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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2005 january 31st to 2005 february 4th
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to the OECD Guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
SRID No. : DEV75332
Physical State and Appearance : Solid, Tan powder
Source of Test Substance : Eastman Kodak Company

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Test System
Six albino rabbits (Hra:(NZW)SPF) obtained from Covance Research Products, Inc .
(Denver, PA) were assigned to the study. The rabbits were young adults (at least three months
old). Rabbits were chosen for this study because they are a common representative species for
eye irritation studies. The rabbit is the species recommended for use in the OECD Guideline.
The protocol was approved by the Institutional Animal Care and Use Committee.
Husbandry
Housing
Animals were housed in an Association for Assessment and Accreditation of Laboratory
Animal Care International-accredited vivarium in accordance with the Guide for the Care
and Use of Laboratory Animals (National Research Council, 1996). The rabbits were
singly housed in suspended, stainless-steel mesh cages. Cages and racks were washed
once a week. Absorbent paper, used to collect excreta, was changed every other day.
Environmental Conditions
The study room was maintained at 19.9 to 23.0 °C and 42.2 to 62.0% relative humidity. .
A photoperiod of 12 hours light was maintained.
Acclimation Period
The animals were isolated upon arrival and allowed to acclimate for a period of 5 days.
Animals were judged to be healthy prior to testing.
Feed
Certified High Fiber Rabbit Diet (PMI #5325) was available ad libitum. Feed containers
were cleaned and refilled at least once a week. No known contaminants which would
interfere with the outcome of this study were present in the feed. Analyses of feed are
maintained on file within the testing laboratory.
Water
Water was available ad libitum through an automatic watering system. The source of the
water was the local public water system. There have been no contaminants identified in
previous water analyses that would be expected to interfere with the conduct of the study.
Semiannual analyses of water are maintained on file within the testing laboratory.
Identification
Upon arrival, all rabbits were identified by uniquely-numbered ear tags. Cage cards
contained the study-specific animal number and the ear tag number.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
The test substance, a solid, was administered as received.
A single dose of 0.1 gram of the test substance was placed into the conjunctival sac of
one eye (left) of each animal.
Duration of treatment / exposure:
Test Substance Exposure
The treated eyes of three animals were immediately washed
with running distilled water; the eyes of the other three animals were not irrigated.
Observation period (in vivo):
Eyes were observed immediately after instillation of the test substance and 1,24,48, and
72 hours thereafter. Observations included indications of immediate sensory irritation
and estimations of chemosis and redness of the adnexal structures. Also evaluated were
effects on the iris, the presence of corneal opacity, andor discharge from the eye. Eyes
were treated with a 2% ophthalmic solution of fluorescein at 24 hours and observed for
staining.
Number of animals or in vitro replicates:
Six albino rabbits
Details on study design:
Test Procedures
This study was conducted according to the Organisation for Economic Cooperation and
Development (OECD) Guideline for Testing of Chemicals: Guideline 405, Acute Eye
IrritatiodCorrosion; and European Economic Community (EEC): Annex V., Test B.5,
Acute Toxicity (Eye Irritation).
Distribution of Animals
Animals were distributed into 2 groups
Not irrigated 3 animals numbered 805,806 and 807
Irrigated 3 animals numbered 808, 809 and 810
Preparation of Animals
Both eyes of each rabbit selected for the study were examined within 24 hours of
administration of the test substance. Animals showing eye irritation, ocular defects, or
pre-existing corneal injury were not used.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 0
Max. score:
0
Remarks on result:
other: irrigated and not irrigated
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: Irrigated and not irrigated
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: irrigated and not irrigated
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: irrigated and not irrigated
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 0
Max. score:
0
Remarks on result:
other: irrigated and not irrigated
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: irrigated and not irrigated
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: irrigated and not irrigated
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: irrigated and not irrigated
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 0
Max. score:
0
Remarks on result:
other: irrigated
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 0.66
Max. score:
2
Remarks on result:
other: not irrigated
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: irrigated and not irrigated
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: irrigated and not irrigated
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: irrigated and not irrigated
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
ca. 0
Max. score:
0
Remarks on result:
other: irrigated and not irrigated
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: irrigated and not irrigated
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: irrigated and not irrigated
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 0
Max. score:
0
Remarks on result:
other: irrigated and not irrigated
Other effects:
Description of Other Ocular Lesions, Including Fluorescein Staining
No other lesions were noted for the unwashed or washed eyes during the 72-hour observation
period. Staining was not evident for unwashed or washed eyes when tested with fluorescein dye
24 hours after administration of the test substance.
Effects of Immediate Washing
Immediate irrigation of the eyes was slightly palliative.
Toxic Effects
No toxic effects were noted during the study.

Any other information on results incl. tables

Prior to initiation of the eye irritation study, a screening procedure was performed in an attempt to avoid testing substances that might produce significant irritation of the rabbit eye. First, the pH of the test substance was measured and the value obtained (5.622) demonstrated that the test substance was neither strongly acid (pH =< 2.0) nor strongly alkaline (pH >= 11.0). Subsequently, an in vitro test (IrritectionTMA ssay) designed to identify eye irritants was conducted. The results of this test suggested that the test substance had the potential to cause, at most, minimal to mild eye irritation. Furthermore, results from an acute dermal irritation study determined that the test substance would not be classified as irritating to skin. Therefore, an in vivo eye irritation study was conducted in which, initially, the eyes of two animals were tested. After instillation of the test substance into one eye of each animal, the treated eye of one animal was washed. Only minimal irritant effects, redness (grade 2) at the one-hour examinations, were noted for the unwashed eye. No signs of irritation were noted for the washed eye one hour after dosing. At the 24-hour examinations, both the unwashed eye and the washed eye appeared clinically normal. Based on the observations in the single unwashed eye and washed eye, the remaining four eyes were dosed in order to complete the full in vivo eye irritation study (a total of three unwashed and three washed eyes). In the in vivo eye irritation study, no signs of irritation were noted for two of the three unwashed eyes and all three washed eyes during the 72-hour observation period. Signs of irritation for the remaining unwashed eye were limited to redness (grade 2) one hour after dosing. At the 24-hour examinations, all unwashed and washed eyes appeared clinically normal. Staining was not evident in unwashed or washed eyes when fluorescein dye was applied. Immediate irrigation of the eyes was slightly palliative. Complete reversibility of the irritant effect was observed by the 24-hour examinations.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on these results, the test substance requires no eye irritation classification as defined in the
28th Adaptation of the EC Classification, Packaging and Labelling of Dangerous Substances
Directive.