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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Administrative data

Description of key information

LD50 values for several animal species are available in the scientific literature. Those values are almost all higher than 2000 mg/kg (a LD50 of 1700 mg/kg bw also is reported for mouse).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
GLP compliance:
not specified
Test type:
other: not specified.
Specific details on test material used for the study:
Sulpiride and sulpiride HCl are expected to be similar for this endpoint.
Species:
dog
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Clinical signs:
other: Behavioral: somnolence (general depressed activity). Lungs, thorax, or respiration: respiratory depression. Gastrointestinal: hypermotility, diarrhea.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The substance has a LD50 of 2000 mg/kg bw.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
GLP compliance:
not specified
Test type:
other: not specified.
Specific details on test material used for the study:
Sulpiride and sulpiride HCl are expected to be similar for this endpoint.
Species:
rabbit
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 000 mg/kg bw
Clinical signs:
other: Gastrointestinal: hypermotility, diarrhea. Lungs, thorax, or respiration: respiratory depression. Behavioral: somnolence (general depressed activity).
Interpretation of results:
GHS criteria not met
Conclusions:
The substance has a LD50 (rabbit) of 4000 mg/kg bw.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Guideline:
other: not specified
GLP compliance:
not specified
Test type:
other: not specified.
Specific details on test material used for the study:
Sulpiride and sulpiride HCl are expected to be similar for this endpoint.
Species:
mouse
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
1 700 mg/kg bw
Clinical signs:
other: not specified.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The substance has a LD50 (mouse) of 1700 mg/kg bw.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
GLP compliance:
not specified
Test type:
other: not specified.
Specific details on test material used for the study:
Sulpiride and sulpiride HCl are expected to be similar for this endpoint.
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
9 800 mg/kg bw
Clinical signs:
other: Lungs, thorax, or respiration: respiratory depression. Behavioral: somnolence (general depressed activity). Gastrointestinal: hypermotility, diarrhea.
Interpretation of results:
GHS criteria not met
Conclusions:
The substance has a LD50 (rat) of 9800 mg/kg bw.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract
GLP compliance:
not specified
Test type:
other: not specified.
Specific details on test material used for the study:
Sulpiride and sulpiride HCl are expected to be similar for this endpoint.
Species:
mouse
Strain:
not specified
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
not specified
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
3 400 mg/kg bw
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
2 300 mg/kg bw
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 (mouse) >= 2000 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.

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
Guideline:
other: not specified
GLP compliance:
not specified
Remarks:
abstract
Test type:
other: not specified.
Specific details on test material used for the study:
Sulpiride and sulpiride HCl are expected to be similar for this endpoint.
Species:
rat
Strain:
not specified
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
not specified
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
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.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Guideline:
other: not specified
GLP compliance:
not specified
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 280 mg/kg bw
Based on:
other: D-Sulpiride
Remarks on result:
other: Tested on mice
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 450 mg/kg bw
Based on:
other: L-Sulpiride
Remarks on result:
other: Tested on mice
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 600 mg/kg bw
Based on:
other: L-Sulpiride
Remarks on result:
other: Tested on rats
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 200 mg/kg bw
Based on:
other: D-Sulpiride
Remarks on result:
other: Tested on rats

Trials on acute toxicity have been carried out on different animal species (mice, rats and rabbits) and using different administration routes (intravenous, oral and intraperitoneal). These studies demonstrated that the levosulpiride is well tolerated by all the animal species examined and by using different administration routes. In fact, signs of toxicity are encountered only with doses of some magnitude greater than those foreseen in therapy (2250-3250 mg/kg) (See Figure). Racemic sulpiride administered by intraperitoneal route is responsible for an LD50 of 210 mg/kg in mice and 270 mg/kg in rats. On considering that LD50 is more or less the same for both racemic compound and levosulpiride, it appears evident that when only the active levoisomer is used in human therapy at half the racemic dosage, the toxic component of the compound is halved.

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 p.o. (mice, rats) >= 2000 mg/kg bw.
Executive summary:

Trials on acute toxicity have been carried out on different animal species (mice, rats and rabbits) and using different administration routes (intravenous, oral and intraperitoneal). These studies demonstrated that the levosulpiride is well tolerated by all the animal species examined and by using different administration routes. In fact, signs of toxicity are encountered only with doses of some magnitude greater than those foreseen in therapy (2250-3250 mg/kg) (See Figure). Racemic sulpiride administered by intraperitoneal route is responsible for an LD50 of 210 mg/kg in mice and 270 mg/kg in rats. On considering that LD50 is more or less the same for both racemic compound and levosulpiride, it appears evident that when only the active levoisomer is used in human therapy at half the racemic dosage, the toxic component of the compound is halved.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
6 000 mg/kg bw
Quality of whole database:
Although the study details were not available to perform an actual reliability assessment of the studies, the LD50 values and adverse effects observed in several animal species and independent studies are consistent. Overall, the quality of the database is acceptable.

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

Overall, the data available are demmed to be conclusive but not sufficient for classification for the acute oral toxicity. No data are available for acute dermal/inhalation toxicity.