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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
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- Endpoint summary
- Stability
- Biodegradation
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- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 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 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Magnusson B. and Kligman A .M., 1969. The identification of contact allergens by animal assay. The guinea pig maximization test. J. Invest. Dermatol. 52: 268-276.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Guinea pig assay was available
Test material
- Reference substance name:
- Cyclohexanol
- EC Number:
- 203-630-6
- EC Name:
- Cyclohexanol
- Cas Number:
- 108-93-0
- Molecular formula:
- C6H12O
- IUPAC Name:
- cyclohexanol
- Details on test material:
- - Name of test material (as cited in study report): Cyclohexanol
- Substance number: 89/843
- Batch No.: 11/tank B 207
- Analytical purity: 98.8%
- Physical state: at 25°C, sample is homogenous liquid
- Sample was stable
- Storage: RT
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White, Dunkin Hartley HOE DHPK [SPF-LAC] BO
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: Versuchstierzucht, Hagemann GmbH & Co . KG, D-4923 Extertal 1, FRG
- Rational for choice of animals: Because of the high sensitivity of guinea pigs to a sensitization of the skin which is supposed to be most like that of man. This animal species is the test object acknowledged worldwide for sensitization studies
- Weight at study initiation: 288-340g
- Randomization: According to Salfi, R. : A Long Peri-od Random Number Generator with Application to Permutation. Compstat 1974, pp. 28 - 35.
- Housing: 5/cage
- Diet: 341 .4 mm-Kaninchen- Meerschweinchen-Haltungsdiaet; ad libitum (Supplier : Firma Klingentalmühle AG , CH-4303 Kaiseraugst, Switzerland)
- Water: ad libitum (tap water; about 2 g of ascorbic acid per 10l water was added to the drinking water twice a week
Quality of water and feed used was ascertained via analysis
- Acclimation: no data
- Clipping of the test animals: if required, about 3 to 5 hours before each reading and before each test substance application at the appropriate application sites
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- olive oil
- Concentration / amount:
- Induction; Intradermal: 5%
Induction; topical: 50%
Challenge: 25%
Rechallenge:25%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- olive oil
- Concentration / amount:
- Induction; Intradermal: 5%
Induction; topical: 50%
Challenge: 25%
Rechallenge:25%
- No. of animals per dose:
- Control I: 10
Control II: 10
Test group: 20 - Details on study design:
- PRETEST TESTS: (performed 4 wks before main study)
Epidermal Application
- No. of animals: 4/concentration
- Site of application: flanks, respectively on the same areas
- Route of exposure: epicuteneous, patches of filter paper (2 x 2 cm) saturated with the test substance
- Type of coverage: occlusive
- Frequency/Duration: 2X for 24h within a period of 96h
- Evaluation (hr after patch removal): 24h and 48h, scoring of findings using Draize score system for scoring skin irritation
- Result: The minimum irritant concentration was found with a 50% test substance preparation in olive oil DAB 9 and the maximum non-irritant concentration with 25% test substance preparation in olive oil DAB 9 (48 h after the beginning of application).
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal Injection:
- Site: shoulder
- Concentration: 5% (0.1 ml/site)
- Vehicle: olive oil DAB 9
- Test group 1: Freund's complete adjuvant (FCA) 1:1 with physiological saline(0.9%).
- Test group 2: The test article in olive oil DAB 9.
- Test group 3: Freund's complete adjuvant 1:1 with physiological saline (0.9%) containing the test article
- Control group 1: Freund's complete adjuvant (FCA) 1:1 with physiological saline(0.9%).
- Control group 2: Olive oil DAB 9.
- Control group 3: Freund's complete adjuvant 1:1 with physiological saline (0.9%)
- Frequency of applications: 1x
- Evaluation (hr after injection): 24h, scoring of findings using Draize score system for scoring skin irritation
Topical Induction Exposure:
- Time Schedule: about 1 week after intradermal injections
- Site: same as intradermal injection
- Concentration: 50% cyclohexanol in Olive oil DAB 9 (test groups), olive oil DAB 9 (control groups)
- Route of exposure: epicuteneous, patches of filter paper (2 x 4 cm) saturated with the test substance
- Type of coverage: occlusive
- Duration: 48h.
- Evaluation (hr after injection): 48h, scoring of findings using Draize score system for scoring skin irritation
B. CHALLENGE EXPOSURE
1st Challenge: Test groups and control group 1 treated identically in the following manner
- Day(s) of challenge: 2 weeks after topical induction exposure
- Route of exposure: epicutaneous, applied to a 2 x 2cm piece of filter paper
- Exposure period: 24 h
- Site: intact clipped flank, right flank (test substance, 25% in vehicle), left flank (vehicle). Left flank of each control group 2 animal was treated with the vehicle. Right flank was not treated
- Vehicle: olive oil DAB 9
- Evaluation (hr after challenge): 24h, 48h and 72h, scoring of findings using Draize score system for scoring skin irritation
2nd Challenge- Test groups, control groups 1 and 2 treated identically in the following manner
- Start of challenge: 7days after 1st challenge
- Route of exposure: epicutaneous, applied to a 2 x 2cm piece of filter paper
- Exposure period: 24 h
- Site: intact clipped flank, right flank (vehicle), left flank (test substance; 25% in vehicle)
- Vehicle: olive oil DAB 9
- Evaluation (hr after challenge): 24h, 48h and 72h, scoring of findings using Draize score system for scoring skin irritation
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% in olive oil DAB 9
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- slight erythema: 5/10 animals. no other findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25% in olive oil DAB 9. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: slight erythema: 5/10 animals. no other findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% in olive oil DAB 9
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no symptom
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25% in olive oil DAB 9. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no symptom.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25% in olive oil DAB 9
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no symptom
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25% in olive oil DAB 9. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no symptom.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% in olive oil DAB 9
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- slight erythema: 12/20 animals. no other findings
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% in olive oil DAB 9. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: slight erythema: 12/20 animals. no other findings.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% in olive oil DAB 9
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no symptom
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% in olive oil DAB 9. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no symptom.
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25% in olive oil DAB 9
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no symptom
- Remarks on result:
- other: Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25% in olive oil DAB 9. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no symptom.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% in olive oil DAB 9
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- slight to moderate erythema: 14/20. no other findings
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 25% in olive oil DAB 9. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: slight to moderate erythema: 14/20. no other findings.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% in olive oil DAB 9
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no symptom
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 25% in olive oil DAB 9. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no symptom.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25% in olive oil DAB 9
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no symptom
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: negative control. Dose level: 25% in olive oil DAB 9. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no symptom.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% in olive oil DAB 9
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- slight to moderate erythema: 14/20. no other findings
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25% in olive oil DAB 9. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: slight to moderate erythema: 14/20. no other findings.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% in olive oil DAB 9
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no symptom
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25% in olive oil DAB 9. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no symptom.
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25% in olive oil DAB 9
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no symptom
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 25% in olive oil DAB 9. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no symptom.
Applicant's summary and conclusion
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