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EC number: 946-745-3 | CAS number: -
The repeated dosel toxicity of the registration substance is derived based on the read-across approach. The supporting substance CAS 71786 -60 -2 was tested for its repeated dose toxicity according to OECD 422 Test Guideline and the NOAEL of 30 mg/kg/day was obtained. The major effect found at 30 and 125 mg/kg/day was changes in forestomach and in stomach, indicating the local irritation as the mode of action.
The repeated dose toxicity of the registration substance is derived based on the read-across approach.
- The supporting substance CAS 71786 -60 -2 was tested for its repeated dose toxicity according to OECD 422 Test Guideline. The major effect found at 30 and 125 mg/kg/day was changes in forestomach and in stomach, indicating the local irritation as the mode of action. Further, the effect on the hematopoietic system was found based on the minimal changes in hematology parameters and the slightly increased spleen weights in males. Also the liver weight was minimally increased for males, which was considered as adaptive responce. Based on the histopathological changes observed in the stomach the NOAEL of 30 mg/kg bw was derived for the systemic toxicity. At dose of 125 mg/kg bw lower litter size was evident. The NOAEL of 30 mg/kg bw was derived for the reproductive toxicity.
No classification is warranted for the registration substance with respect to the endpoint repeated dose toxicity.
In the studies available for the assessment of the repeated dose toxicity (one OECD 422 study and one 14 -day repeated dose toxicity study; oral application for both studies), the tissue damage on the direct contact site in the gatric tract was found to be the most critical effect. Taking into account that the registration substance is classified as corrosive to skin and eye, these effects are to be described as "portal of entry effect" and should be considered as of limited relevance for the chronic toxicity assessment. No apparent systemic toxicity was found up to dose level of 125 mg/kg/day in the OECD 422 study, in which the animals were treated up to forty-five days. No classification is justified.
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