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EC number: 203-624-3 | CAS number: 108-87-2
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 20 Feb - 12 Apr 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study. Refer to endpoint summary Sensitisation and IUCLID Section 13 for reporting and justification of the analogue approach.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Cyclohexane
- EC Number:
- 203-806-2
- EC Name:
- Cyclohexane
- Cas Number:
- 110-82-7
- IUPAC Name:
- cyclohexane
- Details on test material:
- - Name of test material (as cited in study report): cyclohexane
- Molecular formula: C6H12
- Molecular weight: 84.16
- Smiles notation: C1CCCCC1
- InChl: 1S/C6H12/c1-2-4-6-5-3-1/h1-6H2
- Substance type: pure substance
- Physical state: clear liquid
- Analytical purity: 99.98%
- Purity test date: 1996-11-01
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Davidson Mill Breeding Labs, Jamesburg, USA
- Weight at study initiation: 314 – 319 g (main study); 307-379 g (screening study)
- Housing: animals were individually housed in stainless steel cages with elevated wire mesh flooring
- Diet: Purina Guinea Pig Diet #5025, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-27
- Humidity (%): 20-70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12 Mar 1996 To: 12 Apr 1996
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: induction: 95% ethanol; challenge: acetone
- Concentration / amount:
- Induction: 10%
Challenge: 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: induction: 95% ethanol; challenge: acetone
- Concentration / amount:
- Induction: 10%
Challenge: 10%
- No. of animals per dose:
- range-finding test: 20 (in test groups)
main study: 10 (controls), 10 (challenge controls), 20 (in test groups: 9 males and 11 females), 10 (positive controls: 3 males and 7 females), 10 (naive positive controls) - Details on study design:
- RANGE FINDING TESTS: three groups of 4 animals (2 males and 2 females) were exposed to 5, 10, 15, 20 and 25% of test substance in 95% ethanol by using the patching technique described in the induction stage. Necrosis was observed after exposure to 25, 20 and 15% concentration of the test substance in 95% ethanol. At 5 and 10% concentration in 95% ethanol, very faint redness was noted in 1/4 animals. Thus, the 10% concentration was chosen for the induction phase. Two groups of 4 animals (2 males and 2 females) were exposed to 5, 10, 15, 20% of the test substance in acetone in order to select appropriate concentrations for the challenge exposure. After treatment with 20% test substance in acetone, very faint redness was observed in 1/4 animals. All other concentrations did not cause any irritations. Based on these results, 10% test substance was chosen for the challenge exposure.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: test substance in 95% ethanol
- Control group: 95% ethanol
- Site: left flank
- Frequency of applications: every 7 days
- Duration: 0-21
- Concentrations: 10%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 28
- Exposure period: 6 h
- Test groups: test substance in acetone
- Control group: test substance in acetone and acetone
- Site: right flank (test substance) and left flank (vehicle)
- Concentrations: 10%
- Evaluation (hr after challenge): 24 and 48 h after patch removal - Challenge controls:
- An additional challenge control group (5 males and 5 females) was used and treated with 10% of the test substance in acetone according to the conditions described for the challenge exposure.
- Positive control substance(s):
- yes
- Remarks:
- induction: 0.1% 1-chloro-2,4-dinitrobenzene (DNCB) in 50% ethanol/physiological saline; challenge: 0.07% DNCB in acetone
Study design: in vivo (LLNA)
- Statistics:
- The individual body weight gain was statistically evaluated by analysis of variance (ANOVA) and Neuman Keuls test. Statistical significance was indicated at p < 0.05.
Results and discussion
- Positive control results:
- 0.1% of the positive control test substance DNCB in 50% ethanol/physiological saline induced no or moderate redness in the induction phase of the study. After challenge exposure with 0.07% DCNB in acetone, positive skin sensitisation reactions were seen in 8/10 animals (80%), thus meeting the reliability criteria for the non-adjuvant skin sensitisation test (≥ 15%).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%; challenge: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 10%; challenge: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- redness was observed in 1 animal
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 10%; challenge: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: redness was observed in 1 animal.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- induction: 0.1%; challenge: 0.07%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- faint to moderate redness
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: induction: 0.1%; challenge: 0.07%. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: faint to moderate redness.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: challenge control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: naive positive control
- Dose level:
- 0.07%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: naive positive control. Dose level: 0.07%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%; challenge: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 10%; challenge: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 10%; challenge: 10%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- induction: 0.1%; challenge: 0.07%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- faint to moderate redness
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: induction: 0.1%; challenge: 0.07%. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: faint to moderate redness.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: challenge control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: naive positive control
- Dose level:
- 0.07%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: naive positive control. Dose level: 0.07%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The skin sensitisation potential of cyclohexane was investigated in a GLP-compliant study using a modified Buehler test method in accordance with OECD guideline 406.
9 male and 11 female guinea pigs were induced with 10% cyclohexane in ethanol and challenged with 10% cyclohexane in acetone. The test included concurrent negative (vehicle) and positive controls (1-chloro-2,4-dinitrobenzene, 0.1% in 50% ethanol: 0.9% saline at induction and 0.07% in acetone at challenge).
Induction treatment resulted in no redness (14/20 animals) to very faint redness on some tested animals (6/20 animals). Very faint redness was seen 24 h after challenge in 1/20 animals of the test group and no reactions were observed in any animal at 48 h post-challenge.
No skin reactions were observed in negative control animals. The incidence of sensitisation among the positive control animals was 8/10.
The incidence of sensitisation in cyclohexane-induced and -challenged animals was 0/20.
The study results do not fulfil the classification criteria for skin sensitisation according to Regulation (EC) No 1272/2008 and Directive 67&548/EEC.
CLP: not classified
DSD: not classified
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