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EC number: 939-253-5
CAS number: 68424-85-1
of six mated female rabbits received daily oral administration at 0
(vehicle, purified water), 3, 10 or 30 mg C12 -16 ADBAC/kg bw/day from
day 6 to day 28 post-coitum. In the absence of maternal toxicity,
additional groups with dose levels 0, 50 and 100 mg C12 -16 ADBAC/kg
bw/day were added.
-16 ADBAC from Day 6-28 p.c. produced marked maternal toxicity at 50 and
100 mg/kg/day shown by high number of deceased females and severe
clinical conditions in most animals.
30 mg/kg bw/day, slightly high mean number of post-implantation loss
associated with slightly low mean number of live foetuses were recorded.
No maternal toxicity or effects on litter data parameters were noted at
3 and 10 mg/kg/day.
on these results, the 30 mg/kg bw/day dose-level was chosen as the high
dose-level in the further developmental toxicity study (CIT Study No.
The test substance
was not teratogenic in rabbits.
- LO(A)EL maternal toxic effects:
10 mg/kg bw/d, based on necropsy findings in 5/22 animals.
Incidence was increased to 8/22 at 30 mg/kg bw/day (dilated
gallbladder 3/22, accentuated lobular pattern liver 3/22).
Foci (reddish/brownish) in the lung was also observed in 2
females, but also in view of findings in range finding study and
parallel study with comparable compound, this can be caused
by inadvertent presence of substance into the airways and
not attributable to systemic toxicity. Incidence was not
increased in the top-dose group. There is an indication of
lower body weight gain, correlating to a lower food
consumption, but that was not statistical significant and in
the high-dose goup not different from the mid-dose group.
Blackish content in stomack and intestines is indicative of
local corrosive effects of test substance.
- NO(A)EL maternal toxic effects:
3 mg/kg bw/day. There seems to be a dose-response related increase
in necropsy findings in stomach, intestine and liver.
Dilated gallbladder incidence was not increased in highest
dose group compared to mid-dose.
- LO(A)EL embryotoxic / teratogenic effects:
Based on the number of foetuses presenting malformations or
variations and in the absence of a treatment-related
increase of such observation, the embryo-fetal development
was not considered to be affected by treatment.
- NO(A)EL embryotoxic / teratogenic effects:
30 mg/kg bw/day, being the highest tested dose.
study was conducted to determine the developmental toxicity and
teratogenicity of the test substance, C12-16 ADBAC (49.9% active in
water), according to OECD Guideline 414 and US EPA OPPTS 870.3700, in
compliance with GLP. The substance was administered to pregnant rabbits
by gavage from Day 6 to 28 post-coitum at the dose-levels of 0, 3, 10 or
30 mg a.i./kg bw/day. Based on the results of a range-finding study, the
test subsatnce was administered as a solution by daily oral
administration at 3, 10 and 30 mg a.i./kg/day from day 6 to day 28
post-coitum. One group of 22 females received the vehicle alone
(purified water) under the same experimental conditions and acted as a
control group. A standard dosage-volume of 10 mL/kg body weight was used
for each group. Food consumption and body weight were recorded daily
throughout the study period. Clinical signs were checked each day. On
day 29 post-coitum, all the surviving dams were sacrificed and subjected
to a macroscopic post-mortem examination. The foetuses were removed by
hysterectomy and the uterus weighed. The net body weight gain was
calculated. The litter parameters, namely, the number of corpora lutea,
implantation sites, early and late resorptions, dead and live foetuses
were recorded. The foetuses were weighed and submitted to external
examination. The live fetuses were killed and then subjected to a fresh
dissection and detailed examination of soft tissue, including body, head
and brain. The sex was determined. The carcasses were then fixed and the
skeletons (including cartilage) stained and examined. The
dose of 30 mg a.i./kg bw/day caused the death of three females, severe
clinical condition or abortion in two other females and transient, lower
maternal body weight gain. Necropsies revealed in 8/22 females
accentuated lobular patterns in the liver, whitish areas and/or blackish
deposits and/or oedema in the stomach mucosa, reddish or brownish foci
on the lungs, blackish contents in the intestines, dilated intestines
and dilated gall bladder. At 10 mg/kg bw/day, also an indication of
corresponding lower food consumption was observed. Relevant necropsy
findings were noted in 5/22 females ((dilated gall bladder, accentuated
lobular pattern, pale liver, brownish or reddish foci on the lungs,
blackish deposit on the stomach mucosa). Blackish content in stomach and
intestines was considered to be indicative of local corrosive effects of
the test substance. No maternal toxicity or effects on litter data
parameters or embryo-foetal development were noted at 3 mg/kg bw/day.
Moreover, there were no effects on litter data parameters and no
treatment-related findings upon external, visceral or
skeletal observation in any of the dose groups up to 30 mg a.i./kg
bw/day. Under the study conditions, the NOAEL for maternal toxicity and
embryo-foetal development was established at 3 and 30 mg a.i./kg bw/day
respectively in rabbits (Gaoua, 2005).
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