Registration Dossier
Registration Dossier
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EC number: 248-421-0 | CAS number: 27344-41-8
Endpoint summary
Administrative data
Description of key information
oral: NOAEL (female) = 226 mg/kg bw., NOAEL (male) = 190 mg/kg bw. CIBA, 1990, OECD 453
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 190 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Additional information
In a chronic toxicity study (OECD 453, CIBA, 1990) the test substance was administered to 80 albino rats/sex/dose in diet at dose levels of 500, 5000 and 50000 ppm for 24 months. A 5% dietary inclusion level (50000 ppm) of the test substance was well tolerated and without effect on survival, behaviour or appearance. An increased food intake for rats of group 4 (50000 ppm) may reflect some dietary compensation for the level of inclusion of the test substance although this increase failed to maintain bodyweight, for which a 10% decrease was recorded compared with control values. A dose related increase in water intake occurred in groups 3 and 4 (5000 and 50000 ppm), possibly compensating for the increased salinity of the diet (FAT 65029/G contains approximately 7.0% sodium chloride), and was associated with increased urine output in group 4. Hematology and blood chemistry profiles for treated rats were not disturbed by treatment apart from a tendency towards higher platelet counts in some females of group 4 (50000 ppm). Treatment at a dietary level of 5% (50000 ppm) induced hyperplasia in males and females, and in males adenomas and two carcinomas of the exocrine pancreas. Based on the above findings, the dietary level of the test substance producing no findings of toxicological relevance can be defined as 5000 ppm, equivalent to an average daily intake of 190 mg/kg bodyweight for males and 226 mg/kg bodyweight for females. This chronic study in the rat is acceptable and satisfies the guideline requirements for a chronic oral study OECD 453 in rats.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for repeated oral toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for repeated oral toxicity under Regulation (EC) No. 1272/2008.
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