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EC number: 203-631-1 | CAS number: 108-94-1
- 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 an OECD guideline study (404) slight to moderate erythema as well as slight edema were observed after an exposure period of 3 hours. After an exposure period of 1 h our slight to marked erythema and after 4 hours slight to moderate erythema were observed. Additionally, in an EpiDerm test in vitro a corrosive potential of the test substance was seen (BASF, 2003). In a transcutaneous electrical resistance assay according to OECD guideline 430, Cyclohexanone did not show a skin corrosion potential (Envigo 2018). Taken together all the information available, it seems likely that the result obtained in the EpiDerm test represents a false positive response; classification is based on the in vivo test, supported by the TER assay.
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.
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- ldentification of the animals: Ear tattoo. Age at the beginning of the study: About 7 - 8 months. Body weight range at day 0: 3.82 kg - 4.00 kg
The animals were housed in fully air-conditioned rooms, in which a central air-conditioning system ensured a temperature in the range of 20 - 24°C and a relative humidity in the range of 30 - 70%. Illumination period: 12 h light (6.00 a.m. - 6.00 p.m.) / 12 h darkness (6.00 p.m. - 6.00 a.m.). No. of animals per cage: single housing. Type of diet: Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland (about 130 glanimal per day). Watering: Tap water ad libitum. Acclimatization period: At least 5 days before the beginning of the study. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites of the same animal
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 14 days
- Number of animals:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 3 min
- Score:
- 1.7
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 3 min
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 2.7
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 0.3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 1.7
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4 h
- Score:
- 0
- Interpretation of results:
- irritating
- Conclusions:
- Taking into account the described cutaneous reactions and the average scores for irritation under the test conditions chosen as well as the results of the EpiDermTM Skin Cyclohexanone is considered to be a skin irritant.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- (Draft) 2002 and 2000/33/EC
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Test system:
- human skin model
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Duration of treatment / exposure:
- 3 minutes and 1 hour
- Details on study design:
- As test system EpiDerm 200 skin tissue available as kits containing 24 tissues on shipping agarose was used.
Controls included (1) a negative one using bidistilled water, (2) a positive one using potassium hydroxyde purchased from Sigma-Aldrich (Germany), and a tetrazolium salt (MTT) -reduction control using either bidistilled water or test substance.
Incubation time was 3 minute and 1 hour. The estimation of the corrosive potency of the test substance was based on the metabolic activity within the treated tissue measured by means of a colorimetric assay.
In fact, the reduction of the mitochondrial deshydrogenase activity was used as criterion for determining the cytotoxicity of the test substance.
The estimation of the deshydrogenase activity was based on its property to reduce the yellow-colored and water-soluble MTT into the insoluble, blue-colored formazan. The produced formazan was measured spectrophotometrically (measurement of the optical density of the extract) after having been extracted from the tissue samples with isopropanol.
The formazan production of the test-substance treated samples and that of the negative controls were compared and the quotient of both values was used for estimation of the relative viability of the tissue. - Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure
- Value:
- 85
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour exposure
- Value:
- 7
- Interpretation of results:
- corrosive
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Feb 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
- Version / remarks:
- 2015
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Sponsor's identification: cyclohexanone
Batch number: STBF4198V
Product Code: W390909
CAS number: 108-94-1
Purity: 99.8%
Appearance: clear colorless liquid
Recertification date: 30 November 2021
Storage conditions: room temperature in the dark (<30 °C) - Test system:
- isolated skin discs
- Source species:
- rat
- Source strain:
- Wistar
- Details on animal used as source of test system:
- One female Wistar (RccHan™:WIST) strain rat was supplied by Envigo RMS (UK) Limited, Oxon, UK. At the start of pelt preparation the rat was 21 to 23 days old.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- Skin disc preparation:
Following an acclimatization period of 2 days the animal was shaved to remove hair from the dorsal surface. The shaved area was washed using an antibiotic wash. After 3 days a second antibiotic wash was performed. Two days later the animal was killed using ascending concentrations of carbon dioxide followed by cervical dislocation. The animal was in the telogen phase of hair growth and little or no hair growth was visible. When the animal had been humanely killed the dorsal skin was removed from the rat as a single pelt. Care was taken during the procedure to avoid unnecessary damage to the pelt. Excess fat was removed and the pelt mounted, epidermal side uppermost, onto a polytetrafluoroethylene (PTFE) tube. The tissue was secured in place using a rubber “O” ring. Excess tissue was trimmed away and the “O” ring/PTFE interface sealed with soft paraffin wax. The tube was supported by a clamp inside a labelled 30 mL glass receptacle containing 10 mL electrolyte solution (154 mM MgSO4).
