Registration Dossier
Registration Dossier
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EC number: 201-224-3 | CAS number: 79-77-6
Endpoint summary
Administrative data
Description of key information
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
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 71.8 mg/kg bw/day
Additional information
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, respectively.
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 both sexes.
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.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver; glandular: thyroids; urogenital: kidneys
Justification for classification or non-classification
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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