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EC number: 203-652-6
CAS number: 109-16-0
A total of
10 females were proved not pregnant at necropsy: 4 females in the
control group, 2 in the low dose group (including one female which did
not mate), 2 in the mid-dose group and 2 in the high dose group. One
control female showed unilateral total resorption. All remaining females
gave birth and the number of dams with litters per group were: 5 in the
control and 8 each in the remaining treated groups.
observations (Functional Observation Battery
Clinical signs and functional
observation battery tests were unaffected by treatment.
weight and body weight gain
significant reduction in body weight was noted in high dose males
compared to controls from Day 15 of treatment to sacrifice.
on food consumption were observed.
activity and sensory reactivity to stimuli
differences of toxicological significance were seen.
of toxicological significance were seen. No
changes were recorded for coagulation parameters.
showed an increase in almost all treated females.
– males only
cycle, reproductive parameters, pairing combination and mating
related changes were seen.
pre-birth loss data and gestation length of females
treatment-related effects were seen.
data and sex ratio of pups
Litter data and sex ratios were
unaffected by treatment.
signs of pups
signs were comparable between treated and control groups.
findings in decedent pups and in pups sacrificed on Day 4 post partum
body weight and organ weights
increase in absolute and relative liver weight was observed high dose
females compared to controls.
changes were detected at post mortem examination in treated
animals, when compared with controls.
treatment-related changes were seen in selected organs/tissues evaluated
in males or females receiving Triethyleneglycol dimethacrylate nor in
the abnormalities detected in all groups at post mortem including
the staging in the spermatogenic cycle.
a Combined Repeated Dose Toxicity Study with the Reproduction /
Developmental Toxicity Screening Test according to OECD Guideline 422
(22 March 1996) TREGDMA (95.8% a.i.) 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.
mortality occurred in the study. No clinical signs of toxicological
significance were reported. Statistically significant reduction in body
weight was noted in high dose males compared to controls from Day 15 of
treatment to sacrifice; body
weights of females were unaffected by treatment.
consumption was comparable between the control and treated groups.
differences in motor activity, grip strength and sensory reactivity to
stimuli were observed. The differences noted in land foot splay noted in
low dose males and females were considered incidental since they were
inconsistent between males (increase) and females (reduction) and
without any dose correlation.
haematology and urinanalysis no changes of toxicological significance
were seen. The statistically significant decrease of reticulocytes
recorded in females dosed with 1000 mg/kg bw/d was considered of no
toxicological relevance since no associated alterations of the
erythrocytes were observed. No changes in prothrombine time were noted.
Bile acids showed a dose-related increase in almost all treated females.
No other changes of toxicological significance were observed. Two males
of the high dose group showed an increase of urea (mean value 35% above
controls). However, due to the low incidence, this finding cannot be
conclusively attributed to treatment.
statistically significant fluctuations of some biochemical parameters
were recorded in treated animals, such as: chloride, calcium, sodium and
potassium. Changes were of minimal magnitude, not consistent between
sexes and/or not dose-related, therefore considered incidental.
females mated with the exception of on female of the low dose group. Two
females, 1 in the low dose group and 1 in the mid-dose group showed an
irregular cycle (oestrus was never observed); the low dose female did
not mate, the mid-dose female was found sperm positive after 8 days of
not pregnant at necropsy. These isolated cases were considered
incidental. In the control group a total of 5 females were found not
pregnant and 1 female had unilateral implantation with total resorption.
In addition, 1 female in the low dose group, 2 females in the mid-dose
group and 2 females in
the high dose group were not pregnant.
of copulatory index, fertility index Pre-coital interval and the number
of copulation plugs did not show differences between treated and control
groups. 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.
data and sex ratios were unaffected by treatment. Clinical signs of pups
were comparable between groups. Decedent pups were found in all groups
without dose relationship. Necropsy findings in decedent pups and in
pups sacrificed on Day 4post partumdid not reveal any
slight reduction in terminal body weight was noted in the mid- and high
dose males (statistically significant in high dose). Terminal body
weight of females was unaffected by treatment. A slight increase in
absolute and relative liver weight was observed in high dose females
compared to controls. No relevant changes were detected at post
mortem examination in treated animals, when compared with controls.
treatment-related changes were seen in selected organs/tissues evaluated
in males or females nor in the abnormalities detected in all groups at post
mortem including the staging in the spermatogenic cycle.
changes in body weight gain of high dose males, bile acids and liver
weight of high dose females were observed and since the microscopic
examination revealed no lesion in any organs, the dosage of 1000 mg/kg
bw/d is considered to be the NOAEL for this study.
relevant toxic effects were seen in parental animals as well as in pups
up to the highest dose group of 1000 mg/kg bw/d. On the basis of the
results obtained in the study, the NOAEL for both, general toxicity and
reproduction/developmental toxicity was 1000 mg/kg bw/d (males/females).
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