Registration Dossier
Registration Dossier
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EC number: 421-140-2 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity information is only available for the oral administration route.
Oral administration of RSS-4 dry substance to HanIbm Wistar rats for 13 weeks was associated with changes in the kidney and liver at concentrations of 10000 or 30000 ppm and reduced weight gain, food intake and food conversion efficiencies.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 241.7 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Only one study addressing oral repeated dose toxicity is available. The study consists of a 2 -week preliminary study (1997, Klimish rating K3, supporting study) addressing palatability and dose selection, and a 90-day main study (1997, Klimish rating K1, key study).
Both studies are performed according to GLP. The key study has a well described protocol and testing conditions. However, no internationally accepted protocol (e.g. OECD) mentioned in the study report, but the applied protocol is highly similar to OECD 408. Neurobehaviour is not examined in this repeated dose study.
The study shows that administration of RSS-4 dry substance to HanIbm Wistar rats for 13 weeks was associated with changes in the kidney and liver at concentrations of 10000 or 30000 ppm and reduced weight gain, food intake and food conversion efficiencies.
The NOAEL in this study was 3000 ppm as a nominal dietary concentration, which corresponds to 241.7 mg/kg bw/d for male animals and 277.7 mg/kg bw/d for female animals.
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver; urogenital: kidneys
Justification for classification or non-classification
Based on the results from this study, no classification (EC1272/2008) is required.
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