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EC number: 411-070-0 | CAS number: - KY-ET
- 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:
- September 4, 1992 - October 15, 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed according to OECD 406 (1981) and EU Method B.6 (1984) and according to GLP principles. Limited information available to verify the composition of the used test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1981)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- (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: Animal 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:
- A mixture of: 2,4 -bis(N'-(4-methylphenyl)ureido)toluene; 2,6 -bis(N'-(4-methylphenyl)ureido)toluene
- EC Number:
- 411-070-0
- EC Name:
- A mixture of: 2,4 -bis(N'-(4-methylphenyl)ureido)toluene; 2,6 -bis(N'-(4-methylphenyl)ureido)toluene
- Molecular formula:
- C23H24N4O2
- IUPAC Name:
- 3-(2-methyl-5-{[(4-methylphenyl)carbamoyl]amino}phenyl)-1-(4-methylphenyl)urea
- Details on test material:
- - Name of test material (as cited in study report): KY-ET
- Appearance: Light yellow solid
- Storage condition of test material: At room temperature in the dark
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. 9 weeks
- Weight at study initiation: 373 - 448 grams
- Housing: Group housing of 2 animals in labelled metal cages with wire-mesh floors.
- Diet: Free access to standard guinea pig diet, including ascorbic acid (LC 23-B, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands). In addition, hay (B.M.I., Helmond, The Netherlands) 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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Preliminary study: 50%, 25%, 10% and 5%
Main study: 25%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Preliminary study: 50%, 25%, 10% and 5%
Main study: 25%
- No. of animals per dose:
- Preliminary study: 5
Main study: Experimental group: 20; control group: 10 - Details on study design:
- RANGE FINDING TESTS:
- One animal was treated epicutaneously at the shaved left flank with 0.5 mL of a 50% concentration of the test substance in propylene glycol using a Scotchpak-non-woven patch (2.5 x 2.2 cm) mounted on Micropore tape and held in place with Coban elastic bandage. After 24 hours, the dressings and residual test substance were removed using a tissue moistened with tap-water. The treated skin was assessed for erythema and oedema, 24 and 48 hours after bandage removal.
- Four further animals were shaved on the left flank and exposed to 0.05 mL of 50%, 25%, 10% and 5% (w/w) concentrations of the test substance in propylene glycol, occlusively administered by means of Square chambers mounted on Micropore tape. The bandage was fixed in place by means of Coban elastic bandage. After 6 hours, the dressings and residual test substance were removed using a tissue moistened with tap-water. The reaction sites were assessed for erythema and oedema, 24 and 48 hours after bandage removal.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: nine during a period of 3 weeks (days 1, 3, 5, 8, 10, 12, 15, 17 and 19).
- Exposure period: 6 hours. The treated skin area was scored immediately after removal of the dressings on day 19.
- Test groups: one
- Control group: one
- Site: left flank
- Concentrations: 25%
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: ten days after the last induction (day 29)
- Exposure period: 6 hours
- Test groups: one
- Control group: one
- Site: right flank
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 hours after removal of the dressings - Positive control substance(s):
- yes
- Remarks:
- periodically with Formaldehyde.
Results and discussion
- Positive control results:
- See the document Summary of positive control data Buehler test in the attached background material (taken from another report)
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.5% (w/w) formaldehyde
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- positive 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
- Clinical observations:
- No symptoms of systemic toxicity were observed in the animals of the main study during the study period. No mortality occurred during this main study.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals of the main study during the study period. No mortality occurred during this main study..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No symptoms of systemic toxicity were observed in the animals of the main study during the study period. No mortality occurred during this main study.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals of the main study during the study period. No mortality occurred during this main study..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No symptoms of systemic toxicity were observed in the animals of the main study during the study period. No mortality occurred during this main study.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals of the main study during the study period. No mortality occurred during this main study..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No symptoms of systemic toxicity were observed in the animals of the main study during the study period. No mortality occurred during this main study.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals of the main study during the study period. No mortality occurred during this main study..
Any other information on results incl. tables
- Preliminary study: No skin irritation and no signs of systemic toxicity were observed at any concentration.
- Induction: Only 1 experimental animal showed erythema (score: 1) after the last epicutaneous induction exposure. No skin irritation was observed in the other experimental animals.
- Body weights: The average body weight gain of experimental and control animals was similar.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a Buehler test performed according to OECD 406 (1981) and EU Method B.6 (1984) and according to GLP principles, KY-ET showed no skin sensitising properties.
- Executive summary:
Nine epicutaneous exposures of KY-ET in the induction phase resulted in slight erythema in one animal and no skin irritation in the other experimental animals. The epicutaneous exposure of KY-ET in the challenge phase resulted in no sensitisation reactions in response to the 25% test substance concentration. Therefore, the substance needs not to be classified as a skin sensitiser in accordance with the CLP Regulation.
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