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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
Eye irritation
Administrative data
- Endpoint:
- eye 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Two male and two female (nulliparous and non-pregnant) New Zealand White rabbits, at least 10 weeks of age, weighing 2.12 to 2.24 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL (~50 mg)
- Duration of treatment / exposure:
- The test substance was instilled into the left eye by gently pulling the lower lid away from the eye to form a cup into which the test substance was placed. The upper and lower lids were gently held together for approximately one second to prevent the loss of the test substance. The eyes of the test animals were not rinsed at any time following test substance application.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after treatment
- Number of animals or in vitro replicates:
- 4 (1 preliminary and 3 main test animals)
- Details on study design:
- Within the 24 hours prior to dosing, the eyes of the animals selected for the test were examined to ensure that the eyes were free of abnormality, damage and disease, scored according to the Grades for Ocular Lesions and scored by Fluorescein Staining (details provided below). An initial procedure using a 10 % dilution of the test substance was performed on one animal. No irritation of the treated eye was observed and the study proceeded with the dosing of 3 additional animals with the neat test substance.
The animals were dosed in the left eye at a volume of 0.1 mL (~50 mg). The test substance was instilled into the left eye by gently pulling the lower lid away from the eye to form a cup into which the test substance was placed. The upper and lower lids were gently held together for approximately one second to prevent the loss of the test substance. The eyes of the test animals were not rinsed at any time following test substance application. The right eye remained untreated and served as a control. The eyes were examined at 1, 24, 48 and 72 hours after treatment and scored according to the Grades for Ocular Lesions provided below. In addition, after recording the scores at 24 hours, the eyes were further examined with the aid of fluorescein to further characterise corneal opacity. Evaluation of the eyes was facilitated by the use of a hand-held slit lamp. Animals were observed daily for clinical signs of toxicity. Animals were weighed at study start (Day 0) and completion (Day 3).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of the three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 20
- Remarks on result:
- other: total conjunctiva score = redness score + chemosis score x 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of the three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Remarks on result:
- other: total iris score = iris score x 5
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of the three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Remarks on result:
- other: total cornea score = opacity score + area score x 5
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of the three animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: total conjunctiva score = 2 (redness + chemosis x 2)
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: total conjunctiva score = 2 (redness + chemosis x 2)
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: total conjunctiva score = 2 (redness + chemosis x 2)
- Irritant / corrosive response data:
- No corneal or iridial involvement was observed in the test eyes of any animal at any time point. All three animals demonstrated mild conjunctival redness at the 1-hour scoring interval which resolved by the 24-hour observation period. No fluorescein staining was present in the test eyes at any time point during the study.
- Other effects:
- All animals gained weight and no systemic signs of toxicity were observed during the course of the study. No irritation was observed in the control eyes at any scoring interval.
Any other information on results incl. tables
Results
Summary of Results for the Treated (Left) Eyes | |||||||
Animal No. | Effects at 1 hour | ||||||
Cornea | Iris | Conjunctiva | Fluor Exam | ||||
O | A | V | R | C | IS | A | |
10611 | 0 | 0 | 0 | 1 | 0 | n/a | n/a |
10612 | 0 | 0 | 0 | 1 | 0 | n/a | n/a |
10613 | 0 | 0 | 0 | 1 | 0 | n/a | n/a |
Effects at 24 hours | |||||||
10611 | 0 | 0 | 0 | 0 | 0 | n/a | n/a |
10612 | 0 | 0 | 0 | 0 | 0 | n/a | n/a |
10613 | 0 | 0 | 0 | 0 | 0 | n/a | n/a |
Effects at 48 hours | |||||||
10611 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
10612 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
10613 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Effects at 72 hours | |||||||
10611 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
10612 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
10613 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
O: Opacity; A: Area Involved V: Iritis Value R: Redness; C: Chemosis; Fluor: Fluorescein; IS: Intensity of staining; A: Area Involved n/a: not applicable |
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 not irritating.
- Executive summary:
The irritation potential of the test material was investigate din accordance with the standardised guidelines OECD 405 and EPA OPPTS 870.2400 under GLP conditions.
Test substance (0.1 mL, ~50 mg) was instilled into the left eye of 3 New Zealand White rabbits. The eyes of the test animals were not rinsed at any time following test substance application. The right eye remained untreated and served as a control. The eyes were examined at 1, 24, 48 and 72 hours after treatment. Animals were observed daily for clinical signs of toxicity. Animals were weighed at study start (Day 0) and completion (Day 3).
No corneal or iridial involvement was observed in the test eyes of any animal at any time point. All three animals demonstrated mild conjunctival redness at the 1-hour scoring interval which resolved by the 24-hour observation period. No fluorescein staining was present in the test eyes at any time point during the study. All animals gained weight and no systemic signs of toxicity were observed. No irritation was observed in the control eyes at any scoring interval.
Under the conditions of this study, DMBPC is considered to be not irritating.
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