Document ZB3Q3dGVYm6dDN7zMRxeOGgJV
HAZLETON oor women arenes Suttecan Scorers Satin Cl~emica, & BioMedical Sciences Division or se BOTS RABE WON FT PRONE 5 7 UXO RAL WGR U5 3301 KINSMAN BLVD., P.O. BOX 7545. MADISON, WISCONSIN 53707. PHONE (608)241.44;'1. TLX 103gs6 HAZRAL MOS UO
FINAL REPORT
i
51
eae. PERE ROGER ~. PERKINS EmcBin MINING & MANUFACTURING COMPANY MINNESOTA MINING & MANUFACTURING Thane SeRuices TOXICOLOGY SERUICES ER mses ST. PAUL, MN 99101
COMPANY
sanpLE: T3974 LOT 390
SAMPLE: T-~9~4 LOT 30
PURCHASE OROER MUNBER: 1767575 ToR 32
PURCHASE ORDERiNUMBER: T797979-TBR 632
saPLE NBER: 61005209 SaSnApMLPELEENnUeMR8eEDR:: 61100/02932/0869 EPR SAMPLE EPNRTIENRTEEDD:: 0I10//21~3//8867
REPORT PRINTED:
EENNCCLLOOSSEEDD::
PPTRRoIIMMAAoRRoYYoEEVYeEE rIIRRRRiIITTAATTIIOONN
STUDY
STUDY
ININ
RABBITS
RA881TS
--
METHOD,
METHOD,
SUMHARY
SUMMARY
RAW DATA APPENDIX
stone:
SIGNED:
SSp SSTioEUkbeEraNonMn r.ieetGtS Li. A.nZA Wee.
STUDY DI RECTOR ACUTE TOXICOLOGY
bV are E
DATE
oY AND FOR HAZLETON LASORATRIES AMERICA, INC.
ReA nDATA FTOReTHITSMisSoTaUnD,Y UArREScKoEnPeTn:ON FILE BY AND FOR HAZLETON LABORATORIES AMERICA,
RAW DATA FOR THIS STUDY ARE KEPT ON FILE
AT HAZLETON INC.
AT HAZLETON
LABORATORIES
LABORATORIES
AMERICA, INC., MADISON, WISCONSIN.
22880088..00000011
Exhibit
sm 2808n
bon 3MA10001092
@ HAZLETONwomenswvncae Chemica & Sitedint Scances Division HAZt.EI:!::iN
~'~"~
Chemical & BioMedical Sciences Division
ST. 7.58 ROSE WCRI ST HONE 47 CTA RAL Wo 3301 KINSMAN BLVD. P.O. BOX 7545 . MADISON, WISCONSIN 53707 PHONE (608) 241.4471 TLX 703956 HAZRAL MDS UD
SarLe rer: 1005209 SSaArMpPLLEE: NUTM3B9E7R:4 L6O1T005329009
SAMPLE: T-3974 LOT ~90
poe 2
PAGE
eve tmeTaTiOn
EYEOObbjjE esIeeiRaccnRttlgIiilTevveAeS eTs:eIeOxxNppoTTosooE surrddhaeeeetteeooiFrrR h.mm5iiaa.nneettBesI seattttvhheeirmmaaallnttseE meevvurreenliliiasalioolfFS ttBsoriirrooorrvnniiaeattcaattateyiyiieeooonnn oofFnppprraooaanddllcuubbcyciie'enndoede
GfrFuooaillbdllbeooilw~siiinnngges
o
a
for
rabbits
according to the U.S. Environmental Protection Agency's Guidelines For
Testing Pesticides and Toxic Substances.
Test Material: T3976 Lot 390 Test Material: T-3974 Lot 390 Bhyeieet Gesipscornt Fine white poser Physical Description: Fine white powder PAS aoa Sent 1551 R Sponesri svshmep s. ress ponsibility for purity and Purity and Stability: Sponsor assumes responsibility For purity and
stability determinations.
Tost ninals Young sdult rabbits of tha Naw Zealand nite strain vers Test Animal: Young adult rabbits oF the New Zealand White strain were rEortte ed, Tmn oytaautanitnd raodl.10i0ndaiyoatrdtuaarlel)y pirnovsicrdaesdn abcaetsisosntocagceasterInadfeLmipneriattuunre- procured, maintained individually in screen-bottom cages in temperature-
and humidity-controlled quarters, provided access to water ad libitum
nS measied nhount at Bur ine Aig Finer ReGit Chow, snd meld for and a measured amount oF Purina High Fiber Rabbit Chow~ and held For oT pens oF In Tan an acclimation period oF at least 7 days.
Six acelinetod animals, usighing fram 2340 to 2800 3, ers chosen at Fix acclimated animals3 weighing From 2340 to 2800 g3 were chosen at Rg BAe tH Riis rt vy random ?or the test. The animals' eyes were examined within 24 hours Pee teat nator ial dninistration using, sosiun Fluorescein dye prior to test material administration using sodium Fluorescein dye Srscaturess ants these "animals with na sian at seuiar injury or procedures. Only those animals with no sign o~ ocular injury or Totton uae Yond on The teats. Tout animate bere. oentiries sy irritation were used on the test. Test animal~ were identified b~ Ey Nomen Ini" eac responding ear tra. animal number and corresponding ear tag.
Reason far Species Selection: Tha teu Zealand Units albino rabbit is the Reason ?or Species Selection: The Hew Zealand White albino rabbit is the imal or Trois based upon 110" large eruis am man igeentes iris: animal oF choice based upon its large orbit and nonpigmented iris.
Preparation of Test Mstarisis The sample was dosed ss received. 8 bulk Preparation 0F Test Material: The sample was dosed as received. A bulk CEneTiy determination Las bade To Sternine the ueisne sqbioaient of a density determination ~as made to determine the weight equivalent of a a dma 0.1 ml dose.
