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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
Study period:
21/09/1995-05/03/1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
10217-34-2
Cas Number:
10217-34-2
IUPAC Name:
10217-34-2
Constituent 2
Reference substance name:
-
EC Number:
425-050-4
EC Name:
-
IUPAC Name:
425-050-4
Constituent 3
Reference substance name:
[2-(3,4-epoxycyclohexyl)ethyl]triethoxysilane
IUPAC Name:
[2-(3,4-epoxycyclohexyl)ethyl]triethoxysilane
Details on test material:
- Name of test material (as cited in study report): Y-4036

- Physical state: clear, colourless liquid

- Storage condition of test material: at room temperature in original container

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazelton Research Products, Inc., Denver, PA
- Age at study initiation: young adult
- Weight at study initiation: 2379-2688g
- Housing: individual suspended mesh-bottom cages
- Diet: Purina Certified Rabbit Chow, ad libitum
- Water: municipal water, ad libitum
- Acclimation period: minimum of 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.9-20.1
- Humidity (%): 38.2-61.1
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 16/10/1995 To: 03/11/1995

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
single, unwashed exposure
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3M, 3F
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing


SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: UV light / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.1
Max. score:
3
Irritant / corrosive response data:
None of the rabbits vocalized upon instillation of the test material. The left (control) eyes were free of evidence of ocular irritation and other findings for the duration of the study. An iridial reaction was noted in the treated eye of one female animal. There were no corneal findings. Minor conjunctival irritation was noted for all rabbits. All irritation was reversible and completely subsided by termination (day 3) or earlier.
Other effects:
There were no deaths during the study. There were no remarkable changes or differences observed in body weights during the study period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was found not irritating to eye, as determined in a study carried out according to an appropriate guideline and compliant with GLP.