Registration Dossier
Registration Dossier
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EC number: 272-574-2 | CAS number: 68890-66-4
Endpoint summary
Administrative data
Description of key information
Octopirox was investigated for potential systemic effects in repeated dose toxicity studies (subacute, subchronic, chronic) in rats and dogs following oral and dermal exposure. In all of these in-life toxicity studies the no-adverse-effect-level (NOAEL) was consistently placed at or above 100 mg/kg body weight. In addition, in none of these studies Octopirox exhibited any symptomatology which gives evidence for a specific target organ toxic effect.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
Additional information
Based on the available subacute, subchronic and chronic toxicity studies following repeated oral or dermal administration to rats or dogs, Octopirox exhibited neither significant systemic toxicity nor indications of special target organ toxicity. This is valid especially for the dermal exposure route as could be seen in long-term dermal toxicity studies. All NOAELs revealed were consistently at or above 100 mg/kg body weight per day including studies with intracutaneous injection.
Justification for classification or non-classification
Based on the study results with regard to repeated dose toxicity, the NOAELs were all above the threshold for classification. Indications of special target organ toxicity do not exist. Octopirox is not subject to labelling and classification requirements.
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