3-(dimethoxymethylsilyl)propanethiol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-trimethoxysilylpropane-1-thiol

EC Number:

224-588-5

EC Name:

3-trimethoxysilylpropane-1-thiol

Cas Number:

4420-74-0

IUPAC Name:

3-(trimethoxysilyl)propane-1-thiol

Details on test material:

- Name of test material (as cited in study report): Organofunctional Silane Y-9616 (gamma-mercaptopropyltrimethoxysilane)
- Substance type: Organosilane
- Physical state: Liquid
- Stability under test conditions:
- Storage condition of test material: No data

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1, 0.01 and 0.005 ml

Duration of treatment / exposure:

No data

Observation period (in vivo):

up to 21 days as necessary.

Number of animals or in vitro replicates:

Six per volume

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no


SCORING SYSTEM: Similar to OECD test guideline 405


TOOL USED TO ASSESS SCORE: fluorescein staining used to determine corneal injury

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hour

Score:

ca. 0.8

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 4 hours

Score:

ca. 0.7

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 hours

Score:

ca. 0.2

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

No corneal injury or iritis was observed in any of the eyes. Within one hour minor transient conjunctival irritation (redness) was observed in 5/6 animals from the 0.1 ml group. All eyes were normal within 48 hours.

Other effects:

No other effects were reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a detailed summary of an eye irritation study (reliability score 2; not to GLP), Organofunctional Silane Y-9616 (gamma-mercaptopropyltrimethoxysilane) was not irritating to the eyes of New Zealand white rabbits.

Executive summary:

0.1, 0.01, and 0.005 ml of undiluted Organofunctional Silane Y-9616 (gamma-mercaptopropyltrimethoxysilane) was instilled into the lower conjunctival sac of one eye per rabbit (six rabbits per volume). The eyelids were held together for one second. The eyes were scored, by a scoring system similar to that recommended in OECD test guideline 405, at one, four and 24 hours, 2, 3 and 7 days after dosing. Additional readings were made, if necessary, at 14 and 21 days. Fluorescein (2%) staining was used to determine corneal injury before dosing and one day after instillation. No corneal injury or iritis was observed in any of the eyes. Within one hour minor transient conjunctival irritation (redness) was observed in 5/6 animals from the 0.1 ml group. All eyes were normal within 48 hours. Therefore overall the test substance was not irritating to eyes.