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EC number: 209-674-2
CAS number: 590-19-2
-Butadiene is not expected to be genotoxic. As described in Section 7.1
(Toxicokinetics endpoint summary) the presence of the adjacent double
bonds is likely to preclude the formation of an epoxide (Krause and
Hashmi, 2004) unlike its isomer 1,3-butadiene where the double bonds are
separated by a single bond and is genotoxic via its epoxide metabolites
has been tested in bacterial mutation assays (Ames tests) where it was
not mutagenic in the presence and absence of metabolic activation
(Harlan, 2008a). Positive control compounds gave the expected results
demonstrating that the studies were robust. A chromosome aberration (in
vitro cytogenetic – IVC) assay on 1,2 -butadiene in human lymphocytes
was also negative in the presence and absence of metabolic activation
whilst positive control compounds gave the expected results. This
guideline study demonstrated that 1,2 -butadiene was not clastogenic
in vitro gene mutation study on 1,2 -butadiene in mammalian cells has
been conducted. 1,2-Butadiene was non-mutagenic in L5178Y TK +/- mouse
lymphoma cells in the absence of metabolic activation whilst it was
considered to be weakly positive in the presence of 2% metabolic
activation. The weak evidence of gene mutation is only indicated by
increases in large colony mutants. The increases in mutant colonies
observed were equally due to increases in small and large colonies. The
increase in small colony mutants is suggestive of a cytogenetic event.
Any gene mutation effect is therefore small and of likely questionable
significance. Overall, the increases were small, were only seen at very
high test material atmosphere concentrations and did not reproducibly
meet the criteria for a positive of exceeding the Global Evaluation
Factor across all three experiments carried out.
-Butadiene is therefore not concluded to be genotoxic in vitro, and no
further in vivo data are proposed. The rationale for this is:
Ames test for bacterial gene mutation was negative.
IVC assay for cytogenetic activity was negative.
L5178Y assay for gene mutation activity has provided a only weak
positive response which, importantly, was not supported by the results
of the IVC assay, which is designed to look in detail for cytogenetic
all of the available data for the test material, the small increases
seen in the L5178Y assay are not considered to indicate a significant
genotoxic effect of the material in vitro.
weight of evidence across the three core assays is for no reproducible
genotoxic activity. In
vivo follow up experiments are therefore not proposed.
are no genetic toxicity data on 1,2 -butadiene in humans.
(1992). IARC monographs on the evaluation of carcinogenetic risks to
humans. Vol. 54. IARC, Lyon, France pp. 137-285.
-Butadiene has low potential for genotoxicity and therefore does not
warrant classification under Dir 67/548/EEC or GHS/CLP.
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