Treatment: Each rabbit received 0.05 g (0.1 al weight equivalent) of the Treatment: Each rabbit received 0.05 g (0.1 ml weight equivalent) oF the Tort atorie] ploced on ine evried Jousr 154 of Ine soe, with the test material placed on the averted lower lid oF one eye~ with the Sotretataial Soaearuing as" tha intrested contrat. The upper and lover contralateral eye serving as the untreated control. The upper and lower ae Cara gent 13 na1a Cae her For ona. bacond 16 prevent [05a of mater ial lids were gently held together ?or one second to prevent loss oF material [ite SI US ch Shi dish ph and then released. The eyes oF the rabbits remained un?lushed.
Rassan for Route of Gministration: Historically, the route of choics ~eason For Route oF Administration: ARR INE based on the method oF Draize.
Historically~ the route oF choice
22880088..00000022
unto 3MA10001093
EQ HAZLETON wormmencnoe Chemica & BiaModica Sciences Division HAZ :I::)IN
Chemica, & BioMedical Sciences Division
EE EE 3301 KINSMAN BLVD. P.O. BOX 7545 * MADISON, WISCONSIN 53707 . PHONE (608) 241-4471 TLX 703956 HAZRAL MDS UD
SarPLE NuMBER: 61005209
re
SSaArMpPLLEE: NUTM-B3E9R7:4 ~L6o1T005392009
PAGE
SAMPLE: T-~9?4'LOT
eve mRiTaTion conTiveD EYE IRRITATION
(CONTINUED)
Shssrugrionst Tp toyttal Ges yess ghasrusd Fur quulpe ipesiasion a: Observations: The treated eyes were observed for Te 52 nd Se maura ana as 3 supe atrer sreainen. Bateuss I~ 24~ 48~ 72 and 9~ hours~ and at 7 days a~ter at injury was present at 7 dayss observations were
ocular irritation at treatment. Because continued at 14 and
R at tehe Z2chour and 7, 14 and Zsday reedings, sodius flusrascein ues At the 72-hour and 7w 14 end 21-day readingsw sodium ?luorescain was I a Ln ans used to ei~ in revealing possible corneal injury. Irritation was graded oe eaeat atnor ing tothe Braise: recnnidue. and scored~according to the Draize technique. aminals vers ugighed Just prior to test material administration and at Animal~ were weighed just prior to test material administration and at ici eB Ls Bi weekly intervals during the study. Pathology: At study termination all animals were suthanatized and Pathology: At study termination all animals were euthanatizad and Si discarded.
22880088..00000033
---- 3MA10001094
@HAZLETON omnes memcnre Chemical & BloMedicl Scinces Division BioMedical Sciences Division or ha. BRT WATSON WGN7 FG AT UXO EAA U8 3301 KINSMAN BLVD. P.O. BOX 7545 . MADISON, WISCONSIN 53707 . PHONE (608) 241.4471 TLX 703956 HAZRAL MDS UD
ShrpLE NusER: 61005200 SerpLE: T-3974 LOT 390
[--, PAGE
4
eve ieRiTaTIon
continuo
EYE IRRITATION
sur (CONTINUED)
Test BN Test
Animals Rims Animal:
ReAAcllabbtiionnenoodesrraabbebbTiiottsssD2uiS-o0UNtdMNeMoeuAenReYZZeeaaollaaannrdd
SWWrhhiiiettaees.
#1
Source: Haz~eton Research Products~ Inc.~ Denuer PA
Date Test Started: 11/17/86 Date Animals;Received: 10/21/86
Date Test Started: 11/17/86
Date Test Completed: Date Test Completed:
12/08/86 12/08/86
PRIMARY EVE IRRITATION
PRIMARY EYE IRRITATION
Ossewuarion PERIED OBSERUATION PERIOD 4 hours 1 Hour: 24 Horas 24 Hours: i tours: 48 Hours: 52 ura: 72 Hours: 36 tours: 96 Hours: S Boyes 7 Oaym: pa 14 Days: i out 21 Days:
SCORES SCORES* Rabbit roan 6 Rabbit Mean
Shs 0.05 9 Cnimanier (Unwashed)
5.039.0 pfyH34.8 3w2e30.0 32)5.2 3 os20.8 **
+ Te Primary Eye Irritation Score ie the total sys ireitation score * The Primary Eye Irritation Score is the total eye irritation ~core Tor TITTY Sinaia Siotaed sy he number of animals (63 at ach For a11 the animals divided by the number of animals (6) at each paladin observation period.
Based on S-aninal mean. **Based on a ~-animal mean.
22880088..00000044
ountonsioss
3MA10001095
E@ HAZLETONwornore Chemicst & Slowed! Scances vision HAZI=E1;! N - 'oo ~R,=.,~.
Chemical & BioMedical Sciences Division
SAR. 7.58 BADR REGRET AONE 4 EA WAAL Wo 3301 KINSMAN BLVD. P.O. BOX 7E45 MADISON, WISCONSIN 53707 . PHONE (608) 241.4471 I"LX 703956 HAZRAL MDS UD
SaveLE urBER: 6100520 SSAaMrPtLE: 13974 NUMBER: LoT 390 61005209
SAMPLE: T-3924 LOT ~90
a PAGE 5
eve tmiTaTION
continue)
EYE IRRITATION
Individual EsaTT'aub(IbClreeOrNiTt11IaNtUiEoDn) Scores
fWAniienmaanll O ObbsTseermrvvatattiioonn
2Cormes RSeoErs Individual Eye
Cornea
Score
iBrisURSNcoSrs CSonTjuEncNtiTvas Irritation Scores
Iris Score
Conjunctivee
GSScRcoorRree.
