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AR226-2958
Laooratory Project ID
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Haskell Laboratory Report No. 333-91
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Material Tested. Medical Research No.; Haskell No.; Haskell Test Code No.; Physical Form; gurty;
Coinoosit'on;
Synonyms;
Other Codes: CAS Registry No.;
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Material Subsitted By:
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Study Initiated - Completed:| 4/19/01 - 3/207
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Notebook;
There are 12 pages in this report. Distribution:
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Du Font HLR 333-91
Eye Irritation Test with
in Babbits
SUMMARY
ffll------jvi^ evaluated for acute eye irritation potential in 2 rabbits. Theeyesorthe rabbits were|examinedon the day of treatment and on days 1, 2, and 3 following treatmentJ The test oaterial produced no irritation in either the washed or unwasheo rabbit eye* Fluorescein "tain examinations
were negative for corneal injury, and bloaicroscopic examinations revealed no corneal damage in either treated eye.
Under the conditions of this study
ras not an eye irritant.
Work by:
. y ^ ^ ^<2/l&< Carol PinlayQ Technician
Study Director:
/\John ^-JP*^--- L>^ ^CJ^re^ V. Sarver
I J
Technologist
Approved by:
^ NaiS^jCy. Chromey, Ip .^ Manager Acute Toxicology
Reviewed and
Approved for Issue:
^L^. ^ScLfu^^ John 9. Sarver Study Director
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Acknowledgement:
Bryan V. Crossley also participated in the conduct of this
study.
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Du Font HLR 333-91
QUALITY;ASSURANCE DOCUMENTATION
H# 18,920 -1*
Eye Irritation Test with
in Rabbits
AUDITS:
I tens Audited Protocol, conduct
Records, final report
Aufilit Dates
4/23/91 5/14/91
SHORT-TERM AUDIT REPORT NUMBER(jl--------kV
DATE FINDINGS REPORTED TO MANAGEMENT AND STUDY DIRECTOR: 5/15/91
CL^ ^^JLf Reported by:
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(^/JJaammeess Mackay^I
Quality Assurance Auditor
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INTRODUCTION
Du Font BtR 333-91
The purrppooseseoofftthhis study is to evallffttel^e a^ute eye irritation
potential o^xB|B----------------Pyh"o'uing |adult rabbits. This study was conducted
according ttooinmeeaappppTjTiccaable BPAG| ood Laboratory Practice Regulations. Areas of noncompliance are documented! in the study records. No deviations existed that affected the validity of ie study.
MATERIALS AND METHODS
A. Animal Husbandry
Yuung adult female Nev Zealand Vhite rabbits were received from Hare Marluiid, Hevitt, New Jersey,, The rabbits were housed singly in suspended, stainless steel, vlre-mesh cages. Each rabbit was assigned a unique identification numbef which was recorded on a card affixed to the cage. Purina Certified Hig6 Fiber Rabbit Chow9 15325 and water were available ad libitum. Rabbets were quarantined, weighed and observed for general health for approximately 2 weeks. Animal rooms were maintained on a timer-controlled, 12-hpur light/12-hour dark cycle. Environmental conditions of the rooms ver6 targeted for a temperature of 20C 2C and relative humidity of 50? 10!!;. Excursions outside these ranges were judged to have been of insufficient magnitude and/or duration to have adversely affected the validity of the study.
B. Protocol
On the day of treatment,; the eyes of 2 female New Zealand White rabbits were examined using illumination, magnification and fluorescein dye. These animals were selected for this study as they showed no
evidence of preexisting cornjeal or conjunctiva! injury or irritation and
were judged to be in good health. These rabbits weighed 2787 and 2947 grams, respectively, on the ;day of treatment.
Approximately 0.01 mL ofJ^^--Hwas introduced into the lower conjunctival sac of each rablbifsrlght eye. The left eye of each rabbit
was not treated with the test material and served as a control. The treated and control eyes of 1 animal remained unwashed. Approximately 20 seconds after the test material was administered, both eyes of the remaining rabbit were rinsedj for approximately 1 minute with room temperature water. Each rabbit was observed for approximately 30 to 60
seconds before being returned to its cage and any abnormal behavior was
noted.
adiilnistered. t
ewl^ At
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ilhmiha^ojft an
to the Braize ^
any unusual reg;
conjunctiva, ul< BioBicroscopic
W H post-treatnient fl^^^ method of classificattoin|
scored. These untreated
considered "normal^ rel-iN
Pu tftat iK^^
3 days after
denceof^
|e exaalned uin^ . ular reactions accord.. ing !S vere also observlto for s, blistering of toe tive of corrosive Action' is vere also conducted at scored according to the Control eyes vere not ison and vere
C. Record? Retention-
All raw data and the Inal report vt^ te stored in the archives of Hi.ii.cell Laboratory for tig ecology and Xn^trial Medicine, E. I. du Font
de Nemours and Company, ?^evark, E^BlavaN et in the Du Font Records Management Center, Vilnili ;ton, Delaware.
