Document 0qbaKz4gnbLX78BY6X54ryOok
HAZLETON
la bo ra to ries AMERCA. sic.
3301 KINSMAN BLVO.. P.0. BOX 7545 MADISON, Wl 53707 USA
FINAL REPORT
Karen Armstrong 3M Toxicology Services Building 220-2E-02 St. Paul, MN 55144-1000
Sample: T-4415
CO IV, HLA Number: 91201741
Enclosed: Primary Eye Irritation/Corrosion Study in Rabbits (OECD Guidelines)
o Key Personnel o Methodology o Summary of Results o References o Raw Data Appendix
Signed
V
Steven M. Glaza Study Director Acute Toxicology
-- i?. Date
PHONE (608) 241-4471
FAC SIM ILE (608) 241-7227 T ELE X TLX 703956 HAZRAL M D S UD
O O A ftt N Q Laboratory Sorw ioaa C om pany
HAZLETON
l_ABORATOES AMEFCA.rvlC.
3301 KINSMAN BLVD.. P.O. BOX7545
MADISON. Wl 53707 USA
HLA Number: 91201741 Sample: T-4416
Acute Toxicology Steven M. Glaza Study Director Section Supervisor Steven R. Sorenson Study Coordinator Patricia Padgham Group Leader Sharen L. Howery Report Coordinator
Page 2
KEY PERSONNEL Quality Assurance Deborah L. Keller Manager Laboratory Animal Veteri narian Cindy J. Cary, DVM Dipl ornate, ACLAM
PHONE (608) 241-4471 FACSIM ILE (608) 241-7227 T ELEX TLX 703956 HAZRAL M D S UD
HAZLETON
LABORATORIES AMEBCA. MC.
3301 KINSMAN BLVD., P.O. BOX 7545 MADISON. Wl 53707 USA
HLA Number: 91201741
Sample: T-4416
Page 3
METHODOLOGY
Objective: To assess the relative level of ocular irritation/corrosion produced following a single exposure of a test substance to one eye of albino rabbits according to the Organisation for Economic Cooperation and Development's Guidelines for Testing Chemicals.
Test Material : T-4416 Physical Description: Purity and Stability:
Storage and Retention:
Safety Precautions:
Clear colorless liquid Sponsor assumes responsibility for purity and stability determinations (including under test
conditions). The test material was stored at room temperature.
Any unused material will be returned to Sponsor according to HLA Standard Operating Procedure. Normal handling procedures were used according to
HLA Standard Operating Procedure.
Test Animal: Adult albino rabbits, Hra:(NZW)SPF, were procured, maintained individually in screen-bottom cages in temperature- and humidity-controlled quarters, provided access to water ad libitum and a measured amount of High Fiber Rabbit Chow 5326, Purina Mills, Inc., and held for an acclimation period of at least 7 days. Animal husbandry and housing at HLA comply with
standards outlined in the "Guide for the Care and Use of Laboratory Animals".2 If variations from the prescribed environmental conditions existed, they were documented and considered to have no effect on the study
outcome. No contaminants were expected to have been present in the feed or water which would have interfered with or affected the results of the study.
One male and two female acclimated animals, weighing from 2148 to 2500 g, were chosen at random for the test. The animals' eyes were examined within 24 hours prior to test material administration using sodium fluorescein dye procedures. Only those animals with no sign of ocular injury or irritation were used. Test animals were identified by animal number and corresponding ear tag.
Reason for Species Selection: Historically, the New Zealand White albino rabbit 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 determined to be 9.9.
PH O NE (608) 241-4471 FACSIM ILE (608) 241-7227 T ELE X TLX 703956 HAZRAL M D S UD
0 0 **N W Q Laboratory So n n c aa C om pany
HAZLETON
la b o h a to r c s a m e r c a , rgc.
3301 KINSMAN BLVD., P.O. BOX 7545 MADISON, Wl S3707 USA
HLA Number: 91201741
Sample: T-4416
Page 4
Treatment- Each rabbit received 0.1 mL of the 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 together for 1 second to prevent loss of material and then released. The eyes of the rabbits remained unflushed.
Reason for Route of Administration: Historically, the ocular route is the route of choice based on the method of Draize.
Observations: The treated eyes were observed for ocular irritation at 1, 24, 48, 72 and 96 hours, and Days 7, 14 and 21 after treatment.
At the 24- and 72-hour, and 7-, 14- and 21-day readings, sodium fluorescein was used to aid in revealing possible corneal injury. Irritation was graded and scored according to the Draize technique.