ses Number
d2B4Paeem!rHeeieoouwdsrsnoA1I1
8 AXSX5
448B2mo 4
20
A111ss:A X5 5 2223033 )3 3223 k11a4t
1
~9gTa68SehaHHtweooumuesrrssoor3111 035311%1nBa5 mOoD1i1
f553 of3 22 3 3~3111 k x112 3: 3 nn
Re 7 Days
l~Oays
tio: 2
1
I0
1
I
I o
22% 5
2
~
1
12
Fie FI~616 2~ dG1i1irdHDHmoaoeeeyuuesrress 111I114%~441 22m22o00%5o 110113s55F0 o:12212332~33:23311 KI1oo6~u8u
~8 Hours
gem 72Hours aShmreees 96 Hours
o21111fp o:b4~2f1 0B22holnO00mo% oooi21111 :555fa6 iz2222ho 5l2)~)3s3222G1 uI1i1~~4ou
Hew 71Days
14Days
0321
11
1
oaI0 5
40
0
00
O
a2
l
2o1 2o01O
df10 4
Fst F15591
21 Days
ame 1 Hour dGaevee 24 Hours gee
.,
]111110333)}1 B 111aL555s o1 r01113s5F50 oo22220 ::2222 232301ono11a2m44s 138 bf iii on
48Hours
72 Hours
wer ~6 Hours HaSehEeee 7 Days
1
2
10
1
2
I0
110% 1
1
5
1113 %om 2
2
20
iio:
1
5
2
1
5
2
13 2 1
5
2
1o%hh3 1
5
2
2
1
10
2
1
I0
ih 2
1
1O
3ho1 nDo 2
1
i0
40000 8
14 Days
1
1
5
O
O
0
0
0
O
Fie F15618
21 Days
iver 1 Hour ders 24 Hours Ges 48 Hours gue 72Hours mes 96 Hours She 7 Days gts 14Da~s EEA 21 Oay~
111111 444441 103
22m2005 oor011113s5530 B13
2o720z 205131 222303 00i1o06m0 ff on
221111b 34~}11os
20
1
5
2
15
I
5
2
m1 3 2 15
1
5
2
hhooab:bob3 i0
1
5
2
2
2
12
2
1
I0
31h 2
1
i0
3 hoa1% 2
1
I0
ET 0
0
0
0
T0E A0 0A AO
0
0
0
0
0
0
0
O
0
0
22880088..00000055
auntoo0109 3MA10001090
@ HAZLETON venom monn hemi & BoMedica clones Division HAZLEI I IN
Chemical & BioMedical Sciences Division
or Ki so. 0. TOT+ BATSON WCRI ST PHONWoE 47 + TXT AERA Wo 3301 KINSMAN BLVD. P.O. BOX 7545 . MADISON, WISCONSIN 53707 . PHONE (608) 241-4471 TLX 703956 HAZRAL MDS UD
SarpLE NBER: 61005209 SSaArMpPLLeE: NUTM3B9E7R:4 L6O1T005329009
SAMPLE: T-3974 LOT 590
vce 6
PAGE
eve mmaTion (cont tnueo) EYE IRRITATION
final Gbgervetion CsortmaestinTaSspslosrBsn1 CSoIoarniTtseirneuSteeodno)rsSoareCsomumetivas Score Animal Jott J A eo Number ise tree 13 as 1s 2 3 3 1 F15619 Foe dHg PHdGg HCaStSeeoheEwreeehema neeaehmRnessset,seel}d1rf4111133Lfd34d3t333441o030inB%882oB o8ob B omR nnO oo1 oL bi b21v11111so3 o: :3vs:3v3s3333%22oo3332f31 331fF ::3s3332333354 43 s::353ii 33ii% oa u E nn1on8x1oonn F15620
Observation
Period
1 Hour 24iHours 48 Hours
72 Hours 96 Hours
7Days
14 Days
~I Days
1Hour 24 Hours 48Hours
72 Hours 96 Hours
14!Days 21Daya
(CONTINUED)
Table 1 (continued) Individual Eym Irritation Scores
Cornea
A
B
1
~
1
4
1
3
1
~
1
~
1
~
~
5
~
1
Score
AXBX5
19 20 15
15
15
15 45 ~0
Iris
A
1 1 1
1
1
1 1 0
Score
A X 5
~ 5 5
5 5 ~ 5 0
Conjunctivae
A
B
C
2
3
3
2
2
2
2
2
2
2
~
2
2
~
2
2
~
2
~
~
5
2
5
~
1
4
20
1
5
2
~
}
1
4
20
1
5
~
2
2
1
4
20
1
5
2
2
2
1
4
20
i
5
~
~
2
2
1
i0
1
5
~
4
5
4
4
80
*
*
~
4
~
4
1
20
0
0
1
3
2
Score
(A+8+C)2
16
12 12
14
14
14 18 16
16 12 12
16 20
12
+ Unable to visualize dus to savers opacity. * Unable to visualize due to severe opacity.
Taste 2 Table 2 Sodium Fluorescein Examination Sodium Fluorescein Examination
aninat gnrontion Ganson Animal Rial preinitistion teers" Soaps 140ays Number risers es cos ow pos aw Pos aso F15615 FFiizz INbes SSaanw RfoSr nOtno assomm F15616
F15591
Fireie hb Te Gow ros (mo nee F15618 Frets NE 703 Gon FS oo eos cam F15619 Fe NES SG FRGW RRGW F15620
Pre-initietion
NEG NEQ NEG NEG NEG NEG
Observation Period
72 Hours
7 Days
POS (60M) POS (20~) POS (45~)
POS (~0~)
POS (60~) POS (I00~)
POS (25~) PDS (i0~) POS (30~) PDS (15~) POS (70~) POS (60~)
14 Days
POS (15~) POS (5~) POS (5~) NEG
POS (40~) POS (50~)
WEG = to stain retention NEG = No stain retention Iti me tom Carus of curren Invatunt POS = Positive stain retention (area o? cornea involved).
