Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From August 24, 1999 to September 14, 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD Guideline 405 and EU Method B.5, in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Reaktiv Orange F97-0318

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand albino
Details on test animals or tissues and environmental conditions:
- Source: Charles River Deutschland GmbH 88353 Kiβlegg.
- Body weight at treatment: 3.0 kg
- Housing: In fully air-conditioned rooms in separate cages arranged in a battery
- Diet: Ssniff K-H (V2333), ad libitum and hay (i.e., approximately 15 g daily)
- Water: Water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions
- Animal identification: Numbered ear tags

ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Humidity: 50±20%
- Photoperiod: 12 h light/dark cycle

IN-LIFE DATES: From: To: August 24, 1999 to September 14, 1999

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
1, 24, 48 , 72 h and after 7, 14 d and 21 d following administration of the test substance.
Number of animals or in vitro replicates:
1 female
Details on study design:
TEST PROCEDURE

About 24 h before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01% fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.

100 mg test substance was administered once to the conjunctival sac of the left eye of one rabbit. In each case the untreated eye served as a control. 24 h after administration the treated eye was washed out thoroughly with isotonic saline at approximately 37ºC. The eye was also washed out at designated examination times at which discharge was observed or a corneal examination with fluorescein was performed.

The eye was examined 1, 24, 48 and 72 h after administration of the test substance. At 24 and 72 h and after 7, 14 and 21 d, the eye was further examined for corneal lesions under UV light after instillation of one drop of a 0.01% fluorescein-sodium solution. Lesions in cornea, iris or conjunctivae were graded numerically. All other changes or toxic effects were recorded when apparent. Since effects were still present in the eye after 72 h, further examinations were carried out after 7, 14 and 21 d.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 2 d
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
- From 1 h up to 1 d after application the conjunctiva of the animal showed definitely injected blood vessels up to a diffuse crimson red color and swelling with the lid being half closed.
- The irritations were attended by clear substance coloured eye discharge.
- 2 d after application the irritations were reversed.
- Additionally, nictitating membrane, conjunctiva and sclera were discolored orange from 1 h up to the end of the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the substance caused orange discoloration of the conjunctiva, nictating membrane and sclera of one rabbit eye until end of the study period. Irritation was seen in the conjunctiva but this cleared within two days.
Executive summary:

A study was conducted to assess the eye irritancy potential of the test substance in one New Zealand albino female rabbit according to OECD Guideline 405 and EU Method B.5, in compliance with GLP.

A single dose of 100 mg test substance was applied to the conjunctival sac of the left eye of the animal. The treated eye was washed out 24 h after administration. The untreated eye served as a control.

The conjunctiva, nictitating membrane and sclera were discolored orange by the test substance up to the end of the study. The conjunctiva showed definitely injected blood vessels up to a diffuse crimson red color and swelling with the lid being half closed. The irritation was attended by clear substance coloured eye discharge. Two days after application, the irritation was reversed. Based on the individual scores after 24, 48 and 72 hours, the mean score was 0 for opacity of the cornea, iris and chemosis of the conjunctiva. The score was 0.332 for redness of the conjunctiva.

Under the test conditions, the substance caused orange discoloration of the conjunctiva, nictating membrane and sclera of one rabbit eye until end of the study period. Irritation was seen in the conjunctiva but this cleared within two days.