Animals were weighed just prior to test material administration and at weekly intervals throughout the study.
Termination: At termination of the experimental phase, all animals were euthanatized and discarded.
Statistical Methods: No statistical method was performed.
Location of Raw Data and Final Report: The raw data and a copy of the final report will be retained in the archives of HLA.
PHONE (608) 241-4471 FACSIM ILE (608) 241-7227 T ELEX TLX 703956 HAZRAL M D S UD
O O X N n O L a M n w y Som e! Com pany
HAZLETON
LABORATOFIES AMERICA.MC.
3301 KINSMAN BlVD., P.0. BOX 7545 MADISON, Wl 53707 USA
HLA Number: 91201741
Sample: T-4416
Page 5
SUMMARY OF RESULTS
Test Animal: Albino Rabbits - Hra:(NZW)SPF Source: Hazleton Research Products, Inc., Denver PA
Date Animals Received: 12/19/89
Start Date (In-life): 01/10/90
End Date (In-Life): 01/31/90
Average Primary Eye Irritation Scores*
Observation Period
1 Hour 24 Hour 48 Hour 72 Hour 96 Hour Day 7 Day 14 Day 21
Average Score
41.0 49.0 36.0 38.3 34.3 16.0
6.0 0.0
* The average primary eye irritation score is the total eye irritation score for all the animals divided by the number of animals (3) at each
observation period.
PHONE (608) 241-4471 FACSIM ILE (608) 241-7227 TELEX TLX 703956 HAZRAL M D S UD
a O O W N W O Laboratory S o w c w Com pany
HAZLETON
la bo ra to ries a m efc a . i\ ic.
3301 KINSMAN BLVD., P.O. BOX 7545 MADISON. Wl 53707 USA
HLA Number: 91201741
Sample: T-4416
Page 6
Animal Number F31165
F31127
Observation Period
1 Hour 24 Hour 48 Hour 72 Hour 96 Hour Day 7 Day 14 Day 21
1 Hour 24 Hour 48 Hour 72 Hour 96 Hour Day 7 Day 14 Day 21
Table 1 Individual Eye Irritation Scores
Cornea AB
Score AXBX5
Iris A
Score AX5
14 14 13 14 13 21 00
00
20
20
15 20 15 10
0
0
1
1 1 1 1 0 0
0
5
5
5 5 5 0 0
0
14 14
14 14 14
11 11 00
20 20
20 20 20
5 5 0
1 1
1 1 1
1 1 0
5 5
5 5 5
5 5 0
Con iunct'ivae
AB
23 33
32 32 32 21 10 00
3 3
2 2 1 0 0 0
23 33
32 32 32
21 21 00
3 3
1 2 2 0 0 0
Score iA+B+C12
16 18 14 14 12 6 2 0
16 18 12 14 14
6 6 0
F31194
1 Hour 24 Hour 48 Hour 72 Hour
96 Hour Day 7 Day 14 Day 21
14 24 14 14
13 12 00 00
20 40
20 20
15 10 0 0
1 1
1 1
1 0 0 0
5
23
3
16
5
33
2
16
5
32
1
12
5
32
1
12
5
32
1
12
0
21
0
6
0
00
0
0
0
00
0
0
Cornea A - Degree of opacity B - Area of involvement
Conjunctivae A - Redness B - Chemosis
C - Discharge
PHONE (606) 241-4471 FACSIM ILE (608) 241-7227 T ELE X TLX 703956 HAZRAL M D S UD
O O R N IN O Laboratory Sa n n caa C om pany
HAZLETON
LABORATORIES AMERCA.SC
3301 KINSMAN BtVD., P.O. BOX 7545 MADISON, Wl 53707 USA
HLA Number: 91201741
Sample: T-4416
Page 7
Table 2 Sodium Fluorescein Examination
Animal Number
F31165 F31127 F31194
Pre-initiation
NEG NEG NEG
Observation Period
24 Hour
72 Hour
Pay 7
POS (80%) POS (55%) POS (15%)
POS (100%) POS (80%) POS (5%)
POS (75%) POS (80%)
NEG
Dav 14
NEG POS (5%)
NEG
Dav 21
NEG NtG NEG
NEG - No stain retention POS - Positive stain retention (area of cornea involved)
Comments:
A pain response (excessive pawing of the treated eye) was elicited in all three animals following instillation of the test material.
Blanching of the conjunctivae was observed in all three animals at 1, 24, 48, 72 and 96 hours, and Day 7.
Petite hemorrhaging of the conjunctivae was observed in two animals at 24 hours.
