Document x1aow5mV5gY2k0LVe2KEbM5jE
HAZLETON LABORATORIES AMERICA. INC.
3301 KINSM AN BLVD. P.O. BOX 7545 MADISON, WISCONSIN 53707
)R ai6 -O 230
Chemical & BioMedical Sciences Division
PH O N E (608) 241-4471 TLX 703956 H A ZR A L M DS UD
FINAL REPORT
R O G E R G. P E R K I N S MINNESOTA MINING & MANUFACTURING
TOXICOLOGY SERUICES ST. P A U L ? MN 55101
COMPANY
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N2 71988 f
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1 SAMPLE NUMBER: 7090576
SAMPLE ENTERED: 09/25/8
REPORT PRINTED: 01/20/8
SAMPLE: T-4102
PURCHASE ORDER NUMBER: T837389-410 754
ENCLOSED:
P R I M A R Y E Y E IRRI T A T I O N / C O R R O S I O N S T U D Y IN R A B B I T S (OECD GUIDELINES)
o Key Personnel o Method o Summary o References o Raw Data Appendix
SIGNED:
S T E U E N M. G L A Z A STUDY DIRECTOR ACUTE TOXICOLOGY
...........\ r ^ ; 9 r % . DATE
600547
HAZLETON LA B O R A T O R IE S A M E R IC A , INC.
Chemical & BioMedical Sciences Division
3301 KIN SM AN BLVD. P.O. BOX 7545 MADISON, W ISCONSIN 53707 PH O N E (608) 241-4471 TLX 703956 H AZR AL MDS UD
SAMPLE NUMBER: 70905764 SAMPLE: T-4102
PAGE 2
KEY PERSONNEL
Acute Toxicology
S t e v e n M. G l a z a Study Director
C a l v i n L. H o r t o n Group Leader Support Services
S h a r e n L. H o w e r y Report Coordinator
Quality Assurance
Debra Curley Arndt Manage r
Anatomical Pathology;
T h o m a s E. P a l m e r , P h D Anatomical Pathologist
Robert Salava Senior Section Supervisor
Dennis Hoffman Group Leader Necropsy
Anne Mosher Group Leader P a t h o 1o g y D a t a
Laboratory Animal Ueterinarian
C i n d y J. C a r y , D U M Diplomate, ACLAM
000548
HAZLETON LA B O R A T O R IE S A M E R IC A , INC.
Chemical & BioMedical Sciences Division
3301 KINSM AN BLVD. P.O. BOX 7545 MADISON, WISCONSIN 53707 PH O N E (608) 241-4471 TLX 703956 HAZR AL MDS UD
SAMPLE NUMBER: 70905764 SAMPLE: T-41CI2
PAGE J
OECD EYE IRRITATION
Objective: To determine the level of ocular irritation produced following
a sin g l e e x p o s u r e of a test s u b s t a n c e to one eye of albino rabbits a c c o r d i n g to the O r g a n i z a t i o n for E c o n o m i c C o o p e r a t i o n and D e v e l o p m e n t ' s Guidelines for Testing Chemicals.
Test Material: T-4102 Physical Description: Purity and Stability:
Storage and Retention:
Safety Precautions:
Dark amber liquid Sponsor assumes r e s p o n s i b i 1ity for purity and stability determinations. T h e test m a t e r i a l w a s s t o r e d at. r o o m t e m p e r a t u r e . Any unused material will be discarded according to HLA S t a n d a r d Op e r a t i n g Procedure. Normal handling procedures were used according to H L A S t a n d a r d O p e r a t i n g P r o c e d u r e .
