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EC number: 406-370-3 | CAS number: 58890-25-8 MDI/CHA
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 May 1990 - 31 May 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- September 1984
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea
- EC Number:
- 406-370-3
- EC Name:
- 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea
- Cas Number:
- 58890-25-8
- Molecular formula:
- C27 H36 N4 O2
- IUPAC Name:
- 1-cyclohexyl-3-[4-({4-[(cyclohexylcarbamoyl)amino]phenyl}methyl)phenyl]urea
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): MDI/CHA
- Physical state: white yellowish solid
- Storage condition of test material: at room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: Approx. 8 weeks
- Weight at study initiation: Males 197 - 224 g; Females: 164 - 183 g
- Housing: Individually in polycarbonate cages containing purified sawdust as bedding material.
- Diet: Free access to standard pelleted laboratory animal diet (Kliba 343 from Klingentalmühle AG, Kaiseraugst, Switzerland).
- Water: Free access to tap water.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -24
- Humidity (%): 40 -62
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 17 May 1990 To: 31 May 1990
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- corn oil
- Remarks:
- Specific gravity: 0.92 g/mL
- Details on dermal exposure:
- Method: Dermal application
TEST MATERIAL
- Amount applied: 10 mL/kg body weight
Adjustment was made for the specific gravity of vehicle.
TEST SITE
- Area of exposure: 5 x 5 cm for males; 3.5 x 5 cm for females
- Type of wrap if used: A gauze patch fixed successively to aluminium foil and 3M Coban flexible
bandage with drops of petrolatum.
REMOVAL OF TEST SUBSTANCE
- Washing: Residual test item was removed with a tissue moistened with tap-water.
- Time after start of exposure: 24 hours
Frequency: single application, on day 1. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- One day before treatment an area of approx. 5 x 7 cm on the back of the animal was clipped.
- Duration of observation period following administration: 14 days
- Frequency of observations: At periodic intervals on the day of dosing (day 1) and once daily the
reafter for 14 days
- Body weights: Animals were weighed individually on day 1 (pre-administration), 8 and 15.
- Mortality: At periodic intervals on the day of dosing (day 1) and twice daily thereafter for 14 days
- Irritation: Changes of treated skin were described immediately after bandage removal (day 2) and on day 5, 8, and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: none
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: The treated skin surface of the animals showed spots with crusts in 2 females on day 8 and 1 female on day 15.
- Body weight:
- other body weight observations
- Remarks:
- All animals showed body weight gain over the study period.
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to Regulation (EC) No 1272/2008 and its amendments.
- Conclusions:
- In an acute dermal toxicity study with rats, performed according to OECD 402 (1987) and EC B.3 (1984) test guidelines and GLP, an LD50 >2000 mg/kg bw was determined.
- Executive summary:
MDI/CHA was administered by dermal application, to five rats of each sex, at 2000 mg/kg body weight. No animals died during the study.
The treated skin surface of the animals showed spots with crusts in 2 females on day 8 and 1 female on day 15. All animals showed body weight gain over the study period. No abnormalities were found at macroscopic post mortem examination of the animals.
Based on these results, MDI/CHA does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to Regulation (EC) No 1272/2008 and its amendments.
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