Registration Dossier
Registration Dossier
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EC number: 405-800-7 | CAS number: 27955-94-8
Endpoint summary
Administrative data
Description of key information
In a repeated dose toxicity study (oral) the rat NOEL (male and female) = 10 mg/kg/day and LOEL (male and female) = 105.2 mg/kg/day was determined. The effects observed at 100 and 1000 mg/kg/day were considered not to be of appreciable toxicological significance, and were attributed to the laxative effect of the substance and consequent nutritional impairment. Dosage of 10 mg/kg/day was a clear no effect level.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- LOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Repeated dose toxicity oral: The test substance was formulated and administered daily as a suspension in 1% methylcellulose to rats by oral gavage at target doses of 1000, 100, and 10 mg/kg/day for a minimum of 28 consecutive days. Positive controls were completed. At 100 mg/kg a decrease in body weight (<10% of controls) and an increase in liver weight, with no corresponding histopathological effects were observed; BW loss was not significant. At 1000 mg/kg a decrease in body weight (significant week 4, only in males), hyperplasia and distension of the caecum, and an increase in liver and kidney weight with no corresponding histopathological effects were observed. The effects observed at 100 and 1000 mg/kg/day were considered not to be of appreciable toxicological significance, and were attributed to the laxative effect of the substance and consequent nutritional impairment.
Based on the statistical decrease in BW (in males) and liver and kidney weight effects at 1000 mg/kg/day, the NOAEL was 100 mg/kg/day.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver
Justification for classification or non-classification
The substance does not meet classification criteria under EU Directive 67/548/EEC for repeated dose toxicity.
The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for repeated dose toxicity.
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