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EC number: 202-676-4 | CAS number: 98-52-2
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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
- Remarks:
- no data on positive control/strain sensitivity
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in May 1981
- Deviations:
- yes
- Remarks:
- (no data on positive control/strain sensitivity)
- GLP compliance:
- no
- Remarks:
- study performed prior to implementation of GLP
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA method was not available yet by the time the study was conducted.
This test is considered appropriate and it is not justified to conduct an additional LLNA study due to animal welfare. - Species:
- guinea pig
- Strain:
- other: albino guinea pig, Bor:DHPW
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Mean weight at study initiation: 359.1 g (test group), 378.9 g (control group)
- Housing: 1-5 animals/cage in Makrolon cages type IV
- Diet: G4 Alleindiaet fuer Meerschweinchen (Ssniff Spezialfutter GmbH, Soest, Germany); ad libitum
- Water: tap water; ad libitum
- Acclimation period: 4-8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 01 Mar 1988 To: 25 Mar 1988 - Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- intradermal induction: 5% in vehicle
epicutaneous induction: 100%
epicutaneous challenge: 100% - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- intradermal induction: 5% in vehicle
epicutaneous induction: 100%
epicutaneous challenge: 100% - No. of animals per dose:
- test group: 20
control group: 10 - Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections (0.1 mL)):
Injection 1: a 1:1 mixture Freunds complete adjuvant (FCA)/water
Injection 2: 5% test substance in corn oil
Injection 3: 5% test substance in a 1:1 mixture FCA/corn oil
Epicutaneous: 100% test substance
- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture Freunds complete adjuvant (FCA)/water
Injection 2: corn oil
Injection 3: a 1:1 mixture FCA/corn oil
Epicutaneous: corn oil
- Site: shoulder region (intradermal and epicutaneous)
- Frequency of applications: every 7 days
- Duration: Days 0-8
- Concentrations: intradermal 5%, epicutaneous 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1 challenge
- Day of challenge: 21 (challenge)
- Exposure period: 24 h
- Test groups: 100% test substance
- Control group: 100% test substance
- Site: left flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48 h
OTHER: For the epicutaneous treatments, the test item was heated above the melting point to approx. 70 °C. The patches were soaked with the test substance and applied to the skin after cooling down. The patches were covered with a 6 x 6 cm² leukoflex-tape and fixed with an elastic bandage. - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 5% intradermal, 100% epicutaneous; challenge: 100% epicutaneous
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- substance residues in 4/20 animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: induction: 5% intradermal, 100% epicutaneous; challenge: 100% epicutaneous. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: substance residues in 4/20 animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 5% intradermal, 100% epicutaneous; challenge: 100% epicutaneous
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- substance residues in 1/20 animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: induction: 5% intradermal, 100% epicutaneous; challenge: 100% epicutaneous. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: substance residues in 1/20 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0% intradermal, 0% epicutaneous; challenge: 100% epicutaneous
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- substance residues in 6/10 animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0% intradermal, 0% epicutaneous; challenge: 100% epicutaneous. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: substance residues in 6/10 animals.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0% intradermal, 0% epicutaneous; challenge: 100% epicutaneous
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- substance residues in 1/10 animals
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0% intradermal, 0% epicutaneous; challenge: 100% epicutaneous. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: substance residues in 1/10 animals.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The test item showed no sensitising potential in a guinea pig maximisation test.
Reference
Local findings
- after intradermal induction: pronounced erythema and edema including slight necrosis at the FCA/water injection sites (test and control group) and the FCA/vehicle injection site (control group); pronounced erythema and edema at the test item/vehicle injection site (test group); slight erythema and edema at the vehicle injection site (control group) and pronounced erythema and edema including pronounced necrosis at the test item/FCA/vehicle injection site (test group)
- after epicutaneous induction (48 h): bloody inflammation at all sites previously treated with FCA (test group and control group); encrustation after 24 h
Body weight
No effects on body weight gain was seen during the study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitising potential of 4-tert-butylcyclohexanol was assessed in a guinea pig maximisation test according to OECD Guideline 406 adopted in 1981 (88-0486-DKT). 20 female guinea pigs (Pirbright White, Dunkin Hartley, BOR:DHPW) were induced intradermally with 3 pairs of injections (0.1 mL 1:1 mixture FCA/water; 0.1 mL 5% test substance in corn oil; 0.1 mL 5% test substance in a 1:1 mixture FCA/corn oil). The control group, consisting of 10 animals, was injected with the vehicle only and/or FCA. One week later, the epicutaneous induction treatment with the indiluted test substance (100%) or the vehicle alone was conducted in the treated or control animals on the shoulder regions of intradermal injections for a period of 48 h under occlusive conditions. Pronounced local reactions (erythema, edema, necrosis, bloody inflammation) were observed after both induction procedures. On day 21, the challenge treatment was performed by topical application of the undiluted test substance to the skin of all animals (test and control group) for 24 h under occlusive conditions. No cutaneous reactions were provoked 24 and 48 h after challenge treatment with the undiluted test substance in any of the animals. Only substance residues were seen in some animals of both groups. No effects on body weight gain were observed during the study. Based on these results of the guinea pig maximisation test 4-tert-butylcyclohexanol is considered not to be sensitising to skin.
The non-sensitising potential of the test substance was further supported in a human maximization test (Kligman, 1966) carried out on 25 volunteers. No sensitisation reactions were produced at a concentration of 4% 4-tert-butylcyclohexanol in petrolatum (Opdyke, 1974).
References:
Kligman, 1966. The identification of contact allergens by human assay. III. The maximization test. A procedure for screening and rating contact sensitizers, J. invest. Derm. 47: 393
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No data on respiratory sensitisation. Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.
Justification for classification or non-classification
The available data on skin sensitisation of 4-tert-butylcylohexanol do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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.
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