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EC number: 939-719-8 | CAS number: 5502-75-0
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 15, 2012 to May 14, 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Deviation from OECD guideline 429: Animals were individually housed. However, this is standard policy at the testing facility to rule out possibility of cross-contamination.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- Animals were individually housed.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- [(1r,4r)-4-(propan-2-yl)cyclohexyl]methanol; [(1s,4s)-4-(propan-2-yl)cyclohexyl]methanol
- EC Number:
- 939-719-8
- Cas Number:
- 5502-75-0
- Molecular formula:
- C10H20O
- IUPAC Name:
- [(1r,4r)-4-(propan-2-yl)cyclohexyl]methanol; [(1s,4s)-4-(propan-2-yl)cyclohexyl]methanol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Mayol
- Analytical purity: 99.8% (sum of 2 isomers)
- Expiration date of the lot/batch: August 16, 2013
- Storage condition of test material: room temperature in the dark
- Lot/batch No.: 1000877823
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 15 to 23 g
- Housing: individual, solid-floor polypropylene cages furnished with softwood woodflakes
- Diet (e.g. ad libitum): ad libitum, 2014C Teklad Global Rodent diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: April 11, 2012 To: April 24, 2012
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 25, 50, or 100%
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Not reported
- Irritation: scored daily
- Lymph node proliferation response: ear thickness scored daily on Days 1 to 6
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: at least one concentration of the test item results in a threefold or greater increase in 3HTdR incorporation compared to control values.
TREATMENT PREPARATION AND ADMINISTRATION:
prepared using acetone/olive oil as vehicle and applied within 2 hours of preparation to the dorsal surface of the ear. The volume was 25 µL applied to the dorsal surface of each ear (% coverage not reported).
There was no subsequent covering of the application site.
ADDITIONAL INFORMATION: SCORING SYSTEM:
For skin irritation, a mean ear thickness increase of equal to or greater than 25% was considered to indicate excessive irritation (measured using an Oditest micrometer at pre-dose and post-dose on Day 1, post-dose on Days 2 and 3, and on Days 4, 5, and 6).
Scale for Erythema/Overall Irritation
Observation Score
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema 4 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- ANOVA
Results and discussion
- Positive control results:
- Stimulation Index for positive control was 5.76. α-Hexylcinnamaldehyde, tech., 85% was considered to be a sensitizer under the conditions of the test.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Value:
- 44
- Key result
- Parameter:
- SI
- Value:
- 1.88
- Test group / Remarks:
- 25 % v/v
- Key result
- Parameter:
- SI
- Value:
- 3.39
- Test group / Remarks:
- 50 % v/v
- Key result
- Parameter:
- SI
- Value:
- 7.25
- Test group / Remarks:
- 100 % v/v
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
Mean DPM - vehicle = 1943.83 (±437.24)
Mean DPM - 25 % v/v = 3657.87* (±734.59)
Mean DPM - 50 % v/v = 6593.81* (±2088.69)
Mean DPM - 100 % v/v = 14121.54** (±3172.65)
DETAILS ON STIMULATION INDEX CALCULATION
Mean DPM vehicle / mean DPM test group
EC3 CALCULATION
EC3 = c + [[(3-d)/(b-d)] x (a-c)]
a = lowest concentration giving stimulation index >3 <=> 50 % v/v
b = actual stimulation index caused by ‘a’ <=> 3.39
c = highest concentration failing to produce a stimulation index of 3 <=> 25 % v/v
d = actual stimulation index caused by ‘c’ <=> 1.88
CLINICAL OBSERVATIONS:
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. Very slight erythema (barely perceptible) was noted on both ears of the animals treated with the undiluted test item on Days 1, 2, and 3 and also on both ears of the animals treated with the test item at a concentration of 50% v/v in acetone/olive oil 4:1 on Days 2 and 3. There was no evidence of excessive skin irritation (based on ear thickness measurements) due to the test item at any dose concentration evaluated.
BODY WEIGHTS
Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Based on the results of the LLNA assay, the substance is considered to be a sensitizer.
- Executive summary:
Results from the murine local lymph node assay (LLNA) show a positive response to the substance, with the stimulation index (SI) indicating a positive result (i.e., SI value of >3) at the two highest concentrations tested (i.e., 1.88 at a 25% concentration, 3.39 at a 50% concentration and 7.26 at 100% concentration). The EC3 value was 44% v/v. Consequently, the test item was considered to be a sensitizer according to EU labelling regulations Commission Directive 2001/59/EC. The test item was also classified as a contact sensitizer (Category 1B) according to Regulation (EC) No 1272/2008, relating to the Classification, Labelling and Packaging of Dangerous Substances.
Based on the EC3 value of 44%, the substance could be categorized as a weak sensitizer (Loveless et al., 2010).
There was no evidence of skin irritation due to the test item at any dose concentration evaluated. Only very slight erythema (barely perceptible) that was reversible appeared on the ears of animals treated with the undiluted test item or the test item at a concentration of 50% v/v in acetone/olive oil 4:1, and ear thickness measurements did not indicate an irritation response.
Reference:
Loveless SE, Api A-M, Crevel RWR, Debruyne E, Gamer A, Jowsey IR, et al. Potency values from the local lymph node assay: Application to classification, labelling and risk assessment. Regul Toxicol Pharmacol. 2010;56:24-66.
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