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EC number: 939-607-9
CAS number: 1474044-65-9
guideline study was carried out to assess the effects of C16 TMAC on
embryonic and foetal development in New Zealand White rabbits. Twenty
mated female rabbits per group were exposed topically (daily for 2
hours) from Days 7 to 18 of gestation at concentrations of 0, 0.5, 1.0,
or 2.0% (equivalent to 0, 10, 20 and 40 mg a.i./kg bw/day,
respectively). The control group was treated with deionised water only.
Clinical condition and reactions to treatment were recorded at least
once daily. Body weights were recorded on Days 0, 3, 6, 9, 12, 15, 18,
21, 24, 27 and 29 of gestation. All surviving females were sacrificed on
Day 29 of gestation and the foetuses were removed by caesarean section.
At necropsy the females were examined macroscopically. Live foetuses
were weighed, sexed and were examined for visceral and skeletal
abnormalities. Two control animals, one intermediate and one high dose
died during the study. Two of the rabbits that died, aborted prior to
death (one control and one intermediate dose). Two additional abortions
occurred, one each in the intermediate and high dose groups. Deaths or
abortions were not considered to be related to the test substance. No
treatment-related maternal body weight or food intake effects were
noted. The incidence of foetal malformations and genetic and
developmental variations in the treated groups was comparable to that of
the control group. No other treatment-related effects were noted. Under
the conditions of the study, the NOAEL for maternal as well as
developmental toxicity was 40 mg a.i./kg bw/day in rabbits.
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