Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 212-512-3 | CAS number: 823-36-9
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-ethylcyclopentane-1,3-dione
- EC Number:
- 212-512-3
- EC Name:
- 2-ethylcyclopentane-1,3-dione
- Cas Number:
- 823-36-9
- Molecular formula:
- C7H10O2
- IUPAC Name:
- 2-ethylcyclopentane-1,3-dione
- Test material form:
- solid: crystalline
- Details on test material:
- Test item: Ethyl-cyclopentanedioneCAS number: 823-36-9Batch number: S41196NPhysical state: Solid, crystalline substanceColuor: Almost whiteActive ingredient content (Calculated): 93.7%Storage: At a temperature of 15 to 30 °C
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species and strain: New Zealand white rabbitSource: S&K LAP Kft.Hygienic level during the study: good conventionalNumber of animal: 3 malesAge of animals: adult rabbits, 21 weeks oldBody weight range at the beginning of the study: 4226 - 4496 gBody weight range at the end of the study: 4254 - 4603 gAcclimatisation time: 75 days in first animal, 76 days in second animal and 77 days in third animalAnimal health: Only animals in acceptable health condition were used for the test.Housing: Animals were housed individually in metal cage.Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.Temperature: 20 ± 3 °CRelative humidity: 30-70 %Ventilation: 10-15 air exchanges/hour by central air-condition system
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The contralateral eye served as control.
- Amount / concentration applied:
- 0.1 g of the finely grounded test item was used for the study, as a single dose.
- Duration of treatment / exposure:
- The eyes of the test animals were not washed out 24 hour after test item application, because the test item had been removed from the eye of test animal by physiological mechanisms.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours, then 1 week after the application.
- Number of animals or in vitro replicates:
- 3 male
- Details on study design:
- In the first step an initial test was performed using one animal. The test item was placed into the conjunctival sac of the left eye. The eyelids were held closed gently for about one second to prevent any loss of the test item. The contralateral eye served as control.In the initial test slight to severe irritant effect was observed 24 hours after treatment. The confirmatory test was conducted using a second animal, because the assessment of discharge was severe, only. The other irritation symptoms were slight to moderate. Slight to severe irritant effects were observed 24 hour after treatment. Following treatment of the second animal, the second confirmatory test was conducted using a third animal, because the assessment of discharge was severe, only. The other irritation symptoms were slight to moderate.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 1week
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 1.33
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1.33
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 1.33 - <= 2.33
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1.33
- Reversibility:
- fully reversible within: 1 week
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Treated and control eyes were examined at 1, 24, 48 and 72 hours, then 1 week after the application.1 hour after the single application of test item into the eye of the rabbits, slight redness and chemosis, and severe discharge of the conjunctivae occurred, as well.24 hours after treatment slight to moderate redness and chemosis, severe discharge of the conjunctivae occurred, as well. Furthermore, slight cornea opacity was observed. The area of cornea involved was greater than one quarter, but less than half in two animals and the area of cornea involved was greater than one quarter, but not zero (score 1) in one animal, as well.48 hours after treatment slight redness and chemosis, slight to moderate discharge of the conjunctivae occurred, as well.72 hours after treatment slight redness and chemosis, slight to moderate discharge of the conjunctivae occurred, as well.1 week after the treatment all animals were free of symptoms and the study was finished.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- In conclusion, test item Ethyl-cyclopentanedione (CAS 823-36-9) applied to the rabbits' eye mucosa caused conjunctival and corneal irritant effects which were fully reversible within one week. The test item can be classified into Category 2B for eye irritation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.