Corneal epithelial peeling was seen in all three animals at 24, 48, 72 and 96 hours, in two animals at Day 7, and in one animal at Day 14.
REFERENCES
1. "Acute Eye Irritation/Corrosion," Organisation for Economic Cooperation and Development's Guidelines for Testing of Chemicals, Section 405 (adopted May 12, 1981).
2. NIH Publication No. 86-23 (revised 1985).
3. Draize, J. H., "Eye Mucosa," In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics - Dermal Toxicity, Association of Food and Drug Officials of the U.S., pp. 49-50 (1975).
PHONE (608) 241-4471 FACSIM ILE (608) 241-7227 TELEX TLX 703956 HAZ RAL M D S UD
OORNiMOIftborttorySmrificmCompany
iila: qia^nii
PERSOIINEL SIGNATURE SHEET ACUTE TOXICOLOGY
Name
Job T i t l e
Signature
Initials
Becky Beckwi th
Lab Animal Technician
Ann Bursaw
Sr. Clerk
Anthony Cass
Lab Animal As sistant
Cindy J. Cary, DVM Lab Animal Veterinarian
C o-h >l 0 C u liA \ .(jlAL1
ac
Kari Gassen
Sr. Lab Animal A ss is ta n t K o A j / V A oulAC rx _ IC -j
Steven M. Glaza ' Section Supervisor
Ben Haley
Sr. Lab Animal A ssi sta n t S D S L
mL
Jeff Hicks
Lab Animal Technician
/7 ,/ r
K
.77-/
Sharen L. Howery Researcii As sistant
y YltlAltkM-ci rillUVl
Jim Jirschele Wayne Madison
Lab Animal Assi sta nt
(/ i/
Senior Section Supervisor < ( >>r &
(1. </v
<.j
Bud McDonald
Sr. Lab Animal Assi sta nt
Eileen McConnell Administrative Clerk
Dn-'V- f l jJ-r'L-7r'xy
Henry Mikula
Lab Animal As sistant
Albert Oleson
Sr. Lab Animal Assi sta nt r M iiQ j , . *
AO
Patricia Padgham Jane Pol now
Group Leader Lab Animal Technician
iti
Steven R-. Sorenson Study Coordinator
. / C.-- .-- ^
K7
Dawn Thieding Annette R. Turner
Cl erk Sr. Clerk
y / r^/"*'(>''4-rn/iuro
Aeriti A h l
loT K
120
'tiOX .^ttL y-
(09/11/89)
ECDY W E I u HT/LKJSE r e c o r d
H'-a : q i a n n m
S "j l1v t i1 1- Primary Eve I r ritation
72-*^iM-'W'i*is-r*i*Wa'!:^_p_--__^iJiLUe.
rnvs i=31 ''rr'3: TlF^P Cftt^Pt.py.
pH result
Q q ___ with CORNING pri METER NO. OSn 10
Css?: Q.
^ lno l
1ly
o sa b 1e S v r in n e / ^ ^ e a c h cose
up with a
hair. 1 Iton Syr inge
D a t e a n i m a l s r e c e i v e d : _ ____j__i_ii ak i
S p ^ c i e s / s t r a i r . : Kabb i s/he'
i a n c wr, 11
S o u r c e : H a r i e t o n Research Prcouct: Inc.
Room M o :
M //t.L
Review of folder preuaration b y :
__Uate:j/w_y_5_
Initial
Pain Response Following
1 ,, * iA-in*i>nr>an 1
A 1 1 a m u Is appeared n o m a 1
just, pr ior to Technician:
cSofos inc.
Mate:
i/ioRp
- S o d i u n fluorescein exam ina t ior..
ii[G - n e g a t i v e .
POS - Positive. HA - Mot app Iicabic. U - U n a b l e to determine pH. V - Voca 1irat len . r - E x c e s s i v e pawing of treated eye.
M - Mone .Jft C o s e d d i r e c t l y cn the cornea.
-- The eyelids were released 1n r e d i a t e l y without forced blinking cr nan ipulaticn.
.Dosed in the conjunctival sac. The upper and luwer lids were gently held together lor one
secund .
Tire Tech
of nic
i
da an
s
i
n
ga:K_
l
T
?-.SQ*v\ ^ d L e -.
--fioiTP-
ire of first n'-servat :cn : |rSr>M'_
T e chnician : A S _______ M a 1- '[inlRt?-
S ur vi vi ng ani nai s desi gnated f o r s a c r i f i c e and d i s c a r d . Tecr.ni ctan
Reviewed b y : _ _________________ ^ ~ |
(C0Z5 1/vmt)
D a t e . -- 2?w ~~
-----
=} Cita ( - & - 9 Q
>iVuajsoxinately 5 minutes prior to^test
m aterTai^dQ jni s t r a t i on
drops
of proparacaTne~'fb-5-i
Lot S
) was
eye(s) or each rabbit.
