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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- 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 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
20 females,nulliparous and non-pregnant
5 females per group.
Young animals adults were selected (approx. 9 weeks old), with body weight variation within +/- 20% of the sex mean.
ENVIRONMENTAL CONDITIONS
15 air changes per hour
temperature of 21.0 +/- 3°C
humidity range : 40-70%
12/12 hours dark/light.
Animals had free access to tap water and to pelleted rodent diet.
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- five animals per dose, see above.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- group animal numbers induction (test substance ; % w:w)
1 01-05 0 (DMF)
2 06-10 10
3 11-15 25
4 16-20 50 - Details on study design:
- Induction : the dorsal surface of both ears was topically treated (25µL/ear) with the test substance concentration, at approx. the same time on each day. The concentrations were stirred with a magnetic stirrer immediately prior to dosing.
The contro animals were treated in the same way as the experimental animals, except that the vehicle was administered instead of the test substance.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see attached document
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Mean DPM/animal values for the experimental groups treated with test substance concentrations 10, 25 and 50% were 335, 287 and 237 DPM respectively. the mean DPM/animal value for the vehicle control group was 277 DPM. See also the attached document
Any other information on results incl. tables
skin reaction/irritation :
very slight erythema observed on both eards of all animals at 50% on days 2 and 3 : considered not to have a toxicologically significant effect on the activity of the nodes.
systemic toxicity :
no mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
macroscopy of the auricular lymph nodes and surrounding area :
all auricular lymph nodes of the animals of the experimental and control groups were considered normal in size. no macroscopic abnormality observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- the test item is considered as NOT SKIN SENSITIZER.
It does not have to be classified and has no obligatory labelling requirement for sensitization by skin contact according to the GHS system.
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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