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EC number: 220-688-8
CAS number: 2867-47-2
and fate of females
One high dose female (animal no. 97130185)
died during the study, on gestation Day 10. A total of 4 females were
found not pregnant at necropsy: 1 each in the control, low, mid- and
high dose groups. One mid-dose female had unilateral implantation and
another mid-dose female had unilateral total resorption.
number of females with live foetuses on gestation Day 20 was 23 in each
of the control, low and mid-dose groups and 22 in the high dose group.
Scabs and hairloss were the most frequent
signs recorded in control and treated females. These signs were not
considered of toxicological significance.
weight and body weight gain
differences in body weight were noted between control and treated
body weight gain, a statistically significant decrease of approximately
27% was noted on Day 6 post coitum in females receiving 100
mg/kg/day and a statistically significant increase of approximately 33 %
was noted in the same group on Day 18 post coitum, when compared
to controls. These changes were considered of no toxicological
No differences in food consumption were
detected between control and treated groups.
body weight, uterus weight and absolute weight gain
significant differences in terminal body weight, gravid uterus weight
and absolute weight gain were observed in treated groups, when compared
to the control group.
data and sex ratios
data and sex ratios were not affected by treatment.
examination of females
No cause of death was identified in the
animal which died during the study, due to the significant presence of
organs and tissues cannibalized. No treatment-related changes were noted
at macroscopic observation performed at the final sacrifice. The minor
changes observed are suggested to be incidental, having a comparable
incidence in control and treated groups, and/or characteristically seen
in untreated Sprague Dawley SD rats of the same age.
examination of foetuses
Multiple malformations (such as cor
bilocular and ectopic cordis of the heart; malpositioned lungs with
lobes agenesia; thymus agenesia) and anomalies were detected in one
foetus of the low dose group examined externally and internally. One
foetus was found dead in the high dose group. A total of 8 small
foetuses ( <2.7 g) were detected in control and treated groups, without
dose-relationship. All these findings were considered incidental and not
examination of foetuses
Malformations were detected in two foetuses
of the low dose group (no ossification of pubis and ischium in one
foetus and cleaved sternum in the other) and in one foetus of the
mid-dose group (no ossification of pubis). No malformations were
observed in the control and high dose groups. In addition, most of the
anomalies and variants recorded at skeletal examination were noted both
in control and treated groups, with a similar incidence. Considering the
low incidence and the absence of dose-relation, all the findings were
examination of foetuses
findings that could be considered treatment-related were noted at
visceral examination of the foetuses in any group.
developmental toxicity study according to OECD 414 Dimethylaminoethyl
99.79 %) was administered to
female rats (Sprague-Dawley, (SD)) by
oral gavage at dose levels of 0,
100, 300 and 600 mg/kg bw/day
from days 6 through 19 of
Neither clinical signs nor signs of
reaction to treatment were noted in treated females that could be
related to treatment. No significant differences were noted in body
weight, food consumption, gravid uterus weight, litter data and
macroscopic observation of treated females, when compared to controls.
Due to the absence of dose-relation, the findings detected at the
external, visceral and skeletal examination of foetuses from all
groups were considered incidental.
maternal and developmental NOAEL was therefore 600 mg/kg bw/day.
developmental toxicity study in the rat is classified acceptable and
guideline requirement for a developmental toxicity study (OPPTS
870.3700; OECD 414) in rats.
NOTE: Any of data in this dataset
are disseminated by the European Union on a right-to-know basis and
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