Skin disc quality control:
Two skin discs of approximately 0.79 cm2 were taken from the pelt and the TER measured as a quality control procedure. Each disc had to give a resistance value of greater than 10 kΩ in order for the remainder of the pelt to be used in the assay. If either disc fell below the 10 kΩ threshold, the pelt was discarded. The quality control discs were then discarded and new discs from the acceptable pelt were mounted on the PTFE tubes. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test item was used as supplied. A volume of 150 μL was applied to the inner epidermal surface.
- Duration of treatment / exposure:
- The test item, positive and negative control were applied to the epidermal surface of three skin discs per test group for a contact period of 24 hours.
- Number of replicates:
- 3 per test group
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- mean value test item
- Value:
- 7.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- mean positive control
- Value:
- 880.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- transcutaneous electrical resistance (in kΩ)
- Run / experiment:
- mean negative control
- Value:
- 18.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, under the conditions of this transcutaneous electrical resistance assay and following assessment of the data, cyclohexanone was non-corrosive and is considered unlikely to have the potential to cause corrosion in vivo.
Referenceopen allclose all
After the exposure period of 3 minutes slight to moderate erythema, partly extending beyond the area of exposure and slight edema were observed during the course of the study. Additionally dryness of the skin was noted. The average score (24 to 72 hours) for irritation was calculated to be 1.7 for erythema and 0.0 for edema. The cutaneous reactions (with the exception of dryness of the skin) were reversible in the animal within 7 days after removal of the patch. The exposure period of 1 hour caused slight to marked erythema, extending beyond the area of exposure and slight edema, partly extending beyond the area of exposure in addition to dryness of the skin during the observation period. The average score (24 to 72 hours) for irritation was calculated to be 2.7 for erythema and 0.3 for edema. The cutaneous reactions were reversible in the animal within 14 days after removal of the patch. After the exposure period of 4 hours slight to moderate erythema was noted in addition to dryness of the skin during the course of the study. The average score (24 to 72 hours) for irritation was calculated to be 1.7 for erythema and 0.0 for edema. The cutaneous reactions (with the exception of dryness of the skin) were reversible in all animals within 7 days after removal of the patch.
The test substance is not able to directly reduce MTT.
Viability of the test substance treated tissues determined after an exposure period of 3 minutes was 85%. Viability of the test substance treated tissues determined after an exposure period of 1 hour was 7%. These results indicate a corrosive potential of the test substance.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Principles of method if other than guideline:
- The study was performed according to the methods described in the following publications:
• Lüpke N.P. (1985): Hen’s Egg Chorio allantoic Membrane Test for Irritation Potential. Fd. Chem. Toxic. 23, pp. 287 – 291.
• Spielmann, H. (1995): HET-CAM Test. In: Methods in Molecular Biology, 43 (eds.: O’Hare, S. and Atterwill, C. K.) pp. 199 – 204.
• Spielmann, H. et al. (1996): Results of a Validation Study in Germany on Two In Vitro Alternatives to the Draize Eye Irritation Test the HET-CAM Test and the 3T3 NRU Cytotoxicity Test. ATLA 24, pp. 741 – 858.