Tprhnician
Date
HLA: q ia o rw i
PRIMARY EYE IRRITATION TEST OBSERVATIONS
Group :______ !______________ Test material:, T- M<4lU
Test eve: Right
rift
Washed
:_n& .
seconds following Instillation the test eye was washed wi th
of test material, mL of lukewarm
tap water tor ne seconds.
i^-Unwashed
Location of corneal lesions
Tall ---- Head
rnr n oa 0nar 1fv
OUlbservdat1i'Io'!n Preeiriluoud,: 1
11 U S
\l i a i 115*4,--
-- y 'v--
1 <S> C ) (J.
11
)
Iris
Area
c/ l1 I1
4 i*
Conjunctivae Redness
Chemos1s
01scharqe
Sodium fluorescein exam
3
____
Technician:
Date :______
`h o h *
HA - 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.
2 Z6
33
2 e-
Oft' O A
EYE IRRITATION SCORE: m e * _____________ Calculated By:_____ =). Date Verified By:______ A#. Date '/2-)lTO
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:
Date:
tB O
HLA: g i a o r W l PRIMARY EYE IRRITATION TEST OBSERVATIONS
Group :______ !______________
Test material : T- M M IU
Test eve: Right
_2l_Washed:_tl seconds following Instillation of test material, the test eye was washed wi th j<s mL of lukewarm tap water torus seconds.
t ^ nwashed
Location of corneal lesions
Ta __ _ Head
rnrnpa Dnar1fv
_______ ^rvtu !uI rci
nus
W !^)
J - cT'te J - lOC-lp
11
2
W $
-- lcc--
C) o
Area
Iris
Conjunctivae Rednes s
4 l*
^e>
<-4 i*- P --
36
\
Chemos1s
A
D1scharqe
2>c
Sodium fluorescein exam
Technician:,
Date: ____ I - I I - V O
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 swe111ng. H - No reaction to light. I - Injected.
pnsicci?
EYE IRRITATION SCOREt^ V ^ OQ.O
Calculated By:
Date^
Verified By:_____ Date
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.
(-(/ ( & C A U U L ULATIOjJ & UIC.A . K=1
Reviewed by:
Date:
LA: qiaon
PRIMARY EYE IRRITATION TEST OBSERVATIONS
Group:______ [____________________ _ Test material: T- M M IU____________________ _____________________ Test eve: Right
Washed:
seconds following instillation of test material, the test eye was washed with jo, ml of lukewarm
tap water torft seconds.
_J;rl)nwashed
Animal No. Location of corneal lesions
Tall - Head
rnrnpa - ODacltv
Area
Iris
_______ OHi,bservatuiM.o-In Period;
W L S nan iiqg
nk
/
J /*
WA
t*
/
i /J
^0)
/ 7 /T
Q
x ____
\
Conjunctlvae Redness
K
J*
Chemos1s
.7 J
D1scharqe
/c /
Sodium fluorescein exam 4 ___ A//}
AJ/!
Technician:________^~7-/____________ Date :____________ -?Q
EYE IRRITATION SCORE: / V n m _______________
Calculated By:
Date
Verified By:_______4A 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 - 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:
Date: y -- 5 - ^ O
.U: qiaoruU
PRIMARY EYE IRRITATION TEST OBSERVATIONS
Group :______1 _________ Test material : T - M M IU Test eve: Right
,1ft Washed :
seconds following Instillation of test material, the Lest eye was washed with mL of lukewarm
tap water torna seconds.
t^-Unwashed
U] re 1vu - .
Location of corneal lesions
Tail ____ Head
HUS
nan
ri V Pp/
_r-a Z
1
!
w
j: W ? * $ /
--y -- () Q
Area
y i ./
Iris
/r / r / J
Conjunctivae Redness
CMemos 1s
D 1scharqe
v7*
, ?* .
J- J-
-2 <L
J*
/C
^ ______ \
\
Sodium fluorescein exam P c 'S S'Z P k f & / c
\
Technician: Date: ____
7/ / /S-fC'
EYE IRRITATION SCORE: Calculated By:_ Verified By:__
.A Date 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 swe111ng.
