[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Remarks:

Read across data

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data was taken from secondary source

Data source

Reference

Reference Type:

other: Secondary source

Title:

SIDS Initial Assessment Report For SIAM 17

Author:

OECD SIDS

Year:

2003

Bibliographic source:

OECD,SIDS,SIAM,2003

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1981

Principles of method if other than guideline:

- Principle of test: To determind the effect of chemical on eye
- Short description of test conditions: chemical is applied to lower eyelid of animal, commonly rabbit were used, effect of chemicalon cornea, irris and conjuctiva was noted
- Parameters analysed / observed: redness, edema

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

3-aminopropyltriethoxysilane

EC Number:

213-048-4

EC Name:

3-aminopropyltriethoxysilane

Cas Number:

919-30-2

Molecular formula:

C9H23NO3Si

IUPAC Name:

3-AMINOPROPYLTRIETHOXYSILANE

Test material form:

liquid

Specific details on test material used for the study:

Not specified

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Lesser Ketones Manufacturing Association Leesburg, VA
- Age at study initiation: No data avaiable
- Weight at study initiation: No data avaiable
- Housing: No data avaiable
- Diet (e.g. ad libitum): No data avaiable
- Water (e.g. ad libitum): No data avaiable
- Acclimation period: No data avaiable

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data avaiable
- Humidity (%): No data avaiable
- Air changes (per hr): No data avaiable
- Photoperiod (hrs dark / hrs light): No data avaiable

IN-LIFE DATES: From: To:

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

Amount :0.1 ml
Concentration: undiluted

Duration of treatment / exposure:

72 hrs

Observation period (in vivo):

14 days

Duration of post- treatment incubation (in vitro):

8-14 days

Number of animals or in vitro replicates:

9 animals

Details on study design:

Not specified

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: Blistering of the conjunctivae

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: Iritis, redness and chemosis was observe

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: Corneal necrosis was observed for all animals at 24 hours to day 4, and persisted in three animals on days 13 and 14.

Irritant / corrosive response data:

Unwashed group:Corneal opacities were observed in two animals beginning at 48 hours, and were observed in all animals on days 7-14. Corneal necrosis was observed for all animals at 24 hours to day 4, and persisted in three animals on days 13 and 14. Iritis, redness and chemosis was observe in most or all animals by 24 hours, and persisted in at least one animal by day 13. Blistering of the conjunctivae and/or nictitating membrane as well as discoloration of the nictitating membrane was observed for all animals at 24 and 48 hours.
Washed group: Corneal opacities were observed in one animal beginning at 48 hours, and for all animals from 72 hours until day 14. Corneal necrosis was observed for all animals at 24 hours to day 7, and persisted in two animals on days 8 to 10. Iritis, redness and chemosis was observed in all animals by 24 to 48 hours, and persisted in at least one animal by day 13. Blistering of the conjunctivae and/or nictitating membrane was observed for all animals at 24 and 48 hours. Discoloration of the nictitating membrane was observed in one animal at 24 and 48 hours

Any other information on results incl. tables

The treated eyes of six animals remained unwashed. The treated eyes of three animals were washed for 1 minute approximately 5 seconds after installation of the test article. The eyes were scored at 24, 48, and 72 hours, and on days 4, 7, and 8-14 after dosing.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

An unfailing study, like OECD 405, found that test material was extremely irritating to the eye when in contact for 72 h in rabbits for 14 days.

Executive summary:

An unfailing study, like OECD "Acute Eye Irritation/Corrosion" was performed for the RA  chemical 3-aminopropyltriethoxysilane(CAS number: 919-30-2)using rabbits. 

The RA chemical was applied to all the animals at a dose of 0.1ml to the lower eyelid of the animal, one eye serves as a control and the other eye serves as treatment  Unwashed group: Corneal opacities were observed in two animals beginning at 48 hours and were observed in all animals on days 7-14. Corneal necrosis was observed for all animals at 24 hours to day 4 and persisted in three animals on days 13 and 14. Iritis, redness, and chemosis were observed in most or all animals by 24 hours and persisted in at least one animal by day 13. Blistering of the conjunctivae and/or nictitating membrane as well as discoloration of the nictitating membrane was observed for all animals at 24 and 48 hours.
Washed group: Corneal opacities were observed in one animal beginning at 48 hours, and for all animals from 72 hours until day 14. Corneal necrosis was observed for all animals at 24 hours to day 7 and persisted in two animals on days 8 to 10. Iritis, redness, and chemosis were observed in all animals by 24 to 48 hours and persisted in at least one animal by day 13. Blistering of the conjunctivae and/or nictitating membrane was observed for all animals at 24 and 48 hours. Discoloration of the nictitating membrane was observed in one animal at 24 and 48 hours. Hence the test material can be classified as  irritating to the eye of the animals