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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-11-04 to 2010-01-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2008
- Deviations:
- no
- Principles of method if other than guideline:
- NA
- GLP compliance:
- yes (incl. QA statement)
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
- Details on test material:
- - Name of test material (as cited in study report): Thickener TH28
- Chemical name: 3,3’-dicyclohexyl-1,1’-methylenebis(4,1-phenylene)diurea
- Physical state: white solid, odourless
- Analytical purity: > 95 %
- Lot/batch No.: AH-1290/2009-02
- Expiration date of the lot/batch: 07 September 2012
- Stability under test conditions: stable for at least 3 years
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: S&K-LAP Kft., 2173 Kartal, Császár út 135, Hungary
- Age at study initiation: Young adult rabbits, 10 weeks old
- Weight at study initiation: 3098-3218 g
- Housing: Rabbits were individually housed in AAALAC approved metal wire rabbit cages (65 x 65 cm with height of 45 cm, on 2 levels with a shelf to allow rabbits to climb up and to stretch out). Cages were of an open wire structure and were placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet (e.g. ad libitum): The animals received PURINA Base – Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum.
- Water (e.g. ad libitum): The animals received tap water as for human consumption from an automatic watering system ad libitum.
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.3 - 21.2 degree C
- Humidity (%): 30 - 67 %
- Air changes (per hr): 15 - 20 air exchanges/hour.
- Photoperiod: 12 hours light daily, from 6.00 a.m. to 6.00 p.m.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated skin of each animal served as a control.
- Amount / concentration applied:
- TEST MATERIAL
The test item was used undiluted and a single dose of 0.5 g of the test item was applied to the test area. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes, and then at 24, 48 and 72 hours after the patch removal. As no sign of irritation was observed at 72 hours, the study was terminated following the observation at 72 hours.
- Number of animals:
- 3 male animals
- Details on study design:
- TEST SITE
- Area of exposure: Back and flanks of the animals
- % coverage: The test item was applied to an area of approximately 6 cm² of intact skin.
- Type of wrap if used: Semi-occlusive plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The remaining test item was removed with water of body temperature
- Time after start of exposure: After 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- There was no mortality or systemic clinical changes related to the test item administration.
There was no effect of treatment on body weight.
Any other information on results incl. tables
Mean values of skin irritation scores (24, 48, 72 hours reading):
Animal Number |
Sex |
Erythema |
Oedema |
00399 |
male |
0.00 |
0.00 |
00381 |
male |
0.33 |
0.00 |
00382 |
male |
0.00 |
0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this acute skin irritation/corrosion study with rabbits, the test item did not cause any skin irritating effect.
- Executive summary:
In this skin irritation study, albino New Zealand White rabbits were treated with the test item.
A semi-occlusive application procedure was used. The test item was administered undiluted, at a single dose of 0.5 g for a period of 4 hours. Gauze was placed onto the hairless skin of the rabbit, test item was applied to the gauze, additional gauze was placed over the test item and an adhesive clear plastic patch was applied. The trunk was wrapped in clear plastic with medical tubing used to hold the patch in place. The untreated skin of each animal served as control.
There was no mortality or systemic clinical changes related to the test item administration.
There was no effect of treatment on body weight.
At 1 hour after patch removal, well defined erythema (score 2) was observed in 1/3 animals. At 24 hours after patch removal, very slight erythema(score 1) was observed in 1/3 animals. At 48 and 72 hours after patch removal, there were no observed signs on the skin of the treated animals. Accordingly, the study was terminated after the observation performed at 72 hours.
The individual mean scores of the 3 animals (considering readings at 24, 48 and 72 hours) for erythema were 0.00, 0.33 and 0.00. The individual mean scores of the 3 animals (considering readings at 24, 48 and 72 hours) for oedema were 0.00, 0.00 and 0.00.
Under the conditions of this acute skin irritation/corrosion study with rabbits, the test item did not cause any skin irritating effect.
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