Registration Dossier
Registration Dossier
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EC number: 239-753-7 | CAS number: 15676-16-1
Endpoint summary
Administrative data
Description of key information
The substance does not have sensitizing effects.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Remarks:
- not specified.
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Guideline:
- other: not specified
- GLP compliance:
- not specified
- Type of study:
- not specified
- Specific details on test material used for the study:
- Sulpiride and sulpiride HCl are expected to be similar for this endpoint.
- Species:
- other: not specified.
- Strain:
- not specified
- Sex:
- not specified
- Key result
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance does not have sensitizing effects.
- Executive summary:
LD50 of sulpiride in administration into the stomach of male rats and mice is 7200 and 3400 mg/kg, for female rats and mice 6000 and 2300 mg/kg. No significant differences were noted in the species and sex sensitivity of animals to a substance. In intraperitoneal administration LD50 for male rats is 220 mg/kg, for female rats 150 mg/kg. It has not a local irritant effect on the skin. There were no identified skin-resorptive and sensitizing effects. It causes a slight irritant effect on the mucous membranes of the eyes. It has a toxic effect on the central nervous system, liver, kidneys.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Due to little information available, the quality of the database is limited.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Data available are deemed to be inconclusive for the classification for skin sensitization.
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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