Document R0zbmgQMnd6Z1qZR8VYg0Z9k
Experinent Nou:
Conducted At:
bates Conducted: Conducted By:
Reviewed BY:
Jute ocular Irritation Test with 7-349
in Albino Rabbits
o88azB001L
iSseae.fertpyauLlaB,bvoarlMauitanotnrieiosenost,LaabIonrcatory
January 3, 1984 to January 10, 1984
BDooWs. avAarkroer, oItns S TSotxuidcyolDoigriescttor
{zaatte
KTSeanftorroTnoaxriiceroyl,log5ilst J Acute Toxicology
lf we
ar
Xm.mL.. F. b.
ECaosbeens Griffith
WoC. mocormick
005529
i
-- me
resses
of
the
acute ola irsitation est conducted 02 10, 1984 at Riker sahoratesies, Inc: 55
Paul
Samany 3, et
1984 to inticate
Jamary ae T3454
is
sintmally
srsstating (:3/110:0) 2 he ove noF {rics ESproduced
Tr ne ring
femte atsino sabbit, Neither comesd he swdy. Winisal coryunctivitis wae
cpucity noted st
he
one
FONE
tuation and aubaided by the tio day evaluation:
Introdetion oe cnpeceive
of
hia
study
vas to determine the site oouLaE sritation nto the ee of ferie albino zabbite.
peoperties
of do
5-3404 when inseilied not regulated By the food
and
preg
Asinistratien'sGood
ete ty nboratory
practice
Regulation
of
1976, to
souk he the genesed
standezd cperating principles of this
scocasures
of his Laboratory adhere The saw data generated by
the
Study
Dizectar
28
the
fina
report
eotation. vee stored
in
the
conducting
laboratory's
archives:
005530
2
Jroethocdoosuatnandr Radeetssuiiltntastsianbguiptreopoefrctihees Noefyceheaitaensdt barrEeiecdlerereTeused500seevtahloudatveas
modeled after
re tent
that of
article
Draize Sta2
we inseiiied Co the
into the confessed 52 OF the Sreatzent POSS presented in
right
are of "abi
each cabbie according 1 vith the left aye of
each
anisel
serving
se
control. Ae each were exantned
ring tnterval, the comed, na oeaded for drcitation and
Axis and pelpebeal confinctiTe injury according to 2 stangara
scoring
soyrstotne,110Thpeormeasx,imuwmhipcohssiinbdliecastceosremaaxtimaanly SornEeiteaxtaimeinnaatniaondsannadgeosfc0ozFeiarno2g
onutar
cieaues
(carmen, xis, (sable 2).
cenjunctim) we FOES In this scoring SYS special
ssteates no irsitacion inant ie sisced upon
Spsisacion
ox
damage
to
She
CEE
nile
less
eoppasrteseriacpalnapcieedtiounponofdacmhaegetestto,hteheirsicsoreesndcwoenrejuannctaievlas end * The
seseriptive
oye
icrication
rating vas assigned 0 She 228 article. of the descriptive ating 125 he frequency
ettertn used fox assignmenc + wxsent and the persistence
of
station
or
amass RSH occurred to xessics 850presented
or nese ocr tismuns (Fable 3). The sndividu
in Table 4
2 spmoaettoenn ppuutcnelnatnadnsd BtUrEeLe;L DSeIerH: of chemtcads in odes BESSana Cosmetics (1965):
005531
3.
me
rating
is
arrived
at
by
selecting
he
paxinun
mean
irritation If the rate
score
at
one
hour,
one,
tw of three daS agter instillation. does not Feet the requiresents defined
for
the
of
atssipation
of
injury appropriate
for
2
particular
numerical
score,
the
system is
daeessccrriippttiivvee rraattiinngg is zaised by one oF FOX Jevels. The rating in he
presented in Table 3.
The
protocols principal and quality
personnel Assurance
involved statement
are
eudy, composition characteristics
contained in Appendices T = IV+
005532
|
ye
seitation
ate st
1 -
Rbino
BREE
J
pemEiElE, iaw mTpiiilegds emisatee tohmeeySTmemaaeiknpieoerseation
`
DS a6
te 01m pied mone daneanowe30
i .
