Registration Dossier
Registration Dossier
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EC number: 701-466-4 | CAS number: -
Endpoint summary
Administrative data
Description of key information
A 90-day repeated dose oral toxicity study is available for the submission substance.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 275 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- A modern, guideline- and GLP-compliant 90-day rat study is available for the submission substance.
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
A 90 -day repeated dose oral toxicity study performed with the submission substance (Longobardi, 2017) reports a NOAEL of 275 mg/kg bw/d, based on findings (mortality, clinical signs, changes in haematology and clinical chemistry parameters and increased liver weight at the highest dose level of 750 mg/kg bw/d. A slight reversible increase in liver weight without pathological correlates and minor fluctuations in clinical chemistry parameters seen at 275 mg/kg bw/d were not considered to represent an adverse effect.
Justification for classification or non-classification
No classification is proposed: relevant data are not available
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