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EC number: 203-624-3 | CAS number: 108-87-2
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given. Limitations include 24 h occlusive exposure, reading time points only at 24 and 72 h , observation period only 72 h.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
- Principles of method if other than guideline:
- Primary skin irritation study in rabbits according to Draize (Draize, J.H. (1965). Dermal Toxicity. In Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. The Editorial Committee of the Association of Food and Drug Officials of the United States, pp. 46-59)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Methylcyclohexane
- EC Number:
- 203-624-3
- EC Name:
- Methylcyclohexane
- Cas Number:
- 108-87-2
- Molecular formula:
- C7H14
- IUPAC Name:
- methylcyclohexane
- Details on test material:
- - Name of test material (as cited in study report): methyl cyclohexane
- Substance type: technical product
- Physical state: liquid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Laboratory Animals, Inc.
- Age at study initiation: adult
- Housing: individual
- Diet: Purina Lab Rabbit Chow®, ad libitum. Feed was periodically analyzed for concentrations of specified heavy metals, antibiotics, aflatoxin, pesticides, and nitrosamines
- Water: Tap water, ad libitum. The water was routinely analyzed on a retrospective basis for specified microorganisms, pesticides, heavy metals, alkalinity, and halogens.
- Quarantine: Minimum of 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 40-60
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved (intact) and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated sites of the same animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 24 h
- Observation period:
- 72 h
Reading time points: 24 and 72 h - Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: 6.5-9.7 cm² (1 - 1.5" square) intact or abraded skin on the back of the animal
- Type of wrap if used: The treated skin was covered with a gauze patch (two layers thick) held in place with Dermiclear brand transparent tape (Johnson and Johnson). The entire trunk of the animal was wrapped with a non-absorbent binder and the animal was immobilised in a stock for 24 h.
SCORING SYSTEM: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean over 24 and 72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks on result:
- other: animal found dead
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean over 24 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: mean over 24 and 72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: mean over 24 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- no data
- Remarks:
- on reversibility
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: mean over 24 and 72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- 24 h post-application: very slight erythema was noted at all 5 abraded sites and 4 of 5 intact sites. No edema was noted in any animal.
72 h post-application: very slight erythema was noted at 1 of 5 abraded and 1 of 5 intact sites. No edema was noted in any animal. - Other effects:
- No other dermal effects were observed throughout the study. One male animal was found dead prior to the 24 h reading, and was not replaced.
Any other information on results incl. tables
Table 1. Intact skin - Individual skin examination scores after 24h-exposure (Scoring according to Draize scheme)
Observation time |
Rabbit no. |
|||||||||||
1 male |
2 male* |
3 male |
4 female |
5 female |
6 female |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
24 h |
1 |
0 |
- |
- |
0 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
72 h |
0 |
0 |
- |
- |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Mean value 24 + 72 h |
0.50 |
0.00 |
- |
- |
0.00 |
0.00 |
0.50 |
0.00 |
1.00 |
0.00 |
0.50 |
0.00 |
Mean value 24 + 72 h all animals |
0.50 |
0.00 |
|
|
|
|
|
|
|
|
|
|
* Animal found dead prior to the 24 h observation.
Table 2. Abraded skin - Individual skin examination scores after 24h-exposure (Scoring according to Draize scheme)
Observation time |
Rabbit no. |
|||||||||||
1 male |
2 male* |
3 male |
4 female |
5 female |
6 female |
|||||||
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
Erythema |
Edema |
|
24 h |
1 |
0 |
- |
- |
1 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
72 h |
0 |
0 |
- |
- |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
Mean value 24 + 72 h |
0.50 |
0.00 |
- |
- |
0.50 |
0.00 |
0.50 |
0.00 |
0.50 |
0.00 |
1.00 |
0.00 |
Mean value 24 + 72 h all animals |
0.60 |
0.00 |
|
|
|
|
|
|
|
|
|
|
* Animal found dead prior to the 24 h observation.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Methylcyclohexane was tested for primary skin irritation in rabbits following the Draize method (Draize, J.H. (1965). Dermal Toxicity. In Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. The Editorial Committee of the Association of Food and Drug Officials of the United States, pp. 46-59). A group of 3 male and 3 female rabbits was exposed to 0.5 mL of the undiluted test material applied onto both the intact and abraded skin for 24 h using an occlusive dressing. The treated skin was observed for reactions after patch removal and evaluations were made at 24 and 72 h post-application.
One male animal was found dead prior to the 24 h reading, and was not replaced. At 24 h post-application, very slight erythema was noted at 4/ 5 intact sites and at all 5 abraded sites. At 72 h post-application, very slight erythema was noted at 1/5 intact and 1/5 abraded sites. No edema was noted in any animal at any time. The study was terminated 72 h post-application; therefore, no information on the reversibility of the skin effects still seen at the 72 h reading is available. The individual mean erythema scores over 24 and 72 h were 0.5/0.0/0.5/1.0/0.5 for each intact skin site and 0.5/0.5/0.5/0.5/1.0 for each abraded site.
In this study, very slight erythema and no edema were observed in rabbits exposed to methylcyclohexane for 24 h under occlusive conditions; the effects being fully reversible in 4/5 animals within 72 h post-application. Therefore, the study results do not fulfil the classification criteria for skin irritation according to Regulation (EC) 1272/2008 and Directive 67/548/EEC.
CLP: not classified
DSD: not classified
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