Test Animal: Young adult rabbits of the New Zealand White strain were p r o c u r e d , m a i n t a i n e d i n d i v i d u a l l y in s c r e e n - b o t t o m c a g e s in t e m p e r a t u r e an d h u m i d i t y - c o n t r o l l e d q u a r t e r s , p r o v i d e d a c c e s s to w a t e r ayd libit urn and a measured amount of Purina High Fiber Rabbit Chow, and held for an a c c l i m a t i o n p e r i o d of at least 7 days. Animal h u s b a n d r y and h o u s i n g at H L A c o m p l y w i t h s t a n d a r d s o u t l i n e d in the " G u i d e for the C a r e a n d U s e of L a b o r a t o r y A n i m a l s " . If v a r i a t i o n s f r o m the p r e s c r i b e d e n v i r o n m e n t a 1 c o n d i t i o n s existed, they were d o c u m e n t e d and c o n s i d e r e d to have no effect on the s t u d y o u t c o m e . No c o n t a m i n a n t s w e r e e x p e c t e d to h a v e b e e n p r e s e n t in the fe ed or w a t e r w h i c h w o u l d h a v e i n t e r f e r e d w i t h or a f f e c t e d the results of the study.
T h r e e a c c l i m a t e d a n i mals, w e i g h i n g f r o m 2 0 7 6 to 2155 g, were c h o s e n at ran d o m for the test. The animals' eyes were e x a m i n e d w i t h i n 24 hours prior to test material a d m i n i s t r a t i o n u sing s o d i u m f l u o r e s c e i n dye procedures. Only those animals with no sign of ocular injury or irritation were used. Test animals were identified by animal number and c o r r e s p o n d i n g ear tag.
R e a s o n for S p e c i e s S e l e c t i o n : The N e w Z e a l a n d W h i t e a l b i n o r a bbit is the animal of choice based upon its large orbit and nonpigmented iris.
Preparation and Administration of Test Material: The sample was dosed as received. The pH was d e t e r m i n e d to be 9.1.
Treatment: Each rabbit received 0.1 ml of the liquid test material placed
into the everted lower lid of one eye, with the contralateral eye serving
as the untreated control. The upper and lower lids were gently held
t o g e t h e r for one s e c o n d to p r e v e n t loss of m a t e r i a l and then r e l e a s e d .
The eyes of the rabbits remained unflushed.
-
000549
HAZLETON L A B O R A T O R IE S A M E R IC A . IN C
Chemical & BioMedical Sciences Division
3301 KINSM AN BLVD. P.O. BOX 7545 MADISON, W ISCONSIN 53707 PH O N E (608) 241-4471 TLX 703956 H AZR AL MDS UD
SAMPLE NUMBER: 70905764 SAMPLE: T-4102
PAGE 4
OECD EVE IRRITATION
(D O N T INLJED )
Reason for Route of Administration: H i s t o r i c a 11y , the route of choice based on the method of Draize.
O b s e r v a t i o n s : The tr e a t e d eyes were o b s e r v e d for o c u l a r i r r i t a t i o n at 1, 24, 48, 72 and 96 hours, and at 7 and 14 d a y s a f t e r t r e a t m e n t .
At the 72-hour, 7- and 14-day readings, s o d i u m fluorescein was used to a i d in r e v e a l i n g p o s s i b l e c o r n e a l injur y. I r r i t a t i o n w a s g r a d e d and s c o r e d a c c o r d i n g to the D r a i z e t e c h n i q u e .
Animals were weighed just prior to test material administration. Body w e i g h t s were taken a g a i n at w e e k l y i n t e r v a l s t h r o u g h o u t the s t u d y p e r i o d or at death.
Pathology: At s t u d y t e r m i nation s u r v i v i n g a n i m a l s were e u t h a n a t i z e d and discarded. The animal that died on s t u d y was subjected to a gross
necropsy examination and abnormalities were recorded. After necropsy, the animal was discarded and no tissues were saved.
Statistical Methods: Other than average eye irritation scores, no other statistical method was performed.
Location of Raw Data and Final Report: The raw data and a copy of the final r e p o r t w il l be r e t a i n e d in the a r c h i v e s of HLA.