71 oa 21PeOoSsDwhNaEeeyGsts pMPOoSsANNNEEaeGGRs
POS (IOM)
22880088..00000066
owatoootosr
3MA10001097
E@ HrARZLEmTvO0N B3c7overUsRneEnRA 7 RON i + KT -- BRA-- CE 30
[ET ------ SAMPLE NUMBER: 61005209 sampLE: T-3974 LOT 390 SAMPLE: T-3974 LOT 390
faPAGE 7
ere mmiTarion continuo EYE IRRITATION
(CONTINUED)
Comments: Comments:
aEpaain nreesposnss Gvorcearlliizahtiieonn)) aures eSliLcsiteTdIfNroTm MtusIaNniImalsnfoldlowing A pain response (vocalization) was elicited From two animals ~oilowing
instillation o? the test material. Five animals exhibited excessive
he RL a a Re etn ering, pawin9 at the treated eye followin9 dosing.
Blanching of the canjunctives ues seen in sll six animals at 1 hour, 81anchin9 of the conjunctivae wms seen in all six animals at i hour~ a rate nT Th etme 0a) 5% ans als, in Four animals at 24 hours, in all six animals at 48~ 72 and 9& hours, Fillies in Ry ve and in ~iue animals at 2 days.
Petite hemorrhaging of the canjunctives uas exhibited by tuo animals Petite hemorrhaging of the conjunctivae was exhibited by t~o animals ea nate at 38 heures by. rout aninals at 73 hours, et 24 hour~, by three animals at 48 hours~ b~ four animals at 22 hours~ LT I ET aed Ue ant aE anys by all six ~nimals at 9& hours, and by three animals at 7 days.
Mair loss around the eve uss seen in one animal at Day 1. Hair lose around the eye was seen in one animal at Day 14.
Cornest epithelial peeling ues ohssrved in thres animals at 24 hours, Corneal epithelial peeling was observed in three animals at 24 hours~ Three on toata at 28 hore inLealbiayssox eannsimTaolsheote73anianmdale96athou3r1sdave. in three animals at 48 hours, in all six ~nimal~ at 72 and 9~ hours
and 7 days~ in ?ire animals at 14 days, and in three animals at 21 days.
Cornmal neavassytorization ues seen in five animals at 7 daya, in all Corneal neovascularization was seen in five animals at 7 days, in all Ce Ran natn Thr Tet aE a six animal~ at 1~ days, and in three animals at 21 days. Pans wan observed in ans oninel at 96 hours, and in one other animal Pannus was observed in one animal at 96 hours, and in one other animal Treseaeni?mals exhibited granulation scar tissue at 21 dave. Three animals exhibited granulation scar tissue at 21 days. At the 14-day observation, the iris of one sninal (FIS620) could not be At the 14-day observation, the iris of one animal (FIS82O) could not be en eta Tr fies pat tr visualized due to the severe opacity.
Raterances: Re1.ferem re WGHniuicttieccdshheea :,,lt in~Re.SKsKE,..,Ea Su""bnPPTdrriiivmmeiaa, IsrriyynonEE)vyteeF, IILHrraB BrrazriiaottyrtaadettcO iitooEEnlnviaaolnSSS uittauuufttdudiisyyooa,,nnn""y::,a PPOeeFRsHsFuuttmmiiieacconniinddee`oaafnTndAAaessPDssDao)eeo3nssmvsseiammcstieetndniittece
Animals~ U.S. Environmental Protection Agency Office o~ Pesticide and Toxic Substances Series 81-4, pp. 51-~5 (November 1982).
2. bOrrtaaicBe, i3.s., T"aepprraaiisal oolf 1tshe SSafeetyLof hChamicalsRutihn TFeoiodse,sOrugs, Oraize; 3.H.; "Appraisal of the Safety oF Chemicals in Foods~ Drugs, and Cosmetics - Dermal Toxicity." Association of Food and Drug SCT ne UE reas ses Officials of the U.S., pp. 46-~9 (197~).
3. NHS Publication No. CNIW 05-23 1985) Guide for the Care and Use DHHS Publication No. (NIH 85-2~ 1985) Guide for the Care and Use SE Rnanaisry ims: of Laboratory Animals.
22880088..00000077
Suktoooioss
3MA10001098
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ee
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E SrEamnNEa amvm sLtarSo RTT; ---- 2}I
=
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CeeE hHants Berane, Paesr otrveio (7ior 1
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TotalMeximm =10
smn o w r (rtotatsaere) cmscgi cas)
.
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i S @see nS u eartee sim imic snee m ess srta : ------ o11
mm
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22880088..00000088
3aMMAAT1O0000011008999
0
Ji4 lEH: Biad 31 31,
i93E8EC,| W85n8 Sw4gRy EY 3883%84e Sisf8d
g I1fa E1s] aTg AT9dR|E|NR4E4$2
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22880088..00000099
3MAIO001100
Primary Eye Irritation Test Observations
l| o est material:. Sample : 1-297
| rest ger miane Test Eye: Righlt
Let 390
Grove: NA HA to. (1005309
HLA NO-~__o~_~_~_~ Group: )J/~
1
wE~wa_Wawasshheedd::AyLB(yB~
rsseeeccootnneddssstffeooyllelloowwwaiisnnggwaiis.nhnsestdtiillwlliaattthiiooynn ooaffaLtteeossftt
material,
mTautkeerwiaarln,
U~n/~wJanwsahsheedd
the test eye was washed with .~e~mL of lukewarm .
minal to.
cscaunion prion: tap water for UA~ seconds.
