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Diss Factsheets
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EC number: 227-285-6 | CAS number: 5763-44-0
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Tetrahydrocyclopenta[c]pyrrole-1,3(2H,3aH)-dione
- EC Number:
- 227-285-6
- EC Name:
- Tetrahydrocyclopenta[c]pyrrole-1,3(2H,3aH)-dione
- Cas Number:
- 5763-44-0
- Molecular formula:
- C7H9NO2
- IUPAC Name:
- 4,5,6,6a-tetrahydro-3aH-cyclopenta[c]pyrrole-1,3-dione
- Test material form:
- solid: flakes
- Details on test material:
- the test material was suspended in propylene glycol. the formulations were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Controlled environment, with 15 air change/hour, a temperature of 21°C +/-3°C, a relative humidity of 40-70% and a 12 hour light/12 hours dark cycle.
Animals were group housed (5 animals per sex par cage), they had free access to tap-water and to pelleted rodent diet.
Analysis of bedding, paper, diet and water did not reveal any findings that were considered to have affected study integrity.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Vehicle(s)/solvent(s) used: propylene glycol- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
the formulations (w/w) were prepared within 4 hours prior to dosing. - Duration of treatment / exposure:
- DOSE RANGE FINDING STUDY :
seven dose groups, comprising of 1 to 3 male and female animals, received a dose of tetrahydrocyclopenta[c]pyrrole-1,3(2H,3aH)-dione.
the observation period after dosing was 1 to 3 days.
MAIN STUDY :
Since there were no substancial differencies in toxicity between sexes, only male animals were used in the main study.
The dosing volume was 5 ml/kg bodyweight.
Three dose levels used at the first sampling time, which occured 24 h after treatment.
Only one (the highest) at the second sampling time, which occured 48 h after treatment.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
875 mg/kg bodyweight
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
440 mg/kg bodyweight
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
220 mg/kg bodyweight
Basis:
actual ingested
- No. of animals per sex per dose:
- five male
- Positive control(s):
- cyclophosphamide
- Route of administration: single oral intubation
- Doses / concentrations: concentration of 40 mg/kg bodyweight
- Volume : 10 ml/kg bodyweight.
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- ISOLATION OF BONE MARROW :
Both femurs of each animals were removed and freed of blood and muscles.
Both ends of the bone were shortened until a small opening to the marrow canal becale visible.
The bone was flushed with approx. 2 ml of fetal calf serum. The cell suspension was collected and centrifuged at 1000 rpm for 5 min.
PREPARATION OF THE SLIDES :
two slides prepared per animal.
slides prepared with ethanol and cleaned.
the preparations were air-dried, fixed for 5 min in 100% methanol and air-dried overnight.
Electronic data capture : REES centron environmental monitoring system version SQL 2.0 program. - Evaluation criteria:
- test substance considered as positive in the micronucleus test if it induces a biologically as well as a statistically significant increase in the incidence of micronucleated polychromatic erythrocytes (at any dose or at any sampling time) and the number of micronucleated polychromatic erythrocytes are above the historical control data range
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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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