Registration Dossier
Registration Dossier
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EC number: 410-290-4 | CAS number: 80693-00-1 ADK STAB PEP-36
Endpoint summary
Administrative data
Description of key information
The no-observable-effect-level (NOEL) of the test substance in dogs via capsule administration for a period of 3 months was determined to be 2000 mg/kg/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- Study duration:
- subchronic
- Species:
- dog
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
After 3 months of treatment, selected organ/body weight and organ/brain weight ratios were calculated. Complete gross post mortem examinations and histopathological valuation of selected tissues were conducted on all animals. None of the parameters, including mortality, physical observations, body weights and food consumption, hematology, clinical chemistry, ophthalmology, urinalysis, organ weight data and macroscopic and microscopic examination revealed any indication of adverse effects due to administration of the test substance.
Justification for classification or non-classification
No significant toxic effects of relevance to human health were observed at any of the dose concentrations used in a 90 -day repeat dose study on the dog.
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