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EC number: 200-900-5 | CAS number: 75-77-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 2c The study was conducted according to an appropriate OECD test guideline, with acceptable restrictions. The restrictions were limited reporting of test substance information, and animal experimental conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Draize test
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Chlorotrimethylsilane
- EC Number:
- 200-900-5
- EC Name:
- Chlorotrimethylsilane
- Cas Number:
- 75-77-4
- Molecular formula:
- C3H9ClSi
- IUPAC Name:
- chloro(trimethyl)silane
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: No data
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: No data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.005, 0.01 and 0.1 ml - Duration of treatment / exposure:
- No rinsing.
- Observation period (in vivo):
- The eyes were scored at one hour, approximately 6 hours, and at 1, 2, 3, 7, 10, 14 and/or 21 days after dosing.
- Number of animals or in vitro replicates:
- 0.1 (two animals), 0.01 (six animals) and 0.005 (six animals) ml.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: Fluorescein (2%) staining was used to determine corneal injury before dosing and at readings after one day.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: corneal opacity
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- ca. 2.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: 0.1 ml: fully reversible in one animal, but score of 4 in the other at 21 days.
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- other: from 48 hours the iris was not visible due to corneal opacity
- Remarks on result:
- other: 0.1 ml
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 2.8
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Remarks on result:
- other: 0.1 ml
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 3.8
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21 dyas
- Irritant / corrosive response data:
- Two eyes dosed with 0.1 ml of the undiluted material had severe irritation of the cornea, iris and conjunctivae which persisted up to 21 days. Less severe injury resulted from administration of 0.01 and 0.005 ml per eye, but it persisted for several days after dosing.
- Other effects:
- All dosed rabbits had immediate signs of discomfort.
Applicant's summary and conclusion
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a well documented eye irritation study (reliability score 2) (GLP status unknown) 0.1 ml of Organochlorosilane A-161 was severely irritating to the eyes, and 0.01 and 0.005 ml were moderately irritating.
- Executive summary:
New Zealand white rabbits were dosed with volumes of 0.1 (two animals), 0.01 (six animals) or 0.005 (six animals) ml Organochlorosilane A-161. The test substance was instilled into the lower conjunctival sac of one eye per animal, or was placed directly onto the eye. The eyelids were held together for one second. The eyes were scored at one hour, approximately six, 24, 48 and 72 hours after instillation. Additional daily readings were made as necessary up to 21 days after treatment. Fluorescein (2%) staining was used to determine corneal injury before dosing and at readings after 24 hours. Two eyes dosed with 0.1 ml of the undiluted material had severe irritation of the cornea, iris and conjunctivae which persisted up to 21 days. Less severe injury resulted from administration of 0.01 and 0.005 ml per eye, but it persisted for several days after dosing.
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