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Toxicological information

Eye irritation

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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

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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 0.8
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 4 hours
Score:
ca. 0.7
Max. score:
1
Reversibility:
fully reversible within: 48 hours
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 conjuctival 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 conjuctival 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.