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EC number: 245-876-7 | CAS number: 23779-32-0
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the appropriate OECD test guideline and in compliance with GLP. As this study was used as a read across the reliability was set to 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- [3-(trimethoxysilyl)propyl]urea
- EC Number:
- 245-904-8
- EC Name:
- [3-(trimethoxysilyl)propyl]urea
- Cas Number:
- 23843-64-3
- IUPAC Name:
- 1-[3-(trimethoxysilyl)propyl]urea
- Details on test material:
- - Name of test material (as cited in study report): Y-11542
- Physical state: clear, colourless, viscous liquid
- Lot/batch No.: 2131UG060495
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products, Inc., Denver, PA, USA
- Age at study initiation: young adult
- Weight at study initiation: 2425-3073 g (3 males and 3 females)
- Housing: individual housing in suspended mesh-bottom cages
- Diet: Purina Certified Rabbit Chow #5322, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 35-43
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated left eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml - Duration of treatment / exposure:
- single treatment without washing
- Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- 6 (3 males and 3 females)
- Details on study design:
- SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: hand-held pen light
Treatment procedure:
The test material was placed directly into the cupped lower conjunctival sac of the rabbit's right eye. The eyelid was held closed for approximately one second after instillation. The left eye was manipulated in an identical manner to simulate the dosing of the right eye.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 0.61
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- out of all 6 animals
- Time point:
- other: mean over 24, 48, and 72 h
- Score:
- 0.06
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
Any other information on results incl. tables
Table 1: Individual score of the eye irritation study.
Rabbit # |
Time [h] |
conjunctivae |
|
iris |
cornea |
redness |
swelling |
||||
1 |
1 |
2 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.33 |
|
0 |
0 |
|
2 |
1 |
2 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
average |
1 |
|
0 |
0 |
|
3 |
1 |
1 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
1 |
0 |
0 |
0 |
|
average |
1 |
|
0 |
0 |
|
4 |
1 |
1 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.33 |
|
0 |
0 |
|
5 |
1 |
2 |
1 |
0 |
0 |
24 |
1 |
0 |
0 |
0 |
|
48 |
0 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.33 |
|
0 |
0 |
|
6 |
1 |
2 |
1 |
0 |
0 |
24 |
1 |
1 |
0 |
0 |
|
48 |
1 |
0 |
0 |
0 |
|
72 |
0 |
0 |
0 |
0 |
|
average |
0.66 |
|
0 |
0 |
|
|
|
||||
Time [h] |
conjunctivae |
|
iris |
cornea |
|
|
redness |
swelling |
|
|
|
average |
1 |
1.66 |
1 |
0 |
0 |
24 |
1 |
0.17 |
0 |
0 |
|
48 |
0.5 |
0 |
0 |
0 |
|
72 |
0.33 |
0 |
0 |
0 |
|
24+48+72 |
0.61 |
0.06 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a eye irritation study conducted in accordance with OECD 405 and GLP (reliability score 2), the structural analogue [3-(trimethoxysilyl)propyl]urea showed no irritating potential to the eyes of rabbits.
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