Tus Tet[ssa [se OBSERVATION PERIOD:
[=a Tsca |
Location of Corneal Lesions
TTaaiill oo---- HHeeaadd
Co. ea wes
beIris
diy
-
Ene LE'
M. i . Quy ..Ut
~ ~O
Te| a els1]
ir | | clc=FFF]
woe | 5 |3 |o|a [3| |
vires |2 | ae|ac| ac | ac|a |
Teemiton (gre
Technician
Date
-17-%
NA -= Not Applicable
Ee A - Petite hemorrhage Ht B - BlanChing
C - Clear discharge.
goo sige, D - Purulent discharge Le re E - Hair loss around the.eye Eon ar F - Necrotic Areas PI ete G - Unable to visualize due to
ia tpe ias severe swelling
H - NO reaction to light
hi -I - Injected
0 .eevviieewweedd B8yy::
(4253)
Qn
DDaattee::
~
JJ -- CCoorrnneeaall eeppiitthheelliiaall ddaammaaggee,,
JG mee) fe: K - Corneal epithelial damage, 2 Gel me) me L - Corneal epithelial damage,
M - Hypopyon
EDIE ctartzation N - Corneal neovascularization iE P - Pannus DIR wo psatine ae ee R - Unable to visualize due to
ee severe opacity BEE S - Granulation scar tissue
POS - Positive stain retention
8 2 fl sen rn NEG - Negative stain retention
~ [QUN-B EEyvee IIrrrriittaattiioonn SSccoorree::
STiUe ppeeeelliinngg
-
piling
pitting
wfooee NH~:O~'~'4I>(~(~J~
Far
22880088..00001100
swnorir 3MA10001101
Primary Eye Irritation Test Coservations
Primary Eye Irritation Test Cbservations
Ost mterint: Samglel 1-294 Lot 290
Ja to. (21005309
HLA NO.
Test Eye: Right
GGrroouupp:: __NA
M~AA
WWaasshheedd::AyL/p~
it1sshn3eeee5cc'ootnntVededessssttteffryeooyllTeelloorowwwwaaiitssnneggwwaaiiSssnnehhssseettoddiniallwwsllii.aatttthhiiooJ]nnaoo~ffm=Ltteeoossfftt
mmTaauttkeeerrwiieaarlln,,
lukewarm
tap water for ~ seconds.
U~n/'w[Janswahsehedd
|
[I f--ora si
oOaBsSeErRuVaATTiIoOnN PpEeRrIiOoDd:: 29h
5A 0s [N sp [ssa [see[NWis
[sWezEa
|
||
[aaa Cstens
Cornea] Lesions
Taf) oeeeee Head
@Vuo)dX|0W )ey )X |0N)y @|&Gh@)|E= 22
-
| formsHeadLtLEI R EAL
|
Co.rnea - wesOoac!t
4 14> 194 []
be Area Tp [=1p[|v[17]
Iris
Conjunctivae .
UJ owe EH ReRdendneessss 3lala[1 AAR Lo 24e|oeA | 2B l [aa 23[l2 e 2 | |
|
ours ChemOsis | 2 120 | 20 | 2cla |
| CeDism chargepdse r {ue e |eyan|c uae l vl e [va
:
[ SToedoimuimcFnlnu0ore8Fcein[=Exam
i| Toeactheni_c_iyaoni~ ge /~
OMe opacity in this Aree, HE I1E-T
| or emse be etal domes prim | , VI,oe 1
NNAA =- NNoott AApppplliiccaabbllee
i
8A -
B -
Shancning Petite hemorrhage
Blaniching
|
~ED2--2=- CCFRHPNlauuealeeirrtra~aiUrrnlorTleetddaonntigsttiessssccdahhiaairasrraserocoscrgusguhhnenaaederr.agtaeenhee..eeyvee
|
F -
G -
4-
UUNfSsnnoeaeaacvvbmrreeivorarlesteseiestctssooiwweAoellvvrnieiIiassins0uungaagllMiiizzgeehtdduuee
to
to
|
H1I 2-- NIIonnjj~eeeccattceetddion to light
J J
--
CCoorrnneeaall
eeppiitthheelliiaall
damage,
damage,
peeling
peeling
aad
K2- CSoorrnneeanlt eeppiitchneelliaall ddaammaaggee,, ppiiltitnigng
MMLPN R7NZ-----2-CHHfPCDoayo~aE arnpromnnnodpueuepyesasayollonntennopeeioovtvvihaasessulccaiuulaltilaazrreiidzzadamautategiieoot,nno pitting
205RS5
--
-
SsUGSBeenreavvasaneebinurrtluleeielavateoottipoimoaosencntvtiaittisssyynuecaaarlrreitztteeiinsstdssuiuueoeento
PNNOEESGG
- - -
PNNoeesggiaatttiiivvveee
ssstttaaaiiinnn
rreetteennttiioonn
retention
~ 1| en Q.ee viewed BByy:: ,
Qo
DDaattee:: A~.-/JO-0~PZ~lop EEvj,ee IIrrrriittaattiioonn SsccoorrSee:: u3~0H~ SER "
22880088..0000111
awatoooticz
3MA10001102
srinary Eye Irritation Test Qaservations
Primary Eye Irritation Test Observations
O ements: Sam T29e 74 Ll eb2e anl
0Teesstt EMyaet:eriRala:nt
wHLaA vNO.. (1005309
Group: __WA
Group:
Tes: Eye: Rig, ht
~M_A~.WWaasshheedd::~AyL(p~
ttsTshheepeeccootnnTwededassssttterffeeooyyllfeellooornwwwaeii4ssnnkggnwaaiisssnnehhssceettoddniidllwwslli.iaatttthhiiooL.nnj~oomffoLltteeossofftt
mmTaauttkeeerrwiiaaarlla,,
lukewarm
tap water for ~ seconds.
. U~nnwwaasshheesd
|
ALnoicmeatlionNo.o
Ea ens Tail eee ters Corneal Lesions
Tail ~ ...... Head
| || oLersm war | Co.rnea - Opac!t~
OOBBSS[ERRVVAATTIIOONN PPEERRIIOODD:: g hr.
