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EC number: 225-863-2 | CAS number: 5124-30-1
- 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
Respiratory sensitisation
Administrative data
- Endpoint:
- respiratory sensitisation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sept - Oct 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
- Principles of method if other than guideline:
- Lung sensitization study following intradermal induction. For inhalation challenge the criteria specified in OECD TG 403 were fulfilled in so far as these are applicable to this study.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,4'-methylenedicyclohexyl diisocyanate
- EC Number:
- 225-863-2
- EC Name:
- 4,4'-methylenedicyclohexyl diisocyanate
- Cas Number:
- 5124-30-1
- Molecular formula:
- C15H22N2O2
- IUPAC Name:
- 1,1'-methylenebis(4-isocyanatocyclohexane)
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Dunkin-Hartley Pirbright-White (Crl: (HA)BR)
- Source: Charles River, Sulzbach, Germany
- Age at study initiation: approx. 2 months
- Weight at study initiation: at study start the variation of individual weights did not exceed +/- 10 % of the mean
- Housing: in groups of 4 in Makrolon Type IV cages (according to Spiegel & Goennert, Zschr. Versuchstierkunde 1, 38, 1961 and Meister, Zschr. Versuchstierkunde 7, 144-153, 1965)
- Diet and Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): approx. 50 %
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Route of induction exposure:
- intradermal
- Route of challenge exposure:
- inhalation
- Vehicle:
- other: for intradermal induction: olive oil; for aerosol inhalation: air
- Concentration:
- intradermal induction: 100 µl / 0.13 % solution in olive oil
challenge: 68 ± 3.6 mg/m³ (mean concentration) - No. of animals per dose:
- 8 test animals / 8 controls
- Details on study design:
- ADMINISTRATION:
Groups of eight female guinea-pigs were intradermally induced once on Day 0 (injection volume: 100 µl / 0.13 % solution in olive oil). Eight female controls received vehicle alone under otherwise identical conditions. Following a recovery period of approximately four weeks (starting on Day 28) a test material-hapten challenge was performed at 68 ± 3.6 mg/m³ (mean concentration; challenge duration: 30 min). The aerosolized test material was proven to be of adequate respirability.
EXAMINATIONS:
During and after challenge exposures with the hapten, immediate-onset respiratory reactions were evaluated by measurement of respiratory rate, tidal volume, respiratory minute volume, inspiratory and expiratory times, and peak expiratory flow rate. Additional parameters were derived mathematically. During sacrifice the trachea, lung, and lung associated lymph nodes were fixed and subjected to histological evaluation.
Results and discussion
- Results:
- Following induction, slight skin reactions at the injection sites occurred. During or following test material-challenges, the incidence of immediate-onset respiratory reactions was roughly the same in vehicle controls and test substance-induced animals. No deaths or anaphylactic reactions were observed during challenge, and no clinical signs or specific abnormalities were observed at necropsy. The histopathological evaluation of lungs revealed a marked influx of eosinophils in test material-sensitized guinea-pigs, a characteristic feature of asthma and airway hypersensitivity.
The study provides evidence that the test substance is a weak respiratory sensitizer in guinea pigs.
Any other information on results incl. tables
Data from IUCLID4
RS-Freetext:
Following induction, slight skin reactions at the injection sites occurred. During or following test material-challenges, the incidence of immediate-onset respiratory reactions was roughly the same in vehicle controls and test substance-induced animals. No deaths or anaphylactic reactions were observed during challenge, and no clinical signs or specific abnormalities were observed at necropsy. The histopathological evaluation of lungs revealed a marked influx of eosinophils in test material-sensitized guinea-pigs, a characteristic feature of asthma and airway hypersensitivity.
The study provides evidence that the testsubtance is weak respiratory sensitizer in guinea pigs.
Applicant's summary and conclusion
- Executive summary:
4,4´-Methylenedicyclohexyl diisocyanate has been assessed in the OECD HPV programme, 2005.
Cited from SIAR of SIAM 20 (Paris, April 19 -22, 2005): In the study "sensitization of 8 guinea pigs with a single intradermal injection of 4,4´-methylenedicyclohexyl diisocyanate (100 μl, 0.13% solution in olive oil) followed after four weeks by inhalation challenge with the 4,4´-methylenedicyclohexyl diisocyanate hapten (30 min, 68 ± 3.6 mg/m³) was examined. No immediate-onset responses were observed. Gross pathological examinations showed roughly the same incidence of lung changes in all Guinea pigs of this study. The histopathological assessment of the degree of eosinophilia revealed an increased influx of eosinophilic granulocytes in animals sensitized with 4,4´-methylenedicyclohexyl diisocyanate. Because eosinophils are known to play a critical role in pathogenesis of asthma and of other hyperresponsive airway diseases the study provided evidence that 4,4´-methylenedicyclohexyl diisocyanate is a weak respiratory sensitizer in guinea pigs."
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