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EC number: 213-561-3
CAS number: 980-26-7
The toxicity of the test item in Sprague
Dawley rats after daily oral administration (by gavage) for 13
consecutive weeks and recovery from any treatment-related effects during
a recovery period of 4 weeks, have been investigated.
The treatment groups and dose levels were as
+: in terms of test item as supplied
The following investigations were performed
during the in vivo phase: pre- and post-dose observations, clinical
signs, neurotoxicity assessment, motor activity, body weight, food
consumption, ophthalmoscopy and clinical pathology investigations.
Necropsy gross observations and
histopathological examination were performed after sacrifice of animals
at the end of treatment or recovery periods.
No deaths occurred during the study.
Pre- and post-dose observations
No signs of reaction to treatment were
recorded during the study.
Clinical signs, neurotoxicity
assessments, sensory reaction to stimuli, motor activity and observation
of cage trays
No relevant clinical signs were recorded
during the dosing phase including the observation of animals in an open
arena. Neurotoxicity tests and motor activity measurements performed at
the end of treatment and recovery did not show changes attributable to
the test item. In addition, abnormal colour of the faeces, the severity
of which increased with the dose level, was observed in all cages of
treated animals, starting from day 3 of treatment until the end of the
treatment period. This sign disappeared after 3 days of the recovery
period (data not tabulated).
Body weight was not affected by treatment.
No differences were noted in mean food
consumption in treated groups when compared to the control group.
No significant lesions were observed in the
control and high dose group at the examination performed during week 13
Following 13 weeks of treatment no
toxicologically significant changes were observed in the haematological
No alterations of toxicological significance
were seen in the clinical chemistry parameters.
No changes of toxicological significance
were observed during the dosing phase.
Terminal body weight and organ weights
No relevant changes were observed in
terminal body weight and in absolute and relative organ weights among
treated animals, when compared with controls.
No macroscopic finding was described that
could be considered correlated with the administration of the test item,
apart from instances of dark/red or pink granular material seen in the
gastro-intestinal tract of animals receiving 1000 mg/kg/day and killed
at the end of the treatment period. This abnormal content probably
represented residues of the test item in the gastro-intestinal tract.
The histopathological examination did not
reveal any evident differences in the incidence of the findings observed
in treated and control animals, which could be considered
The toxicity of the test item when given by
oral administration (gavage) to rats for 13 consecutive weeks at dosages
of 50, 200 or 1000 mg/kg/day, and recovery from any treatment-related
effects over a recovery period of 4 weeks, have been investigated. No
toxicologically relevant changes were observed during the in vivo phase
or at the post mortem examinations.
On the basis of these results, it could be
concluded that the No Observed Adverse Effect Level (NOAEL) in this
study was 1000 mg/kg/day.
Liver and blood plasma samples of male and female rats of the 1000 mg/kg
bw/day group collected at the end of the exposure period were below
quantifiable limit concentrations of 1.5 ug/g dried liver and 0.4 / 0.6
ppm dried blood plasma.
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