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EC number: 926-564-6
CAS number: 1179964-22-7
In a repeated dose oral toxicity study in rats (Wistar, OECD TG 407),
the substance was adimistered via gavage to 5 rats/sex/dose at 0, 10,
30, 90 mg/kg bw (male) or 0, 5, 15, 45 mg/kg bw (female) in corn oil for
4 weeks. Up to and including 90 or 45 mg/kg bw no mortality occured. The
behavior of the rats were not influenced by the treatment up to and
including 90 mg/kg (males) or 45 mg/kg (females). There were no clinical
findings induced by treatment with the test item in rats dosed at low
and mid dose. In all high dose rats (both sexes) treatment with the test
item induced changed feces consistency (soft, pulpish). Related to body
weight mid and high dose males consumed more water. High dose females
had a slightly higher water intake in the last 2 weeks.The body weight
gain, the food intake, clinical chemistry and organ weights were not
affected up to and including 90 mg/kg in males and 45 mg/kg in females.
The results from Functional Observational Battery (FOB) measurements in
males and females receiving up to and including 90 mg/kg bw or 45 mg/kg
bw did not differ from the control animals. Motor and Locomotor
Activity(MA/LMA) tests did not indicate neurotoxicity up to and
including 90 mg/kg or 45 mg/kg.
At necropsy consistency changes of small and large intestine and/or
cecum dilations were observed (mid and high dosed animals).
Histopathological examinations revealed minor inflammatory changes in
the intestine (mainly cecum, mid and high dose, both sexes, one low
dosed male). Possibly related to this a tendency towards minor
unspecific histopathological changes were noted in mesenteric
lymph nodes (all treated animals, no dose relation).
Therefore, under the condition of the present study, the NOAEL
(no-observed-adverse-effect-level) for the test item after 4-week daily
oral treatment by gavage is 10 mg/kg bw and 5 mg/kg bw for male and
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