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EC number: 201-224-3
CAS number: 79-77-6
Repeated dose toxicity:- sub-chronic, 90 days: NOAEL = 83 mg/kg bw/day (female), NOAEL = 71.8 mg/kg bw/day (male) (OECD 408)- 28 days: LOAEL = ca. 390-510 mg/kg bw/day
Repeated dose toxicity was analyzed in a 28-days range finding study and
in a subchronic 90-days study performed according to OECD Guideline 408
(BASF AG, 2003, 2004). In the subchronic study the compound was
administered to groups of 10 male and 10 female Wistar rats at dietary
concentrations of 0, 100, 1000 and 10000 ppm for 3 months. These
concentrations corresponded to dosages of about 7 and 8 mg/kg bw/day, 72
and 83 mg/kg bw/day or 720 and 801 mg/kg bw/day for males and females,
After 90 days substance related effects in liver, kidney and the thyroid
gland were detected, including central and peripheral hypertrophy of
hepatocytes, decreased thyroxine as well as changes in urinary
parameters. The NOEL under the conditions of the present study was
100 ppm for both sexes (about 7 and 8 mg/kg bw/d for males and females).
Based on adaptive liver effects in both sexes and minor urine
findings in males the NOAEL was 1000 ppm which correspond to a dosage of
72 and 83 mg/kg bw/day for males and females, respectively.
The LOAEL was found to be 10 000 ppm (720 and 801 mg/kg bw/day for males
and females) due to liver, kidney and thyroid findings in
In the 28 day range finding study 5 animals per sex and dose were
administered to 1000, 5000 and 15000 ppm, corresponding to ca. 80-100,
360-510 and 1090-1260 mg/kg bw/day. The observed effects were changes in
organ weights and food consumption, so that the NOAEL was found to be
80-100 mg/kg bw/day and the LOAEL 390 – 510 mg/kg bw/day.
In two other studies rats were administered for 5 or 90 days, where a
NOAEL of 10 mg/kg bw/day was found after the 90 day application
(Hoffmann-LaRoche, 1975; Ford, 1983). However, both studies showed clear
deficits in the protocol or given data, so that their results could not
be taken into account for evaluation.
Due to the NOAEL values of 83 mg/kg bw/day for females and 71.8 mg/kg
bw/day for males found in a subchronic OECD guideline 408 study, no
classification is required.
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