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EC number: 228-532-0
CAS number: 6290-03-5
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. Values generated on the source substance will represent a very similar or slightly worse case than the target substance.
No. pregnancies total
% Pregnancies (20 matings)
Viable fetuses total
% Viable fetuses/implant sites
% Resorptions/implant sites*
*: mutagenic index
fed (R/S)-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.
generated on the source substance will represent a very similar or
slightly worse case than the target substance. It is predicted that oral
consumption of (R)-1,3 -butanediol would not induce dominant lethal
study was performed at high doses, which produced body weight gain.
Deficiencies of this study are the incomplete data reporting (e.g. with
respect to substance purity, statistical analysis of the results). In
summary, this study is judged to be reliable with restrictions.
weight gain of male rats is presented in the following table:
Dietary level (%)
Mean weight gain (g)
Twenty five animals of both sexes were fed
either control diet or diet supplemented with 1,3-butylene glycol at
dose levels of 5, 10 or 24% of the diet (2500, 5000 or 12000 mg/kg bw/d). Treatment
with the test item had no influence on reproduction and lactation
parameters for all but one group of dams and pups. The pregnancy rate of
F1A rats decreased during five successive mating cycles (likely
secondary to parental toxicity and stress): no pups were obtained at the
high-dose level group of the fifth series of litters (F2E generation). However,
the added stress of a highly ketogenic, semi-synthetic diet may have
contributed significantly to this effect. A significant increase in the
concentration of ketone bodies in blood, urine and liver tissues was
noted in rats fed diets contain 1,3-butanediol at the levels of 20 or
25% (study referenced in journal article). Therefore, physiological
stress may be associated with increased ingestion of 1,3-butanediol.
Excluding F2E group, the viability of F2
generation pups revealed no significant differences between litters or
between control and test groups. Body
weight gains of male rats in all four generations were slightly
depressed with an apparent dose relationship. Body weight gain of
females was not affected.
Documentation of this well-planned study is
insufficient: Exposure duration is not clearly stated, purity of the
test item is not given. Examination of the parental generation is
insufficient (e.g.no histopathological examination of sexual organs),
test results were not evaluated statistically. Despite these
shortcomings the study was judged to be reliable with restrictions as it
indicates that fertility is not impaired through 1,3-butylene glycol
exposure up to 10% in diet (5000 mg/kg bw/d).
Conducted as part of
no definitive dose-related
teratological findings in either soft or skeletal tissue.
delayed ossification of sternebrae) noted at 10% and 24% doses, 5000 and
12000 mg/kg bw/d, respectively.
Incidence of fetal
skeletal abnormalities in F3B generation:
No. of fetuses examined
More than 13
*: significantly different
from respective control, p </= 0.025
different from respective control, p </= 0.01
implantation data for F3B generation:
Mean no. of pups per litter
No. of pregnant females
Implantations (mean per dam)
Resorptions (mean per dam)
Mean fetal weight (g)
effects of (R/S)-1,3-butylene glycol were investigated as part of a
multi-generation study in rats receiving 0, 5, 10 and 24%
(R/S)-1,3-butylene glycol in the diet (0, 2500, 5000, 12000 mg/kg bw/d).
No conclusive teratogenic effects were seen in pups of the F3B
generation at levels up to 12000 mg/kg bw/d (R/S)-1,3-butylene glycol in
the diet. Incomplete sternebral ossification at mid- and high-dose
levels and missing sternebrae at high-dose level were noted, probably
indicating slight delayed development of fetal skeletal tissue (likely
secondary to parental toxicity and stress). The NOAEL for fetotoxicity
was 2500 mg/kg bw/d of (R/S)-1,3-butylene glycol in the diet.
was judged to be reliable with some minor restrictions due to some
shortcomings of the study (e.g. not according to guideline, missing data
on test substance purity, no data on sex distribution of the offspring
reported although this endpoint was recorded according to the method
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 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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