Chlorotrimethylsilane

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:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Draize test

GLP compliance:

not specified

Test material

Test material information

Constituent 1

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

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

Results

Results 1

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.

Results 2

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

Results 3

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

Results 4

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.