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EC number: 938-702-2 | 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
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- Endpoint summary
- Stability
- Biodegradation
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- 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
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- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
One reliable (Klimisch 1) sensitisation study was available for Cyclohexanol, 4-C11-12-alkyl, branched. The sensitising properties of Cyclohexanol, 4-C11-12-alkyl, branched to mice, assessed as a Local Lymph Node Assay (LLNA) was reported by Lütkenhaus K., (2012) in an OECD 429 guideline and GLP compliant study.
Based on the results of the prescreen test the test item Cyclohexanol, 4 -C11 -12 -alkyl, branched was assessed for sensitising properties at concentrations of 6.25%, 12.5% and 25% (v/v), each diluted with AOO (4:1(v/v) acetone/olive oil). At the daily clinical observation the animals did not show any visible clinical symptoms and no case of mortality was observed. 5 mice per test and control group were examined.
Two of three tested concentrations exceeded the stimulation index of 3 (SI = 2,1 at 6.25%, SI = 3.7 at 12.5% and SI = 9.3 at 25% test substance concentration). The EC3 value (derived by linear interpolation) was calculated to be at a test item concentration of 9.72%.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August - November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP comppliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsD
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: 17 - 22g
- Housing: in groups of 5 animals in IVC cages, type II L, polysulphone cages on Altromin saw fibre bedding
- Diet: Altromin 1324 maintenance diet for rats and mice ad libitum
- Water: tap water, sulphur acidified to a pH of approx. 2.8 ad libitum (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Ear thickness prescreen test: 100%, 50%, 25%
Main test: 6.25%, 12.5% and 25% - No. of animals per dose:
- Prescreen test: 2 for test substance groups, 1 for control group
Main test: 5 - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: soluble in vehicle
- Irritation: Animals treated with 100% (undiluted) and 50% test substance showed sticky fur from day 2 until day 6, erythema grade 1 from day 4 until day 6 and slight eschar formation on days 5 and 6. In the animals treated with 25% test substance, wet fur at the application sites was observed on days 2 and 3. No signs of systemic toxicity were detected (including cageside observations of spontaneous activity, lethargy, recumbent position, convulsions, tremors, apnoea, asphyxia, vocalisation, diarrhoe, changes in the skin and fur, eyes and mucous membranes, salivation and discharge)
- Lymph node proliferation response: no lymph node proliferation assessment performed in the prescreen test
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local lymph node assay
- Criteria used to consider a positive response: Stimulation Index equal to or greater than 3.0
TREATMENT PREPARATION AND ADMINISTRATION:
- Clinical observation: prior to application and once a day thereafter all animals were observed in order to detect signs of toxicity, including dermal irritation at site of application
- Weight assessment: animals were weighed prior to the application and at the end of the test period (prior to the treatment with 3HTdR)
- Dose groups: 3 test groups (6.25, 12.5 and 25%) and 1 negative control group (vehicle: AOO, 4:1 (v/v) acetone/olive oil), 5 animals per group
- Test regime:
Topical application: application of 25 µl of the selected solution to the entire dorsal surface of each ear, performed once daily over 3 consecutive days
Administration of 3H-methyl thymidine: dosing with 20 µCi 3H-methyl thymidine by intravenous injection (tail vein) of 250 µL 3H-methyl thymidine, diluted to a working concentration of 80 µCi/mL 5 days after the first topical application
Preparation of cell suspension: 5 hours after 3H-methyl thymidine test animals were sacrificed by cervical dislocation, the draining auricular lymph nodes were excised, individually pooled for each animal (2 lymph nodes per animal), cell suspensions of lymph node cells were prepared according to guideline, transferred into scintillation vials and stored at room temperature overnight
Determination of incorporated 3H-methyl thymidine: measurement in a ß-counter and expressed as number of disintegrations per minute (DPM), background 3H-methyl thymidine levels also measured (5% trichloroacetic acid), determination of radioactivity performed individually for each animal - Positive control substance(s):
- other: P-Phenylenediammine
- Statistics:
- Calculation of mean values and standard deviation, test on outliers (Grubbs, Nalimov and Dixon), EC3 values (determined by linear interpolation: EC3 = c+[(3-d)/(b-d)]x(a-c), between two points of the stimulation indices axis, one above (a,b) and one below (c,d) the stimulation index of three)
- Positive control results:
- Reliability checks were performed on a regular basis in the test laboratory, the recent reliability check performed in October 2012.
