Registration Dossier
Registration Dossier
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EC number: 200-317-6 | CAS number: 57-15-8
Endpoint summary
Administrative data
Description of key information
Chlorobutanol has been widely used as sedative-hypnotic agent used for procedural sedation, particularly in the pediatric population, and to treat anxiety, insomnia, and alcohol withdrawal syndrome, preservative in ophthalmic, parenteral, and optic preparations. It is strutural similar to chloral hydrat and has a similar toxicity as this substance.
In therapeutic use several symptoms such as CNS depression,ataxia, GI irritation including gastritis and vomiting may occur. Therapeutic doses for adults range from 0.3 to 3g.
several studies on animals result in LDo of 200 - 300 mg/kg bw
The lethal dosis for humans is estimated 50 -500 mg/kg bw.
The key study on rats (Bandman et al) results in an LC50 of 510 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- no description provided
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- rat
- Route of administration:
- oral: unspecified
- Control animals:
- not specified
- Key result
- Dose descriptor:
- LD50
- Effect level:
- 510 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- Category 4 based on GHS criteria
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 510 mg/kg bw
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
Justification for classification or non-classification
The key study on rats (Bandman et al) results in an LC50 of 510 mg/kg bw
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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