1 5 fi (@ ; | ( J
| \Q
f
n
CE
| [Pre]ICRU]
To ~ yl To[alal]
CF Fe oT
o
Redness
gees
| a |3 |2 [5G0a g |al S |
||
verse | ac| on | mw]mlano | [ommrwrecncml an | me | m| e uelwl
:
| TTeecchhnniicciiaann _( Ane.
| DDaattee, -1a-H
||
NNAA -= NNoott (AApppplliiccaabbllee
JJ -- CCoorrnneeaall eeppiitthheelliiaall ddaammaaggee,, ppeeeelliinngg
-
|! |
AA&B --22C52-
PCPCBSBleelulletteraaiailinntrtrtcceeehhddniihihsnineesggsmmoicoohshrraearrrnrhhgagaaergge.seee
"
K1KMLL\ ----7
CCHHCCCooyyooorrpprrmnnaonneeeespeaaaayyallllloanneeneepppepiiioittttvhhhhaeeeesllllciiiiuaaaatllllarddiddaazaammmamaaaatggggieeeeo,,,,n
pitting ppiilliinngg
pitting
|||
EDF2Z F
fHPNaaueiicrrrr~olllteooinssc~ssdAiaarsrrecooahusuannrddgtethhee.eevyee UNnea~ioteifcoAvriesasualize due to
|
~ Severe swelling
R7PN -72- FPUCaonanramnnbuelasael tnoeovviassucaulliazerizaavteiotno
R
5
-
.
SsSUeernvvaaeenbrrluseetaoottspoieaoccnviiittssyyueaalrizteissduuee
to
LHH12= UNNsTnooehavdrb~eeelerceaaetccatttssoiiwooevnnlilsttiouonagllHiiozgehttdue to
#PNO0ES3SE ~--T PPGRooressamiintttuiiilvvvaeeetiosssnttcaaaiiisnnncarrrreeetttteeiennsnttstiiuioooennn
I - Injected
]| Q evieved y: __pO
Date:
NEG - Negative stain retention
JHDB(p. Eve Irritation Score:
aG e i P
.eviewed By:
Date:
Eye Irritation Score:
O | ({4e2z5s3mA))
\
|
@Endryeqor HA WIM
|
22880088..00001122
3aMMAAT1O0000011110033
Primary Eye trrisation Test Oaservations
Primary Eye Irritation Test Observations
Qest mrerint: Samglel T-2974 LLoe+b 3p = wo 1005309 est Material:
| TTeesstt EEyyee:: RRiigghhtt
GGrroouupp:: __NA
w~e.lb,
WWaasshheeddi:g~ HhB
LtssiheeepeccoontntwdeedassssttterffeeooyyllTeelloorowwweeaiwissnniggpwwaaiisssnenhhcsseeottddniidllwsilli.aatttthhiioo.ynnaljooJffL~mLtteeoossfftt
mmTaauttkeeerrviiaaarlln,,
lukewarm -
tap water for U~ seconds.
unwashed
u-'~nwashed
ETSTeTETE i
OoBeSsEeRrVuAATTIIOONN PPEERRIIOODD:: 2
|
|
[i ALLconoooicrcmamaatem~liaiotonnNeov.oesften, s eFl~-sehsg e|[s7yL2a)[5 ToE%p20Tfonial ToopSehde|
_
IECorneal seas Lesions
adh
ANCA AN AR
|
Tail -..... Head
carne - oosett
Fo7
!
F>P
ilkll
| Co.rnea - resOpacity [2 lw 15 [3 Ja lo |
Iris
0 mms om ge loe | ge lg Conjunctivae -
|
meee Redness
Ch si,
suns
a la lo[20 la la | | jo lon se |re 100la]
Dls~har~e
[wes sree | oe _saney Sodium Fluorescein Exam
|
Teemtctan AIC /Ga
Technician ~ /~
Date 11.~
NAAAB8 --2--2 pCPNBBlellaoteaattianni)trcceAehhpdiiphihnnleseggimmecoonarrabrrrlhhgeaaeggee
CED2---22 CHhfNPluaeuaericriairrUrrtallesefodnnoissttcissscaadhriaaiersasroosccruusghhnnaaeddrr.ggtteehhee..eeyyee
&F
6
H
2-
-
=
UnfNssnoeeaeavvbcnreeirerrltoaeeetcitcStssooiwwoAeenvvllreiillsastiiuosunnaagglllitizzgeehtdduuee
ttoo
Those H - No ~eaction
I - Injected
to
light
O zs) oO .veiveiewweedd BByy:: (
Qu
Date:
(~2~3A)
Rp XKJ Z--2 CCCEoooorrrrnnnneeeeataal]ll eeeeppppiiiitttehhhheeeelllriiiaaaallll ddddaaaammmmaaasggggeeee,,,, ppppiieil1etiiltnniiggnngg
5MFtN\ l---2aHpCCCmyoooparrrenonneppeseaaydllsonnenpeeiootvvhaaesslcciuualtlaarriidzzaaamtatgiieoo,nn pitting
P72o
R
5
. -
SPsSDUeeranavvnaaeenntbrrualeeesetaaocttoppoisaoccnvvtiiisttssysuueaaalrliizzteeisadsuuueee
to
to
P2C0O5$SR--
PGorsaintuilvaetiosntaisncarretteinstsiuoen
Positive stain retention
NEE - Negative stain retention
Foote
(D408 EEyyee IIrrrriittaattiioonn SSccoorree:: 33
shh 120-
280.0013
2808.0013
MA10001104
3MA10001104
veri: Seng
Leb wa Lloosaa Primary Eye Irritation Test Observations HLA NO. ~_o~_~L_
TTeesstt EEyyee:: RRiigghhtt
GGrroouupp::
Ah Washed: yp seconds following instillation of test material, Washed: ~ seconds following instillation of test material,
the test eye was washed with .~/!~cmL of lukewarm tap water for U~ seconds.
~NJ A~
iZlmuashed
|EET TEE @ ( a a i i eatin o
Ulan eee ens Corneal Lesions Tail - ..... Head fU om TE RP [PR Co.rnea - Opac~t~ .
