Registration Dossier

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:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1 kg
- Housing: Housed individually in labelled cages with perforated floors
- Diet (e.g. ad libitum):approximately 100 g per day (Teklad Global Rabbit Diet, code 2030, Harlan, Blackthorn, England); hay provided twice a week
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eye remained untreated and served as the reference control
Amount / concentration applied:
0.1 ml in the conjunctival sac of one of the eyes
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): solution of 2% fluorescein in water (adjusted to pH 7) instilled into both eyes
- Time after start of exposure: 24 hours

SCORING SYSTEM: numerical scoring system assessing corneal irritation, area of cornea involved, iris, conjunctival irritation, chemosis and discharge

TOOL USED TO ASSESS SCORE: where standard lighting was considered inadequate for observing minor effects, eye examinations were performed using an ophthalmic examination lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
opacity
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean 24-72 hours
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean 24-72 hours
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: mean 24-72 hours
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: mean 24-72 hours
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: mean 24-72 hours
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24-72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24-72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean 24-72 hours
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Irritant / corrosive response data:
Corneal opacity, epithelial damage, iridial irritation and redness/chemosis/discharge of conjunctiva observed - maximum grade 1. All effects fully resolved by Day 7.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dihydro-3-[3-(triethoxysilyl)propyl]furan-2,5-dione has been tested for acute eye irritation in a study conducted according to OECD TG 405 and in compliance with GLP. Corneal injury was seen as opacity maximum grade 1) and epithelial damage (maximum 75% of the corneal area). The corneal injury had resolved within 72 hours in one animal and within 7 days in two animals. Iridal irritation (grade 1) was observed in one animal and had resolved within 24 hours. Irritation of the conjunctivae was seen as redness, chemosis and discharge, which had completely resolved within 7 days in all animals. There was no evidence of ocular corrosion. The test substance is classified as a category 2 eye irritant, based on the conjunctival redness reading of >2 in 3 animals..