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EC number: 906-627-4 | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
In a primary skin irritation test a mixture of cyclohexanone and cyclohexanol (not further specified) was found to be irritating to the skin (Monsanto 1978).
No irritating properties of the mixture of cyclohexanone and cyclohexanol have been observed in an acute eye irritation test (Monsanto 1981).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Principles of method if other than guideline:
- Primary Skin Irritation Test
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: New Zealand Albino Rabbits
- Type of coverage:
- other: unspecified patch
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 168 hours
- Number of animals:
- 6
- Details on study design:
- DETAILS OF TEST SITE:
- The test substance was applied to intact and abraded skin areas of the test animals
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported
- Time after start of exposure: 24h
SCORING SYSTEM:
Draize score;
Time schedule for scoring of skin changes: immediately after application, after 10 min, 1h, 24h, 48h, 72h, 5 days and after 7 days - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Defatting Effect - Skin sloughed off in seven to ten days. There was no injury in depth
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
Reference
Hours |
24 |
48 |
72 |
168 |
Mean score (24 - 72 h) | |||||
Animal No |
Eryth. |
Edema |
Eryth. |
Edema |
Eryth. |
Edema |
Eryth. |
Edema |
Eryth. | Edema |
1 |
4 |
4 |
4 |
4 |
4 |
4 |
0 |
0 |
4 | 4 |
2 |
4 |
4 |
4 |
4 |
4 |
4 |
0 |
0 |
4 | 4 |
3 |
4 |
4 |
4 |
4 |
4 |
4 |
0 |
0 |
4 | 4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
0 |
0 |
4 | 4 |
5 |
4 |
4 |
4 |
4 |
4 |
4 |
0 |
0 |
4 | 4 |
6 |
4 |
4 |
4 |
4 |
4 |
4 |
0 |
0 |
4 | 4 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Principles of method if other than guideline:
- Acute Eye Irritation Test
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Analytical purity/Composition: no data
- Species:
- rabbit
- Strain:
- other: New Zealand Albino Rabbits
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 168h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: Draize Score
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Score:
- 27.9
- Max. score:
- 110
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- 24/48/72 h
- Score:
- 0.95
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (6 animals)
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Classification: irritating
Reference
Time following instillation |
|
1 |
2 |
3 |
4 |
5 |
6 |
24 hours |
Cornea |
2 |
2 |
2 |
2 |
2 |
2 |
Iris |
2 |
2 |
2 |
2 |
1 |
2 |
|
Conj. Redness |
3 |
3 |
3 |
3 |
3 |
3 |
|
Chemosis |
4 |
4 |
4 |
4 |
4 |
4 |
|
48 hours |
Cornea |
1 |
1 |
1 |
1 |
1 |
1 |
Iris |
1 |
1 |
1 |
1 |
1 |
1 |
|
Conj. Redness |
2 |
2 |
3 |
2 |
2 |
2 |
|
Chemosis |
1 |
1 |
1 |
1 |
1 |
1 |
|
72 hours |
Cornea |
1 |
1 |
1 |
1 |
1 |
1 |
Iris |
0 |
1 |
0 |
0 |
0 |
1 |
|
Conj. Redness |
1 |
2 |
2 |
2 |
1 |
2 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
|
168 hours |
Cornea |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conj. Redness |
0 |
0 |
0 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Cyclohexanol:
From the available animal data, cyclohexanol is considered to be a skin irritant. In two skin irritation studies which were performed according to the method described in the FHSA (six rabbits, 24h-exposure, occlusive dressing), cyclohexanol exhibited slight to moderate erythema and edema which were reversible within 7 days.
In one OECD 405 guideline study the application of cyclohexanol resulted in moderate to severe eye irritating effects. In 1/4 animals corneal opacity was not fully reversible within 21 days (pannus), in another animal an iris score of 1 was reported after 21 days. However, in three reliable eye irritation test performed according to the OECD guideline 405 or the FHSA method cyclohexanol exhibited reversible eye irritating effects.
In a well documented human study the substance was assessed to have respiratory tract irritating properties from concentrations of 427 ppm (1.77 mg/ml)
Cyclohexanone:
An OECD guideline study (404) showed slight to moderate erythema as well as slight edema after an exposure period of 3 hours.
After an exposure period of 1 hour, slight to marked erythema and after 4 hours slight to moderate erythema were observed. In an EpiDerm test in vitro a corrosive potential of the test substance has been observed (BASF, 2003).An in vitro eye irritation test (HET-CAM) showed serious eye damage (BASF, 2006). This was in concordance with an older BASF in vivo study (1966), where severe irritating eye effects were found.
Reaction mass of cyclohexanol and cyclohexanone:
In a primary skin irritation test a mixture of cyclohexanone and cyclohexanol (not further specified) was found to be irritating to the skin (Monsanto 1981). No irritating properties of the mixture of cyclohexanone and cyclohexanol have been observed in an acute eye irritation test (Monsanto 1981).
Justification for classification or non-classification
Cyclohexanol:
Skin Irritation
According to Annex VI of Regulation (EC) No. 1272/2008 the substance is classified with Cat. 2 for skin irritating properties.
The available relevant data support the legal classification. The result of the key study yields to a GHS classification with Cat. 2. As for all animals in the key study a erythema score of >= 2,3 was observed, the GHS classification with Cat. 2 "irritating to skin" was considered to be warranted.
Eye Irritation
On the basis of the Bagley (1992) study a classification with Cat 1 (CLP) may be warranted.
However, in three other studies being acceptable for an assessment of classification and labeling (studies comparable to OECD guideline 405), the effects on eyes were shown to be less severe and reversible within 21 days. Thus, a classification with Cat. 2 according to CLP criteria is considered to be warranted.
Respiratory irritation
Cyclohexanol is classified with STOT SE cat.3 (H335) according to Annex VI of Regulation (EC) No. 1272/2008 (CLP).
The legal classification is supported by the findings on respiratory tract irritation described in the available human studies.
Cyclohexanon:
Based on the data available, cyclohexanone is classified for its irritating properties according to Regulation (EC) No. 1272/2008 (H315, H318 and H 335).
Reaction mass of cyclohexanol and cyclohexanone:
The substance consists of cyclohexanone and cyclohexanol (see identification/composition). Cyclohexanone is classified with Eye damage/eye irriation Cat. 1 according to Regulation (EC) No. 1272/2008. Cyclohexanol is classfied with eye damage/eye irritation Cat. 2 according to Regulation (EC) No. 1272/2008. However, there is one study available addressing the eye irritating properties of the mixture itself. The findings of this study would not result in any classification regarding eye irritation. Based on all data available, a classification of the mixture with eye irritation Cat. 2 was regarded to be warranted.
Respiratory tract irritation:
There are no data on the mixture of cyclohexanone and cyclohexanol. However, the mixture is classified with STOT SE cat. 3 (H335) based on the legally binding classification of the individual consituents.
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