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EC number: 229-745-1
CAS number: 6701-13-9
a Combined Repeated Dose Toxicity Study with the Reproduction /
Developmental Toxicity Screening Test according to OECD Guideline 422
(22 March 1996) 1,4-Butanediol dimethacrylate was administered to 10
Hsd: Sprague Dawley SD rats/sex/dose orally by gavage at dose levels of
0 (control), 100, 300 and 1000 mg/kg bw/d. The treatment schedule
included 2 weeks before pairing, during pairing, post coitum and post
partum periods up to day 3 post partum. Animals were administered for
approximately 5 and 8 weeks for males and females, respectively.
No mortality occurred in the study. A total of 8 females were
found not pregnant at necropsy: one each in the control and low dose
groups and 6 in the high dose group.
The number of females with live pups on Day 4 post-partum were: 9 in the
control group, 9in the low dose group, 10 in the mid-dose group and 4 in
the high dose group.
No clinical signs of toxicological significance were reported.
Body weight and body weight gain were lower in the high dose group
compared to controls throughout the study.
Food consumption was reduced in the high dose group compared to
controls.No relevant differences were noted in all parameters
investigated between control and treated groups.
No changes of toxicological significance were found.
The main relevant change was an increased value of bile acids in treated
groups compared to controls with a clear dose-relation in males.
No changes were recorded in urinalysis.
Measurements of oestrus cycle, pre-coital intervals and copulatory index
did not show differences between treated and control groups. On the
contrary, fertility index was marked lyreduced in the high dose group
(40% compared to 90% of the control group).
No significant differences were observed in the number of implantation,
corpora lutea, total litter size, pre-implantation loss, pre-birth loss
and gestation length between control and treated groups.
Reduced litter and mean pup weights were found in the high dose group
compared to controls. The percentage of cumulative pup loss on Day 4
post partum starting from the total litter size at birth, was increased
in the high dose group.
No differences were found in sex ratio between the groups.
Small pups were generally observed in all groups including the control
group. Cold to touch and apparently no food intake were the signs noted
in pups of the treated groups only.
No relevant differences were recorded in decedent pups between the
No abnormalities were observed in pups sacrificed at term.
Terminal body weight was lower in the high dose group compared to
controls and this difference was statistically significant in females.
Statistically significant higher kidneys weight was observed in high
dose males and females compared to controls. In addition, thymus weight
was significantly decreased in high dose males.
No treatment-related changes were noted at macroscopic examination.
Treatment-related findings at microscpopic observations were limited to
the high dosed animals and were seen in the stomach of both sexes and in
the liver of the females only.Stomach (non-glandular)
The treatment-related change seen in the high dosed animals (1/10 and
5/10, respectively inmales and females), consisted of mild diffused
hyperplasia of the squamous epithelium in thenon-glandural stomach,
which was associated with mild thickening (i.e., hyperkerathosis) ofthe
keratin layer. This change was not associated with any indication of
In 3/10 high dose animals (females), minimal degree of multifocal
perilobular hepatocytic vacuolaiton, which is suggested to be consistent
with fatty change, was noted. The vacuoles were of mixed type (i.e.,
micro- and macrovesicular) and no presence of inflammation
and/ornecrosis was noted.
Evaluation of the spermatogenic cycle did not show differences between
the groups. Regular layering in the germinal epithelium was noted.
On the basis of the results obtained in the study, the NOAEL (No
Observed Adverse Effect Level) for both general toxicity and
reproduction/developmental toxicity could be considered 300 mg/kg/day
for males and females.
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