Registration Dossier
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EC number: 700-127-8 | CAS number: 21862-63-5
- 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

Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- other: human data
- Adequacy of study:
- supporting study
- Study period:
- 2009-03-23 to 2009-05-01
- Reliability:
- other: not rated acc. to Klimisch
- Rationale for reliability incl. deficiencies:
- other: Relevant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- To determine by repetitive epidermal contact the potential of a test material to induce primary or cumulative irritation and/or allergic contact sensitisation.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- (1r,4r)-4-tert-butylcyclohexan-1-ol
- EC Number:
- 700-127-8
- Cas Number:
- 21862-63-5
- Molecular formula:
- C10H20O
- IUPAC Name:
- (1r,4r)-4-tert-butylcyclohexan-1-ol
- Details on test material:
- - CAS name: Cyclohexanol, 4-(1,1-dimethylethyl)-, trans-
- Molecular formula: C10H20O
- Molecular weight: 156.3 g/mol
- Physical state: solid
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 115 qualified subjects of which 106 subjects completed this study. The remaining subjects (4 females; 4 males) discontinued their participation for various reasons, none of which were related to the application of the test material.
- Sex: males: 32; females: 83
- Age: Ranging in age from 18 to 70 years.
- Inclusion criteria:
a. Male and female subjects, age 16 (with parental or guardian consent) and over.
b. Absence of any visible skin disease which might be confused with a skin reaction from the test material.
c. Prohibition of use of topical or systemic steroids and/or antihistamines for at least seven days prior to study initiation.
d. Completion of a Medical History form and the understanding and signing of an Informed Consent form.
e. Considered reliable and capable of following directions.
-Exclusion criteria:
a. Ill health.
b. Under a doctor's care or taking medication(s) which could influence the outcome of the study.
c. Females who are pregnant or nursing.
d. A history of adverse reactions to cosmetics or other personal care products. - Clinical history:
- No data
- Controls:
- No data
- Route of administration:
- dermal
- Details on study design:
- 10% of the test substance in neutral oil was used for application.
The upper back between the scapulae served as the treatment area. Approximately 0.2 g of the test material or an amount sufficient to cover the contact surface, was applied to the 3/4" x 3/4" absorbent pad portion of an adhesive dressing and allowed to volatilize for several minutes. This was then applied to the appropriate treatment site to form an occlusive patch.
Induction phase:
Patches were applied three times per week (e.g., monday, wednesday, and friday) for a total of nine applications. The site was marked to ensure the continuity of patch application. Following supervised removal and scoring of the first induction patch, participants were instructed to remove all subsequent Induction patches at home, twenty-four hours after application. The evaluation of this site was made again just prior to re-application. If a participant was unable to report for an assigned test day, one makeup day was permitted. This day was added to the Induction period.
With the exception of the first supervised Induction patch reading, if any test site exhibited a moderate (2-level) reaction during the induction phase, application was moved to an adjacent area. Applications were discontinued for the remainder of this test phase, if a moderate (2-level) reaction was observed on this new test site. Applications would also be discontinued if marked (3- level) or severe (4-level) reactivity was noted.
Rest periods consisted of twenty-four hours following each tuesday and thursday removal, and forty-eight hours following each saturday removal.
Challenge phase:
Approximately two weeks after the final induction patch application, a challenge patch was applied to a virgin test site adjacent to the original induction patch site, following the same procedure described for induction. The patch was removed and the site scored at the clinic twenty-four and seventy-two hours post-application.
EVALUATIONCRITERIA (Erythema and additional Dermal Sequelae):
0 = No visible skin reaction
0.5/+ = Barely perceptible
1 = Mild
2 = Moderate
3 = Marked
4 = Severe
E = Oedema
D = Dryness
S = Staining
P = Papules
V = Vesicles
B = Bullae
U = Ulceration
Sp = Spreading
Erythema was scored numerically according to this key. if present, additional Dermal Sequelae were indicated by the appropriate letter code and a numerical value for severity.
Results and discussion
- Results of examinations:
- With one exception, observations remained within normal limits throughout the test interval.
It was noted that one female subject exhibited mild (1) to moderate (2) erythema and oedema response within the second induction exposure, resulting in the discontinuation of subsequent patch applications at the sixth induction exposure and again seventy-two and ninety-six hours post- challenge application.
Any other information on results incl. tables
Please also refer to "Attached background material" below for raw data.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test material, SymSitive® 1609 pur (10% in neutral oil), did not indicate a clinically significant potential for dermal irritation or allergic contact sensitisation. One subject did exhibit a pattern of skin reactivity indicative of a pre-existing hypersensitivity to one or more ingredients in this formulation. There was no evidence of induced allergic contact sensitisation.
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