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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
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 substance has the appearance of beige flakes. It has been stored at rool temperature, in the dark.
The test solution have been prepared with porpylene glycol, formulations were prepared 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. The concentration of the test substance in vehicle was varied to allow constant dosage volume in terms of mL/kg body weight.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animals are 9 females, nulliparous and non-pregnant., young adult (8-10 weeks old).
the body variation did not exceed +/- 20% of thesex mean.
They were identified by earmark.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Doses:
- 2000 mg/kg bw
300 mg/kg bw - No. of animals per sex per dose:
- 3 animals for the dose of 2000 mg/kg
2 X 3 animals for the dose of 300 mg/kg - Control animals:
- not specified
- Details on study design:
- The fisrt group was treated at a dose of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step.
The onset, duration and severuty of the signs of toxicity were taken into account for determination of the time interval between the dose groups.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 20 000 mg/kg bw
- Mortality:
- at 2000 mg/kg; 2 out of 3 animals were found dead or were sacirifed in extremis on days 2 and 3 respectively. The other animal at 2000 mg/kg, and all animals at 300 mg/kg survived up to scheduled necropsy.
- Clinical signs:
- other: At 2000 mg/kg : - lethargy - hunched/flat posture - piloerection - chromodacryorrhea - uncoordinated movements - ptosis were noted among ALL animals. The surviving animal at 2000 mg/kg had recovered from the symptoms by day 4. At 300 mg/kg : - hunched
- Gross pathology:
- one animal, at 2000 mg/kg showed red-brown foci on the galndular mucosa of the stomach.
No mascroscopic abnormalities were found among the other animals at 2000 mg/kg or among any animal at 300 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information if swallowed Criteria used for interpretation of results: EU
- Conclusions:
- The LD 50 value of 852 IMIDE Brute (tetrahydrocyclopenta[c]pyrrole-1,3(2H,3aH)-dione) in Wistae rats was established to be within the range of 300-2000 mg/kg bodyweight.
According to the OECD423 Guideline, the LD50 cut-off value was considered to be 1000 mg/kg bodyweight.
According to the regulation EC n°1272/2008, this substance should be classified as category 4 and should be labelled as H302 : HARFULL IF SWALLOWED.
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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