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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).
in vitro: Ames: negative, Evonik, 1571/0020, 2009, OECD 471
HPRT: negative, BASF AG, 1290609, 2010, OECD 476
MNT: negative, BASF SE, 33M0015/08M018, 2014, OECD487
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.
The exact numbers of micronucleated cells as well as on cytotoxicity are
summarized in the attached documents
Valid experimental data were available to assess the genetic toxicity of
Octene (hydroformylation products, high-boiling) in vitro.
Gene mutation in bacteria:
The substance was tested for its mutagenic potential based on the
ability to induce back mutations in selected loci in Salmonella
typhimurium strains TA 1535, TA 100, TA 1537, TA 98, and E. coli
WP2uvrA- at concentrations ranging from 50 to 5000 µg/plate in the Ames
test according to OECD Guideline 471 (Evonik, 1571/0020, 2009). The
assay was performed using the Standard plate test with and without
metabolic activation (phenobarbitone/ß-naphthoflavone induced rat liver
microsomes), respectively. The test material caused no visible reduction
in the growth of the bacterial background lawn at any dose level and
was, therefore, tested up to the maximum recommended dose level of 5000
µg/plate. A fine, particulate precipitate was observed at and above 1500
µg/plate, this observation did not prevent the scoring of revertant
colonies. No significant increases in the frequency of revertant
colonies were recorded for any of the bacterial strains, with any dose
of the test material, either with or without metabolic activation. This
result is supported by another study similar to OECD Guideline 407 which
shows similar results.
Gene mutation in mammalian cells:
A valid study according to OECD Guideline 476 was done by BASF in 2010.
In this study, three independent experiments were performed, using two
parallel cultures each. The first main experiment was performed with and
without liver microsomal activation and a treatment period of 4 hours.
The second experiment was performed with a treatment time of 4 hours
with and 24 hours without metabolic activation. To verify the results of
the second experiment a third experiment was performed under identical
general conditions with and without metabolic activation and adjusted
concentrations. The tested concentrations were between 0.16 and 640
µg/mL. No substantial and reproducible dose dependent increase of the
mutation frequency was observed in both main experiments. Appropriate
reference mutagens, used as positive controls, induced a distinct
increase in mutant colonies and thus, showed the sensitivity of the test
item and the activity of the metabolic activation system.
In vitro Micronucleus test:
The ability of the test substance to induce mircronuclei in V79 cells in
vitro (clastogenic or aneugenic activity) was determined according to
OECD Test guideline 487 and GLP (BASF SE, 2014). Three independent
experiments with duplicates for each condition were carried out with and
without the addition of liver S9 mix from induced rats (exogenous
metabolic activation). At least 1000 cells per condition were analyzed
The vehicle controls gave frequencies of micronucleated cells within our
historical negative control data range for V79 cells. Both positive
control substances, EMS and cyclophosphamide, led to the expected
increase in the number of cells containing micronuclei.
Cytotoxicity indicated by clearly reduced cell count was observed at
least at the highest applied test substance concentration in all
experimental parts of this study.
On the basis of the results of the present study, the test substance did
not cause any biologically relevant increase in the number of cells
containing micronuclei either without S9 mix or after adding a
Thus, under the experimental conditions described, Oxooel 9N is
considered not to have a chromosome-damaging (clastogenic) effect nor to
induce numerical chromosomal aberrations (aneugenic activity) under in
vitro conditions in V79 cells in the absence and the presence of
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for
classification purposes under Regulation 1272/2008. As a result the
substance is not considered to be classified for genetic toxicity under
Regulation (EC) No. 1272/2008.
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