OBSERVATION PERIOD:
ri
E
EAN
7h
ANTAN
T pi
ANAN
Areai
0 casneen T[ A eoTlae ; eT] Ta2 e] [T aao2 5Tl[aae5lT[ya]]nd
| anne
|
date 1I-2/-8L
i
NA -= NNoott iAApppplliiccaabble
JJ -- CCoorrnneeaal) eeppiitthheelliiaall ddaammaaggee,, ppeeeelliinngg
-
|
A8B --< PBBelltaainntccehhiihnneggmorrhage
K LL
- - =
CCCooorrrnnneeeaaall)
eeepppiiittthhheeelllifiaaalll
ddaammaaggee,,
damage,
ppiiltitnigng
pitting
C - Cle(r discharge D - PurUlent discharge E Hai~ loss around the.eye
M - Hypopyon N - Corneal neovascularization P - Pannus
F - Necrotic Areas G - Unable to visualize due to
severe swelling
R - Unable to visualize due to severe opacity
S - Granulation scar tissue
H - NO ~eaction to light I - Injected
OQ.ei viewed BByy:: ((~422B5)3A8))
Sa
._ Ovaattee::
POS - Positive stain retention NEG - Negative stain retention
JQ-D-Flp EEvyee IIrrrriittaattiioonn SSccoorree::
70
00
A
|
-
22880088..00001144
3MA10001105
primary Eye Irritation Test Observations
Primary Eye Irritation Test Observations
O est merits Samplel T3074 Leb 3ap
| Test ge: Riont Test Eye: Ri~t
wave. al005209
GGrroowunp:: NB
weA
Washed:
Washed:
tH~pb
sseeccooTnneddssstffeoovllelloowwwaiisnnggwaiisnnhssettdiillwlliaattthiiooynnAooffoltteesostft mmTaauttkeeerrwiiaaarlla,,
tThaep tweasttereyfeorwaasxwassehceodndwsi.th IL~mL of lukewarm
tap .water for ~ seconds.
U~nJwnwaasshheedd
are, |C(e0 (IHDIDD - [Er ;
| TCoocranteialonLesions Corneal Lesio,~s
| , Tcaarivles-..m.a.tey.e,d
|
Co.rnea - weOpac!t~, .
| [ee
oOnBsSeERRvVaATTtIoONN
PERIOD:
PERIOD:
7
a
TsuS Tsp,
[ssa
[sed
3
[spGien hT| a# z|
.| 2 [Tg No3 | pT1 TPT[FEEETT T ~ ~- o ~ TT sTa| [F = ZTo FF]
Conjunctivae -
owes Q a RReeddnneessss I
g [ g oSle E e 2 l.
|a| 9 |2 |a |a [ox]
ore | te| 1c | mw {we | ge| ar |
Sot Fresco Sel Brun3 rat [e202 mez Pos 10 ns]
| Teeictan_camc Technician
Laeoa,te Lod
| Erdry excor i-okadte . || " NNAA8AA <---- PpNNBeeooltttatiinAAtctppeheppihlhlneieigmcmcoaoarrbbrrllhheeaaggee
XKJJL=Z--- CCCCCooooorrrmrnnneneeeaeaaalalll eeeeepppppiiiitttttenhhhneeeeellllliiiiiaaaaalllll dddddaaaaammmmmaaaaagggggeeeee,,,,, pppp~iieielleteiilltnniiiggnnnggg
-
|.
DC B
-
- -
CCBPlllueeraaaun~rlCehddniiitnssgccdhhiaasrrcggheaer.ge
D HPauirru)leonstsdairsocuhnadrgtehe eye
HMLNZZ-- HCtCyyooppronomeppayyeloonnenpeiotvhaeslciuallaridzamaatgieo,n pitting ?N ~- pCaonrnnueasl neovascularization
FEF Z- nHNNeeaaccdirrriobielttoiistecsoAAvarrieerosaauussnadlizthee.deuyeeto ~ - Usneavbelree tsowevlilsiunaglize due to
P#R 7-5-
PssUGUeenanrvvanaaeebnbnrrullsesseetaootttppooiaaoccnvviiiittsssyyuutaaalrliiztzeiesdsduuueee
to
to
H =- NNsooevrree~raaeccttsiiwooennllttioonglMiegnhtt
a $ - Granulation scar tissue
POS - Positive stain retention
-I1 - IInnjjeecCtteedd
NNEETGG-B--loNNoeedggaattiilvvheee ssdttuaaiidnnarrreeeetteeHnnttIiiooRnn I . 0 gly
| Oo evieved oy: or]
Dvaattee:: ~ JID-Rly EEyvee ,Irrrriitt'attiioonn SSccoorree:: 3~5'ZZz_",
| O.ev(i42e5w38e)d By= ( ~
2
(4253A)
t
22880088..00001155
3MAI0001108
3MA10001106
primary Eye Irritation Test Observations
Primary Eye .Irritation Test Observations
Dio
O weset mMaateerriail:: Sam T29p 74 Ll ete 2Ap ! test eye miant
HhLAtNeO. (51005309 Gow: _NA
Group:
Test Eye: Right
Hip water for aa seconds. L~_&d_~WWaasshhee~ci: y~ H i esseeccoonTnddessstffaoovllelloowwwaiisnnggwaiisnnhssettdiillwlliaattthiioonyn aooffiLtteesostft
material, mlautkeerwiaarlm,
the test eye was washed with ~/~mL of lukewarm
tap water for ~seonds.
Unwashed
i
oOsBsSeErRuVaAtTiIoOnN pPeErRiIoOdD:: [9 doy
Tomar ES iD | So [AninmalaeNnos. e-lsge Is aie {ssa Tope [| ST
Location of
|
Corneal Lesions
Ta ees ead
..
