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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
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:
2015
Bibliographic source:
Gig Sanit. 2015; 94(1):114-7.

Materials and methods

Test guideline
Guideline:
other: not specified
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Sulpiride
EC Number:
239-753-7
EC Name:
Sulpiride
Cas Number:
15676-16-1
Molecular formula:
C15H23N3O4S
IUPAC Name:
sulpiride
Specific details on test material used for the study:
Sulpiride and sulpiride HCl are expected to be similar for this endpoint.

Test animals

Species:
other: not specified.
Strain:
not specified

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified

Results and discussion

In vivo

Irritant / corrosive response data:
Not irritant to the skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Not irritant to the skin.
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.