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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions. Lack of details on test material (analytical purity).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- lack of details on test material (analytical purity)
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single instillation without washing
- Observation period (in vivo):
- 7 days
Reading time points: 1, 24, 48, and 72 h, and at 4 and 7 days - Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of animals #1-3 and #5, #6
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over all 6 animals
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritant / corrosive response data:
- 1 h post-instillation: conjuctival redness (vessels injected above normal) was noted in 4/6 rabbits as only eye effect.
24 h post-instillation: conjuctival redness (vessels injected above normal) was noted in 1/6 rabbits as only eye effect.
48 h to 7 days: No corneal opacity, iritis, conjunctival redness, chemosis or discharge were observed. - Other effects:
- No further local or systemic effects were reported.
Any other information on results incl. tables
Table 1: Evaluation of the eye reaction
Rabbit No. / sex |
Scoring [h] |
Cornea |
Iris |
Conjunctiva |
|
Redness |
Chemosis |
||||
#1 / m |
1 |
0 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
Mean (24, 48, 72 h) |
0 |
0 |
0 |
0 |
|
|
|||||
#2 / m |
1 |
0 |
0 |
1 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
Mean (24, 48, 72 h) |
0 |
0 |
0 |
0 |
|
|
|||||
#3 / m |
1 |
0 |
0 |
1 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
Mean (24, 48, 72 h) |
0 |
0 |
0 |
0 |
|
|
|||||
#4 / f |
1 |
0 |
0 |
1 |
0 |
24 |
0 |
0 |
1 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
Mean (24, 48, 72 h) |
0 |
0 |
0.33 |
0 |
|
|
|||||
#5 / f |
1 |
0 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
Mean (24, 48, 72 h) |
0 |
0 |
0 |
0 |
|
|
|||||
#6 / f |
1 |
0 |
0 |
1 |
0 |
24 |
0 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
Mean (24, 48, 72 h) |
0 |
0 |
0 |
0 |
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 eye irritation in 3 male and 3 female rabbits in a study following a protocol similar to OECD guideline 405. The test material (0.1 mL) was applied into the conjunctival sac of one eye, the other eye serving as control. The eyes were examined and scored 1, 24, 48 and 72 h as well as 4 and 7 days after application. No corneal opacity, iritis or chemosis were observed in any animal at any reading time point (all scores 0.0). Slight conjunctival redness was seen in 4/6 rabbits 1 h post-application, which persisted in only 1/6 animals at the 24 h reading. No conjunctival redness was observed at the following scoring time points. The mean conjunctivae score over 24, 48 and 72 h was 0.3 for this animal and 0.0 for the remaining 5 animals.
In this study, no corneal opacity, iritis or chemosis and only slight and transient conjunctival redness were observed in rabbit eyes treated with methylcyclohexane; the effects being fully reversible within 24-48 h post-instillation. Therefore, the study results do not fulfil the classification criteria for eye irritation according to Regulation (EC) 1272/2008 and Directive 67/548/EEC.
CLP: not classified
DSD: not classified
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