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EC number: 245-826-4 | CAS number: 23694-14-6
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- reproductive development of female offspring
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
Data source
Reference
- Reference Type:
- publication
- Title:
- Effects of maternal exposure to the galactagogue Sulpiride on reproductive parameters in female rats.
- Author:
- de Azevedo Camin N
- Year:
- 2 015
- Bibliographic source:
- Physiol Behav. 2015; 140: 247-53.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The aim of the study was to investigate whether maternal exposure to Sulpiride during lactation could impair reproductive development of female offspring.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Sulpiride
- EC Number:
- 239-753-7
- EC Name:
- Sulpiride
- Cas Number:
- 15676-16-1
- Molecular formula:
- C15H23N3O4S
- IUPAC Name:
- N-[(1-ethylpyrrolidin-2-yl)methyl]-2-methoxy-5-sulfamoylbenzamide
Constituent 1
- Specific details on test material used for the study:
- Sulpiride and sulpiride HCl are expected to be similar for this endpoint.
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration of treatment / exposure:
- The dams were treated throughout the lactation period.
- Frequency of treatment:
- Daily.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2.5 mg/kg bw/day (nominal)
- Remarks:
- SUL 2.5mg group
- Dose / conc.:
- 25 mg/kg bw/day (nominal)
- Remarks:
- SUL 25mg group
- Control animals:
- yes, concurrent vehicle
Examinations
- Litter observations:
- During early life, body weight, anogenital distance, and vaginal opening were analyzed on the female offspring. In adulthood, estrous cycle, sexual behavior, estrogen levels as well as the weight of the reproductive organs were evaluated.
Results and discussion
Results: P1 (second parental generation)
General toxicity (P1)
- Details on results:
- There were no differences regarding body weight, anogenital distance, puberty onset, frequency and duration of the estrous cycle and estradiol levels on female offspring. Nonetheless, there were changes in sexual behavior. There was an increase in the number of observations in reflex magnitude 0 (absence of lordosis) and reflex magnitude 2 as well as a reduction of reflex magnitude 3 in the rats of SUL 25mg group in relation to the Control group, suggesting a decrease in sexual receptivity of these animals.
Applicant's summary and conclusion
- Conclusions:
- Study results suggest that maternal exposure to Sulpiride can alter reproductive function in female offspring rats.
- Executive summary:
The dams were treated daily by gavage with Sulpiride doses of 2.5mg/Kg (SUL 2.5mg group) and 25mg/Kg (SUL 25mg group), or distilled water (Control group) throughout the lactation period. During early life, body weight, anogenital distance, and vaginal opening were analyzed on the female offspring. In adulthood, estrous cycle, sexual behavior, estrogen levels as well as the weight of the reproductive organs were evaluated. There were no differences regarding body weight, anogenital distance, puberty onset, frequency and duration of the estrous cycle and estradiol levels on female offspring. Nonetheless, there were changes in sexual behavior. There was an increase in the number of observations in reflex magnitude 0 (absence of lordosis) and reflex magnitude 2 as well as a reduction of reflex magnitude 3 in the rats of SUL 25mg group in relation to the Control group, suggesting a decrease in sexual receptivity of these animals. These results demonstrate that maternal exposure to Sulpiride can alter reproductive function in female offspring rats.
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