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: GLP and appropriate guidelines
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Principles of method if other than guideline:
n/a
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
E-AF098T (Batch No. T# 164), a white powder. Stored at room temp, dry, closed container.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source - Kuiper Rabbit Ranch, Inc. (Gary, IN).
Number of animals - 3 male rabbits
Age of start of treatment- Approximately 2-4 month old mail and female.
Bodyweight: 2.11 to 2.39 kg
Identification- Ear tag
Husbandary: Daily average animal room temperature and relative humidity: 73 ± 2oF and 59± 5%, respectively.
Light: 12 hr artificial light 12 hr dark.
Accommodation: Individually in labelled cages
Acclimatisation period was at least 5 days before start of the treatment
Diet- Harlan Teklad Certified Hi-Fiber Rabbit Diet #T2031C.
Water- City of Chicago water ad libitum by means of an automatic watering system.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
ca 100 MG
Duration of treatment / exposure:
24h
Observation period (in vivo):
1, 24, 48 and 72h after test material administration.
All rabbits were observed at least once each day for mortality and moribundity.
Number of animals or in vitro replicates:
3 treated animals
Details on study design:
On the day of the treatment, a 0.1 g dose was placed in the everted lower lid of the right eye of each test subject. The lids of each treated eye were held closed for approximately two seconds following administration of the test material. The test material was rinsed from the eye with water 24h after instilation. All rabbits were observed at least once each day for mortality and moribundity. The treated and control eyes of each test rabbit were examing using a penlight. The cornea was observed for presence and/or degree of opacity; the iris for deepened rugae, congestion, swelling and circumcorneal injection, and reaction to light; and the conjunctiva for redness and chemosis. Fluorescein and ultraviolet light were used to aid in theexemination at the 24- and 48- hour scoring interval.
Evaluation of the results: For each animal, mean scores for corneal opacity, iris lesions, conjunctival redness and chemosis were calculated by adding the scores at 24, 48 and 72 hours and dividing by three. The irritation potential of the test material was assessed according to the criteria cited in the OPPTS 870.2400 grading of ocular lesions.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Max. score:
0.33
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: .33 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Max. score:
0
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Irritation parameter:
cornea opacity score
Max. score:
0.33
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: .33 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Conjunctival redness and/or chemosis were seen in two rabbits at the 1-hour scoring interval and persisted as conjunctival redness in one rabbit at
the 24h interval. A small corneal opacity was seen in one of the rabbits at the 24h scoring interval (score of 1). All rabbits were completely recovered
from all signs of ocular irritation by the 48-hour scoring interval.
No death occured.

Other effects:
No other effects.

Any other information on results incl. tables

See attached document.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: other: According to the criteria cited in the OPPTS 870.2400 grading of ocular lesions (see attached document).
Conclusions:
The test item was found to be not irritant to rabbit eyes according to the conditions of this study.
Executive summary:

The study was performed according to EPA OPPTS 870.2400 (Acute Eye Irritation).

Conjunctival redness and/or chemosis were seen in two rabbits at the 1-hour scoring interval and persisted as conjunctival redness in one rabbit at the 24h interval. A small corneal opacity was seen in one of the rabbits at the 24h scoring interval (score of 1).

All rabbits were completely recovered from all signs of ocular irritation by the 48-hour scoring interval.

No death occured.