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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 18 to 21 April 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- OECD Guideline study performed according to GLP. The study was fully reliable (Klimisch score = 1), however the reliability score was lowered to 2 which is the maximum score for read-across. 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-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- 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): Cepionate
- Substance type: pure active substance
- Physical state: colorless liquid
- Stability under test conditions: stable
- Storage condition of test material: in a cool and dark place
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Conelli S.n.c., Via Milano 61, 28041 ARONA (Novara) - ITALY
- Age at study initiation: ca. 4 months
- Weight at study initiation: 2-3 kg
- Housing: metal cages measuring 62x47.5x38h cm with stainless steel feeders.
- Diet (e.g. ad libitum): ad libitum (produced by Charles River), periodically analyzed
- Water (e.g. ad libitum): ad libitum, periodically analyzed
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C ± 2
- Humidity (%): 50 % ± 15
- Air changes (per hr): ca. 15 per hour filtered on HEPA 99.97%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: ca. 6 cm2
- Type of wrap if used: gauze patch loosely held in contact with the skin by an impermeable, non-irritant, hypoallergenic tape (Blenderm3M Italia)
SCORING SYSTEM:
- Erythema and Escar formation (maximum score possible: 4):
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beef redness) to slight eschar formation (injuries in depth)
- Oedema formation (maximum score possible: 4):
0: No edema
1: Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well defined by definite raising)
3: Moderate oedema (raised approximately 1 mm)
4: Severe oedema (raised more than 1 mm and extending beyond area ofexposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: # 1, #2 and #3
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No erythema was observed at any time
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2 and #3
- Time point:
- other: mean 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: No oedema were observed at any time
- Irritant / corrosive response data:
- See Table 1 in "Any other information on results incl. tables"
- Other effects:
- None (no animal died during the study, no clinical signs or behavioural alterations were observed during the study in any rabbits).
Any other information on results incl. tables
Table 1: Dermal reactions observed
|
Time of observation |
Animal n° |
||
1 |
2 |
3 |
||
Erythema and Eschar |
3 min 60 min 24 hours 48 hours 72 hours |
0 0 0 0 0 |
- 0 0 0 0 |
- 0 0 0 0 |
Oedema |
3 min 60 min 24 hours 48 hours 72 hours |
0 0 0 0 0 |
- 0 0 0 0 |
- 0 0 0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- At the application sites, no signs of dermal irritancy were noted in any animal. The test material is not classified as irritant to the skin.
- Executive summary:
Introduction. The purpose of the study was to evaluate the acute dermal irritation and/or corrosive effects on skin following the application of the test article CEPIONATE (High ratio of Methylepi-dihydrojasmonate). The test method was in accordance with European Economic Community Guidelines - Annex to Commission Directive 92/69/EEC of July 31, 1992 adapting to technical progress for the seventeenth time Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (B.4) and with Organization for Economic Cooperation and Development Guidelines (section 4, subpart 404, Paris 1981 and subsequent revisions).
Methods and Results. 0.5 ml of pure test article was applied to abraded skin of New Zealand White rabbits in occlusive conditions. Firstly one rabbit was used and three treatment sites of the skin were prepared. On the first site the test article was applied for an exposure period of 3 minutes. Since no serious gross skin reactions were noted, the test article was applied for an exposure period of 1 hour on the second site. Since no serious gross reactions were observed after the one-hour exposure period, the test article was applied for an exposure period of 4 hours on the third skin site. The test was completed using two additional animals with a 4 hour exposure period and a 72 hours observation period. None of the treated animals showed clinical signs or behavioural alterations. At the application sites, no signs of dermal irritancy were noted in any animal.
Conclusion. The test material is not classified as irritant to the skin according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and the Directive 67/548/EC.
This study is considered as acceptable and satisfies the requirement for skin irritation 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).
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.