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EC number: 223-773-8 | CAS number: 4066-02-8
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-11-08 - 1991-02-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP according to EU method B.1 and OECD guideline 401 on the registered substance itself. The method is to be considered scientifically reasonable with negligible deficiencies in documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- as set out in 84/449/EWG (1984-09-19)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted 1987-02-24
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Phenol, 2,2'-methylenebis-(6-cyclohexyl-4-methyl)
- IUPAC Name:
- Phenol, 2,2'-methylenebis-(6-cyclohexyl-4-methyl)
- Reference substance name:
- 2,2"-Methylen-bis-(6-cyclohexyl-4-methylphenol)
- IUPAC Name:
- 2,2"-Methylen-bis-(6-cyclohexyl-4-methylphenol)
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Phenol, 2,2'-methylenebis-(6-cyclohexyl-4-methyl); 2,2"-Methylen-bis-(6-cyclohexyl-4-methylphenol)
- Substance type: pure substance
- Stability under test conditions: formulations are stable at room temperature
- Storage condition of test material: cool, dry
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Wistar Bor: WISW (SPF Cpb)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder Winkelmann, Borchen
- Age at study initiation: 8 weeks (males), 10 weeks (females)
- Weight at study initiation: average 185 g (males), 166 g (females), weight variation not exceeding ±20%
- Fasting period before study: yes, 16h prior to application
- Housing: In groups of five in Makrolon cages type III on low-dusting wood pellets
- Diet (e.g. ad libitum): "fixed-formula" standard diet Altromin® 1324 Pellets (Altromin GmbH und Co KG, Lage) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 50 ± 10%
- Air changes (per hr): ca. 10/h
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 / sex / dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on application day, otherwise twice a day for clinical symptoms, weighing on day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No animal died during study duration.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No animal died during study duration.
- Mortality:
- No animal died during the 14-day observation period.
- Clinical signs:
- other: After single gavage of 2000 mg/kg bw no symptoms of poisoning were observed in males and females.
- Gross pathology:
- All animals killed after 14 days were without pathological findings.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU-GHS criteria not met
- Conclusions:
- The study was conducted under GLP according to EU method B.1 and OECD guideline 401 on the registered substance itself. The method is to be considered scientifically reasonable with negligible deficiencies in documentation. Hence, the results can be considered as sufficiently reliable to assess the acute oral toxicity in rats. The determined LD50 value is >2000 mg/kg bw, the LD0 ≥ 2000 mg/kg, as none of the animals died after gavage of 2000 mg/kg bw. The result is suitable to determine the classification of Phenol, 2,2'-methylenebis-(6-cyclohexyl-4-methyl). According to Regulation (EC) No. 1272/2008, the substance does not need to be classified as acute toxic cat. IV or higher.
- Executive summary:
In an acute oral toxicity study under GLP according to EU method B.1 and OECD guideline 401, groups of fasted 8-10 weeks old Wistar Bor: WISW (SPF Cpb) rats (5/sex) were given a single oral dose of Phenol, 2,2'-methylenebis-(6-cyclohexyl-4-methyl) in arachis oil at a limit dose 2000 mg/kg bw and observed for 14 days.
Oral LD50> 2000 mg/kg bw
Oral LD0≥ 2000 mg/kg bw
None of the animals died during the test or showed any signs of toxicity
Phenol, 2,2'-methylenebis-(6-cyclohexyl-4-methyl) is of low toxicity based on the LD50 and does not need to be classified as acute toxic cat. IV or higher.
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