Positive control substance: P-Phenylenediammine (CAS 106-50-3, Sigma, puritiy > 98%, Lot 041M0045V) 1%
Vehicle: AOO (4:1 (v/v) acetone/olive oil)
Species/strain: healthy CBA/CaOlaHsd mice
Source: Harlan Winkelmann, Borchen, Germany
Concentrations: 1% on 3 consecutive days
Results: SI = 8.5 ± 2.4 - Key result
- Parameter:
- SI
- Remarks on result:
- other: Stimulation indices at test substance concentrations (2 of 3 tested concentrations exceeded the stimulation index of 3): 6.25%, SI = 2.1 12.5%: SI = 3.7 25%: SI = 9.3 EC3 = 9.72% (derived by linear interpolation)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see table below
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The EC3 value (derived by linear interpolation) was calculated to be at a test item concentration of 9.72%. According to the guideline solutions or preparations containing more than 9.72% Cyclohexanol, 4-C11-12-alkyl, branched are expected to have a stimulation index of > 3 and are therefore considered to be dermal sensitiser.
- Executive summary:
A sensitisation study (Local Lymph Node Assay) with Cyclohexanol, 4 -C11 -12 -alkyl, branched was performed on mice according to OECD Guideline 429, adopted July 22, 2010.
Based on the results of the prescreen test the test item Cyclohexanol, 4 -C11 -12 -alkyl, branched was assessed for sensitising properties at concentrations of 6.25%, 12.5% and 25% (v/v), each diluted with AOO (4:1(v/v) acetone/olive oil). At the daily clinical observation the animals did not show any visible clinical symptoms and no case of mortality was observed. 5 mice per test and control group were examined.
Two of three tested concentrations exceeded the stimulation index of 3 (SI = 2,1 at 6.25%, SI = 3.7 at 12.5% and SI = 9.3 at 25% test substance concentration). The EC3 value (derived by linear interpolation) was calculated to be at a test item concentration of 9.72%.
According to the guideline solutions or preparations containing more than 9.72% Cyclohexanol, 4-C11-12-alkyl, branched are expected to have a stimulation index of > 3 and are therefore considered to be dermal sensitiser.
Reference
Table: Radioactive Determination | ||||||
Test item | Concentration [%] |
DPM (mean ± SD) |
DPM - mean Background | number of lymph nodes evaluated* | DPM/node (mean ± SD) |
SI |
Negative control | - | 1113.3 ± 417.2 | 1058.7 ± 417.2 | 8 | 529.3 ± 208.6 | 1.0 |
Cyclohexanol, 4-C11-12-alkyl, branched | 6.25 | 2306.3 ± 919.3 | 2251.7 ± 919.3 | 8 | 1125.8 ± 459.6 | 2.1 ± 0.9 |
Cyclohexanol, 4-C11-12-alkyl, branched | 12.5 | 3972.0 ± 598.7 | 3917.4 ± 598.7 | 8 | 1958.7 ± 299.3 | 3.7 ± 0.6 |
Cyclohexanol, 4-C11-12-alkyl, branched | 25 | 9879.8 ± 1260.1 | 9825.2 ± 1260.1 | 10 | 4912.6 ± 630.0 | 9.3 ± 1.2 |
Background: Scintillation fluid and TCA | - | 54.6 ± 3.8 | - | - | - | - |
DPM = disintegrations per minute, SD = standard deviation, SI = stimulation index, TCA = trichloroacetic acid | ||||||
* should be 10 lymph nodes per group, if less some could not be evaluated or were outliers (5 animals per test group, 2 lymph nodes per animal) | ||||||
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the classification criteria of regulation (EC) 1272/2008 Cyclohexanol, 4-C11-12-alkyl, branched has to be classified with Skin sensitization, Subcategory 1B, H317.
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