HAZLETON LA B O R A T O R IE S A M E R IC A . INC.
3301 KINSM AN BLVD. P.O. BOX 7545 MADISON, WISCONSIN 53707
Chemical & BioMedical Sciences Division
PH O N E (608) 241-4471 TLX 703956 H A ZR A L MDS UD
SAMPLE NUMBER: 70905764 SAMPLE: T-4102
BEST COPY AVAILABLE PAGE 5
OECD EYE IRRITATION
(CONTINUED)
SUMMARY
Test Animal: Albino rabbits - New Zealand White S o u r c e : H a z l e t o n R e s e a r c h P r o d u c t s , Inc.., D e n v e r P A Date Animals Received: 10/20/87
Date Test Started: 11/06/87
Date Test Completed: 11/20/87
PRIMARY EYE IRRITATION SCORES*
OBSERUATION PERIOD
3 Rabbit Mean 0.1 ml
(Unwashed)
1 Hou r : 24 Hours: 48 Hours:
72 Hours:
96 Hours: 7 Days:
14 Days:
24. 0
29.3 21.3 16.5**
5.5** 1.0**
0. 0**
* T h e P r i m a r y E y e I r r i t a t i o n S c o r e is the total ey e i r r i t a t i o n s c o r e for all the a n i m a l s d i v i d e d by the n u m b e r of a n i m a l s (3) at each observation period.
** Based on a two-animal mean.
000551
HAZLETON L A B O R A T O R IE S A M E R IC A , INC,
Chemical & BioMedical Sciences Division
3301 KINSM AN BLVD. P.O. BOX 7545 MADISON, WISCONSIN 53707 PH O N E (608) 241-4471 TLX 703956 H AZRAL MDS UD
SAMPLE NUMBER: 70905764 SAMPLE: T-4102
PAGE
OECD EYE IRRITATION
Animal Number F20347
F20333
F20344*
O b s e rva t ion Pe r iod
1 Hour 24 Hours 48 Hours 72 Hours 96 Hours
7 Days 14 Days
1 Hour 24 Hours 48 Hours 72 Hours 96 Hours
7 Days 14 Days
1 Hour 24 Hours 48 Hours
(CONTINUED)
Table 1 Individual Eye Irritation Scores
Cornea AB
Score AXBX5
Iris Sco re A AX5
C o n j u n c t ivae ABc
00
0
1
5 222
1 3 15
1 5 221
1 3 15
1 5 221
1 2 10
1 5 221
11
5
0
0 100
00
0
0
0 100
00
0
0
0 000
11
5
1 5 233
12
10
1 5 232
11
5
1
5 233
00
0
0
0 211
00
0
0
0 110
00
0
0
0 000
00
0
0
0 000
1 2 10
1 5 232
1 2 10 1 5 2 3 2
00
0
0
0 211
Score (A +B +0 2
12 10 10 10
2 2 0
16 14 16
8 4 0 0
14 14
8
Cornea A = Degree of opacity B = Area of involvement
Con junct ivae A = Redness B = C h e m o s is C = Discharge
Table 2 S o dium Fluorescein Examint ion
An ima 1 Number
Observation Period
P r e - in it ia t i o n
72 Hours
7 Days
14 Day
F20347
F20333 F20344
NEG
POS (40%)
NEG
NEG
NEG NEG NEG NEG NEG * * *
NEG = No stain retention POS = Positive stain retention (area of cornea involved).
* A n i m a l found de a d at 7 2 - h o u r o b s e r v a t i o n .
000552
( H A Z U |T G N LABORATORIES AM ERICA, INC.
Chemical & BioMedica! Sciences Division
3301 KIN SM AN BLVD. P.O. BOX 7545 MADISON, W ISCONSIN 53707 PH O N E (608) 241-4471 TLX 703956 HAZR AL M DS UD
SAMPLE NUMBER: ?0905764 SAMPLE: T-4102
PAGE ?
