Registration Dossier
Registration Dossier
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EC number: 806-795-8 | CAS number: 909419-73-4
Endpoint summary
Administrative data
Description of key information
In chronic studies (rat and dog, 6-mo and 1-yr) sedation was the primary drug-related clinical sign and was observed at all doses, with severity being dose related.
[FDA]
As stated in CLP Guidance, where the same target organ toxicity of similar severity is observed after single and repeated exposure to a similar dose, it may be concluded that the toxicity is essentially an acute (i.e. single exposure) effect with no accumulation or exacerbation of the toxicity with repeated exposure. In such a case classification with STOT-SE only would be appropriate.
Since sedation and other CNS effects (reversible effects) has been observed both in acute and chronic, at all dose levels tested and these types of effects has been considered for the classification as STOT RE is not relevant.
Other types of adverse effects reported are less relevant and are inconclusive for the classification of the substance.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
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
Justification for classification or non-classification
As stated in CLP Guidance, where the same target organ toxicity of similar severity is observed after single and repeated exposure to a similar dose, it may be concluded that the toxicity is essentially an acute (i.e. single exposure) effect with no accumulation or exacerbation of the toxicity with repeated exposure. In such a case classification with STOT-SE only would be appropriate.
Since sedation and other CNS effects (reversible effects) has been observed both in acute and chronic, at all dose levels tested and these types of effects has been considered for the classification as STOT RE is not relevant.
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