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EC number: 700-425-8
CAS number: 521284-22-0
The experimental laboratory concluded in the report that no NOAEL for
parental effects could not be derived based on the clinical signs
observed in combination with lower motor activity, and changes in
bodyweight and food intake observed. On review of the data, it was
considered that the effects observed at 12.5 mg/kg were not considered
adverse in nature and as such the parental NOAEL was set as 12.5 mg/kg.
The following justifications are provided showing a NOAEL value of 12.5
mg/kg as appropriate:
No adverse effects were observed in the majority of experimental
endpoints including clinical pathology, macro and microscopic pathology,
FOB parameters (excluding locomotor activity) and organ weights in any
dose group along with no observed treatment related deaths at any dose.
The clinical signs observed were shown intermittently and showed full
reversibility at approximately 3-7 hours post dose in both sexes. The
signs observed were less apparent in animals that received 12.5 mg/kg
and all signs observed were graded as slight or moderate rather than
severe in the laboratories grading system.
With regards to the locomotor activity, females that received 25 or 50
mg/kg showed reduced motor activity scores for total movements and
ambulations with statistical significance only for total movements, with
no statistically significant effects observed in animals that received
12.5 mg/kg. In males, minor effects were observed although no
statistical significance was obtained in any dose and no clear dose
response was apparent.
With regards to bodyweight gain, males in all dose groups had a slightly
lower bodyweight gain during the mating period and by the end of the
study bodyweight gain in treated males was 4-5% lower than controls. As
no dose response was indicated for this change it was not be considered
adverse, and also the possible bodyweight effects in females were
considered as not significant (a result of slight weight loss in two
With regards to food consumption, no statistically significant effects
were observed in males for food consumption and in females the effects
observed during lactation showed no dose related change and as such are
Based on this information it could be concluded that no adverse effects
were observed at any dose, although based on the effects, it was
considered that a NOAEL value of 12.5 mg/kg was conservative and as such
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