OECD EVE IRRITATION
(CONTINUED)
Comment s :
A p a i n r e s p o n s e (ex c e s s i v e p a w i n g at the tr e a t e d eye) was e l i c i t e d from two animals immediately following instillation of the test material.
B l a n c h i n g of the c o n j u n c t ivae w a s s e e n in all t h r e e a n i m a l s at 1, 24, a n d 48 h o u r s , a n d in the r e m a i n i n g two a n i m a l s at 72 h o u r s .
P e t i t e h e m o r r h a g i n g of the c o n j u n c t i v a s w a s s e e n in two a n i m a l s at 48 hours.
Corneal epith e l i a l peeling was e x h i b i t e d by two anim a l s at 1 hour, by all three a n i m a l s at 24 hour s , by two a n i m a l s at 48 h o u r s , and by one animal at 72 and 96 hours.
A n i m a l No. F 2 0 3 4 4 wa s f o u n d d e a d on S t u d y D a y 3. The g r o s s n e c r o p s y revealed no visible lesions.
Re ferences:
1. O r g a n i s a t i o n for E c o n o m i c C o o p e r a t i o n a n d D e v e l o p m e n t ' s G u i d e l i n e s for Testing of Chemicals, Section 405, Acute Eye Irritt i o n/Co r r o s i o n ; a d o p t e d May 12, 1981.
2. D r a i z e J . H . , " A p p r a i s a l of the S a f e t y of C h e m i c a l s in F o o d s , D r u g s , and Cosmetics - Dermal Toxicity", Association of Food and Drug Officials of the United States, p p . 46-59 (1975).
3. 40 C F R 792.
4. N I H P u b l i c a t i o n No. 8 6 - 2 3 ( R e v i s e d 1 98 5).
Personnel Signature Sheet Acute Toxicology
HLA No.
Name
Job Title
Signature
Becky Beckwith
Sr. Lab. Animal Asst.
Steve Beloungy
Lab. Animal Asst.
Ken Bridges Pat Crary
Sr. Lab. Animal Asst. Sr. Lab. Animal Asst.
Shane E1th
Lab Animal Asst.
Shawn Frazier
Lab Animal Asst.
Steven N. Slaza
Group Leader
Nolly Hahn
Admin. Clerk
Kevin Hamilton
Lab. Animal Asst.
Jeff Hicks
Sr. Lab. Animal Asst.
Calvin Horton
Group Leader
Sharen L. Howery Administrative Asst.
6regory Johnson
Lab. Animal Tech.
Paul Krebs
Lab. Animal Asst.
Wayne Null son
Section Supervisor
Scott NcConnell
Lab. Animal Tech.
Shelley NcConnell Dawn Conant
Lab. Animal Tech. Sr. Lab. Animal Asst.
Don Navis
Lab. Animal Asst.
Robin Olson
Lab. Animal Asst.
Patricia Padgham Joseph J. Daun
Team Leader Lab. Animal Asst.
Nlchael Patzka
Lab. Animal Asst.
John Paulson
Sr. Lab.' Animal Asst.
Jane Polnow
Lab. Animal Tech.
Dennis B. Steiner Lab. Animal Tech.
Nlchael Theslng
Lab. Animal Asst.
Paula 6. Vangen
Administrative Asst.
Albert Olson
Manpower
Jim Jirschele
LTE
Ben Haley
Sr. Lab Animal Asst.
Eileen M. McConnell Admin. Clerk
Annette R. Turner Manpower
000554
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Initials
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BODY WElGHT/u^E RECORD
hla: IcF in S l^
Study title: Primary Eye Irritation_______
Test material : ~ T - 4 102.
