Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 June 1990 - 09 August 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 406 (Skin Sensitisation)
- Version / remarks:
- 12 May 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- September 1984
- Deviations:
- no
- Principles of method if other than guideline:
- "Experimental Skin Sensitization in the Guinea Pig and Man", Buehler E. V. and Griffith F. in: Animals
models in dermatology (ed. H.I. Maibach), pp. 56-66, Edinburgh, Churchill Livingstone, 1975. - GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An appropriate Buehler test is available which would not justify conducting an additional LLNA due to animal welfare.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Himalayan albino
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland.
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: approximately 11 weeks
- Weight at study initiation: 299 - 409g
- Housing: Group housing of 2 animals per cage with wire-mesh floors.
- Diet: Free acces to standard guinea pig diet, including ascorbic acid (1600 mg/kg); LC 23-B, pellet diameter 4mm (Hope farms, Woerden, The Netherlands). In addition, hay was provided once a week.
- Water: Free access to tap-water, diluted with decalcified water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: 02 July 1990 To: 09 August 1990
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 25% (w/w) / 0.5 mL
- Day(s)/duration:
- 6 hours on days 1, 3, 5, 8, 10, 12, 15, 17 and 19
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 25% (w/w) / 0.5 mL
- Day(s)/duration:
- 6 hours on day 29
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 25%, 10% and 5% (w/w) / 0.05 mL
- Day(s)/duration:
- 6 hours on day 36 (1 week after the first challenge)
- Adequacy of challenge:
- other: series of three concentrations
- No. of animals per dose:
- Treatment group: 20
Control group: 10 - Details on study design:
- PRIMARY IRRITATION EXPERIMENT:
A primary irritation study was conducted in order to select test item concentrations suitable for the induction and challenge phase in the main study.
One animal was treated with 0.5 mL test item with a concentration of 50% (w/w). Four further animals were treated with 0.05 mL of a 50%, 25%, 10% and 5% (w/w) test item concentration.
- Epidermal application: Test item in corn oil was applied the shaved left flank using a Metalline patch 2x3 cm mounted on Micropore tape and held in place with Coban elastic bandage.
After 24 hours, the dressing was removed and the residual test item removed with a tissue moistened with tap-water. The treated skin areas were assessed for irritation 24 and 48 hours after removal of the bandage. After the 24 hour skin assessment the treated areas where re-shaved.
MAIN STUDY
INDUCTION
- No. of exposures: 9
- Exposure period: 6 hours, after each exposure period residual test item was removed with a tissue moistened with tap-water.
- Test group: test item
- Control group: vehicle
- Site of application: the scapula region (left side), prior to each application the skin was clipped
- Frequency of applications: Days 1, 3, 5, 8, 10, 12, 15, 17, 19
- Duration: 3 weeks
- Concentration: 25% (w/w)
- Method of application: The test item suspended in corn oil was applied to skin under a piece of
metalline (2 x 3 cm) attached to aluminium foil by means of petrolatum, mounted on sleek tape which was kept in place by elastic bandage.
CHALLENGE EXPOSURE
- No. of exposures: 1
- Days after last induction: 10
- Exposure period: 6 hours, after each exposure period residual test item was removed with a tissue moistened with tap-water.
- Test group: test item
- Control group: test item
- Site: Right flank, prior to application a 5 x 5 cm area was clipped and shaved.
- Concentration: 25% (w/w)
- Method of application: In a similair way as in the induction phase.
- Evaluation (hr after challenge): 24 and 48 hours after removal of the dressings.
The control animals were treated equally with omission of the test item
RE-CHALLENGE EXPOSURE
- No. of exposures: 1
- Days after first challenge: 7
- Exposure period: 6 hours, after each exposure period residual test item was removed with a tissue moistened with tap-water.
- Test group: test item
- Control group: test item
- Site: contralateral shaved flank, prior to application a 5 x 5 cm area was clipped and shaved.
- Concentration: 25%, 10% and 5% (w/w)
- Method of application: In a similair way as in the induction phase, except that Square chambers, attached to Micropore tape, were used for complete occlusive conditions.
- Evaluation (hr after challenge): 24 and 48 hours after removal of the dressings.
The control animals were treated equally with omission of the test item
OTHER OBSERVATIONS
- Mortality: Once daily.
- Clinical signs: Once Daily.
- Body weights: During acclimatisation and at termination of the study. - Challenge controls:
- Not performed
- Positive control substance(s):
- yes
- Remarks:
- 0.5% (w/w) formaldehyde in milli-RO water
Results and discussion
- Positive control results:
- The sensitivity check with the positive control was perfomed on April 1990.
Clear positive results were observed in the animals after an induction and challenge phase with 1.0% and 0.5% (w/w) formaldehyde in milli-RO respectively. A sensitisation rate of 35% was obtained.
The sensitivity check with formaldehyde indicates that the Himalayan strain of guinea pig is an a
ppropriate animal model for the performance of studies designed to evaluate the sensitising
potential of a substance.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.5%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5, 10 and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5, 10 and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5, 10 and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5, 10 and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- other: to clarify the possibly sensitisation reaction, a re-challenge was carried out
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
INTERPRETATION
The results evident in test animals at the challenge application(s) were compared with the results evident in control animals.
A positive skin reaction would have been considered a sign of sensitisation, provided that such reactions were not observed in the control group.
The readings after the challenge applications were compared to assess the sensitisation rate i.e. the number of sensitised animals in proportion to the total number of animals of the experimental group.
OTHER RESULTS
Results of the primary irritation study: Based on the results, a test item concentration of 25% (w/w) in corn oil was selected for the induction phase and challenge phase respectively, as higher concentrations were too viscous.
Induction phase: No animals showed skin irritation after the last epicutaneous induction exposure.
First challenge phase: Seven animals in the test chemical group showed red spots in response to the 25% test substance concentration in the second reading. To clarify if this was a clear sensitisation reaction, a re-challenge under complete occlusive conditions was performed one week later.
Re-challenge phase: None of the animals showed a skin reaction in response to any of the concentrations tested.
- Mortality / systemic toxicity: No mortallity occurred and no symptoms of systemic toxicity were observed in the animals.
- Bodyweights: A marked difference in the average body weight gain of the test and control group was noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a Buehler-Test, performed according to OECD guideline 406 and GLP, an epicutaneous exposure of 25% (w/w) MDI/CHA caused no sensitization reaction to guinea pig skin in the re-challenge phase (sensitization rate of 0%). Based on these results, the test substance is not classified as skin sensitizing according to Regulation (EC) No 1272/2008 and its amendments.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.