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EC number: 212-855-9
CAS number: 873-94-9
3,3,5-trimethylcyclohexanone did not cause bacterial reverse
mutation in an Ames test according to OECD 471 (Hüls 1996). In a
mammalian cell gene mutation assay (HPRT Test) according to OEDC 476,
V79 cells cultured in vitro were exposed to
3,3,5-trimethylcyclohexanone, dissolved in DMSO, at concentrations of
62.5 – 1000 mg/L in the presence and absence of mammalian metabolic
activation (LPT 2010). 3,3,5-Trimethylcyclohexanonee was tested up to
cytotoxic concentrations (1000 mg/L). All test results were within the
range of the negative controls. The positive controls did induce the
appropriate response. There was no evidence of induced mutant colonies
In a mammalian cell cytogenetic assay [Chromosome aberration], human
lymphocyte cultures were exposed to 3,3,5-trimethylcyclohexanone
(99.7%), dissolved in DMSO, at concentrations of 0 – 10 mM with and
without metabolic activation (CIT 2004 a). 3,3,5-Trimethylcyclohexanone
was tested up to cytotoxic concentrations. A statistically significant
increase to 3-30% cells with aberrations (vs. controls) was reported at
the top concentration with metabolic activation. In contrast to the
other in vitro findings there was evidence of a mutagenic effect in this
study. However, the increase in the frequency of cells with structural
chromosome aberrations was limited to the highest concentration tested.
Hence, a dose dependency could not be demonstrated. In addition a marked
decrease in the mitotic index was also observed at this concentration
indicating some degree of cytotoxicity.
In addition to the in vitro testing battery an in vivo
micronucleus test according to OECD 474 was conducted (CIT 2004 b). 5
Swiss mice/sex/dose were treated with two i.p. injections of
3,3,5-trimethylcyclohexanone (99.6 %) at dose levels of 0, 175, 350, and
700 mg/kg bw. The maximum tolerated dose (MTD) was determined in a
preliminary toxicity study. Bone marrow polychromatic erythrocytes,
collected 24 hours after last treatment, were examined microscopically
for micronucleated polychromatic erythrocytes (PCE). There were no
clinical signs of toxicity in the 175 and 350 mg/kg group. At 700 mg/kg
sedation was noted in all treated animals after 15 minutes following the
first treatment. There was no significant increase in the frequency of
micronucleated polychromatic erythrocytes in bone marrow after any
treatment time. Hence, 3,3,5-trimethylcyclohexanone shows no genotoxic
potential under condition of this in vivo study.
The indication of a positive result reported in an in vitro
chromosome aberration test (CIT 2004a) was considered not strong enough
to affect the overall conclusion that 3,3,5-trimethylcyclohexanone is
The test substance is non-genotoxic.
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