Physical description:
Aknrcq. l-t o u t ^
pH result: 9.) w ith Hanna lleter No. 6890
Dose:o.> ml/ oft g ( i a iSTegulvalent)
^-'dosed with a 1-mL disposable syringe/ ioft each dose individually drawn up with a lOft-ul Hamilton Syringe
Date animals received:
______________
Species/strain: Rabbit/New Zealand W h i t e __________
Source: Hazleton Research Products, Inc.____________
Room Ho:
IQI -_________________________________
Review of folder preparation by: ! i Date: //'6 %7
8EST COPY AVAILABLE
Pain Response
Initial Following
Animal Body Weights (g)
All animals appeared normal
Animal No. Group Sex SF*
Dosing
Initiation Day 7 Day 14 Day 21 just prior to dosing.
------------------------------------- 1---------------------------------------------------- ---------------------------------------------- -----------------------Tv----
fRTTeocrhhnniicriian: \y Q
lDlaatteo:
DM l
1?
AAul
* - Sodium fluorescein examination.
P3 03 3 3
1 ? /OEk E
2 ISA
3 lu
NEG - Negative.
O
O O c/i en
! 4o MEG P
aenu
PoufoiG>eaQ 1tif is i i?v
Kt
POS NA
-
Positive. Not applicable.
U - Unable to determine pH.
V - Vocalization.
E - Excessive pawing of treated eye.
N - None
on
KlA Dosed directly on the cornea. The eyelids were released
Immediately without forced blinking or manipulation.
Technician
j7/ J t/
kM/
/
u
V
),
K
f$ Sf>
Hate ______ m i //3' / / '5 . " L
i u i n li/x>
Scale Used
K-dtoid *501^ M iSft
Surviving animals designated for sacrifice and discard. Technician ft
Dosed in the conjunctival sac.
t The upper and lower lids were
gently held together for one second.
Time of dosing: Q'-Sf)
Technician Kft/zr.V Date: n/fr/M~>
Time of first observation: i '.3b Pft Technician: /V? Date: it/fo/i
Date
Reviewed by:_________ __________ (00261/vmt)
Date:
Hu: im n s i ( * 4
PRIMARY EYE IRRITATION TEST OBSERVATIONS
Group:______[_____
_______
Test material : -f - 4 l > ______________________________
Test eve: Right
ilftWashed:^
seconds following Instillation of test, material, the test eye was washed with o A mL of lukewarm tap water forO A seconds.
^ Unwashed
Animal No. Location of corneal lesions
Ta11 ---- Head
Cornea - Ooadtv
Area
Iris
Conjunctivae Redness
Chemosis
Observation Period: / h o U l T
-A3<n
\
w Cs)o ()T-Sc%
Oi
\O 1
I 1 I1
I1
\\3 s 3 s O 6
\ \
5 33
Olscharae
2 e-
3 e- __ 3
\
Sodium fluorescein exam N A
Technician:____Sc6 ) jW *
Oate: _____-'.J S . 7 ___
(OA i _ A
M oEYE IRRITATION SCORE:.
Calculatedd By: J & lK Date
Verified By: W
Date //-13~$ 1
NA - Not applicable. A - Petite hemorrhaging. B - Blanching. C - Clear discharge. D - Purulent discharge.
E - Hair loss around the eye.
F - Necrotic areas. G - Unable to visualize due to
severe swelling. H - No reaction to light. I - Injected.
J - Corneal epithelial damage, peeling. K - Corneal epithelial damage, piling. L - Corneal epithelial damage, pitting. M - Hypopyon. N - Corneal neovascularization.
P - Pannus.
R - Unable to visualize due to severe opacity.
S - Granulation scar tissue. POS - Positive stain retention. NEG - Negative stain retention.