8a 8a4
wo i
8:
able 2
ye Irritation Test = Albino Rabbits
GradinsgeatteheofSevWeeriigthytedofScOocruelsar fLoresions
EEE
eng ------ Description
iTsonsuunecstiva
RReeddnneessss Rete
((MNM)aers to Gefinitely
ipnajlepcetberdalabcrooevnd,ejunniocnrtdmiiavvlai,dounally):
NToereeeltsfunsote,eadseiclpyerdisccreirmnsiobnle:
DCShiheeeenfnaoisseinsbe(ge3)fy arbeodv:ewitnhopmaarti(ailnceluwdresdionnictofitathreindlidpse:nbrane).
BSSienrgewttiitnihnllgiiddss aabboouutt hhaali--cclloosseedd.to completely closed.
RDDoiyscoahmaoresgev(eaC)idttoirnenntnferrancanonfotmhtauhlse o(1fDiodnessoramnnaodlth1aanirinsmadJlu)ss.tmall
adjacent
tho etnhemoLjisdst.ening an moistening
of
the
lids
and
hairs
and
Dereiderable Score (A+B
area +C)
around x2
eye: Total
maximum
=
20
GrBaudei ' 2 3 12 43 '
2 3
cornea
o9PpBraAecCeHiEtYy1a((Mt")agkernaeieefofroufsreedaeadnrisenaig,t)y.de(taarielasvhoifchkriiss
most cleaorfly
visite.
12
e SiEreeiesrose ileiigrhntlaiyrebaolsb,sacuntroredad.nestlauiclesntofarieraiss, vdiestiabilles, sizeof
3
SSeeopaaivaeo,bfarCieorlriysnedaiinsvIcinesvrionblilvbeel.dbeu.t(2)not zero.
a 12
OBCreEetoeiornn(ooonrnee--lqenusaaslz)ft,erb,utbulteuslspesttsohatnWhhaotnlhereense-erq-eub:aarltters:
34
Ce han Score equals
three-quarters, AX BX S
otal
maxinun
=
80
xis
JvEaaolmlueoensvln(vAe)ealnoimnajle,ctcioonnge(satniyonoi,rriasslwlesltloiiflnlgt,hreesaectoiFng
'
C Smtoitonn(sloutfgogaiLnsiyhghtrt,heearcheteoimfoo)nr,rhiasgep,osigtriovses).
2
Nosiraction (any or all of these).
Score
equals total
Ax 5 score
ie
otal maximus = 10 fhe 1 of all scores
obt0ai0n5ed5f3or4 the
ote: The maximm
nmetivas
BLE
Rating Non-Irritating pNroanctzircrailtlayting wIirnriintaaltliyng iTrtrailtyating MTordreirtaatteilnyg
seIvrerirtealtying
ETxeerrietnaetliyng
.
able 3
=
ye seritation Test = Albino Rabbits
ClassoinficvaetioInrroiftaTteisotn WPartoepreiratlises
Range
.
0.0 - 0.5
50.5 = 2:5
52.5 = 15:0
515.0 = 25:0 . 528.0 = 50.0
550.0 = 80.0
580.0 = 110:0
petinition BYrTooremTaihieonetoan,ien ditanhycirseraersaaedtiinrngagt,minuagsltlobnseecoZlreeervsoe)l: z1BormTiahicenetoan,ien ditanhycirseraersaaedtiinrngagt,imniagsltlonbseecolZreeervose)l:
oTeimenaientt,ahirneeitnhcdirasyearsraeetaidrniagnt,ginagmlslotnsecboelreeZvseerlo:: nIroeshiaesinetsae,ivnenitnhdciarsyearsraeetsirdnaignt,ginagmlslotnsecboelreeveserle:s rTyoeemaeihnlmteaatin.bethi"sA1l0sroa,ftoirmnega6,n0%dsascoeyorvrepemnesardnebayySocffSoereveoerr Er52e50hoePahen<20n6.0oc8aanInoffienxeaacnlveieemadnamloasngsschtoohrroesesocfosrh3eo0suts CaSoiensueisrn>ati10nigs toonebelemvaeiln.tained; others Jo ramieantelaainp.et<hiAsl3s0roa,ftoirmnege6,n0%sscoeorvremenmesoadrnbaeYySocsfSoercevo
TOh0e.o27heetSdoo,6.08theIotfn 3ent0hoveceaanannnidimeamaxyalcleseadmsohnagorstchoorre EOForetmaevnigJsfes,croartreiasnigs>e israttoinbge onmeainlteavienle:d;
005535
ee RTA TmES s-NBII MSIE
BESTCOPY AVAILABLE
wien 7-0494
rr
3 Co=w
ELfo em
pit
mat
on |e | son | oon
|soeo
jis ps
Le
a
ES TTe olE LL E os| gon
ee junejuepe PT
.
