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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 423-070-8 | CAS number: 58890-25-8
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 October, 1994 - 18 November, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to OECD Guideline 406 and GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: "Allergic Contact Dermatitis in the Guinea-Pig: Identification of Contact Allergens" Magnusson B. Kligman A.M., 1970 published by C.C. Thomas, Springfield, Illinois, USA
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 423-070-8
- EC Name:
- -
- Cas Number:
- 58890-25-8
- Molecular formula:
- not applicable (reaction mass)
- IUPAC Name:
- 3-cyclohexyl-1-[4-({4-[(cyclohexylcarbamoyl)amino]phenyl}methyl)phenyl]urea; 3-cyclohexyl-1-[4-({4-[(phenylcarbamoyl)amino]phenyl}methyl)phenyl]urea; 3-phenyl-1-[4-({4-[(phenylcarbamoyl)amino]phenyl}methyl)phenyl]urea
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): KY-RB
- Description: White powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel, Switzerland
- Age at study initiation: Approx. 6 weeks
- Weight at study initiation: 323 - 464 g
- Housing: Group housing of 2 animals per labelled metal cage with wire-mesh floors.
- Diet: free access to standard guinead pig diet, including ascorbic acid; LC 23-B, pellet diameter 4 mm.
- Water: free access to tap water diluted with decalcified water.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- Intradermal injections: 1%
Epidermal applications: 25%
Challenge: 5, 10 and 25%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Intradermal injections: 1%
Epidermal applications: 25%
Challenge: 5, 10 and 25%
- No. of animals per dose:
- Test animals: 10
Control animals: 5 - Details on study design:
- RANGE FINDING TESTS (4 animals)
For the intradermal induction exposure (1 animal):
- Concentration: 0.2 and 1% (w/w)
- Amounts: 0.1 mL were injected into two injection sites in the right and left clipped scapular regions.
- Scoring: the skin reactions were scored 24 and 48 hours after application
- Result: The intradermal injections resulted in an acceptable level of necrosis. The 1% test substance concentration was the maximum suitable concentration and was selected for the main study.
For the epicutaneous induction (same animal as used for the intradermal induction and 3 other animals):
- Concentration: 25% test sustance concentration was chosen as the highest useable concentration, as higher concentrations were dry and not homogeneous. Test substance concentrations of 1, 5, 10 and 25% were tested to the animals.
- Amount: 0.5 mL, to the shaved flank
- Exposure period: 24 hours (occlusive)
- Scoring: the skin reactions were scored 24 and 48 hours after patch removal
- Result: no signs of irritation at the highest concentration of 25%. Therefore the test sites were treated with 10% SDS approx. 24 hrs before the epidermal induction in the main test.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
1) Intradermal injections on day 1:
- Concentration: 1%
- Site: scapular region.
Three pairs of intradermal injections:
1) 0.1 mL: FCA (50% in water)
2) 0.1 mL: 1% test substance in propylene glycol (control animals: 0.1 mL of propylene glycol)
3) 0.1 mL: 50% with 2% test substance + 50% FCA (undiluted).
- Use of SDS (all animals): on day 7, 24 hrs before the topical induction application, the scapular area between the injection sites was clipped and subsequently rubbed with 10% SDS in petrolatum using a spatula.
2)Topical application on day 8:
- Amount: 0.5 mL (control animals: 0.5 mL of propylene glycol), on the SDS treated area
- Area: approximately 8 cm^2
- Exposure period: 48 hours (occlusive)
- Readings: scores were rated directly after patch removal
B. CHALLENGE EXPOSURE (all animals)
- Day of challenge: day 22
- Concentration: 5, 10 and 25% in propylene glycol
- Exposure period: 24 hours (occlusive)
- Site: flank
- Amount: 0.05 mL of the diluted substance; 0.05 mL of propylene glycol
- Readings: scores were rated 24 and 48 hours after patch removal - Challenge controls:
- Not applicable
- Positive control substance(s):
- yes
- Remarks:
- (the results of the latest reliability check, performed in July 1994 with HCA, are reported)
Results and discussion
- Positive control results:
- The latest reliability check (performed less than 6 months ago) shows a sensitisation rate of 100%.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5, 10 and 25%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5, 10 and 25%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5, 10 and 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5, 10 and 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% (propylene glycol)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0% (propylene glycol). No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% (propylene glycol)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0% (propylene glycol). No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: None.
Any other information on results incl. tables
RANGE FINDING TESTS (4 animals)
For the intradermal induction exposure:
- Result: The intradermal injections resulted in an acceptable level of necrosis. The 1% test substance concentration was the maximum suitable concentration and was selected for the main study.
For the epicutaneous induction (same animal as used for the intradermal induction and 3 other animals):
- Result: no signs of irritation at the highest concentration of 25%. Therefore the test sites were treated with 10% SDS approx. 24 hrs before the epidermal induction in the main test.
Main test:
- Five test group animals showed slight erythema after the 48 hours occluded epidermal induction exposure. The control animals showed no skin reactions.
- No mortality occurred and no symptoms of systemic toxicity were observed in the animals.
- The average body weight gain of experimental and control animals was considered to be similar.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this adjuvant type guinea pig test method for skin sensitisation according to OECD 406 guideline and GLP principles, two out of ten test substance group animals (sensitisation rate of 20%) showed a positive reaction in response to the 25%, 10% and 5% KY-RB concentrations.
- Executive summary:
KY-RB was tested in an adjuvant type guinea pig test method for skin sensitisation according to OECD 406 guideline and GLP principles. No mortality occurred and no symptoms of systemic toxicity were observed in the animals. Five test group animals showed slight erythema after the 48 hours occluded epidermal induction exposure.
Two out of ten test substance group animals showed a positive reaction in response to the 25%, 10% and 5% KY-RB challenge concentrations (sensitisation rate of 20%). Reliable negative and positive controls were included. Based on the results, KY-RB does not need to be classified as a skin sensitiser in accordance with Regulation (EC) No 1272/2008.
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.