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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:
17.06.2002 to 23.09.2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
[3-(2,3-epoxypropoxy)propyl]triethoxysilane
EC Number:
220-011-6
EC Name:
[3-(2,3-epoxypropoxy)propyl]triethoxysilane
Cas Number:
2602-34-8
Molecular formula:
C12-H26-O5-Si
IUPAC Name:
triethoxy[3-(oxiran-2-ylmethoxy)propyl]silane
Constituent 2
Reference substance name:
[3-2,3-epoxypropoxy)propyl]triethoxysilane
IUPAC Name:
[3-2,3-epoxypropoxy)propyl]triethoxysilane
Details on test material:
- Name of test material (as cited in study report): Silan GF 82
- Substance type: Alkoxysilane
- Physical state: Colourless liquid
- Stability under test conditions: >0ne year
- Storage condition of test material: Room temperature, dark, dry, tightly closed

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG
- Age at study initiation: Approx. 4 months
- Weight at study initiation: 2-2.3 kg
- Housing: Individually in cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ±3
- Humidity (%): 55 ±15
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17.06.2002 To: 19.07.2002

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
N/A
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Remarks:
Conjuctival redness Grade 1 at 1 h but not subsequently.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Remarks:
Conjuctival redness Grade 1 at 1 h but not subsequently.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Remarks:
Conjuctival redness Grade 1 at 1 h but not subsequently.
Irritant / corrosive response data:
Grade 1 conjunctival redness one hour after instillation in all animals. This redness had disappeared by the 24 hour reading.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
In an eye irritation study conducted according to OECD 405 and in compliance with GLP (reliability score 1) [3-2,3-epoxypropoxy)propyl]triethoxysilane was not irritating to the eyes of rabbits.