Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 203-806-2 | CAS number: 110-82-7
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP status unclear, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of the test method for skin irritation as prescribed by OECD and EEC
- Author:
- Jacobs G and Martens M
- Year:
- 1 987
- Bibliographic source:
- J. Toxicol.-Cut. & Ocular Toxicol. 6(3), 215-225
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- Cyclohexane was applied to shaved rabbit skin and erythema and oedema recorded (using Draize criteria) at 1, 24, 48, and 72 hr after removal of the patch. Observations continued thereafter every 2 days until dermal responses had resolved in at least one rabbit.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Cyclohexane
- EC Number:
- 203-806-2
- EC Name:
- Cyclohexane
- Cas Number:
- 110-82-7
- Molecular formula:
- C6H12
- IUPAC Name:
- cyclohexane
- Details on test material:
- - Name of test material (as cited in study report): cyclohexane
- Lot/batch No.: 3100
- Supplier: Merck, Brussels, Belgium
- Purity: no further details
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Proefstations voor Veeteelt (Merelbeke, Belgium)
- Age at study initiation: 9-24 weeks
- Weight at study initiation: 2.75-5.2 kg
- Housing: individual mesh wire bottom cages
- Diet: Conventional Laboratory diet ad libitum
- Water: Tap-water ad libitum
- Acclimatisation period: At least 7 days
- Normal housing conditions
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours, occluded
- Observation period:
- Animals examined for signs of erythema and oedema formation at 1, 24, 48 and 72 hr after removal of the test patch
- Number of animals:
- 5 or 6 (not specified)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- for all animals, all timepoints
- Time point:
- 24/48/72 h
- Score:
- 1.93
- Remarks on result:
- other: time course information not available
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- maximum erythema score (Smax)
- Time point:
- other: 119 h (time of Smax)
- Score:
- 2.56
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- for all animals, all timepoints
- Time point:
- 24/48/72 h
- Score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- Cyclohexane caused erythema (overall mean 1.93) when applied to shaved rabbit skin under occlusion for 4 hr. The magnitude of the response was below the threshold for classification.
- Executive summary:
The skin irritation potential of cyclohexane toward shaved rabbit skin was evaluated according to Annex V of directive 67/548 EEC. The sample (0.5 mL) was applied under occlusion for 4 hr with an area of untreated skin serving as control. The overall mean score for erythema (all animals over all times points) was 1.93; no oedema was reported. The results indicate that cyclohexane is not irritating to rabbit skin.
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