Reviewed by: ( 00 2 61 /vmt)
rP
Date: 3. S' ? ^
G0556
HU: I m n F n t n il
PRIMARY EYE IRRITATION TEST OBSERVATIONS
Group:______[_____
Test material: T Test eve: Right
_______ ______________________________
llftWashed:O A seconds following Instillation of test, material, the test eye was washed w1th Oft mL of lukewarm
tap water f o r O A seconds.
i x X jnwashed
Animal No. Location of corneal lesions
Tall ---- Head
VObservation Period: 3 ^ f)O u rS
vgjn
(X)o
o
Cornea - Ooacitv
f //
Iris
Area
.05
/. ?
cQ
/ 'jr
0 / _r
\
Conjunctivae Redness
Chemosis
OA
a3
Dlscharoe
1 OJ <0 D
Sodium fluorescein exam m ____
3
Of\ J U B ____
\\ \ \
Techn1c1an:____
Date:_______ t h 7 ' 6 7
EYE IRRITATION SCORE:
Calculated Bv: S M JU Date
Verified Bv:
Date '/T7
NA - Not applicable. A - Petite hemorrhaging. B - Blanching.
C - Clear discharge. 0 - Purulent discharge.
E - Hair loss around the eye. F - Necrotic areas. G - Unable to visualize due to
severe swelling. H - No reaction to light.
1 - Injected.
J - Corneal epithelial damage, peeling. K - Corneal epithelial damage, piling. L - Corneal epithelial damage, pitting. M - Hypopyon. N - Corneal neovascularization.
P - Pannus. R - Unable to visualize due to
severe opacity. S - Granulation scar tissue. POS - Positive stain retention. NEG - Negative stain retention.
Reviewed by: ( 0 0 2 6 1 /vmt)
nd
Date: 13-
>557
HLA _ J t 3 D E J i A
PRIMARY EYE IRRITATION TEST OBSERVATIONS
Group:______j_____
__ _______
Test material: ^ . <-ll)L
______________________________
Test eve: Right
ilflWashed:iA seconds following Instillation of test, material, the test eye was washed w1th oft ml of lukewarm
tap water foro A seconds.
( ^ Unwashed
Animal No. Location of corneal lesions
Tall ---- Head
Cornea - Ooadtv
Area
Iris
Conjunctivae Redness
Chemosis
Dlscharae
Observation Period: ^ K . h u r S
\
jifN
00o oV / j
\3 \ix
I 1
o
o
-> u t z
\\3z 1
V
\| \
1 3e
Sodium fluorescein exam h ____
Ai A
Technician:. Date:______
EYE IlR\ IRUITI MATUIUOIN1 SCORE: . Z I . S
_____________
Calculated By:
Date l.t-tf -^<1
Verified Bvy: t f ' Date U'\7)"<R1
NA - Not applicable. A - Petite hemorrhaging. B - Blanching. C - Clear discharge.
D - Purulent discharge.
E - Hair loss around the eye. F - Necrotic areas. G - Unable to visualize due to
severe swelling.
H - No reaction to light. I - Injected.
J - Corneal epithelial damage, peeling. K - Corneal epithelial damage, piling. L - Corneal epithelial damage, pitting. M - Hypopyon. N - Corneal neovascularization.
P - Pannus. R - Unable to visualize due to
severe opacity. S - Granulation scar tissue. POS - Positive stain retention. NEG - Negative stain retention.
Reviewed by: ( 00261/vmt)
________ Date
37
HU: I f f in K lt n li
Group:______j___
Test material: f
Test eve: Right
PRIMARY EYE IRRITATION TEST OBSERVATIONS
____
______________________________
nftWashed:fOft seconds following Instillation of test, material, the test eye was washed w1th oft mL of lukewarm
tap water foro A seconds.
Unwashed
Animal No. Location of
corneal lesions
Tall ---- Head
Cornea - Opacity
^ 1
Area
<0
Iris
Conjunctivae Redness
Chemosis
5* <3
Discharge
Sodium fluorescein exam
Technician: ( jTVV<-
Oate:
JlrftSI
NA - Not applicable. A - Petite hemorrhaging.
B - Blanching.
C - Clear discharge. D - Purulent discharge.
E - Hair loss around the eye. F - Necrotic areas. G - Unable to visualize due to
severe swelling.
