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Diss Factsheets
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EC number: 203-268-9 | CAS number: 105-08-8
- 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
- Study period:
- 15 May 2002 - 29 May 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (OECD)
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,4-cyclohexanedimethanol (CHDM)
- IUPAC Name:
- 1,4-cyclohexanedimethanol (CHDM)
- Reference substance name:
- Cyclohex-1,4-ylenedimethanol
- EC Number:
- 203-268-9
- EC Name:
- Cyclohex-1,4-ylenedimethanol
- Cas Number:
- 105-08-8
- Molecular formula:
- C8H16O2
- IUPAC Name:
- cyclohexane-1,4-diyldimethanol
- Reference substance name:
- [4-(hydroxymethyl)cyclohexyl]methanol
- IUPAC Name:
- [4-(hydroxymethyl)cyclohexyl]methanol
- Details on test material:
- - Name of test material (as cited in study report): 1,4-cyclohexanedimethanol
- Substance type: pure active substance
- Physical state: White waxy solid
- Analytical purity: Min 99%
- Impurities (identity and concentrations): not available
- Composition of test material, percentage of components: 99%
- Isomers composition: not applicable
- Purity test date: not available
- Lot/batch No.: 0090
- Expiration date of the lot/batch: 31 March 2003
- Radiochemical purity (if radiolabelling): not applicable
- Specific activity (if radiolabelling): not applicable
- Locations of the label (if radiolabelling): not applicable
- Expiration date of radiochemical substance (if radiolabelling): not applicable
- Stability under test conditions: not determined
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Highgate Farm, Market Rasen, Lincolnshire, England.
- Age at study initiation: At least 8 weeks
- Weight at study initiation: 3.03kg - 3.63kg
- Housing: housed individually in stainless steel cages with perforated floors at the Eye Research Centre, Eye, Suffolk, IP23 7PX.
- Diet (e.g. ad libitum): Special Diet Services STANRAB (P) SQC pellet
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: At leat 18 days
-Identification: Each animal was identified by a numbered tag placed through the edge of one ear. This identification was unique within the Department throughout the duration of the study. Each cage was identified by a coloured label displaying the study number, animal number, phase of study and initials of the study Director and Home Office licensee.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15- 23
- Humidity (%): 40 - 70
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (06:00-18:00 GMT)
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g of the test substance
- Concentration (if solution): not applicable - Duration of treatment / exposure:
- three exposures (of three minutes, one or four hours duration)
- Observation period:
- at approximately 1, 24, 48, 72 hours after administration
- Number of animals:
- three animals used.
- Details on study design:
- TEST SITE
- Area of exposure: 2-ply 25mm x 25mm
- % coverage: 100
- Type of wrap if used: Tubigrip elasticated bandage dressing
-Application site: dorsolumbar region og each rabbit
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washed with lukewarm water (30-40 degrees) to remove any residual test substance
- Time after start of exposure: at end of exposure period
SCORING SYSTEM:
No erythma and eschar 0
Very slight erythema (barely perceptibla) 1
Well-defined erythema 2
Moderate to severe erythema 3
Servere drythema (beet redness) or eschar formation (injuries in depth) 4
No erythma 0
Very slight erythema (barely perceptibla) 1
Slight oedema (edges of area well-defined by definite rasing) 2
Moderate oedema (edges raised approximately 1 millimetre) 3
Servere oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 3976
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: 3977
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: 3998
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 3976
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 3977
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 3998
- Time point:
- other: 24, 48, and 72 hours
- Score:
- 0
- Irritant / corrosive response data:
- No dermal irritation was observed in any animal throughout the duration of the study.
- Other effects:
- There was no sign of toxicity or ill health in any rabbit during the observation period
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Since there was no skin irritation, it can be conclued that CHDM has no dermal toxic effect.
- Executive summary:
A study was performed to assess the skin irritation potential of CHDM to the rabbit. Three rabbits received a single four, semi-occlusive, dermal administration of approximately 0.5 g of the test substance as supplied and were observed for four days. No dermal irritation was observed in any animal throughout the duration of the study.
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