oo
e
ee os a
CEoomeat) o| 2 , ore PE
0o.0o
'
o fes|sonswmetiu
os| gow
.
ee 1e |00
a& Fone|
o
00
8 lunsfnctisn G0] gn
eee
ee oo
=r
00
konguncttva
eeea,
ws
+. GEST COPY AVAILABLE
.
kor Exparinont No;-- eman-- s -- TT
Le
APPPREOMTDOIXCIOL
JcGepOsotN:nDsUoGnT_E_ADoqutBeYuO:oeiSsraferrtayetEiovnanlsuTaettGi.oan uLacboriatory, ker Laboratories, Inc. St. Paul, Minnesota oii
TEST ARTICLEC: ee
CPORNOTPROOSLSETDAERSMTT:IACRLFET:a IeNGImNC. oOwaMZPeLlaElTaeInOdNWrDiAtTeEAbOFRoTERSeTs:if tsJs SfJ. 4
weve oh
JEST SY
source: TT ve
Dar
BET: TT he al iscioavl atceosmtnwtlsl)ooofoaellomeisn,eJe0s,s0etoaf(taon0nd0ipnogetae7netGoiietnwaheelrraoteassvteaalllotacbolidtyt.aotshtehoocutloasrt
METHOD: (Tmheena,niHmala ewil beahowu,asteedrlncorSed Ea oiurno.meEsdhxocfaSg1eO0s,CInHwLtsimppeoo,raaetssusrtieganaernddiahwnuiumlmibbdeteyrnecdsonoets
T roomo srWh r1000se10A8
card afdCto teo ii may bo added fo rte
orau roe a phoeogcualarr rsceoae ricnp tgosryso st)th,eemisosf|u
C (ofaalobS .aA)ftcorcsoecooarmnptgloenrttiaaoacnleidoscf othrEeivtretsea,xtatomhnienaa"ntsdcioornjessywmiaslayhcbec5edoranianelfn,yzBOeERd,hanaidn8d`trdhemesaciraiiipdntgiovfe8.seoydeiauinrmditfda3ltu0uioocnr
O e ccoonnttaace ctppee rroiodd w0i0h, & R orro Al Y caAcwyrcdhdiiveaec,HqoUSnrteG,.rPaowalawuelednMb4ae1gseoBSO:LEYRSGr?acioe danwtihlebfeincalorneport
Be er Laborstorie"
aEPurr ina Rao AbsteClhowt,rnRaaellSsaoClntoPymuomrifintaCe,heeSmoLfiLcTaohlaus1AsMFsEooScoCidaustroDntof,FoaonddaCnodsmDertuigcsOf(f1ic9i6a5l)s a of the United States.
Sponsor
-
Tale Study Drecior
005537
APPENDIX II peineipal participating personel Intoled i the study
raze bu ne mares, Jer BS Xo 1. Ebene, BS x. D. o'maller, BS a. c. pecore
Function
rSotxuidcyolpoigriescttor sTuopxeircvoilsoogry Testing sSeenuitoer TTooxxiiccoloolsoysist sfuipneravlisLoarboratory
005538
20.
AppEwDIX TIT
composition Charscteristics
Inte study ie niontfoFremgautiisotnedpebrytatihneinGgoatdo LCaObmoOraStIoIrOyncFhraacrtaicctteraicsttiocfs
L676 ana therefore 1s not applicable for
inclusion
in
this
study:
005539
un.
appENDIX TV
This study is not officially regulated by the Good Laboratory Practice
Regulation of 1978, and therefore a statement signed and prepared by the Compliance Aulit department is not applicable.
The standard operating procedures of this laboratory does adhere to the general principles of this regulation. The Compliance Auit department does inspect different significant phases for studies undervay in the Acute Toxicology Laboratory on a recurring cycle, and the facilities are exanined on a three month schedule. In addition a select number of Research & Development studies are routinely picked at random from the Archives by the Compliance Audit department for review.
005540