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EC number: 251-649-3
CAS number: 33704-61-9
In a 90-d oral repeated dose toxicity study, Cashmeran was
administered to male and female Sprague-Dawley rats by gavage at 0, 10,
50, 125, and 250 mg/kg bw. Viability, clinical observations (including
detailed clinical observations), body weights, body weight changes, feed
consumption, and necropsy observations were recorded, and rats were
evaluated for ophthalmological changes, estrous cycling, functional
observational battery, motor activity, urinalysis and sperm
analysis. Blood samples were collected for hematology and clinical
chemistry analysis. A four-week recovery study was included to study
reversibility of effects.
In the three highest dose levels of 50, 125 and 250 mg/kg/day
increased adverse clinical observations (principally excess salivation,
urine-stained abdominal fur, rales and ungroomed coat), decreased pH and
increased ketones in the urine of female rats, increased kidney weights,
increased liver weights for female rats only and increased incidence
and/or severity of histological changes in the kidney (i.e., changes
consistent with chronic progressive nephropathy and increased tubular
dilatation in the renal outer medulla) were observed. Furthermore, in
the 125 and 250 mg/kg/day treatment group male rats reduced body weight
gain, increased relative feed consumption, decreased pH and increased
urinary ketones, and reduced heart weights were observed. A minimal
hyaline droplet change was also observed in the cortical tubules of
individual males in the 125 and 250 mg/kg/day treatment groups. In the
250 mg/kg/day treatment group, male and female rats displayed increased
motor activity and changes in clinical chemistry parameters.
During the four-week recovery period, body weight gains and
relative feed consumption values were increased for male and female rats
in the 250 mg/kg/day treatment group. Increases in motor activity
continued for female rats during the recovery period. Test
substance-related changes in clinical signs, urine pH and ketones,
kidney weight/kidney histopathology and clinical pathology were not
observed in the recovery animals and were therefore considered to be
Although decreased urine pH for female rats and increased kidney
weight for male and female rats occurred at the lowest dose level of 10
mg/kg bw/d, the changes were considered to be small and were not
associated with histopathological changes in the kidneys. Therefore, the
10 mg/kg/day treatment level was considered to be the NOAEL.
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