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EC number: 701-196-7
CAS number: -
Analysis of preparations:
The test substance preparations tested were stable and homogeneous. At
the beginning of the administration period measured concentrations were
within the expected range, i.e. 90.9 -100% of nominal concentrations. At
the end of the administration period measured concentrations for the 75
and 250 mg/kg bw/d group revealed values within 95 -100% of nominal
concentrations. However, measured concentrations for the 1000 mg/kg bw/d
group showed values at 72% (mean value of all samples) of the nominal
concentration with an unknown reason. This deviation did not have an
influence on the validity of the study as clear signs of toxicity were
noted in animals at 1000 mg/kg bw/d.
Estrous cycle: No treatment-related effect on cycle length and number of
cycle was noted.
Sperm parameters: No treatment-related effect was seen on sperm
motility, sperm count (testis/cauda epididymis) and percentage of
In a 90-d oral gavage study performed according to GLP Wistar rats were
given 0, 75, 250 and 1000 mg/kg bw/d. Next to parameters according to
OECD 408 (1998) also sperm parameters and estrous cycle were determined.
No treatment-related effects on mortality, clinical signs, body weight,
food consumption, ophthalmoscopy, neurobehaviour were noted. Platelet
count was decreased in both sexes at 1000 mg/kg bw/d and males at 250
mg/kg bw/d. In both sexes at 1000 mg/kg bw/d ALT was increased and
albumin was increased in females at 1000 mg/kg bw/d. A higher incidence
of phosphate crystals occurred in the urine of both sexes at 1000 mg/kg
bw/d. The increased liver weights in males and females at 1000 mg/kg
bw/d as well as the increased absolute and relative weights of thyroid
glands in females at 1000 mg/kg bw/d were considered treatment-related.
Three females at 1000 mg/kg bw/d showed an enlarged liver. Fatty change
(cytoplasmic vacuolization) of hepatocytes was observed in 3 males and 9
females (2 with enlarged liver) at 1000 mg/kg bw/d. The fatty change was
located in the peripheral periportal hepatocytes and characterized by
lipid-containing vacuoles. The incidence of minimal or slight diffuse
follicular hypertrophy/hyperplasia in thyroid glands was increased in
males at 250 and 1000 mg/kg bw/d (3 and 6 vs 1 in control) and females
at 1000 mg/kg bw/d (4 vs 0 in control).
Based on decreased platelet count and increased incidence of follicular
hypertrophy/hyperplasia in the thyroid glands in males at 250 mg/kg bw/d
and above, the NOAEL was set at 75 mg/kg bw/d.
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