Registration Dossier
Registration Dossier
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EC number: 228-391-5 | CAS number: 6258-06-6
Endpoint summary
Administrative data
Description of key information
Subacute oral application of the test substance to rats caused signs of hyaline droplets as well as inclusions in the tubulus epithelium in male rats at doses of 200 mg/kg bw (Bayer 21366, 1992). These findings are exclusively found in male rats and not relevant for humans. The NOEL was therefore set at 40 mg/kg bw for males and 200 mg/kg bw for females.
Key value for chemical safety assessment
Additional information
Data on the repeated dose toxicity of the test substance is available only as secondary source (ECB-IUCLID, 2000, Val. 4):
In the first study, which was performed according to EU guideline 84/449/EWG and under GLP conditions, Wistar male and female rats (5 per sex) were orally treated with the test substance at concentrations of 40, 200 and 1000 mg/kg bw on 28 consecutive days (Bayer 21366, 1992). The substance was dissolved in demineralized water. A concurrent vehicle group was included in the study design. At 200 mg/kg bw slight hepatocytomegaly, hyaline droplets and intraepithelial eosinophilic cytoplasmic inclusions in the tubulus epithelium were observed in the male rats. At 1000 mg/kg bw reduced weight gain, reduced food intake, reduced erythrocyte count, reduced haemoglobin and haematocrit content, increased spleen weight, congestion, increased extramedullary hematopoiesis were observed in male and female animals. On these observed effects the NOEL for males was set at 40 mg/kg bw and at 200 mg/kg bw for female animals. No further information was given.
In the second study, 5 male Wistar rats were treated orally with 1000 mg/kg bw of the test substance on 26 consecutive days (Bayer 20020, 1991). No death were observed. From the 3rd week of treatment, squatting position (of all 5 test animals), decreased food intake and a decrease of mean body weights by up to 12 % were observed. At pathology, no treatment-related alterations of organ weights were seen.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
Based on the available data of the test substance, classification for repeated dose toxicity under Directive 67/548/EEC is not warranted.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
Based on the available data of the test substance, classification for repeated dose toxicity under Regulation (EC) No. 1272/2008 is not warranted.
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