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EC number: 429-330-7
CAS number: -
Subacute 28 -day oral toxicity with PDTN by
daily gavage in the rat.
Based on the results of a 5-day range
finding study, the dose levels for the 28 -day toxicity study were
selected to be also 0, 50, 200 and 1000 mg/kg/day. The study was based
on the following guidelines: EEC Directive 96/54/EEC, B.7, and OECD 407.
The test substance was administered daily
for 28 days by oral gavage to SPF-bred Wistar rats. One control group
and three treated groups were tested, each consisting of 5 males and 5
females. The following parameters were evaluated: clinical signs
(daily); functional observation tests (week 4); body weight and food
consumption (weekly); clinical pathology and macroscopy (at
termination); organ weights and histopathology on a selection of
tissues. Accuracy, stability and homogeneity of test substance
formulations in polyethylene glycol were demonstrated by analyses.
Slightly high values for the accuracy of group 2 formulations were
detected due to technical problems.
50 rng/kg/day: No treatment-related findings
200 mg/kg/day: No treatment-related findings
1) Clinical signs included hunched posture,
piloerection and severe brown staining of the fur (males and females)
and red discolouration of the urine (females).
2) Increased alanine aminotransferase
activity was noted in males and females.
3) Statistically significantly increased
relative liver weights were noted in males. Relative liver weights were
also slightly higher in females
4) Centrilobular hepatocyte hypertrophy was
noted microscopically in 4/5 males and 2/5 females.
From the results presented in this report a
No Observed Adverse Effect Level (NOEL) of 200 mg/kg/day was concluded.
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