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Diss Factsheets

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetrakis(2-butoxyethyl) orthosilicate
EC Number:
242-560-0
EC Name:
Tetrakis(2-butoxyethyl) orthosilicate
Cas Number:
18765-38-3
Molecular formula:
C24H52O8Si
IUPAC Name:
tetrakis(2-butoxyethyl) orthosilicate
Details on test material:
- Name of test material (as cited in study report): Dynasil BG
- Substance type: Organosilane
- Physical state: Liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: Small white russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr Karl Thomae GmbH
- Age at study initiation: No data
- Weight at study initiation: 1.8-1.9 kg
- Housing: no data
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm3



Duration of treatment / exposure:
24 hours
Observation period (in vivo):
60 minutes, 24, 48 and 72 hours
Number of animals or in vitro replicates:
Three males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: washed after 24 hours


SCORING SYSTEM: According to OECD 405 and Draize


TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein (24 hours after treatment)

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:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
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
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
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
Irritant / corrosive response data:
After 60 minutes two of the rabbits had conjunctival chemosis (grade 1) and all three had conjuctival erythema (grade 1 and 2), which had reversed by 24 hours. There were no other effects on the eye.
Other effects:
No other effects reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a good quality OECD 405 study, conducted to GLP, the test material was not irritating to the eyes of three male rabbits following a 24 hour exposure.
Executive summary:

Three male small White Russian rabbits had 0.1 cm3 (undiluted) test material dropped into one of their eyes. The other eye served as a control. The eyes were held closed for approximately one second to prevent loss of the test substance. Eyes were washed with saline after 24 hours. Reactions were recorded at 60 minutes, 24, 48 and 72 hours. After 60 minutes two of the rabbits had conjunctival chemosis (grade 1) and all three had conjuctival erythema (grade 1 and 2), which had reversed by 24 hours. There were no other effects on the eye. The test substance was concluded not to be irritating to eyes.