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EC number: 228-532-0
CAS number: 6290-03-5
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. Values
generated on the source substance will represent a very similar or
slightly worse case than the target substance.
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.
Values generated on the source substance will represent a vey similar or
slightly worse case than the target substance. Therefore, it is
predicted that consumption of the target substance (R)-1,3 -butanediol
would not result in an increase in chromosomal aberrations.
This study was well performed with doses high enough to cause a reduced
body weight gain. Despite some conceptional deficiencies (no positive
controls, low numbers of cells per dose group examined) as well as
incomplete data reporting (e.g. with respect to substance purity, time
point of examination, statistical analysis of the results) this study is
judged to be reliable and sensitive, due to the repeated application of
high doses over long time periods and several generations.
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