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:
r - . Date: - 5 - ^ 0
LA-, q \ a o n * PRIMARY EYE IRRITATION TEST OBSERVATIONS
Group :______ !_____________ Test material : T- M<4 IU
Test eve: Right
Washed:
seconds following instillation of test material
the test eye was washed with
roL of 1ukewa rm
^ Unwashed
tap water tor hcx seconds.
Anlmi 1 Nfl. Location of corneal lesions
(si)(jfP(w ( ) QL'!NPrvrtiiui
nus
n a n iiqd
-X -
Tail _ -- Head
j - Z U _i -T5 7. J ;
rnrnp,i - flnar 11v
( //
Area
-3 H
Iris
Conjunct 1vae Rednes s
Chemos1s
01 scharqe
1^
Sodium fluorescein exam /viA-
1*
aja
/* 3 Afl 2-
Kj A
\\ \\ ------
Techniclan:_____ A -
Oate:_______ i-lU- - ^hTJ
NA - Not applicable. A - Petite hemorrhaging. B - Blanching. C - Clear discharge. Q - Purulent discharge. E - Hair loss around the eye. F - Necrotic areas. G - Unable to visualize due to
severe swel1ing. H - No reaction to light. I - Injected.
EYE IRRITATION SCORE:
_______________
Calculated Bv:
ic=n Date
Verified By:______ /IP Date
Corneal epithelial damage, peeling. Corneal epithelial damage, piling. Corneal epithelial damage, pitting.
Hypopyon. Corneal neovascularization.
Pannus. Unable to visualize due to
severe opacity. S - Granulation scar tissue. POS - Positive stain retention. NEG - Negative stain retention.
Reviewed by:_
Date : /C
LA: q \ a o n 4 1
PRIMARY EYE IRRITATION TEST OBSERVATIONS
Group:______ ^ _____________ -_____ Test material : T- M<4 IU ---------------------------------------Test eve: Right
W a s h e d : h r seconds following instillation of test material, the test eye was washed with mL of lukewarm tap water torna seconds.
_ fc;=tJnwashed
An 1mA 1 Nn . Location of corneal lesions
Tail
- Head
r n m p ,i - Onac 1tv
_L!J va 1M-M rci
nus v /
ubi
V^ )
j r S'Jv
\
C) Q-- ^ -^r--
\ ______
Area
Iris Conjunct 1vae -
Redness Chemos1s
D1scharqe
I1
0 1 X-
Il a
Is I
11
oOo
Sodium fluorescein exam
K--)
Technician: Date: _____
- n -*>>
EYE IRRITATION SCORE: l U . ^ ___________
Calculated Bv : s ^ Date x-il-A'Q
Verified Bv:
A Date /sigo
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.
- Corneal epithelial damage, peeling.
- Corneal epithelial damage, piling.
- Corneal epithelial damage, pitting.
- Hypopyon. - Corneal neovascularization.
- Pannus. - Unable to visualize due to
severe opacity. S - Granulation scar tissue. POS Positive stain retention. NEG Negative stain retention.
Reviewed by:
Date:
HLA: q iaorW l
PRIMARY EYE IRRITATION TEST OBSERVATIONS
Group :______ !_________________ _____ _
Test material : T-
IL, __________ ______________ ____ __________
Test eve: Right
1* Washed:
seconds following instillation of test material, the test eye was washed with mL of lukewarm
tap water tor^cx seconds.
_ k;rUnwashed
OUlbservvaatLimoin Period:
Animal No. Location of corneal lesions
n (>)o3 nus Il
I I ea
Ta 11 -- - Head
4
C)o
Cornea - Opacity
Area
Iris
Conjunctlvae Redness
P 1o
C) i D
n i*
o
( 2- o
\
Chemos1s
n 1o
D1scharqe Sodium fluorescein exam
0
n
5 7*
o
Technician:_____ ____________ 6 k --
EYE IRRITATION SCORE: (.,r>_____________
Calculated By: x A Date
Verified Bv:
^ Date i- M - q o
Date:__________________________ '^Y>
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:_______________ \f--- j Date: ,7 - - Q C j
.U: q iaorW l
PRIMARY EYE IRRITATION TEST OBSERVATIONS
Group :______ !______________ Test material : T- M<4 IL. Test eve: Right
>10.Washed: j r seconds following Instillation of test material,
^ the test eye was washed wi th mL of lukewarm tan water torwft seconds.
^Unwashed
Technician:
_______________ _
Date:
/ - .*>1- Q Q ______
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.
EYE IRRITATION SCORE: Calculated Bv: Verified By:
Q.c-s_______________
Datei- ,^1 - ^ O
Date >-- 9 0
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:
Date: 1 - ^ - ^
