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EC number: 931-335-9
CAS number: 90622-74-5
of performance of mated females
Treatment dose (mg/kg/d)
No. of mated females
No. of pregnant females
No. of females
with premature litter
No. of mortalities
No. of females with live
fetuses at termination
One dam out of these was not included because the weights of fetuses
were not determined
A study was conducted to evaluate the
prenatal developmental toxicity of the test substance, C12-18 and
C18-unsatd. DEA, according to OECD Guideline 414, in compliance with
GLP. The substance was administered to groups of 30 female rats by
gavage at dose levels of 0, 100, 300 and 1000 mg/kg bw/day, once daily
from Gestation Days (GD) 6 to 15 inclusive. Control animals were dosed
with the vehicle alone (arachis oil, DAB 9). Clinical condition and
reaction to treatment were recorded at least once daily. Body weights
were reported on GD 0, 6, 16 and 20. All surviving females were
sacrificed on GD 20 and the foetuses were removed by caesarean
section. At necropsy, the females were examined macroscopically. Live
foetuses were weighed, sexed and examined for visceral and skeletal
abnormalities. No deaths or treatment-related changes in body weight
gain and necropsy findings were observed in dams at any dose level.
Treatment-related symptoms observed in all groups were salivation and
propulsion of the head. The highest dose group showed severe
salivation. Apart from the control (1 dead foetus) and the 100 mg/kg
bw/day groups (7 dead foetuses), all females had viable foetuses.
Pre-implantation loss and mean numbers of resorptions were not
affected by treatment. The data for post-implantation loss, embryonic
deaths and total foetuses showed some deviations, which were
considered to be non-treatment-related. Mean placental and uterus
weights were not affected by the treatment. Foetal sex ratio was
comparable in all groups. No treatment-related foetal abnormalities
were found at necropsy. The examined foetuses showed no
treatment-related visceral and skeletal abnormalities/variations. One
foetus at 300 mg/kg bw/day showed a stump tail and missing coccigycae
vertebrae. Further, the data for skeletal ossifications showed some
deviations in the two highest dose groups. However, all these effects
were assessed to be non-treatment-related. Under the study conditions,
the NOAELs for parental toxicity and developmental toxicity were
considered to be 1000 mg/kg bw/day (Pitterman, 1994).
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