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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 225-562-6 | CAS number: 4927-39-3
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was well performed and well documented. No OECD guideline was followed, however, the study is similar to the Draize test and the obtained scores can directly be interpreted for the classification according to the GLP regulation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of albino rabbits.
- Deviations:
- yes
- Remarks:
- occlusive dressing; 24 h application; examination of erythema and edema according to Draize only 24 h after application;
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-cyclohexyl-4-methylpentan-2-one
- EC Number:
- 225-562-6
- EC Name:
- 4-cyclohexyl-4-methylpentan-2-one
- Cas Number:
- 4927-39-3
- Molecular formula:
- C12H22O
- IUPAC Name:
- 4-cyclohexyl-4-methylpentan-2-one
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5 - 3.0 kg
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and 72 hours after application
- Number of animals:
- 6 for treatment on intact skin, 6 others for abraded skin
- Details on study design:
- TEST SITE
- Area of exposure: hairs were clipped, 2.5 x 2.5 cm
- Type of wrap: patches are fixed to the application site by means of adhesive tape and the entire trunk of the rabbits is wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances.
- Abrasions: minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no, only removal of patches
- Time after start of exposure: 24 hours
SCORING SYSTEM:
Draize method for reading time point 24 h
A. Erythema and eschar formation
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)
B. Edema formation
0: No edema
1: Very slight edema (barely perceptible)
2: Slight edema (edges of area well defined by definite)
3: Moderate edema (raised approximately 1 millimeter)
4: Severe edema (raised more than 1 millimeter and extending beyond the area of exposure)
CIVO-grading system, which comprises abnormalities of scaliness and/or necrosis for reading time point 72 h
0: No reaction at all
1: Very slight scaliness
2: Distinct scaliness or very slight incrustation
3: Distinct incrustation
4: Severe incrustation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.67
- Max. score:
- 4
- Remarks on result:
- other: Test item on intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0.67
- Max. score:
- 4
- Remarks on result:
- other: Test item on intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.17
- Max. score:
- 4
- Remarks on result:
- other: Test item on abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: Test item on abraded skin
- Irritation parameter:
- other: scaliness/incrustation (CIVO-grading)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.8
- Max. score:
- 4
- Remarks on result:
- other: Test item on intact skin
- Irritation parameter:
- other: scaliness/incrustation (CIVO-grading)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.8
- Max. score:
- 4
- Remarks on result:
- other: Test item on abraded skin
- Irritant / corrosive response data:
- The test item caused moderate skin irritation. Its dermal effects generally consisted of very slight to well-defined erythema, very slight ischemia, focal haemorrhages, slight to distinct scaliness, slight incrustation and very slight edema.
Any other information on results incl. tables
Individual and average skin irritation scores
A. Intact skin
Rabbit |
24 hours - erythema |
24 hours - edema |
72 hours - scaliness/incrustation |
8803 |
4 |
1 |
2 |
8804 |
2 |
1 |
2 |
8805 |
4 |
1 |
2 |
8806 |
1 |
0 |
2 |
8807 |
1 |
0 |
1 |
8808 |
4 |
1 |
2 |
Average |
2.67 |
0.67 |
1.8 |
B. Abraded skin
Rabbit |
24 hours - erythema |
24 hours - edema |
72 hours - scaliness/incrustation |
8797 |
4 |
1 |
2 |
8798 |
2 |
1 |
2 |
8799 |
1 |
1 |
2 |
8800 |
4 |
2 |
2 |
8801 |
1 |
1 |
1 |
8802 |
1 |
0 |
2 |
Average |
2.17 |
1 |
1.8 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2 (irritant) based on CLP criteria
- Conclusions:
- On the basis of the present results it can be concluded that the test item is a moderate skin irritant.
- Executive summary:
In the current study the test item was examined for skin irritation in New Zealand White albino rabbits. No OECD test guideline was followed, however the study is similar to the Draize test. The study was not GLP.
The test item was used undiluted and caused moderate skin irritation. Its dermal effects generally consisted of very slight to well-defined erythema, very slight ischemia, focal haemorrhages, slight to distinct scaliness, slight incrustation and very slight edema.
According to the CLP Regulation (EC) No 1272/2008 the main criteria for the skin irritant category is that at least 2 of 3 tested animals have a mean score of >= 2.3 - =< 4.0. In the present study 6 animals were tested, thus, by extrapolation 4 of 6 tested animals should have a mean score of >= 2.3 - =< 4.0. This is not the case. Nevertheless, the mean score for erythema after contact with the test item on an intact skin was 2.67. Therefore, in the current study the test item should be classified as moderately irriting.
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.