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EC number: 259-515-6 | CAS number: 55184-72-0
The following source information was taken into account for DNEL calculation:
- A 28 day study with dietary feeding of a registered substance containing 97 -98% active ingredient was available in male rats dosed at 100, 1000 and 10000 ppm in the diet (corresponding with 7.47, 74.7 and 812 mg act.ingr./kg bw/day on average). Animals dosed at 1000 and 10000 ppm levels showed a slightly greater retardation in growth than rats at 100 ppm. Food consumption for all groups was comparable to the controls during the 28-day period. One control animal died after 4 days of feeding. Gross autopsy revealed some incidence of intestinal irritation at all levels. Various other findings were observed at necropsy, however a respiratory infection was present, therefore the interpretation of the study is difficult. The study was considered to be supporting, and further 28 -day testing was waived based on the availability of 90 -day toxicity data.
- A key 90-day study was available for the registered substance in 40 albino rats (20 males, 20 females) were fed with 1% of various test items mixed into the diet. In the same study, various members of the Sulfosuccinates Diester Group were tested (Plank et al, 1969). No significant differences in clinical blood chemistry studies and absolute organ weights have been detected, except a slight increase in SGPT (serum glutamic pyruvic transaminase) and SAP (serum alkaline phosphatase). Body weights, organ to body weight ratios, hematologic studies and urinalysis were not different between test and control animals. No deaths or abnormal behavioral reactions occurred; no gross pathological findings were noted. Administration of category members at 1% in the diet (10000 ppm equivalent to ca.750 mg act. ingr./kg body weight/day on average basis) for 90 days in rats did not result in any relevant changes in the subchronic toxicity study. The NOAEL was therefore considered to be worst case 750 mg/kg bw/day.
- The fact that no relevant target organ changes were seen up to highest concentration of 1% in diet for 90 days, allows to conclude that corresponding intake of 750 mg/kg bw is NOAEL. A justification for calculation of DNELs is attached.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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