Registration Dossier
Registration Dossier
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EC number: 700-162-9 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Two repeated oral dose studies with WS400128 are available. In the sub-acute study (5 weeks, 5 animals per sex and dose group) slight effects in the kidneys of the high dose animals (1000 mg/kg/d) were observed in the histopathological examinations (each 3 of 5 animals per sex). Therefore, the NOAEL was derived at the mid dose of 300 mg/kg/d.
In the sub-chronic study (13 weeks) slight effects were observed in some blood parameters that were reversible after a 4 week recovery phase. Histopathological effects were not observed. The NOAEL of this study (with 10 animals per sex and dose group) was derived at the highest dose of 1000 mg/kg/d.
Based on the longer exposure duration and the greater number of animals per dose group the NOAEL as derived in the sub-chronic study is taken into account in the safety assessment of WS400128.
Justification for classification or non-classification
The NOAEL in adult male and female rats after 13 weeks of oral treatment was 1000 mg/kg/day. Classification regarding repeated exposure according to European classification rules [REGULATION (EC) 1272/2008 and DIRECTIVE 67/548/EEC] is not necessary.
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