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EC number: 236-039-7 | CAS number: 13114-72-2
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16.02.-24.02.2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-methyl-1,1-diphenylurea
- EC Number:
- 236-039-7
- EC Name:
- 3-methyl-1,1-diphenylurea
- Cas Number:
- 13114-72-2
- Molecular formula:
- C14H14N2O
- IUPAC Name:
- 3-methyl-1,1-diphenylurea
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material: 3-Methyl-1,1-diphenylurea- Physical state: white solid powder- Composition of test material, percentage of components: main component: 3-Methyl-1,1-diphenylurea CAS:13114-72-2 >98% (w/w) impurities: unlisted additives: unlisted-Molecular formula: C14H14N2O-Molecular weight: 226,27-Batch No.: 14015- Expiration date of the lot/batch: 11/2019- Stability under test conditions: stable- Storage condition of test material: in closed container, in dry room at room temperature (at laboratory conditions)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760152- Weight at study initiation: 2,4-2,8 kg- Housing: Conventional animal room – individually in metallic cages- Diet: Pelleted standard diet for experimental animals ad libitum- Water: Drinking tap water ad libitum (quality corresponding to the Regulation No.: 252/2004 Czech Coll. of Law) - Acclimation period: yesENVIRONMENTAL CONDITIONS- Room temperature: 20± 3°C, permanently monitored - Relative humidity: 30 – 70%, permanently monitored- Light period: 12 hour light/12 hour dark Study Time ScheduleAnimal supply: 03. 02. 2015Experimental part of study: 16. 02. – 24. 02. 2015Evaluation of results and final report elaboration: 24. 02. – 03. 03. 2015
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied: 0,1 g- Test substance: it was used in delivery form-pH approximately 7
- Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 1, 24, 48, and 72 hours
- Number of animals or in vitro replicates:
- 1 female/initial test2 females/confirmatory test
- Details on study design:
- APPLICATION OF THE TEST SUBSTANCE- The test substance was placed in the conjunctival sac of one eye of animal after gently pulling the lower lid away from the ball. CLINICAL OBSERVATIONThe eyes were examined at 1, 24, 48 and 72 hours after application. After recording the observations at 72 hours, the eyes of rabbit were examined with the aid of fluorescein and the ophthalmoscopy. The grades of ocular reaction for single animal (observation of conjunctivae, cornea and iris) were recorded at each examination. In the end of observation period the animals were sacrificed by injection of veterinary preparation T61 (1 mL/kg).TOOL USED TO ASSESS SCORE: fluorescein and ophthalmoscopy
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 7,8.10
- Time point:
- other: 24,48,72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: 7,8,10
- Time point:
- other: 24,42,72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 7,8,10
- Time point:
- other: 24,48,72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal: 7,8,10
- Time point:
- other: 24,48,72h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
Table No. 5 – Summary results of reaction of treated eye(grades)
Animal No. | Ocular lesions | Time interval of examination | |||
1h | 24h | 48h | 72h | ||
7 | Cornea Iris Conjunctivae Chemosis | 0 0 0 0 | 0 0 0 0 | 0 0 0 0 | 0 0 0 0 |
8 | Cornea Iris Conjunctivae Chemosis | 0 0 1 0 | 0 0 0 0 | 0 0 0 0 | 0 0 0 0 |
10 | Cornea Iris Conjunctivae Chemosis | 0 0 0 0 | 0 0 0 0 | 0 0 0 0 | 0 0 0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No changes were observed on eye at 1 hour after application: only in animals No. 8: Conjunctivae - Some blood vessels were hyperaemic (injected). No negative changes of eyes of all rabbits were observed for the rest of the study. During the observation period (24, 48 and 72 hours after application) no irritating effects on the eye was observed in all animals. No clinical signs of systemic intoxication were detected.Akardit, is not irritating to eye of rabbit.
- Executive summary:
The test substance, Akardit, was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed).
The test was performed according to the Method B.5 Acute Toxicity: Eye Irritation/Corrosion.Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
The test was performed initially using one animal (No. 7). Because no corrosive or severe irritating effects were observed in initial test, the response was confirmed using two additional animals (No. 8 and No. 10).
No changes were observed on eye at 1 hour after application: only in animal No. 8: Conjunctivae -Some blood vessels were hyperaemic (injected).
No pathological changes of eyes of all rabbits were observed for the rest of the study. During the observation period (24, 48 and 72 hours after application) no irritating effects on the eye was observed in all animals.
No clinical signs of systemic intoxication were detected.
Evaluation of results after single application demonstrated that the test substance, Akardit,is not irritating to the eye of rabbit.
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