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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 406-670-4 | CAS number: 61203-83-6
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 12 until February 26, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted February 24, 1987
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-pentylcyclohexanone
- EC Number:
- 406-670-4
- EC Name:
- 4-pentylcyclohexanone
- Cas Number:
- 61203-83-6
- Molecular formula:
- C11H20O
- IUPAC Name:
- 4-pentylcyclohexan-1-one
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SAVO-lvanovas, Kisslegg
- Age at study initiation: 15 - 16 weeks
- Weight at study initiation: mean 2.87 (2.77 - 2,98) kg
- Housing: kept separately in cages type KK 017
- Diet: ad libitum, acidified, fully demineralized water from an automatic drinking device
- Water: ad libitum, Altromin Standard Diet TPF 2113
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 38-56
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- 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:
- 14 days
- Number of animals:
- 3 (1m and 2f )
- Details on study design:
- TEST SITE
- Area of exposure: 24 hours before the start of the study the backs and flanks of the animals were cautiously shaved with an electronic clipper so that the skin stayed intact.
- Type of wrap: The application sites were wrapped with polyethylene foil which was kept in place by leather sleeve.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: After 4 hours of occlusive exposure the patches were removed and any test material left was wiped off.
OBSERVATION TIME POINTS
The rabbits were investigated for skin alterations, behavior, and general condition 1 hour after removal of the patches, and then daily for a period of further 14 days.
All rabbits were weighed before start of the study and on days 5, 8, 11 and 15.
SCORING SYSTEM:
- Method of calculation: Skin changes at the application site were evaluated according to the DRAIZE and OECD recommendations.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Other effects:
- - Other adverse local effects:
Single application of 0.5 mL test item to the intact dorsal skin of rabbits led to irritation of the skin.
Beginning from day 2, and then up to day 7 of the study, erythema and edema were observed. They were followed by other irritation symptoms i.e. formation of large scales and smaller scales from day 5 up to day 12.
- Other adverse systemic effects:
No signs of systemic toxicity were detected. The body weight development was normal. All rabbits survived the 15 day observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, the test item did show slight irritation to the skin. However, the test item is not requiring classification for skin irritation according to (EC) No 1272/2008.
- Executive summary:
A study was performed according to OECD 404 under GLP conditions. To test for primary skin irritation the test item was applied to intact skin (for a 4 hour period under occlusive conditions) of rabbits. The first examination of the treated skin sites followed 1 hour after removal of the patches. Then examinations were performed daily for a further 14 days. The skin irritation test revealed slight irritation. Beginning at the second reading, up to day 7 of the study, erythema and edema occurred (max. score 1), which from day 5 up to 12 were followed by other irritation symptoms, i.e. formation of large scales and smaller scales. Under the conditions of the present study, the test item did show slight irritation to the skin. However, the test item is not requiring classification for skin irritation according to (EC) No 1272/2008.
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.