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EC number: 254-837-3 | CAS number: 40203-73-4
- 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
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented study following a method equivalent to recognised guidelines in accordance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 16 CFR 1500.42
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Modification of a procedure described by Draize: J.H. Draize, "Dermal Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (The Association of Food and Drug Officials of the United States, 1975), pp. 49-51.
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl cyclopentylideneacetate
- EC Number:
- 254-837-3
- EC Name:
- Methyl cyclopentylideneacetate
- Cas Number:
- 40203-73-4
- Molecular formula:
- C8H12O2
- IUPAC Name:
- methyl 2-cyclopentylideneacetate
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: 12 weeks
- Weight at study initiation: approximately 2kg.
- Housing: housed individually in galvanized or stainless steel cages
- Diet: Rabbit chow ad libitum
- Water: ad libitum
- Acclimation period: 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported.
- Humidity (%):not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days. Observations at 24, 48, 72 hours and 4 and 7 days.
- Number of animals or in vitro replicates:
- 6 (six)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, any residual test article remained in the eye this was removed with saline after the 24 hour reading.
- Time after start of exposure: 24 hours.
SCORING SYSTEM: Proceedure followed a modification to that described by J.H. Draize. Numerical scores were assigned to lesions observed according to the Draize scale. The presence of lesions not described in the Draize scale was also noted.
J.H. Draize, "Dermal Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (The Association of Food and Drug Officials of the United States, 1975), pp. 49-51.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 0.775
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Based on applicant's recalculation of the scoring; all organisms
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 0.385
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 4 days
- Remarks on result:
- other: Based on applicant's recalculation of the scoring; all organisms
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 0.998
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Based on applicant's recalculation of the scoring; all organisms
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 0.998
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: Based on applicant's recalculation of the scoring; all organisms
- Irritant / corrosive response data:
- Irritation response data is presented in table 1.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test substance cannot be considered as an eye irritant.
- Executive summary:
The study was performed to assess the irritancy potential of the test material to the eye following a single application in the New Zealand White rabbit. The non-GLP study was completed under a method similar to OECD 405 and following definitions similar to the US 16 CFR 1500.42. A volume of 0.1 ml of the test material was placed into the conjunctival sac of one eye of 6 animals. The other eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made approximately 24, 48 and 72 hours following treatment, and further assessments made at 4 and 7 days using scoring based on Draize et al. Corneal, iritis and conjunctival irritation was observed in the majority of test animals on all 3 days. Under the conditions of this study the test material is considered to be a mild eye irritant. Based on the applicants recalculation of the mean scores following grading at 24, 48 and 72h, 4 out of 6 organisms mean scores did not meet the EU classification criteria. The mean scores indicated that not more than three organisms met a positive scoring criteria for corneal opacity which in all cases fully reversed within 7 days. Furthermore there was an absence of significant variation in effects. Mean iritis and conjunctival scores in all organisms were insufficient for classification purposes. The substance has the potential to produce mild transient eye irritation but is insufficient for classification. Therefore the substance cannot be considered as an eye irritant under Regulation (EC) 1272/2008.
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