In addition the study follows the testing strategy for determination of eye irritation/corrosion as given in the following guideline: Organization for Economic Co-operation and Development (OECD), OECD Guidelines for testing of chemicals, Guideline No. 405: "Acute Eye Irritation / Corrosion", adopted April 24, 2002. - GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Species:
- other: in vitro test
- Strain:
- other: in vitro test
- Vehicle:
- other: Pluronic PE 6200
- Controls:
- no
- Amount / concentration applied:
- 10, 20, 40%
- Duration of treatment / exposure:
- up to a maximum time period of 3.5 minutes
- Observation period (in vivo):
- 210 seconds
- Number of animals or in vitro replicates:
- 3 eggs for 10% concentration, 2 eggs for 20% concentration and 1 egg for 40% concentration
- Details on study design:
- Type of eggs: Fresh, fertilized hen eggs produced under controlled SPF conditions.
Strain/quality: White Leghorn, SPAFAS Inc., USA, SPF Premium.
Origin: Charles River Deutschland GmbH, Extertal.
Identification: At start of incubation period continuous numbering of the eggs with a felt pen.
Weight range at start of incubation period: 48.5 g – 61.1 g
Randomization: A randomization was not performed. For each solvent eggs of comparable weight (± 10 g) were used.
Reasons for the selection: Hen eggs are recommended as preferred type of eggs in the quoted references. Analogous to test animals, controlled SPF housing guarantees a defined microbiological status of the eggs.
Climate: Breeding in an incubator at constant temperature of 37.5°C (± 0.5°C) and a relative humidity of 62.5% (± 7.5%).
Automatic rotating device: Until including incubation day 8 and/or day 9, the eggs were rotated automatically 5 times a day. On the day before application the eggs were placed with the blunt end upward and were not rotated until preparation. The incubation conditions were checked daily. Deviations were recorded.
Candling of the eggs: The eggs were candled before the start of incubation and on the 9th and/or 10th day. Any defective or unfertilized eggs were discarded. - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 10 % in Pluronix PE 6200, 210 sec
- Value:
- 0
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 20 % in Pluronic PE 6200, 210 sec
- Value:
- 1 - 2
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 40 % in Pluronic PE 6200, 210 sec
- Value:
- 2
- Interpretation of results:
- highly irritating
- Conclusions:
- Based on the results of this study and applying the evaluation criteria it is concluded, that the threshold concentration for effects indicating serious eye damage was > 10% < 20% for Cyclohexanone.
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- BASF-internal standard
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- Male rabbit weighing 2.84 kg, femal rabbit weighing 2.7 kg.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.05 ml
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Irritation parameter:
- conjunctivae score
- Time point:
- other: 1h
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Time point:
- other: 8d
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Time point:
- other: 1h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- cornea opacity score
- Time point:
- other: 8d
- Score:
- 2
- Max. score:
- 3
- Irritant / corrosive response data:
- Results after 1 hour: Slight reddening, severe edema, slight cloudiness.
Results after 24 hours: Slight reddening and edema, moderately cloudiness.
Results after 8 days: slight reddening, moderately cloudiness, scar (eye lid).
Results with common salt: no irritation - Interpretation of results:
- other: serious damage for eyes
Referenceopen allclose all
Concentration | Egg No. | Time (seconds) until appearance of | Grading of effects | Additional findings | ||
Haemorrhagia | Coagulation | Haemorrhagia | Coagulation | |||
10% in Pluronic PE 6200 | 1 | 210 | 210 | 0 | 0 | none |
2 | 210 | 210 | 0 | 0 | none | |
3 | 210 | 210 | 0 | 0 | none | |
Mean: | n = 3 | 210 | 210 | 0 | 0 | |
20% in Pluronic PE 6200 | 1 | 60 | 60 | 1 | 2 | intravascular coagulation |
2 | 76 | 76 | 1 | 2 | intravascular coagulation | |
Mean: | n = 2 | 68 | 68 | 1 | 2 | |
40% in Pluronic PE 6200 | 1 | 20 | 20 | 2 | 2 | intravascular coagulation |
Mean: | n = 1 | 20 | 20 | 2 | 2 |
Grading: 0 = no reaction; 1 = slight; 2 = moderate; 3 = severe
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the data available, cyclohexanone is classified for its irritating properties according to Regulation (EC) No. 1272/2008 (H315, H318 and H 335).
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.

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