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EC number: 429-380-1 | CAS number: 133336-92-2
- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 429-380-1
- EC Name:
- -
- Cas Number:
- 133336-92-2
- Molecular formula:
- C29H28N4O2
- IUPAC Name:
- 1-(4-methylphenyl)-3-{4-[(4-{[(4-methylphenyl)carbamoyl]amino}phenyl)methyl]phenyl}urea
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Particle size distribution: 10%: < 23.94 µm
- Density: 1.32 g/cm3 (20°C)
- Test substance storage: at room temperature in the dark
- Stability under storage conditions: stable
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Broekman Institute, Someren, The Netherlands.
- Age at study initiation: Animals used withihn the study were approx. 13 weeks old.
- Weight at study initiation: 2510 - 2589 grams.
- Housing: Individually housed in cages with perforated floors.
- Diet: Free access to pelleted diet for rabbits (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands).
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
set to maintain:
- Temperature (°C): 21
- Humidity (%): 55
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 03 January 1994 to 06 January 1994
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: One eye of each animal remained untreated and served as the reference control.
- Amount / concentration applied:
- TEST MATERIAL- Amount applied: 79 ± 1 mg
- Duration of treatment / exposure:
- Single instillation on Day 1.
- Observation period (in vivo):
- The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- TREATMENT
On test day 1, the test substance was instilled in the conjunctival sac of one eye of each animal.
REMOVAL OF TEST SUBSTANCE
-Washing (if done): No
OBSERVATIONS (beschrijf beperkt)
- Mortality/Viability: Twice daily.
- Toxicity: At least once daily.
- Body Weight: Day of treatment (prior to instillation).
- Necropsy: No histopathology was performed
- Irritation:
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours after instillation of the test substance.
The irritation scores and a description of all other (local) effects were recorded.The irritation was assessed according to OECD 405.
Immediately after the 24 hour observation, a solution of 2% fluorescein in water (adjusted to pH 7.0) was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Irritation
Instillation of KY-AF into one eye of each of the animals resulted in slight redness of the conjunctival tissues, which had resolved within 2 daysafter treatment. Treatment of the eyes with 2% fluorescein, 24 hours after test substance
instillation revealed no corneal epithelial damage ·in any of the animals.
Corrosion
There was no evidence of ocular corrosion. - Other effects:
- No staining of peri-ocular tissues by the test substance was observed.
No toxic symptoms were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating.
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- In an eye irritation study with rabbits, performed according to OECD/EC test guidelines, no corrosion was observed. Irritation of the conjunctivae was seen as redness which had completely resolved within 48 hours. No corneal opacity, corneal epithelial damage or iridial irritation was observed. Based on these results KY-AF does not have to be classified and has no obligatory labelling requirements.
- Executive summary:
Assessment of acute eye irritation/corrosion was performed with KY-AF in the rabbit according to OECD/EC guidelines and in accordance with GLP principles. Installation of single samples of KY-AF into one eye of each of three rabbits resulted in slight redness of the conjunctival tissues, which had resolved within 2 days after treatment. There was no evidence for ocular corrosion. No corneal opacity, corneal epithelial damage or iridial irritation was observed.
Based on these results, KY-AF does not have to be classified and has no obligatory labelling requirement for eye irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all 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.
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