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EC number: 629-765-4
CAS number: 1226892-44-9
Accuracy of preparation: The concentrations
analysed in the formulations of Group 2, Group 3 and Group 4 were in
agreement with target concentrations (i.e. mean accuracies between 90%
and 110%). A small response at the retention time of the test substance
was observed in the chromatograms of the Group 1 formulation. It was not
considered to derive from the formulation since a similar response was
obtained in the analytical blanks.
Homogeneity: The formulations of Group 2 and
Group 4 were homogeneous (i.e. coefficient of variation = 10%).
Stability: Formulations at the entire range
were stable when stored at room temperature under normal laboratory
light conditions for at least 6 hours.
Fatty acids, C18 unsat, reaction products
with diethylenetriamine (AAI-DETA)was evaluated for developmental
toxicity/teratogenicity in a study performed according to theOECD
414 guideline and in compliance to GLP. Eighty-eight mated female Wistar
Han rats were assigned to four dose groups. The test item was
administered once daily by oral gavage from Days 6 to 19 post-coitum at
doses of 15, 50 and 150 mg/kg.
Females were checked daily for the presence
of clinical signs. Food consumption and body weight were determined at
periodic intervals. Formulations prepared on one day during treatment
were analyzed for accuracy, homogeneity and stability. On an additional
occasion, extra stability measurements were performed.
All animals surviving to Day 20 post-coitum
were subjected to an examination post-mortem and external, thoracic and
abdominal macroscopic findings were recorded. A laparo-hysterectomy was
performed on each surviving female of the groups. The uteri, placentae
and ovaries were examined, and the numbers of fetuses, early and late
resorptions, total implantations and corpora lutea were recorded. Gravid
uterine weights were recorded, and corrected body weights (changes) were
calculated. The fetuses were weighed, sexed and examined for external,
visceral and skeletal malformations and developmental variations. All
live fetuses were euthanized. One half of the fetuses were decapitated
and the heads were fixed in Bouin’s fixative, all fetuses were dissected
and examined for visceral anomalies and subsequently fixed in 96%
aqueous ethanol and stained with Alizarin Red S. Skeletal examinations
were performed for all fetuses of de control and high dose group..
Accuracy, homogeneity and stability of
formulations were demonstrated by analyses.
Maternal toxicity was noted at 150 mg/kg,
and consisted of reduced body weight gain and food consumption. The two
dams that were most affected, also showed corroborative macroscopic
abnormalities (gastro-intestinal tract distended with gas, small thymus
and spleen, irregular surface of the stomach and/or emaciation), and one
of these showed clinical signs (hunched posture, piloerection and
reduced faeces) during the last two days of treatment. No maternal
toxicity was observed in the 15 and 50 mg/kg groups.
No developmental toxicity was observed up to
the highest dose levels tested (150 mg/kg).
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