in an additional verifying experiment. A
significant dose dependent trend of the mutation frequency indicated by
a probability value of <0.05 was also detected in the first culture of
the first experiment with metabolic activation and in the second culture
of the second experiment with metabolic activation. These trends
however, were judged as irrelevant since both were reciprocal, going
down versus increasing concentrations.
In the main experiments (with and without S9 mix) the range of the
solvent controls was from 5.0 up to 31.0 mutants per 1000000 cells; the
range of the groups treated with the test item was from 0.0 up to 453.1
mutants per 1000000 cells.
EMS (0.15 mg/mL in experiment I and II, and 0.075 mg/mL in experiment
III) and DMBA (1.1 μg/mL) were used as positive controls and showed a
distinct increase in induced mutant colonies.
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