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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

The substance has not a local irritant effect on the skin. Instead, it causes a slight irritant effect on the mucous membranes of the eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Guideline:
other: not specified
GLP compliance:
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
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Irritant / corrosive response data:
Not irritant to the skin.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
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
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
Vehicle:
not specified
Irritant / corrosive response data:
Slightly irritant to the mucous membranes of the eyes.
Interpretation of results:
GHS criteria not met
Conclusions:
The substance is slightly irritant to the eye.
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Due to little information available, the quality of the database cannot be assessed.

Justification for classification or non-classification

Data available are deemed to be inconclusive for the classification for skin/eye irritation.