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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
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Levosulpiride was studied by different test methods and was not found to be genotoxic.
Moreover, the substance was predicted to be non-mutagenic by 3 individual QSAR models. The predictions show good reliability.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- (Q)SAR
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: ECHA guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals.
- Type of assay:
- bacterial reverse mutation assay
- Statistics:
- The applicability domain of predictions is assessed using an Applicability Domain Index (ADI) that has values from 0 (worst case) to 1 (best case). The ADI is calculated by grouping several other indices, each one taking into account a particular issue of the applicability domain. Most of the indices are based on the calculation of the most similar compounds found in the training and test set of the model, calculated by a similarity index that consider molecule's fingerprint and structural aspects (count of atoms, rings and relevant fragments).
For each index, including the final ADI, three intervals for its values are defined, such that the first interval corresponds to a positive evaluation, the second one corresponds to a suspicious evaluation and the last one corresponds to a negative evaluation.
List of indices:
- Similar molecules with known experimental value.
- Accuracy of prediction for similar molecules.
- Concordance for similar molecules.
- Atom Centered Fragments similarity check.
- Model descriptors range check.
- Global AD Index. - Key result
- Genotoxicity:
- negative
- Conclusions:
- The substance is predicted to be non-mutagenic.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- (Q)SAR
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: ECHA guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals.
- Type of assay:
- bacterial reverse mutation assay
- Statistics:
- The applicability domain of predictions is assessed using an Applicability Domain Index (ADI) that has values from 0 (worst case) to 1 (best case). The ADI is calculated by grouping several other indices, each one taking into account a particular issue of the applicability domain. Most of the indices are based on the calculation of the most similar compounds found in the training and test set of the model, calculated by a similarity index that consider molecule's fingerprint and structural aspects (count of atoms, rings and relevant fragments).
For each index, including the final ADI, three intervals for its values are defined, such that the first interval corresponds to a positive evaluation, the second one corresponds to a suspicious evaluation and the last one corresponds to a negative evaluation.
List of indices:
- Similar molecules with known experimental value.
- Accuracy of prediction for similar molecules.
- Concordance for similar molecules.
- Atom Centered Fragments similarity check.
- Global AD Index. - Key result
- Genotoxicity:
- negative
- Conclusions:
- The substance is predicted to be non-mutagenic.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- (Q)SAR
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: ECHA guidance on information requirements and chemical safety assessment Chapter R.6: QSARs and grouping of chemicals.
- Type of assay:
- bacterial reverse mutation assay
- Statistics:
- The applicability domain of predictions is assessed using an Applicability Domain Index (ADI) that has values from 0 (worst case) to 1 (best case). The ADI is calculated by grouping several other indices, each one taking into account a particular issue of the applicability domain. Most of the indices are based on the calculation of the most similar compounds found in the training and test set of the model, calculated by a similarity index that consider molecule's fingerprint and structural aspects (count of atoms, rings and relevant fragments).
For each index, including the final ADI, three intervals for its values are defined, such that the first interval corresponds to a positive evaluation, the second one corresponds to a suspicious evaluation and the last one corresponds to a negative evaluation.
List of indices:
- Similar molecules with known experimental value.
- Accuracy of prediction for similar molecules.
- Concordance for similar molecules.
- Atom Centered Fragments similarity check.
- Global AD Index. - Key result
- Genotoxicity:
- negative
- Conclusions:
- The substance is predicted to be non-mutagenic.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- 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
- Type of assay:
- other: see executive summary
- Conclusions:
- Levosulpiride was studied by different test methods and was not found to be genotoxic.
- Executive summary:
The mutagenic potential of levosulpiride was studied by using different methods. The point mutation test in Saccharomyces cerevisiae, the bacterial test of B. Ames on Salmonella tiphymurium, the study on the DNA repairing activity, the chromosomal aberration test in human diploid cells, the DNA repair and damage test (evaluated by mitotic crossing-over and by gene conversion in Saccharomyces cerevisiae), and the gene mutation test in Schizosaccharomyces Pombe Pl, did not document any increase in mutation rate induced by levosulpiride. Furthermore, levosulpiride was tested in vitro for possible induction of structural and numerical chromosome aberration in PHA-stimulated human lymphocytes. The compound was added to the medium at various concentrations 48 h after the culture had been set up. The mean structural aberration rates for the levosulpiride cultures were between 0.5 and 3.0% (for aberrant metaphases including gaps) or 0 and 1.5% (for aberrant metaphases excluding gaps) and were thus found within the range of variation of long-term in-house negative controls. No aberration other than gaps, breaks and isolated isochromatid fragments was observed. There was no substance-related increase in comparison to the concurrent negative controls. Numerically aberrant metaphases were also included in the evaluation for structural aberrations. Under these experimental conditions the induction of structural chromosomal aberrations and numerical aberrations in the form of hypoploid and polyploid metaphases induced by levosulpiride is ruled out.
Referenceopen allclose all
The result appears reliable as the predicted compound is into the applicability domain of the model.
The result appears reliable as the predicted compound is into the applicability domain of the model.
The result appears reliable as the predicted compound is into the applicability domain of the model.
The mutagenic potential of levosulpiride was studied by using different methods. The point mutation test in Saccharomyces cerevisiae, the bacterial test of B. Ames on Salmonella tiphymurium, the study on the DNA repairing activity, the chromosomal aberration test in human diploid cells, the DNA repair and damage test (evaluated by mitotic crossing-over and by gene conversion in Saccharomyces cerevisiae), and the gene mutation test in Schizosaccharomyces Pombe Pl, did not document any increase in mutation rate induced by levosulpiride. Furthermore, levosulpiride was tested in vitro for possible induction of structural and numerical chromosome aberration in PHA-stimulated human lymphocytes. The compound was added to the medium at various concentrations 48 h after the culture had been set up. The mean structural aberration rates for the levosulpiride cultures were between 0.5 and 3.0% (for aberrant metaphases including gaps) or 0 and 1.5% (for aberrant metaphases excluding gaps) and were thus found within the range of variation of long-term in-house negative controls. No aberration other than gaps, breaks and isolated isochromatid fragments was observed. There was no substance-related increase in comparison to the concurrent negative controls. Numerically aberrant metaphases were also included in the evaluation for structural aberrations. Under these experimental conditions the induction of structural chromosomal aberrations and numerical aberrations in the form of hypoploid and polyploid metaphases induced by levosulpiride is ruled out.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Available information allows to rule out genotoxicity of sulpiride.
Justification for classification or non-classification
Overall, data available are conclusive but not sufficient for classification.
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