&/ | \u Ahy)||
-
| [ore Tail -.__N Head [7] 1
I Pl
ali al
Co.rnea - resOpaclit7 Lo
aT3 [aol
| lT e Area( I olT ololFlr]
Iris
Confunctivae
=
Oo
Runes:
oem
|
2
3
|1
|o 0 0 3 o [4]
|
bisenarse ml olol[ on ana]|
{0 teemictangne|(57
| oe aw
oF ||]
NWAAAA3 --2- pPNNSeeoohttttaii!nltAActepephppilhhlneeigcmmcaooabrrblrrlehheaaggee
.
C B 8
-
- 2
CCpBlluleeraaasnrrtcehddniitnisgscdchinasarcrghgeae.rge
D Z- tPuariUlleonstsdairsocuhnadrgtehe eye
||
&EGF2Z--UHUNNsnneeeaaaccvib~brretlooreetlteoiisStccssoou.rAevavrleiirelsossaisuuusnnaagdltiizztheee.ddeuuyeeettoo
|
H#12-= fNSTooehver~eceerkaaeeccdttsiiwooennllttioanglliigghhtt
I - Injected
KXJ{3 2--C-CoCCCoooornrrrnnneneeeaeaasllal eeeeepppppiiiiittthhhtteeenhlllfiieieaaaaalnll)) dddccaaaaammmmmaaaaagggggeeeee,,,,, pppppiieeillestiilltnniiiggnnnggg "
M L
~--fHCCyyopopromnooepeyaytolonnneepiotvhaeslciuatlaridzaamtagieo,n
pitting -.
PPNR Z--2 PUpConaaranmnnbueulsasel tnoeovviassucaulliazreizdauteiotno
R
7035S
-
-
-
sEPsUGeeonrrvvsaaaeeibnnrrtluteeielavatooettippoioaaosccnntviiaittisssyynuccaaarlrreizstteeiinsstsdsiuuuoeeento
PNOESG PRoesgiattiivvee ssteaaiinn rreetteennttiioonn
0%
NEG - Negative stain retention
/~1) n.~(~
:
;i
J QO evieved
O.eviewed
By:
By:
Se vate: 1. 9-IN~ -Bl EEvyee IIrrrriittaattiioonn SSccoorree:sShD~)'2<~
i~ (~Z53A) gy esroria- 34m
.
|
uNFlEeTeoM"IThHMEiALInNA(BIuFLI1TAY5T6O,2Ss0tio)tRSS.SATCHRREEEIRRIeSfOlFets A
i
|
22880088..00001166
aMATo001107
3MA10001107
primary ye trritation Test Observations
Primary Eye Irritation Test Observations
OQ ese meerint: ~ Sameled T-2a1 Let 300 est Material:i Test eye: pion Test Eye: Right
wa vo. _Lalosa08
HLA NO-
GGrroouup:: WA
Uh vashea:
~_~_Washed:
yy
issnee0ec5coonrnaaddssstr. ffeoaoyllaelloowwwaiiasnnggwaifSsnnehssecttdoiillnwll.iaattthiiooynn aooffeltteeossftt
mmTaauttkeeerrviiaaarlln,,
the test eye was washed with .~mL of lukewarm .
Uvn~Jwnawsashheedd
tap water for ~ seconds.
[nim se. Location 5 Animal No. Location of
!
Corneal Lesions
TTaaiill -w.ee.e..e.ti HHeeaadd
Tove Tap, [ssa [T sew ap[sea an | OOBBSSEERRVVAATTIIOONN PPEERRII0O0D:: <,::P~!1 Jdl~a I 7
)|(Cp> OO (@| 8 IL)
Co.rnaa - resOpac)t Mien|+[Vv To1T 1| fe Area lo0 lorab loo lo0 la0 lo0l
Iris
Q Revers Conjunctivae
o
o
0 la
\
ose Redness |2 |2 0[0|3 [3|
swowse Chem~sis |1<|& |0 |0| 30] ov|
son rrDairsechsacreane cul Neo, [or 5%] en |Nea. [06 25% fos 0%
Sodium Fluorescein Exa~
TTecehcnhinciciiaann, [
=
DDaattee
2-320
NNAAA3A--=2- PpNNBeeoolttttaiin~itActAepehppiphlhlneeigimsccooaarrbbrrllhheeaaggee
CB5 --= 2D-Z
CCfPBuluallrraieeifnaailrrIceoThnnddoiiisitnasssgccdihhiaaasrsrrcocgguhheneaad.rrsgteehe.
eve
&EF-2UHUeSNnaneeciicavrar~beot.lroteeletotiscttcssoowAAevarvrlireeilosaasiususunnaagdlliitzzheee.dceuuyeeettoo
H#1-2 NWsMoeosvk(rr~eeertaseeccststiiwoeonln IttioongMliggnhtt
KXJJ-2-- CCCCCooooorrrrrnnnnmeeeeaaaaallnll eeeeepppppiiiiittttthhhhheeeeellllliiiiiaaaaellll] dddddaaaaammmmmaaaaagggggeeeee.,,,. pppppiieeilleetiilltnniiiggnnnggg
-
%ML73N ---2fHpm~Cyyaoope~nrrononnaoueepyasaytellonnnenepeiootvvhaaesslcciuuatllaarrsidzzaaamattgiieoo,nn pitting .
P2R 2-5-
PssUUBaeennrnvvaaaneebbnurrlltseeeeatoottip~oooaacncvviiiittsssyyuueaaarlliizzseiessdduuueee
to
to
PPE 0O3SS ~-- SPGR oorssaiinttuiilvvaeetE iossnttaaiisnncarrrReettteeinnsG ttsiiuooenn 0 0
In j l~cted
OQu.eviiewed:By: Qo
((e~B2~5A3)) Oentry errors
tate: S9NEG4-N,e0gatitvyee sttraritnatrieotnenscio:rieo:n,,[~-1-~t5~-1/i{~oj")"Ib"~('~ Date: ~-/O-~(.# E~,e Irritation Score: We
0 12-230
22880088..00001177
aMATO001108
3MA10001108