Registration Dossier
Registration Dossier
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EC number: 204-552-5 | CAS number: 122-52-1
Endpoint summary
Administrative data
Description of key information
In study according to OECD guideline 407 (adopted 1981) and under GLP conditions repeated oral dosing by gavage to rats (32 days treatment) at doses of 30, 150, and 750 mg/kg bw/day led to a NOAEL of 150 mg/kg bw, based on mortality and histopathological effects on the lung.
Key value for chemical safety assessment
Additional information
Repeated dose toxicity, oral
A study according to OECD guideline 407 (adopted 1981) was performed under GLP conditions with repeated oral dosing by gavage to rats (32 days treatment; 5 animals/sex/dose) at doses of 30, 150, and 750 mg/kg bw/day. At the highest exposure level, an increase in mortality in both sexes and, in males only, changes in blood parameters indicative of a stimulation in erythropoiesis were found (increases in red blood cell count, hemoglobin, hematocrit together with a decrease in mean corpuscular volume and mean cell volume) together with increases in various organ weights, in particular of lungs and adrenals. Body weight gain, food and water consumption were markedly reduced when compared to the controls. Histopathological examination of high dose animals revealed effects in the lung, such as inflammatory changes, fibrosis and hyperplasia of bronchial epithelium. The study did not include the histopathological examination of spinal cord, stomach, small and large intestines, thymus, thyroid, trachea, gonads, accessory sex organs, urinary bladder, lymph nodes, peripheral nerve, bone marrow. A NOAEL of 150 mg/kg bw/day was established based on mortality and histopathological effects on the lung (Bayer AG, 1992).
Repeated dose toxicity, inhalation
No data available.
Repeated dose toxicity, dermal
No data available.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
- No classification required for repeated dose toxicity
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008:
- No classification required for specific target organ toxicity after repeated exposure through oral route.
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