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EC number: 219-110-7 | CAS number: 2362-14-3
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Reference substance name:
- 4,4'-cyclohexylidenedi-o-cresol
- EC Number:
- 219-110-7
- EC Name:
- 4,4'-cyclohexylidenedi-o-cresol
- Cas Number:
- 2362-14-3
- Molecular formula:
- C20-H24-O2
- IUPAC Name:
- 4-[1-(4-hydroxy-3-methylphenyl)cyclohexyl]-2-methylphenol
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Dimethyl cyclohexyl bisphenol (DMBPC; CAS No. 2362-14-3)
- Synonyms: Dimethyl bisphenolcyclohexane; 4,4’-cyclohexylidene di-o-cresol; 1,1-Bis(4-hydroxy-3-ethyl)cyclohexane; Bis-OC-Z
- Appearance: fine white powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Details on test animals and environment: Two male and one female (nulliparous and non-pregnant) New Zealand White rabbits, at least 10 weeks of age, weighing 2.09 to 2.26 kg were obtained from the supplier. The animals were acclimated for at least five days and individually housed in suspended stainless-steel cages with hardwood chips for bedding. They were provided food and tap water ad libitum. Room temperature was 68 ± 5 °F and the relative humidity ranged between 30 - 70 %. Room lights were on a 12-hour light/dark cycle.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Approximately 0.5 gram of the test substance was applied to a small area of the skin (approximately 6 cm²).
- Duration of treatment / exposure:
- 4 hour exposure period
- Observation period:
- Test sites were observed for signs of erythema and oedema 1, 24, 48 and 72 hours after patch removal. Daily clinical observations included all toxicologic and pharmacologic signs.
- Number of animals:
- 3
- Details on study design:
- Approximately 24 hours prior to dosing, the application sites were prepared by clipping the skin of the trunk free of hair (not less than 10 % of the body surface was clear for the application of the test substance). Approximately 0.5 gram of the test substance was applied to a small area of the skin (approximately 6 cm²). The application site was covered with a gauze patch and secured with non-irritating tape. The test was conducted with 3 animals, each receiving one patch for an exposure period of 4 hours. Test sites were observed for signs of erythema and oedema 1, 24, 48 and 72 hours after patch removal. Daily clinical observations included all toxicologic and pharmacologic signs. Animals were weighed on Day 0 (prior to dose administration) and at the end of the observation period (Day 3). All animals were euthanised with an injectable barbiturate after body weight collection on Day 3 and discarded without further evaluation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of erythema or edema were present at any of the test or control sites at any of the observation periods.
- Other effects:
- All animals gained weight over the course of the study. No overt signs of toxicity were evident in any of the animals during the course of the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to EU criteria
- Conclusions:
- Under the conditions of this study, DMBPC is considered to be a non-irritant.
- Executive summary:
The irritation potential of the test material was investigate din accordance with the standardised guidelines OECD 404 and EPA OPPTS 870.2500 under GLP conditions.
The shaved skin of three New Zealand White rabbits was exposed to the test material in a semi-occlusive fashion for 4 hours. Approximately 0.5 gram of the test substance was applied to a small area of the skin (approximately 6 cm²).
Test sites were observed for signs of erythema and oedema 1, 24, 48 and 72 hours after patch removal. Daily clinical observations included all toxicologic and pharmacologic signs.
Animals were weighed on Day 0 (prior to dose administration) and at the end of the observation period (Day 3). All animals were euthanised with an injectable barbiturate after body weight collection on Day 3 and discarded without further evaluation.
No signs of erythema or oedema were present at any of the test or control sites at any of the observation periods.
All animals gained weight over the course of the study. No overt signs of toxicity were evident in any of the animals during the course of the study.
Under the conditions of this study, DMBPC is considered to be a non-irritant.
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