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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
Genetic toxicity: in vitro
Administrative data
- 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
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Pharmacotoxicological aspects of levosulpiride.
- Author:
- Rossi F
- Year:
- 1 995
- Bibliographic source:
- Pharmacol Res. 1995 Feb;31(2):81-94.
Materials and methods
Test guideline
- Guideline:
- other: not specified
- GLP compliance:
- not specified
- Type of assay:
- other: see executive summary
Test material
- Reference substance name:
- N-[[(2S)-1-ethylpyrrolidin-2-yl]methyl]-2-methoxy-5-sulfamoylbenzamide
- Cas Number:
- 23672-07-3
- Molecular formula:
- C15H23N3O4S
- IUPAC Name:
- N-[[(2S)-1-ethylpyrrolidin-2-yl]methyl]-2-methoxy-5-sulfamoylbenzamide
- Test material form:
- not specified
Constituent 1
Results and discussion
Any other information on results incl. tables
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.
Applicant's summary and conclusion
- 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.
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