RESULTS
^
_____produced no irri tation in either treated rabbit eye.
Fluorescein "stain examinationjss were negative for oorneal injury, and biomicroscopic examinations rjevealed no cerneal damage in either treated eye. Individual eye irritation scores are presented in Tables 3 and 4.
! CONCLUSION Under the conditions of this study,
'as not an eye irritant.
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Du font HLR 333-91
TABLE 1 DRAIZE^ SCALE FOR SCORING OCULAR LESIONS
(1) Cornea
(A) Opacity-degree of density (area ost dense
taken for readinj;)
No opacity
Scattered or dius<; area, details of iris
.................... clearly visible
Easily discernible iranslucent areas, details of
............... iris slightly obncured
Qpalescent_areaSt_jMLdetai.ls ofjiris visible,
. . . . . . . . . . . . size of pupil barely discernible
Opaque, iris invisible
..................... (B) Area of cornea involved
One quarter (or les^) but not zero Greater than one quarter, but less than half
. . . . . ...... Greater than one half, but less than three
quarters
............. ...... Greater than three quarters, up to whole area
.
.
0
1 (Slight) 2 (Mild)
3 (Moderate) 4 (Severe)
1 (Localized) 2 (Small)
3 (Moderate) A (Generalized)
(2) Iris
(A) Values Normal Folds above normal) congestion, swelling, circum-
...................... corneal injection (any or all of these or
combination of aiiy thereof) iris still reacting
to light (sluggish reaction is positive)
. . . No reaction to light, hemorrhage, gross
. . . . . . . destruction (any or all of these)
0
1 (Moderate) 2 (Severe)
(3) Conjunctiva
:
(A) Redness (refers to palpebral and bulbar conjunctiva
excluding cornea and iris)
Vessels normal
Vessels definitely injected above
.................. More diffuse, deeper crimson red,
. . . . . vessels not easily discernible
........................ Diffuse beefy red
normal
individual
0
1 (Mild)
2 (Moderate) 3 (Severe)
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(B) Cheopsis No swelling Any i?K6XU^
Beibrane)t Obvious svel^
Uds . ...t Swelling i^l Swelling vitjte
closed .
(C) Discharge
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Ho discharge . , . ,
Any amount different
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Discharge vlth inoisttaii^ of
^|hairs
t^N^ just adjacent tQllHis. , '.''i.^'^ji ^^ . . . .
Discharge with moistening of this lids ^indliairs,
. . . . and considerable Bi'ea aEOHnd^d^eyn^.'^
1 Draize, J. H., "Dermal Toxici y" Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics The EditoiciltItl^fflMBttee of the Association o*.cf Foo^o^Jd a^n^dJ rDr--u.g_ nOffffji^cji^alljs- o^<f the United States, Austin, Texas, 1959, pp. 46-59.
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Du Font BLR 333-91
BIOMICROSCOPE CLASSIFICATIONOSF CORNEAL INJURY
0 No|injury; cornea within normal limits.
Slight (1)
Ep thelial changes visible only with biomlcroscope y include localized area of mild injury).
Mild (2)
Opacity visible with ophthalmoscope or light but shaving epithelial changes only with biomicroscope
y Include localized area of moderate inj'iry).
Moderate (3)
Opacity visible with ophthalmoscope or light but shaving epithelial and stromal changes with biboiicroscope (may include localized area of
severe injury).
Moderate to Severe (4)
Opacity visible with ophthalmoscupe or light but
shewing epithelial and stromal changes and
endothelial relucency with unremarkable swelling. This type of injury shows evidence of healing (reversible damage) within 14 days.
Severe (5) = Opaqueness or opacity visible with ophthalmoscope or:light but shoving epithelial and stromal changes and endothelial relucency and swelling or other distortion. This type of injury does not shbv evidence of healing (permanent damage) within
14'days.
No biomicroscope evaluation performed.
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Du Font BLR 933-91
UNVAESTHCEDIRRRAIBTBAITTK5M1 EfAfriT^ER|iTSREiA'iT^HmrfWI[THHjr^eM-f;
Rabbit Number
Q^QQO
Cornea Opacity Area
Iris
Conjunctiva Redness Chemosis Discharge
Biomicroscopic Examination of Cornea
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1 Hour
1
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0 0 0
4 Hours
0 0
0
0 0 0
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Day
Days
Days
0
0
0
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0
0
0
0
0
0
0
0
0
0
0
0
Fluorescein examinations!
negative for corneal injury at all observation
periods.
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Fluorescein examinations: a negative for corneal injury at all observation
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