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EC number: 239-622-4
CAS number: 15571-58-1
Dose Formulation Analysis
The results for chemical homogeneity and dose concentration
verification are within the acceptance limits of ± 10 % of the nominal
Table 1: Maternal Body Weights (g)
Dose Group (mg/kg)
Table 2: Maternal Body Weight Gain
GD 5-18 (g)
GD 5-18 (% of control)
GD 5-18 (% gain compared to control)
Table 3: Litter Data
No. of Corpora Lutea (mean)
Implantation Sites (mean)
Live Foetuses (mean)
No. of Early Resorptions (mean)
No. of Late Resorptions (mean)
Mean Pre-implantation Loss (%)
Mean Post-implantation Loss (%)
Group & Dose (mg/kg)
Mean Thymus weight (g)
G1 (0 mg/kg)
G2 (15 mg/kg)
G3 (30 mng/kg)
G4 (60 mg/kg)
* p < 0.05
Table 4: Summary of Foetal Examinations
Group (Dose mg/kg)
G3 (30 mg/kg)
No. of foetuses
The purpose of this study was to assess the effects of prenatal exposure
of pregnant female Swiss mice and their developing foetuses to the test
material when administered by oral gavage in a peanut oil vehicle at 5
mL/kg to the mated females from gestation day [GD] 5 to 17. In life
examinations included checks for mortality and clinical signs of
toxicity, body weight measurements and an evaluation of food
consumption. All the animals were sacrificed on gestation day 18 by
carbon dioxide exposure and subjected to detailed gross pathology; the
gross pathology included a determination of thymus size. The gravid
uterus was collected by hysterectomy and foetuses were removed by
caesarean section. Foetuses were subjected to external, soft tissue and
No deaths were observed during the experimental period and there were no
clinical signs recorded which were indicative of overt toxicity. There
were no statistically significant differences in maternal body weights
across the dose groups on any single gestation day. However, there was a
clear dose-related pattern of reduced body weights beginning after GD6,
the first day of dosing, and continuing for the duration of the study.
The high dose was the most severely affected and a dose-related
decrement relative to the control body weights can be seen across all
doses particularly from GD16 to GD18. At 30 mg/kg the maternal weight
effect was marginal, but maternal body weight gain in the 60 mg/kg high
dose group was 11.5 [uncorrected] and 26.6 % [corrected] less than the
vehicle control, a clear adverse effect. There was a treatment-related
macroscopic finding of reduced maternal thymus weight.
The mean maternal thymus weight was statistically significantly reduced
in the 30 mg/kg [mid] and 60 mg/kg [high] dose groups. The mean maternal
thymus weight in the low dose mice was reduced relative to controls, but
was not a statistically significant difference. No other gross
pathological findings were noted in any dose group.
No treatment related effects were noted in mean gravid uterus weight,
no. of corpora lutea, no. of implantations in all the groups, no. of
early or late resorptions and percentage of post implantation loss.
No external abnormalities were noted during gross examinations of
foetuses at any dose and no treatment-related abnormalities were
observed during visceral examinations of foetuses at any dose.
Therefore, under the conditions of the study the NOAEL for maternal
toxicity was determined to be 15 mg/kg based on a biologically relevant
depression in thymus size at the 30 mg/kg dose. However, no
treatment-related effects were noted in any of the developmental
toxicity parameters investigated; therefore the NOAEL for developmental
toxicity was concluded to be 60 mg/kg, the highest dose tested.
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