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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
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-Cyclohexan-1-ol, dodecyl-, branched
- EC Number:
- 938-702-2
- Molecular formula:
- not applicable UVCB
- IUPAC Name:
- 4-Cyclohexan-1-ol, dodecyl-, branched
- Details on test material:
- - Storage condition of test material: room temperature in a closed container
- Name of test material (as cited in study report): Cyclohexanol, 4-C11-12-alkyl, branched
- Molecular weight (if other than submission substance): 267-280 g/mol
- Physical state: liquid
- Analytical purity: 95.8 %
- Lot/batch No.: 04152/MA
- Expiration date of the lot/batch: May 2014
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 14-15 weeks old
- Weight at study initiation: > 2 kg
- Housing: individually housed in ABS-plastic rabbit cages, floor 4200 cm²
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet for rabbits (lot no 0650), rich in crude fibre, ad libitum
- Water (e.g. ad libitum): tap water (drinking water, municipal residue control, microbiological controls at regular intervals) ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2012-09-09 To: 2012-10-31
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated other side served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL per test site - Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 72 hours after patch removal
- Number of animals:
- 3 females
- Details on study design:
- TEST SITE
- Area of exposure: approx. 6 cm² of shaved skin on one side of the dorsal area
- % coverage: not mentioned
- Type of wrap if used: gauze patch, which was held in place with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, the residual test item was removed with tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to guideline
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.9
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.8
- Max. score:
- 4
- Irritant / corrosive response data:
- Under the conditions of the present study, the single dermal application of the test item to three rabbits at a dose of 0.5 mL showed irritant effects, which were not fully reversible within the observation period in two of three animals.
Animal No. 1: 14 days after patch removal erythema grade 1.
Animal No. 3 showed after 14 days time after Patch Removal extensive desquamation.
Animal No. 2: The changes were fully reversible within 4 days after patch removal.
Animal No. 1: Erythema: grade 2 after 1, 24, 48 hours, 4, 5, 6, 7 days, grade 1: until 14 days
Edema: grade 1 after 1, 24, 48, 72 hours, grade 2 after 4 days, grade 1 after 5, 6, 7, 8 days and then they were fully reversible
Animial No. 2: Erythema: grade 1 after 1, 24, 48, 72 hours and then they were fully reversible
Edema: none
Animal No. 3: Erythema: grade 1 after 1 hour, grade 2 after 24 hours, grade 3 after 48, 72 hours, 4 days, grade 2 after 5 days, grade 1 after 6 and 7 days and then they were fully reversible
Edema: nothing after 1 hour, grade 1 after 24 hours, grade 2 after 48 hours, grade 1 after 72 h, 4, 5, 6 days and then they were fully reversible.
Animal No. 1 showed after 4 until 9 days desquamation. On the other time intervals not.
Animal No. 2 showed no specific findings.
Animal No. 3 showed after 5 until the end of the observation period extensive desquamation. - Other effects:
- There were no significant body weight changes during the contact and observation period.
Any other information on results incl. tables
Table #: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Specific local findings (apart from erythema/oedema)*) |
Max. score: 4 |
Max. score: 2 |
||
60 min |
2/1/1 |
1/0/0 |
nsf/nsf/nsf |
24 h |
2/1/2 |
1/0/1 |
nsf/nsf/nsf |
48 h |
2/1/3 |
1/0/2 |
nsf/nsf/nsf |
72 h |
2/1/3 |
1/0/1 |
nsf/nsf/nsf |
day 4 |
2/0/3 |
0/0/0 |
des./nsf/nsf |
day 5 |
2/-/2 |
1/-/1 |
des./-/ext.des. |
day 6 |
2/-/1 |
1/-/1 |
des./-/ext.des. |
day 7 |
2/-/1 |
1/-/0 |
des./-/ext.des. |
day 8 |
1/-/0 |
1/-/0 |
des./-/ext.des. |
day 9 |
1/-/0 |
0/-/0 |
des./-/ext.des. |
day 10 |
1/-/0 |
0/-/0 |
nsf/-/ext.des. |
day 11 |
|||
day 12 |
|||
day 13 |
|||
day 14 |
|||
Average 24h, 48h, 72h |
|||
Reversibility**) |
|||
Average tine for reversion |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the conditions of the present study, the single dermal application of the test item to three rabbits at a dose of 0.5 mL showed irritant effects, which were not fully reversible within the observation period in two of three animals. One animal showed at the end of the observation time of 14 days erythema grade 1, one animal showed after 14 days extensive desquamation. The total mean value irritation scores (mean 24-72 hours) were 1.9 (erythema) and 0.8 (edema).
- Executive summary:
Under the conditions of the present study, the single dermal application of the test item to three rabbits at a dose of 0.5 mL showed irritant effects, which were not fully reversible within the observation period in two of three animals. Therefore the substance Cyclohexanol, 4 -C11 -12 -alkyl, branched is an skin irritant Category 2 and has the H-Phrase H315 .
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