H - No reaction to light. I - Injected.
Hn\C\)o ()
o ___ Aifl
c>
7>
1
p
N/
EYE IRRITATION SCORE Calculated By: Verified By:_
\
\l
\\ \
L_A
M jtU frhU A O .
J - Corneal epithelial damage, peeling. K - Corneal epithelial damage, piling. L - Corneal epithelial damage, pitting. M - Hypopyon. N - Corneal neovascularization.
P - Pannus. R - Unable to visualize due to
severe opacity. S - Granulation scar tissue. POS - Positive stain retention. NEG - Negative stain retention.
Reviewed by: (00261/vmt)
Date:
3559
HU: I M n S lt o lJ
PRIMARY EYE IRRITATION TEST OBSERVATIONS
Group :______\_____
Test material : -1" . <-l
Test eye: Right
_______ ______________________________
llflWashed :
seconds following Instillation of test, material, the test eye was washed w1th O A mL of lukewarm
tap water forM A seconds.
^ Unwashed
Animal No. Location of corneal lesions
Tall ---- Head
Cornea - ODadtv
Area
Iris
(#)2-<33<n o>
1 ao
Conjunctivae Redness
Chemosis
Dlscharqe
11 o1 oo
Sodium fluorescein exam
\(X)o o
N>ft
\\ \
\
\
/\
Technician:. Date:______
r/9 Ma
ll-lo -% 7
EYE IRRITATION SCORE:.
( 2 - Q tVW^
Calculated By:__ Sv* Oate i I '! * '
Verified By:____ ~777~ Date //-/3-fr
NA - Not applicable. A - Petite hemorrhaging. B - Blanching. C - Clear discharge. 0 - Purulent discharge.
E - Hair loss around the eye. F - Necrotic areas. G - Unable to visualize due to
severe swelling. H - No reaction to light.
1 - Injected.
0 - Corneal epithelial damage, peeling. K - Corneal epithelial damage, piling. L - Corneal epithelial damage, pitting. M - Hypopyon. N - Corneal neovascularization.
P - Pannus. R - Unable to visualize due to
severe opacity. S - Granulation scar tissue. POS - Positive stain retention. NEG - Negative stain retention.
Reviewed by:
(00261/vmt)
000560
HU: 1 m n S lt f ill
PRIMARY EYE IRRITATION TEST OBSERVATIONS
Group:______|_____
_______
Test material: T - 4 1 0 3 . ______________________________
Test eve: Right
ilflWashed:
seconds following Instillation of test, material, the test eye was washed w1th lift mL of lukewarm
tap water for o A seconds.
^ Unwashed
Animal No. Location of corneal lesions
Tall ---- Head
n H <ws>o ()
Cornea - Ooacltv Area
Iris
00 00 0
\ \
Conjunctivae Redness
Chemosis
\
0
Dlscharae
0
Sodium fluorescein exam .
Technician: Date:
it 4a
nV
0\
0 >/
\ L_A
EYE IRRITATION SCORE:
Calculated By:__ ~ L oate. J t i h X 1
Verified By:____C h Date
NA - Not applicable. A - Petite hemorrhaging. B - Blanching. C - Clear discharge. 0 - Purulent discharge.
E - Hair loss around the eye. F - Necrotic areas. G - Unable to visualize due to
severe swelling. H - No reaction to light.
1 - Injected.
J - Corneal epithelial damage. peeling. K - Corneal epithelial damage, piling. L - Corneal epithelial damage, pitting. M - Hypopyon. N - Corneal neovascularization.
P - Pannus. R - Unable to visualize due to
severe opacity. S - Granulation scar tissue. POS - Positive stain retention. NEG - Negative stain retention.
