Registration Dossier
Registration Dossier
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EC number: 239-753-7 | CAS number: 15676-16-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicity assessment of sulpiride as the basis of its hygienic standardization.
- Author:
- Martynova NA
- Year:
- 2 015
- Bibliographic source:
- Gig Sanit. 2015; 94(1):114-7.
Materials and methods
Test guideline
- Guideline:
- other: not specified
- GLP compliance:
- not specified
- Remarks:
- abstract
- Test type:
- other: not specified.
Test material
- Reference substance name:
- Sulpiride
- EC Number:
- 239-753-7
- EC Name:
- Sulpiride
- Cas Number:
- 15676-16-1
- Molecular formula:
- C15H23N3O4S
- IUPAC Name:
- sulpiride
Constituent 1
- Specific details on test material used for the study:
- Sulpiride and sulpiride HCl are expected to be similar for this endpoint.
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 7 200 mg/kg bw
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 6 000 mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance has a LD50 (rat) >= 6000 mg/kg bw. No significant differences were noted in the sex sensitivity of animals to a substance.
- 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.
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