Registration Dossier

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:
1997-03-10 to 1997-03-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1992
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1992
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: small white Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Møllegaard Breeding/Research Centre, Ltd., Tombjergvej 40, Ejby, DK-4623 LI. Skensved, Denmark
- Age at study initiation: adult
- Weight at study initiation: 2.0-2.6 kg
- Housing: single animal per stainless steel cage
- Diet (e.g. ad libitum): Ssniff K 4, complete diet for rabbits, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3°C
- Humidity (%): 30-70% (deviations of short duration are caused by cleaning of the animal room)
- Air changes (per hr): 15 times
- Photoperiod (hrs dark / hrs light): artificial light 12/12

IN-LIFE DATES: From: 10th March 1997 to 14th March 1997

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 cm³
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
Evaluation of the eyes was performed 1, 24, 48 and 72 hours after application of test substance
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm physiological saline solution
- Time after start of exposure: 24 hours

TOOL USED TO ASSESS SCORE: fluorescein test

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: No effects on the iris
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: No effects on the cornea
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
0
Remarks on result:
other: No chemosis observed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.11
Max. score:
0.33
Remarks on result:
other: Conjunctiva redness
Irritant / corrosive response data:
Within one hour of application, distinct hyperaemia of several blood vessels occurred in all animals. On one animal, the redness of the connective tissue was accompanied by a slight swelling, including the nictitating membrane. The cornea and iris showed no changes. Only one animal showed a slight redness of the connective tissue in the form of distinct hyperaemia of the blood vessels 24 hours after treatment. Further changes in the eye and conjunctiva were not observed. After 48 and 72 hours the eyes of all three animals were normal.
Other effects:
None reported.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an eye irritation study conducted according to OECD 405 and to GLP, [2-(perfluorohexyl)ethyl]triethoxysilane was only very slightly and transiently irritating to the eyes of small white Russian rabbits and therefore was not classified as an eye irritant.