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EC number: 701-068-0
CAS number: 2156592-58-2
A guideline conform teratology study in New Zealand rabbits with
Oleylamine as test substance has been performed. Prior to initiation of
the main study, a range-finding study at dose levels of 5, 25, 50, 100
and 150 mg/kg bw/d had been conducted. During the range finding-study,
treatment-related deaths had occurred in the 50, 100, and 150 mg/kg bw/d
groups. Outward clinical signs of toxicity were observed at the 5 mg/kg
bw/d dose level and above. Body weight losses occurred in the 25, 50,
100 and 150 mg/kg bw/d dose groups. A dose level of 50 mg/kg bw/d was
considered to be excessive for a high dose level for the main study.
Conversely, 25 mg/kg bw/d did not produce sufficient maternal toxicity
to be considered suitable as a high dose level. Thus 30 mg/kg bw/d as
top dose level was selected for the main study in anticipation of
producing sufficient maternal toxicity.
In the main study groups of 22 inseminated females were treated
orally (gavage) with dosages of 3, 10, and 30 mg/kg bw/d or with the
vehicle (Mazola corn oil) during gestation days 6 to 18. During the
study animals were examined daily. Any clinical signs of toxicity
including physical or behavioural abnormalities were recorded.
Individual body weights were recorded on gestation days 0, 6, 9, 12, 1,
19, 24 and 29. Individual food consumption was measured daily. Two
animals in each group were selected to be sacrificed and necropsied
after treatment on gestation day 18 to determine the appearance and
severity of gastrointestinal tract irritation. On gestation day 29
caesarean section was performed on all surviving animals. The numbers of
viable fetuses, early and late resorptions as well as the number of
corpora lutea were recorded. Fetuses were examined for external,
visceral and skeletal abnormalities.
As result of the study, treatment-related mortality occurred as
two females died in the 30 mg/kg bw/d group, one on gestation day 9 and
the other on gestation day 25. In addition, one female each at the 3,
10, and 30 mg/kg bw/d levels aborted prior to scheduled sacrifice.
Outward clinical signs of toxicity were observed at the 10 and 30 mg/kg
bw/d levels. In the 10 mg/kg bw/d dose group, rales and laboured
breathing were noted. Additional findings in the 30 mg/kg bw/d level
included few or no feces and emaciation. Irritation of the mouth area
also developed in females in this group. The irritation was
characterised by swollen raised white areas, scab-like lesions and /or
sloughing of the skin of the lips and the chin. No other signs of
treatment-related gastrointestinal irritation or internal changes were
observed at gross necropsy at gestation days 18 and 29. Dose-dependent
body weight loss (gestation days 6-9, respectively 6-19) or reduced
weight gain, along with a corresponding reduction in food consumption
occurred during the treatment period in the 10 and 30 mg/kg bw/d groups.
Net body weight gain (adjusted for gravid uterine weight) was also
lower. Following cessation of treatment, weight gain increased in the 30
mg/kg bw/d group. No such effects were observed in the dose group
treated with 3 mg/kg bw/d. Caesarean section data obtained from the
treated groups did not reveal any meaningful differences (concerning
number of corpora lutea, implantation sites, viable fetuses,
implantation loss, fetal sex and fetal weight) when compared with the
controls. Fetal evaluations of type and frequency of malformations and
variations did not reveal any indications for a treatment related
teratogenic effect. In summary, oral administration of octadecenylamine
to pregnant rabbits produced dose-dependent maternal toxicity in the 10
and 30 mg/kg bw/d dose groups. No indications of an embryotoxic,
fetotoxic or teratogenic effect was observed at any tested level. A
NOAEL/maternal toxicity of 3 mg/kg bw/d and a NOAEL/developmental
toxicity of>30 mg/kg bw/d can be derived from the study.
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