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EC number: 639-566-4
CAS number: 165184-98-5
a bacterial reverse mutation test (Wild et al., 1983),
alpha-Hexylcinnamaldehyde (HCA) was tested for toxicity similarly to
OECD Guideline 471 (Bacterial Reverse Mutation Assay).
strains S. typhimurium TA1535, TA1537, TA1538, TA98 and
TA100 were treated with HCA at 5 concentrations up to 3.6 mg/plate (if
not toxic, toxicity not reported) in DMSO, with and without activation
with liver preparations (S9 mix) from rats treated with Aroclor 1254.This
study was carried out using the standard plate incorporation method.Vehicle
and positive controls were performed in both tests.
biologically significant increase in the number of revertants was noted
in any strain, either with or without metabolic activation.
study does not meet modern standards where a limit of 5 mg/plate is
required. The difference between 3.6 and 5.0 mg/plate is small and I it
would be highly unusual to see something positive at 5.0 and negative at
3.6. Therefore the study is considered as acceptable.
the experimental conditions used and according to the positive criteria,
it is concluded that the test substance was not mutagenic.
Mouse lymphoma assay:
Hexyl Cinnamic Aldehyde was tested for
mutagenic potential in an in vitro mammalian cell mutation assay. This
test system is based on detection and quantitation of forward mutation
in the subline 3.7.2c of mouse lymphoma L5178Y cells, from the
heterozygous condition at the thymidine kinase locus (TK+/-) to the
thymidine kinase deficient genotype (TK-/-). The study consisted of a
preliminary toxicity test and two main tests comprising three
independent mutagenicity assays. The cells were exposed for either 3
hours or 24 hours in the absence of exogenous metabolic activation (S9
mix) or 3 hours in the presence of S9 mix.
No increase in mutant frequency exceeded the
sum of the mean concurrent vehicle control mutant frequency. In all
tests the concurrent vehicle and positive controls were within the
acceptable historical control ranges.
It was concluded that Hexyl Cinnamic
Aldehyde did not demonstrate mutagenic potential in this in vitro cell
mutation assay, under the experimental conditions described.
Micro nucleus assay in vivo:
an in vivo micronucleus assay (Wild et al., 1983),
performed similarly to the OECD guideline No. 474 with minor deviations,
male/female NMRI mice were exposed to alpha-Hexylcinnamaldehyde (HCA)
diluted in olive oil by a single intraperitoneal dose. Different
concentrations (324, 540, 756 mg/kg bw) were tested (8 animals per
dose). 30 hours after the injection, the bone marrow cells were
collected and one thousand polychromatic erythrocytes were observed in
order to quantify the number of micronucleated polychromatic
erythrocytes. Concurrent vehicle animals were used as negative control,
no data was available on positive control.
the test conditions, there was no significant increase of micronucleated
plychromatic erythrocytes, if compared with the concurrent control. No
mortality was observed.
under the study conditions it is concluded that HCA is neither
clastogenic nor aneugenic.
In conclusion, the available data does not
indicate potential genotoxicity. The endpoint on chromosomal aberration is
covered by the in vivo micronucleus study. The data are
considered to be adequate for risk assessment and classification and
harmonized classification is available according to the Regulation (EC)
No 1272/2008 including ATP1.
The available data are considered adequate
for the purpose of classification and labelling. The evidence available
does not justify the classification of Hexylcinnamaldehyde for genotoxicity.
No self-classification is proposed according to the Directive 67/548/EEC
and the Regulation (EC) No. 1272/2008 (CLP Regulation).
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