Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2001-01-30 to 2001-03-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD study, GLP, read across substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted on 24-Feb-1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, F-01400 Chatillon sur Chalaronne / France
- Age at study initiation:
13-14 weeks (male)
15-16 weeks (females)
- Weight at study initiation: 2.5-2.7 kg
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with autoclaved wood (RCC Ltd, Fullinsdorf) and haysticks for gnawing.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Six days under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 21-22 °C
- Humidity: 40-62 %
- Air changes: 10-15 h
- Photoperiod: 12 hours light and 12 hours dark

IN LIFE DATES:
29-Jan-2001 to 21-Feb-2001

Test system

Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g (per animal) of test item

Duration of treatment / exposure:
single treatment
Observation period (in vivo):
Daily from delivery of the animals to the termination of test.
Number of animals or in vitro replicates:
1 male and 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- washing: the treated eyes were not rinsed after instillation

SCORING SYSTEM: The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 hours
Score:
0.33
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1
Time point:
other: 24, 48, 72 hours
Score:
0.67
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 2
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Application of the test item to healthy rabbit conjunctivae resulted in a primary irritation score of 1.67.
The eye reactions (mean values from 24 to 72 hours) consisted of grade 0.11 corneal opacity, grade 0.00 iris lesions, grade 1.00 redness of the conjunctivae and grade 0.56 chemosis of the conjunctivae.
A slight opacity was observed in one female 72 hours after treatment. No abnormal findings were noted in the iris in any animal at any reading.
Slight reddening of the conjunctivae was observed in all animals 1 hour after treatment and persisted in the male up to the 10-day reading, in one female up to the 72-hour reading and up to the 7-day reading in the other female. Obvious swelling (with partial eversion of lids) was noted in the male from 1 to 24 hours after treatment and in one female 1 hour after treatment. Slight swelling persisted in the female up to the 72-hour reading. In the other female, slight swelling was evident at the 1-hour reading only.
Slight reddening of the sclera was observed in the male from 1 hour to 10 days after treatment and in one female from 1 hour to 7 days after treatment. In the other female reddening of the sclera was observed at the 1-hour reading only.
A slight watery discharge was present in two animals at the 24-hour reading and persisted up to 48 or 72 hours after treatment.
Yellow remnants of the test item in the eye or conjunctival sac were noted in all animals at the 1 -hour reading and persisted in two animals up to 48 hours after treatment. All eye reactions had cleared 14 days after treatment.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU