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EC number: 214-192-0 | CAS number: 1112-55-6
- 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
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- Stability: thermal, sunlight, metals
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- Dissociation constant
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- Additional physico-chemical information
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- 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
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- Biotransformation and kinetics
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- 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:
- From 2019-06-04 to 2019-06-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2017
- Deviations:
- yes
- Remarks:
- Housing room temperature and humidity has small deviations from Guideline, but not affect the quality and integrity of the study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tetravinylsilane
- EC Number:
- 214-192-0
- EC Name:
- Tetravinylsilane
- Cas Number:
- 1112-55-6
- Molecular formula:
- C8H12Si
- IUPAC Name:
- tetraethenylsilane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch No.: 707001
Purity: 98.5%
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Japanese White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Shenyang Tenghua Biotechnology Co., Ltd.
- Age at study initiation: 98-115 days
- Weight at study initiation: 2373.6-2517.0 g
- Housing: individually raised in suspended, stainless steel cages (W 40 cm× L50 cm×H40 cm) on cage racks (L167 cm×W70cm×H171 cm)
- Diet: pellet rabbit diet, ad libitum
- Water: ad libitum
- Acclimation period: 8-15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4-25.1
- Humidity (%): 48-77
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL test item
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Initial Test: 1
Confirmatory Test: 2 - Details on study design:
- ADMINISTRATION METHOD
- Dosing: The rabbits were held firmly but gently until quiet. 0.1 mL of the test item was placed in the conjunctiva! sac of right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were gently held together for approximately one second in order to prevent loss of the material. The left eye remained untreated and served as a control.
- Dosing Frequency: Each animal was dosed once.
- Dosing Time: In the morning.
The time interval between initial test and confirmatory test was about 6 days
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: Fluorescein sodium and slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2 & #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2 & #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1, #2 & #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, #2 & #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Three treated eyes showed no abnormal symptoms in cornea, iris and conjunctivae and there were no any other lesions in three treated eyes at 1 hour and 24, 48, 72 hours after administration
There was no any retention of fluorescein for three treated eyes and three control eyes approximately 24 hours prior to dosing and at approximately 24 hours after administration. - Other effects:
- - Clinical Observations:
No adverse systemic effects were observed in any animals during the study.
- Body Weights
The body weights of all animals showed growth trends during the observation periods.
Any other information on results incl. tables
Eye Reaction Scoring:
No. |
Conjunctivae |
Chemosis |
Cornea opacity |
Iris |
||||||||||||
24h |
48h |
72h |
Mean |
24h |
48 h |
72 h |
Mean |
24h |
48h |
72 h |
Mean |
24h |
48h |
72 h |
Mean |
|
1100 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1101 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1102 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- The test item was considered to not be irritating to eye in rabbits.
- Executive summary:
The study was performed to assess the acute eye irritation/corrosion of test item in rabbits in accordance with OECD 405.
Three male rabbits were used for the study. Each animal was administered about 0.1 mL of the test item into right eye. Untreated left eye served as the control.
No adverse systemic effects were observed in any animals during the study.
Three treated eyes showed no abnormal symptoms in cornea, iris and conjunctivae and there were no any other lesions in three treated eyes at 1 hour and 24, 48, 72 hours after administration
There was no any retention of fluorescein for three treated eyes and three control eyes approximately 24 hours prior to dosing and at approximately 24 hours after administration.
Individual and mean scores of Cornea Opacity, Iris, Conjunctival Redness and Chemosis were all 0 for three treated eyes at approximately 24, 48, 72 hours after administration.
The body weights of all animals showed growth trends during the observation periods
The test item was considered to not be irritating to eye in rabbits.
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