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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline. No mention of GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Trimethoxysilane
EC Number:
219-637-2
EC Name:
Trimethoxysilane
Cas Number:
2487-90-3
Molecular formula:
C3H10O3Si
IUPAC Name:
Trimethoxysilane

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
No data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1, 0.01 or 0.005 ml
Duration of treatment / exposure:
Eyes were not washed
Observation period (in vivo):
Seven days
Number of animals or in vitro replicates:
Six per dose volume
Details on study design:
Six rabbits were dosed with 0.1 ml.  Six rabbits were dosed with 0.01 ml.  Six rabbits were dosed with 0.005 ml. Eyes were not rinsed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
87-29376
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
0.1 mL
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
87-29377
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak irritation
Remarks:
0.1 mL
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
87-23978
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
0.1 mL
Irritation parameter:
cornea opacity score
Basis:
animal #4
Remarks:
87-29415
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak irritation
Remarks:
0.1 mL
Irritation parameter:
cornea opacity score
Basis:
animal #5
Remarks:
87-29416
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
0.1 mL
Irritation parameter:
cornea opacity score
Basis:
animal #6
Remarks:
87-29417
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Remarks:
0.1 mL
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
87-29376
Time point:
24/48/72 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of weak irritation
Remarks:
0.1 mL
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
87-29377
Time point:
24/48/72 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of weak irritation
Remarks:
0.1 mL
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
87-23978
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak irritation
Remarks:
0.1 mL
Irritation parameter:
iris score
Basis:
animal #4
Remarks:
87-29415
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
0.1 mL
Irritation parameter:
iris score
Basis:
animal #5
Remarks:
97-29416
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
0.1 mL
Irritation parameter:
iris score
Basis:
animal #6
Remarks:
87-29417
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak irritation
Remarks:
0.1 mL
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
87-29376
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Remarks:
0.1 mL
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
87-29377
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of weak irritation
Remarks:
0.1 mL
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
87-23678
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Remarks:
0.1mL
Irritation parameter:
conjunctivae score
Basis:
animal #4
Remarks:
87-29415
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
0.1 mL
Irritation parameter:
conjunctivae score
Basis:
animal #5
Remarks:
87-29416
Time point:
24/48/72 h
Score:
2.66
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
positive indication of irritation
Remarks:
0.1 mL
Irritation parameter:
conjunctivae score
Basis:
animal #6
Remarks:
87-29417
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Remarks:
0.1 mL
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
87-29376
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak irritation
Remarks:
0.1 mL
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
87-29377
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak irritation
Remarks:
0.1 mL
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
87-23978
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of weak irritation
Remarks:
0.1 mL
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
87-29415
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Remarks:
0.1 mL
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
87-29416
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Remarks:
0.1 mL
Irritation parameter:
chemosis score
Basis:
animal #6
Remarks:
87-29417
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
probability of weak irritation
Remarks:
0.1 mL
Irritant / corrosive response data:
See Table 1 for summary of results. Instillation of 0.1 ml of sample into rabbit eyes resulted in minor corneal injury (opacity) in 3/6 animals.  Iritis and moderate to severe conjunctival irritation (including necrosis in 5) were observed in all 6 animals.  All rabbits had a purulent ocular discharge. Except for alopecia in the periocular area of each dosed eye and a substantial discharge in one eye, all eyes appeared to be essentially healed by 7 days. Alopecia was still evident on each rabbit at 14 days,  but no other effects were observed.

Any other information on results incl. tables

Table 1 Summary of results for 0.1ml instillation (volume specified in OECD 405), mean scores


   

 1 h

4 h

 24h  48 h 72 h 7 days 14 days 

Cornea

   
Opacity 0.5 0.5  0.5 0.2  0.2   0  0
Area 0.5 0.5 0.5 0.2 0.2  0  0
Iris          
Inflam.  0.8 0.8 1.0 0.7 0.3 0 0
Conjunct.          
Redness 2.0 2.0 2.2 1.5 1.2 0 0
Chemosis 2.0 2.3 1.5 0.5  0.3 0 0
 Discharge  3.0  3.0  3.0  1.3  1.5  0.5  0


After doses of 0.01 ml were applied directly on the cornea, 5/6 eyes developed minor to moderate corneal opacity.  Iritis and moderate to severe conjunctival irritation (with necrosis in 3) was apparent in all 6 rabbits. A purulent discharge was evident in 5/6 eyes. By 24 hours, one rabbit exhibited hemorrhaging of the nictitating membrane.  Two eyes appeared normal at 48 hours. Two others had only slight conjunctival irritation. Four eyes were healed at 72 hours and the other 2 developed a normal appearance by 7 days.

Table 2 Summary of results for 0.01ml instillation, mean scores


   

 1 h

4 h

 24h  48 h 72 h 7 days

Cornea

   
Opacity 0.7 1.0 0.3 0.2  0  0
Area 0.7 1.0 0.5 0.2 0  0
Iris        
Inflam.  0.7 1.0 0.8 0.3 0 0
Conjunct.        
Redness 1.5 2.0 1.5 0.8 0.3 0
Chemosis 1.0 2.0 1.0 0.3 0 0
 Discharge  2.0  2.5  1.7  0.7 0.2  0


No corneal injury was apparent after the administration of 0.005 mL of sample into rabbit eyes. Iritis developed in 4/6 rabbits. Minor to severe conjunctival irritation (with necrosis in 4) was observed in 6/6 animals. One eye appeared normal at 48 hours and 5 exhibited only slight conjunctival irritation. By 72 hours, all eyes were healed. One rabbit was found dead at 6 days with no indication that the death was dose-related.

Table 3 Summary of results for 0.005 ml instillation, mean scores


   

 1 h

4 h

 24h  48 h 72 h

Cornea

 
Opacity 0.0 0.0 0.0 0.0 0.0
Area 0.0 0.0 0.0 0.0 0.0
Iris      
Inflam. 0.5 0.7 0.3 0.3 0.0
Conjunct.      
Redness 1.0 1.2 1.0 0.8 0.0
Chemosis 1.0 1.3 0.3 0.0 0.0
 Discharge  1.0  2.8  0.3  0.2  0.2


Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
In an eye irritation study (reliability score 2) conducted using a protocol similar to OECD Test Guideline 405 but with no mention of GLP, 0.1 ml trimethoxysilane was moderately irritating to the eyes of rabbits.
Executive summary:

In an eye irritation study (reliability score 2) conducted using a protocol similar to OECD Test Guideline 405 but with no mention of GLP, trimethoxysilane was instilled into one eye of each of six rabbits per dose (0.1, 0.01 and 0.005 ml). The animals were then observed for seven days. Since it is a volume of 0.1 ml that is recommended by OECD Test Guideline 405, only the results from this dose group are included in this summary: minor corneal opacity in 3/6 animals. 

Iritis and moderate to severe conjunctival irritation (including necrosis in five) were observed in all six animals.

All rabbits had a purulent ocular discharge. Except for alopecia in the periocular area of each dosed eye and a substantial discharge in one eye, all eyes appeared to be essentially healed by seven days. Alopecia was still evident in each rabbit on day 14 but no other effects were observed. It was concluded that trimethoxysilane was moderately irritating to the eyes of rabbits.