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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:
4 March 2002 to 30 July 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Laboratory of Pharmacology and Toxicology KG, branch Löhndorf, D-24601 Löhndorf/Post Wankendorf
- Age at study initiation: approximately nine months
- Weight at study initiation: 2.6 to 3.1 kg
- Housing: singly in cages measuring 425 mm x 600 mm x 380 mm.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3 (deviations from maximum range may have occurred e.g. during cleaning)
- Humidity (%): 55± 15 (deviations from maximum range may have occurred e.g. during cleaning)
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: for each animal, the left eye served as an untreated control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
Until the end of the observation period as the eyes were not rinsed
Observation period (in vivo):
Eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours after administration
Number of animals or in vitro replicates:
Three females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done

SCORING SYSTEM: According to OECD 405 (see "Any other information on materials and methods incl. tables")

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal: 1, 2 and 3
Time point:
other: All
Score:
0
Reversibility:
other: n/a
Remarks on result:
other: No signs of eye irritation were seen in any animal at any time point
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:
No effects
Other effects:
No other effects observed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In a GLP study, conducted to OECD Test Guideline 405, no signs of irritation were seen in the eyes of female rabbits treated with 0.1 ml of undiluted Siloxan HSi2.
Executive summary:

In a GLP-compliant study carried out according to OECD Test Guideline 405, Siloxan HSi2 was tested for its potential to irritate the eyes of rabbits.

 

Three female Himalayan rabbits were each given a 0.1 ml instillation of undiluted Siloxan HSi2 into the right eye, with the left eye acting as an untreated control. Treated eyes were not washed, and were examined at 1, 24, 48 and 72 hours after treatment. After 24 hours, the eyes were examined with the aid of fluorescein.

 

There were no signs of irritation to the cornea, iris or conjuctivae over the course of the study in any of the treated rabbits. Under the conditions of this study, 0.1 ml of Siloxan HSi2 was not irritating to the eyes of rabbits.