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EC number: 239-753-7 | CAS number: 15676-16-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
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
- 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
- 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.
Referenceopen allclose all
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.
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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