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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- The study will be performed according to:
The Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice
Guidelines (1997).
Which essentially conform to:
The United States Food and Drug Administration Good Laboratory Practice Regulations.
The United States Environmental Protection Agency Good Laboratory Practice Regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
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
Constituent 1
Test animals
- Species:
- human
Test system
- Type of coverage:
- open
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- The solid test substance (10.7 to 10.9 mg ; with a samll galss weight boat) with 5 µl Milli-Q water was added into 12-well plates on the top of the skin tissues.
- Duration of treatment / exposure:
- 15 minutes
- Observation period:
- incubation for 42 hours at 37°C.
- Number of animals:
- 3 tissues per test substance
- Details on study design:
- negative control : 3 tissues treated with 10 µl PBS (phosphate buffered saline)
positive control : 3 tissues treated with 10 µl 5% SDS (sodium dodecyl sulphate)
After exposure, the tissues were washed with PBS to remove residual test substance. The cell culture inserts were dried carefully and moved to a new well on 2ml pre-warmed maintenance medium until all tissued were dosed and rinsed. After, tissues were incubated for 42 hours at 37°C.
After incubation, they were dried carefully and transferred into a 12-wells plate prefilled with 2ml MTT medium (03 mg/ml) and incubated 3h at 37°C. Afterward, tissues were placed on blotting papers, to be dried, and the biopsy occured.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 15 min
- Value:
- ca. 96
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The relative mean tissue viability obtained after 15 minutes treatment with tetrahydrocyclopenta[c]pyrrole-1,3(2H,3aH)-dione compared to the negative control tissues was 96%. Since the mean tissue viability for 852 imide brute was above 50%, the test item tetrahydrocyclopenta[c]pyrrole-1,3(2H,3aH)-dione was considered to be NON IRRITANT.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test is valid and the test item is considered as NON IRRITANT in the in vitro skin irritation test.
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