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EC number: 203-630-6 | CAS number: 108-93-0
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation
Irritant, Category 2, Monsanto (1978a)
Mild irritant, Category 3, Monsanto (1978b)
Eye irritation
Irritating to eyes, Category 2, OECD 405, Koch (1985)
Irreversible effects on the eye, Category 1, OECD 405, Bagley (1992)
Category 1 or 2, OECD 492, Kaluzhny (2011)
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Primary Skin Irritation Test according to the Federal Hazardous Substances Act (FSHA)
- Version / remarks:
- not specified
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Study prior to GLP
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Monsanto, Pensacola Plant, Gonzalez FL
- Purity: Not reported - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- no details provided
- Type of coverage:
- not specified
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 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
OBSERVATION TIME POINTS
- 4, 24, 48, 72 and 168h
SCORING SYSTEM:
- Method of calculation: Draize score - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- of 6 animals
- Time point:
- 24/48/72 h
- Score:
- 2.7
- 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:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4.5
- Max. score:
- 8
- Reversibility:
- fully reversible within: 7 days
- Other effects:
- - Other adverse local effects: 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
- Conclusions:
- In this in vivo study on rabbits, the results indicate that the test item is a Skin Irritant (UN GHS: Category 2).
- Executive summary:
This dermal irritation study was performed according to the method described in the FHSA (Federal Hazardous Substance Act). Six New Zealand Albino rabbits were dermally exposed to 0.5 mL of the test substance of unknown purity for 24 hours. The test substance was applied to shaved intact and abraded skin using occlusive coverage. Animals were observed for up to 7 days following exposure. The skin was scored at 24, 48, 72 and 168 hours after application. Mean Draize scores (mean of all animals, mean of 24 - 72 hour readings) for the intact skin were 2.7 for erythema (three animals with a score of 3.0, 1 animal with a score of 2.7 and 2 animals with a score of 2.3) and 1.7 (four animals with a score of 2.0, one animal with 1.3 and one with 1.0) for oedema. No irritation was found after 7 days (168 hours) and no injury in depth was found.
Reference
Hours |
24 |
48 |
72 |
168 |
Mean score (24 - 72 h) | |||||
Animal No |
Eryth. |
Edema |
Eryth. |
Edema |
Eryth. |
Edema |
Eryth. |
Edema |
Eryth. | Edema |
1 |
3 |
3 |
3 |
2 |
3 |
1 |
0 |
0 |
3.0 | 2.0 |
2 |
3 |
3 |
3 |
2 |
3 |
1 |
0 |
0 |
3.0 | 2.0 |
3 |
3 |
3 |
2 |
2 |
2 |
1 |
0 |
0 |
2.3 | 2.0 |
4 |
3 |
2 |
3 |
2 |
3 |
2 |
0 |
0 |
3.0 | 2.0 |
5 |
3 |
2 |
3 |
1 |
2 |
1 |
0 |
0 |
2.7 | 1.3 |
6 |
2 |
1 |
2 |
1 |
3 |
1 |
0 |
0 |
2.3 | 1.0 |
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Fluka AG, Switzerland
- Purity: 99% - Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dörröds Djur- och Foderservice, Veberöd (Sweden)
- Housing: Individual housing
- Diet (e.g. ad libitum): A controlled amount of feed (Ewos avelsfoder för kanin, Batch nr 3, Ewos AB, Södertälje, Sweden)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 4s, 30s, 24h
- Observation period (in vivo):
- 1h, 24h, 48h, 72 h, 10d and 21d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsing with water
- Time after start of exposure: 4s, 30s, 24h
SCORING SYSTEM:
- Draize
TOOL USED TO ASSESS SCORE:
- ophthalmoscope, biomicroscope, fluorescein - Irritation parameter:
- cornea opacity score
- Remarks:
- (24h exposure)
- Basis:
- mean
- Remarks:
- for each of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Mean (24,48; 72h) scores of each animal: animal #1 = 1.7; animal #2 = 2; animal #3 = 2
- Irritation parameter:
- iris score
- Remarks:
- (24h exposure)
- Basis:
- mean
- Remarks:
- for each of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (24h exposure)
- Basis:
- mean
- Remarks:
- for each of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Remarks:
- (24h exposure)
- Basis:
- mean
- Remarks:
- for each of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In this in vivo study on rabbits, the results indicate that the test item is irritating to the eyes of rabbits.
- Executive summary:
In this GLP compliant OECD 405 study, one eye of each of 3 rabbits was treated with 0.1 mL cyclohexanol (purity 99%) for a period of 24h, 30s or 4s. Draize scoring of eye changes were performed at 24h, 48h, 72h after instillation. Regarding the 24 hour application, the mean cornea score (all animals, mean of 24 - 72 hour readings) was 1.9 (one animal with a score of 1.7 and two animals with a score of 2.0), the mean iris score was 0, the mean conjuctivae score was 2.1 (one animal with a score of 2.3 and two animals with 2.0) and the mean chemosis score was 2,3 (one animal with a score of 2,3, one with 2,7 and one with 2.0). Effects were reversible within 10 days in all animals.
Reference
As the erythema and oedema scores resulting from the 4-sec-exposure are less relevant for an assessment of the eye irritating property of the substance, the details are not reported here.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
In a well-documented human study (van Thriel et al. 2006), cyclohexanol was observed to have respiratory tract irritating properties from concentrations of 427 ppm (1.77 mg/mL).
Justification for classification or non-classification
Skin Irritation
The substance is classified as Skin Irritant Cat. 2. The available relevant data support the legal classification. The result of the key study triggers a classification with Cat. 2 under Regulation (EC) No 1272/2008, Annex I, whereas the result of a supporting study triggers a classification with Cat. 3. Both studies are of comparable quality. Since an erythema score of >= 2.3 was observed for all animals in the key study, the more stringent classification of Cat. 2 "irritating to skin" is recommended.
Eye Irritation
The harmonised CLP classification of this substance does not contain a classification for eye irritation.
On the basis of the Bagley (1992) study, a classification with Cat. 1 under the Regulation (EC) No. 1272/2008, Annex I, may be warranted. However, in three other studies being adequate for an assessment of classification and labelling, the effects on eyes were shown to be less severe and reversible within 21 days. Thus a classification with Cat. 2 according to Regulation (EC) No. 1272/2008, Annex I, criteria is recommended, based on weight-of-evidence.
Respiratory irritation
The harmonised CLP classification of cyclohexanol includes a classification regarding its irritation potential to the respiratory tract. The legal classification is supported by the findings on respiratory tract irritation described in the available human studies.
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