Registration Dossier
Registration Dossier
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EC number: 242-005-2 | CAS number: 18109-80-3
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 164 mg/kg bw
- Quality of whole database:
- The available DL50 is the result of an acute toxicity study with butamirate citrate (the final Active Pharmaceutical Ingredient)
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
It's not possible to judge between the study in rat and the study in mouse to select the most appropriate since the study reports are not available, but only the results. The preferred test species for evaluation of acute toxicity by the oral route is the rat.
Justification for selection of acute toxicity – oral endpoint
The preferred test species for evaluation of acute toxicity by the oral route is the rat.
Justification for classification or non-classification
The DL50 is > 2000 mg/kg and the substance is not classified for the acute oral toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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