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EC number: 203-529-7 | CAS number: 107-88-0
There are no in vitro studies available investigating genotoxicity of butane-1,3 -diol. An Ames Assay with the structurally related read-across substance butane-1,4 -diol revealed negative results, both in the presence and absence of metabolic activation.
The study used as source investigated butane-1,4-diol.The study results of the source compound were considered applicable to the target compound and were used for classification and labelling acc. to REGULATION (EC) No 1272/2008. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.
A bacterial mutagenicity test (according to OECD guidelines 471 and 472 and GLP-compliant) was performed in Salmonella typhimurium TA1535, TA1537, TA98 and TA100, and in Escherichia coli WP2 uvrA as preincubation test, with and without metabolic activation.
Tests with and without S9 mix were conducted twice, within the range of 313 -5000 μg/plate with a common ratio of 2.
For the test of TA1537, without the addition of S9 mix, the result in Test I for the 625 μg/plate showed an increase in revertant colony count which was more than twice that of the solvent control value. However, in the testing of TA1537 with the addition of S9 mix and in the tests with all the other bacteria, there was no increase in revertant colony count more than twice that of the solvent control.
For TA1537, since the results without S9 mix were different for Test I and Test II, the main test was repeated using identical doses. As a result, no increase in revertant colony count more than twice that of the solvent control was noted.
In all of the tests conducted, the positive control group showed an increase in revertant colony count for all of the test bacteria, which meant that, along with the values measured for the solvent control group, the revertant colony count was within the range of historical values, so the efficacy of this test series was confirmed.
It is concluded, based on the above results that the test material is not mutagenic (negative) for the test strains used.
Negative in an in vivo chromosome aberration test and dominant lethal test.
Based on these in vivo studies the substance is not considered to be genotoxic.
The number of abnormal cells was not increased with respect to the normal range of aberrant cells in untreated F1A, F2A and F3A animals. No specific abnormalities were observed in the treated animals and no dose-related effects were noted.
Rats were fed butane-1,3-diol in concentrations up to 24% of the diet and paired to produce F1A, F2A and F3A litters. Analysis of the femur bone marrow of at least two animals per sex and dose of these litters revealed no increase in chromosomal aberrations. This study was performed with doses high enough to cause a reduced body weight gain (Hess et al., 1981).
The percentage of pregnancies as well as the percentage of viable fetuses per implantation site were not significantly different between treatment and control groups. The mutagenic index did not show a trend with increasing doses.
Rats were fed butane-1,3-diol in concentrations up to 24% of the diet and paired to produce F1A and F1B litters. Males of the F1B generation were used to examine dominant lethal effects after mating them with virgin females. The exposure did not cause a significant effect with respect to fertility, viable fetuses per implantation sites and percentage of resorption per implantation sites (mutagenic index). A dose-related trend was not evident. This study was performed at high doses, which produced reduced body weight gain (Hess et al., 1981).
In the absence of information on species specific effects or metabolism the results are regarded as relevant for humans.
There are no studies available investigating genotoxicity of butane-1,3 -diol in vitro. However, in a reliable Ames Assay with the structurally closely related substance butane-1,4 -diol negative effects were reported, both in the presence and absence of metabolic activation. Additionally, negative results were obtained with butane-1,3 -diol in two in vivo genotoxicity assays, a chromosome aberration test and a dominant lethal test (Hess et al., 1981). Both test systems cover chromosomal aberrations and the latter gene mutational effects as well. Based on these data it is concluded that butane-1,3 -diol is not genotoxic.
Further, butane-1,3 -diol is rapidly metabolised to gamma-hydroxybutyrate (Mehlmann et al., 1971; Tate et al., 1971; Tobin et al., 1978), which is an endogenous product of mammalian metabolism and not considered to be genotoxic. Negative results in two carcinogenicity studies in rats and dogs with butane-1,3 -diol further support the conclusion that butane-1,3 -diol is not genotoxic.
Based on the negative effects (no genotoxicity observed) in in vivo assays with butane-1,3 -diol and an Ames Assay with the structurally related read-across substance butane-1,4 -diol no classification for mutagenicity is required according to Regulation (EC) No 1272/2008.
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