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EC number: 203-529-7
CAS number: 107-88-0
In a five generation study with embedded continuous breeding study no
effects on fertility were observed in 4 generations up to the highest
concentration tested (24% in diet; 12000 mg/kg bw/d). The pregnancy rate
of F1A rats decreased during 5 successive mating cycles, no pubs were
obtained at the highest concentration of the fifth series of litters
(F2E). Therefore, the mid dose group (10% in diet; 5000 mg/kg bw/d) was
selected as NOAEL. No effects on fertility were observed in additional
studies of lower reliability at comparable dose-levels.
Body weight gain of male rats is presented in the following table:
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 four of
five generations of dams and pups. The pregnancy rate of F1A rats
decreased during five successive mating cycles: no pups were obtained at
the high-dose level group of the fifth series of litters (F2E
generation). Excluding this 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 (Hess et al., 1981).
The study indicates that fertility is not impaired through 1,3 -butylene
glycol exposure up to 10% in diet (5000 mg/kg bw/d).
Effects on fertility were investigated in rats which received up to 24%
1,3 -butylene glycol in the diet (12000 mg/kg bw/d). No effects were
observed in 4 generations of a five generation study. But the pregnancy
rate of F1A rats decreased during 5 successive mating cycles and no pubs
were obtained at the highest concentration of the fifth series of
litters (2FE). Additionally, in this study a dose dependent influence of
the test item on the body weight gain of male rats was observed (Hess et
al., 1981). The highest dose (24%, 12000 mg/kg bw/d) was therefore
regarded as LOAEL and the mid dose (10% in diet, about 5000 mg/kg bw/d)
as NOAEL. Instead of some shortcomings in the documentation, this well
planned and performed study was judged to be reliable and was selected
as key study for this endpoint.
The findings of the key study are supported by the data from two other
multigeneration studies, which did not report an impairment of fertility
by 1,3 -butylene glycol concentrations of 20% or 24% in diet (10000 or
12000 mg/kg bw/d, respectively; Dymsza and Adams, 1969; Celanese, 1974).
However, due to their incomplete documentation these studies were judged
to be of lower reliability (RL3). In a multigeneration study in rats
which received about 5000 mg 1,3 -BD/kg bw on two days per week no
impairment of fertility or reproductive disturbances were observed
Taking into account all information available for 1,3 -butylene glycol
there is only single evidence from the continuous breeding study in rats
which revealed adverse effects on fertility in the fifth litter of the
F1 in the highest dose group. As the effects were only observed under
extreme conditions (continuous breeding) in the highest dose group at a
dose which is irrelevant under normal use conditions and far (about ten
times) above the limit dose usually used for such kind of studies these
data are regarded as irrelevant with respect to a possible
classification. This conclusion is supported by the data on reproductive
toxicity available for the structurally closely related 1,2- and 1,4
-butylene glycol for which there is also no evidence of adverse effects
on fertility (see read-across document in section 13) as well as by data
from additional studies on fertility of 1,3 -butylene glycol, which did
not observe adverse effects on fertility at comparable dose levels.
Therefore, it is concluded that no classification of 1,3 -butylene
glycol for effects on fertility is required.
No teratogenic effects were observed in the presence of 1,3-butylene glycol. Fetotoxic effects in the presence of 1,3-butylene glycol were decreased birthweights (NOAEL 4236 mg/kg bw/d), or missing or incomplete ossificated sternebrae (NOAEL 2500 mg/kg bw/d).
Conducted as part of reproduction study; no definitive
dose-related teratological findings in either soft or
skeletal tissue. Fetotoxicity(e.g., delayed ossification of
sternebrae) noted at 10% and 24% doses, 5000 and 12000 mg/kg bw/d,
Incidence of fetal skeletal abnormalities in F3B generation:
*: significantly different from respective control, p </= 0.025
**: significantly different from respective control, p </= 0.01
Resorption and implantation data for F3B generation:
Teratogenic effects of 1,3-butylene glycol were investigated as part of
a multigeneration study in rats receiving 0, 5, 10 and 24% 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 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. The NOAEL for fetotoxicity
was 2500 mg/kg bw/d of 1,3-butylene glycol in the diet (Hess et al.,
No teratogenic effects were observed in two studies on developmental
toxicity. In a nearly guideline conform test a NOAEL for fetotoxic
effects (decreased birthweight) of 4236 mg/kg bw/d was observed (Mankes
et al., 1986). Additionally, in this study a number of minor,
growth-related structural variations were observed in pups, which were
in accordance with the findings of the key study. In the study which was
selected as key study (Hess et al., 1981) fetotoxic effects (missing
sternebrae, incomplete ossification of sternebrae) were recorded at
concentrations of 10% and 24% 1,3-butylene glycol in the diet (5000 and
12000 mg/kg bw/d). The NOAEL was 5% 1,3 -butylene glycol in the diet
(2500 mg/kg bw/d).
The effects observed in fetuses, especially the effects on sternebrae,
are regarded as substance related and adverse. However, as these effects
were only observed at doses which clearly exceed the limit values
recommended in current guidelines and as no such effects were observed
in investigations with the structural closely related compounds 1,2- and
1,4 -butylene glycol they are not regarded as relevant for
classification. Therefore it is concluded that no classification for
effects on development is required for 1,3 -butylene glycol.
In the absence of information on species specific effects or metabolism
the results are regarded as relevant for humans.
Based on the available data it is concluded that 1,3 -butylene glycol
has not to be classified for toxicity on reproduction according to
Regulation (EC) No 1272/2008.
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