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Diss Factsheets
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EC number: 810-495-2 | CAS number: 93452-03-0
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Acceptable, well-documented publication/study carried out according to national standards. The supporting substance is considered adequate for read-across purpose as data relates to a mixture of cis- and trans-isomers whereas the registered substance is the pure cis-isomer (see Iuclid section 13 for additional justification).
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: US-Federal Hazardous Substance Act (FHSA) Guideline 16.CFR 1500.40
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Methyl 3-oxo-2-pentylcyclopentaneacetate
- EC Number:
- 246-495-9
- EC Name:
- Methyl 3-oxo-2-pentylcyclopentaneacetate
- Cas Number:
- 24851-98-7
- IUPAC Name:
- methyl (3-oxo-2-pentylcyclopentyl)acetate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Hedione
- Substance type: pure active substance
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Not provided in study report
- Age at study initiation: Not provided in study report
- Weight at study initiation: Not provided in study report
- Fasting period before study: Not provided in study report
- Housing: Not provided in study report
- Diet (e.g. ad libitum): Not provided in study report
- Water (e.g. ad libitum): Not provided in study report
- Acclimation period: Not provided in study report
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not provided in study report
- Humidity (%): Not provided in study report
- Air changes (per hr): Not provided in study report
- Photoperiod (hrs dark / hrs light): Not provided in study report
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: area ca. 12 cm wide covering the entire circumference of the rabbit. Skin was abraded
- % coverage: > 10% body surface area
- Type of wrap if used: animals were wrapped with binders of rubber dam, gauze and adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 g/kg
- Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg bw (limit test)
- No. of animals per sex per dose:
- 10 (sex not specified)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animal were weighted before and after treatment and were observed 24 hours after application and for a period of 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, skin irritation - Statistics:
- Not applicable (limit test)
Results and discussion
- Preliminary study:
- Not performed/Not Applicable
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no 95% CL provided
- Mortality:
- One rat died after 3 days
- Clinical signs:
- other: Diarrhea was observed in 4 rabbits on day 1 (reversible)
- Gross pathology:
- No abnormalities were noted
- Other findings:
- Skin irritation, type of irritation observed and number of rats reacting:
- Slight redness: 3, Moderate redness: 7
- Slight oedema: 6, Moderate oedema: 3
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Dermal LD50 > 5000 mg/kg bw.
- Executive summary:
Introduction. Acute dermal toxicity of the test material was determined according to the Federal Substance Hazardous Act (FHSA) test guideline 16 CFR 1500.40 on acute dermal toxicity.
Methods. Pure test material was tested at a unique dose level of 5000 mg/kg bw in occlusive conditions for 24 hours on abraded skin in a group of ten New Zealand white albino rabbits. Animals were observed for 14 days for mortality, clinical signs and bodyweight changes. A necropsy was performed on all animals at the end of the study.
Results and conclusions. Diarrhea was observed in four animals on day 1 and one animal died on day 3. The harsh skin test conditions used in that test (48h exposure on abraded skin, occlusive conditions) lead to local skin irritation in some animals. No clinical signs were otherwise observed, expected bodyweight gains were monitored at the end of the study and no abnormalities were noted during the necropsy.
The LD50 was therefore determined to greater than 5000 mg/kg bw and the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC.
This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint
The supporting substance is considered adequate for read-across purpose as data relates to a mixture of cis- and trans-isomers whereas the registered substance is the pure cis-isomer (see Iuclid section 13 for additional justification).
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