Reviewed by:. (00261/vmt)
/ r ? Date: /3- ~8 ~8 'J
000561
HLA: i m O S l k d
PRIMARY EYE IRRITATION TEST OBSERVATIONS
Group:______j_____
_______
Test material: f . 4 l > a ______________________________
Test eve: Right
nftWashed: ^ seconds following Instillation of test, material, the test eye was washed with kift mL of lukewarm
tap water forxjA seconds.
^ Unwashed
Animal No. Location of corneal lesions
Tall ---- Head
nn
o or-- T
Cornea - Ooadtv
O
Area
O
Iris
0
Conjunctivae Redness
0
Chemosis
0
Dlscharoe
0
Sodium fluorescein exam .N W
Technician:. Date:______
a
O N ft O
0 0 0 M 6k
\/
\\\\
EYE IRRITATION S C O R E : __________________
Calculated By:
Date n
Verified By: /K? Date
NA - Not applicable. A - Petite hemorrhaging. B - Blanching. C - Clear discharge. D - Purulent discharge.
E - Hair loss around the eye. F - Necrotic areas. G - Unable to visualize due to
severe swelling. H - No reaction to light.
I - Injected.
J - Corneal epithelial damage, peeling. K - Corneal epithelial damage, piling. L - Corneal epithelial damage, pitting. M - Hypopyon. N - Cornea] neovascularization.
P - Pannus. R - Unable to visualize due to
severe opacity. S - Granulation scar tissue. POS - Positive stain retention.
NEG - Negative stain retention.
Reviewed by: !nn?fil /vnvM
H Y ^ ______ Date:
000562
BEST COPY AVAILABLE
HLA:
SCALE FR SCORING OCULAR LESIONS (DRAIZE' TECHNIQUE)
(1) Cornea
(A) Opacity - degree of density (area most dense taken for reading)
No opacity _____________ ;_______________________________________________________ _ Scattered or diffuse area, details of iris clearly v i s i b l e __________________________ Easily discernible translucent areas, details of iris slightly obscured Opalescent areas, no details of iris visible, size of pupil barely discernible Opaque, iris invisible____________________________________________________________ _
0 1*
2* 3* 4*
(ti) Area of cornea involved
One quarter (or less), but not zero
_______________________________________________
Greater than one-quarter, but less than half
~
Greater tnan half, but less than three-quarters______________________ _____________________
Greater tnan three-quarters, up to whole area______________________________________________
1 2 3 4
AxBx5
Total maximum 80
U ) Iris
(A) Values
Normal
________________________ _________________________ ^ _________ ______________
Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or
combination of any thereof) iris still reacting to light (sluggish reaction is positive
0 1*
No reaction to light, hetaorrhage, gross destruction (any or all of these)
2*
Ax5
Total maximum * 10
(3) Conjunctivae
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
Vessels normal
________________________________________________________________________
Vessels definitely injected above normal
More diffuse, deeper crimson red, individual vessels not easily discernible
Diffuse beefy red___________________________________________________________________________
0 1 2* 3*
(B) Chemosis
No swelling
______ _____ __________________________________
Any swelling above normal (includes nictitating membrane)
Obvious swelling with partial eversion of lids_____________________________________________
Swelling with lids about half closed________ ______________________________________________
Swelling with lios aDout half closed to completely closed
0 1 2*
3* 4*
1C) Uischarge
Ho discharge
______ _____________________ __________ __ _____________
Any amount different from normal (does not include small amounts observed in inner
cantnus of normal animals)
________ ____ ________________
Uiscnarge witn moistening of the lids and hairs just adjacent to lids
Uischarge with hoistening of the lids and hairs, and considerable area around the eye
0 1
2 3
Score (A + B + 0) x 2
Total maximum * 20
The total score for the eye is the sum of all scores obtained for the cornea, iris, and conjunctivae.
* Indicates positive effect. (FHSA Interpretation)
1 uraize, J. H., "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics - Dermal Toxicity", Association of Food and Drug Officials of the United States, pp. 46-59 (1975).
(00261/vmt)
000563
