Document 10x5RmNmdB2Be91gpGQJXgR3E
AR226-3016
Study Titl Bye Irritation Test vith B-21095 in Rabbits
Laboratory Project ID Baskell Laboratory Report No. 271-95
Author Carol Finlay
Study Completed On
April 20, 1995
Performing Laboratory
Haskell
E. I. du
Laboratory
Font de Neaours and Company
for Toxicology and Industrial
Elk ton Road, P. 0. Box 50
Nevark, Delaware 19714
Hedicine
Hed i cal Research No.
Company Sanitized. Does not contain TSCA CBI'
Page i of 10
SSm?Srfkw':-tl'"~ ..ailaaBaseiU^
^.^^ml^.,
Physical Fora; Coapogition;
Transparent tan liquid H-21095 contains;
Cont--iMtfttas gagiey; CASJIyjistry Hp.;
Spongors
Study InitiatOd - Coapletedi Zn Life Hbase Initiated - CoBpletedji
None 30?
Hone available DuPont Specialty Chemicals
E. I. du Pont de Seaours and CoBpany
Wiliiogton, Delaware 4/3/95 - 4/20/95
4/4/95 - 4/7/95
f&sg&
Eye Irritation Tot vith g210*S ia iiafchitg
sununr
H-21095 was evaluated for acute eye irritatioa potential in. 2 rabbif*
An
aliquot
of 0.01 L of the test sac of the right eye
substance was instilled intoSfthe lover of each rabbit. Approxi--tly 20 seceadf
corajunctival
after instillation,
the
treated and
control eyes of
1 rabbit
ver vxhed. washed. Ittf
The treated and control eyes of the renaining rabbit were not
eyes of the rabbits vere ex&Rined on the day of treafent and on days 1, 2,
and 3 following treafent.
H-21095 produced aild conJunetival redness in the treated unvashed eye.
Mild conjunctival rednesisn, sthliegheytecvhaesBhosdisa, ftaendr Mtroedaefraetne t.bloTohde-titnrgeeadted ey--
discharge vere observed
of both rabbits vere norul by 4 hours after Instillation.
No clinical l-CKi
of toxicity ere observed during-the study.
Under the conditions of this study, H-21095 was a aild, transient eye irritant.
ork by:
L ^A^^jilkl^ Oarer Finfay Toxicology Associate
Reviewed b^y:
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Reviewed and
Approved for Issue:
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DuPont BU 271-95
IHTKOPOCnOII
The purpose of this study was to evaluate the acute eye irritation potential of H-21095 in young adult rabbits.
MATERIALS AND METHODS
A. Aniaal Husbandry Young adult female HM;(NZV)fBR rabbits were received from Hare
Marland, Hewitt, Nev Jersey. The rabbits were housed singly in suspended, stainless steel, wire-mesh cages. Each rabbit was assigned a unique identification number which vas recorded on a card affixed to the cage. The last 3 digits of the identificatior number were written on the inside of each rabbit's ear vith a water insoluble marker. The rabbits were offered approximately 125 grans of Purina Certified High Fiber Rabbit Chow* #5325 daily during the study. Vater was available ad libitum.
Haskell Laboratory has an animal health moritoring program. This program is monitored and administered by the Lafcoratory Veterinarian. Water sanples are periodically analyzed for total bacterial counts and for the presence of coll forms, lead, and other contaminants. Additipr.ally, samples from freshly washed cages and cage racks are periodically analyzed to assure adequate sanitation by the cagevashers. Data from this program are maintained separately from study records. Animal feed is certified by the manufacturer to meet specified
nutritional requirements and to be free of a list of specified
contaminants. On the basis of these analyses, there is no evidence suggesting that contaminants were present in the feed or vater in anounts which may have interfered with the results of this study.
Rabbits were quarantined, weighed, and observed for general health for approximately 2 weeks. Animal rooms were maintained on a timercontrolled, 12-hour light/12-hour dark cycle. Environmental conditions
of the rooms were targeted for a temperature of 20"C 1*C and relative lucidity of 50t IOX. Excursions outside these ranges were judged to have been of insufficient magnitude and/or duration to have adversely affected the validity of the study.
S. Protocol On the day of treatment, the eyes of 2 female New Zealand White
rabbits were examined using illwination, magnification, and fluorescein
dye. Animals used on this study were free of pre-existing corneal or
^Panysa^^;
* -
'^^^rsCACSf
DufORt KM 271-95
conjunctiva!
injury
or
irritation end
2622
vr
judged to be in good h--lth. th day of tr--t--aito
The-- rabbits weighed 2269 or
grau on
to
aliquot
of 0.01 BL of H-21095 of eaeh right eye.
vas The
introduced into the lover
left eye of each rabbit was
not
eonjunctival
ac
the
teat
substance
and served aa a
control. Approxi--tely both eyec of 1
treated with
20 seconds after
the
test
substance vas
1
administered, with rooa
teperature
rabbit
were The
rinsed for approxiiately treated and control eyes
ainute of the remaining
rabbit
vere
not
for approxiaately 30 to 60 seconds
water.
washed.
Each rabbit vas observed
abnoroal behavior vas noted.
before being
returned to its cage, and any of visible evidence to the contrary,
the
test
substance
the conditions of adainistration.
In the abaence
^.as assured to be stable under
Approxiaately
1
and
4
hours, and 1, exanined
2, and 3 days a;cer for evidence c? eye
H-21095 vas
iritrtion.
administered,
the rabbits were observation periods,
eyes vere exaalned using
according
Ailtluemacinhaotifontheansde ag(npirfeicsaentitoend ainnd Tsacbolered1).for Eoyecsulawerereaaclstioonosbserved for
to the Draize scale
any unuuual responses
to
treatment
such
as pannus, blistering of the indicative of corrosive action.
conjunctiva,
ulceration, or other effects the rabbits were exaained for
clinical
signs
of
toxieity at
Additionally, each observation period.
A Henastix* reagent strip vas used to detect of 1 rabbit. Control eyes
occult
blood
in
discharge from the treated eye These untreated eyes vere used
for
conparison
and
vere
were not scored. considered "normal"
relative
to
the
treated
eye.
C. Records Retention
All
raw
data
and
the
final
report
and
will be stored in the archives of
Industrial Medicine, E. I. du Font
HdeasHkoenlol uLrsabaonrdatoCroympfaonry, TNoexwicaorklo., gyDelaware OK in the DuPont Records
Management Center, Wiloington, Delaware.
RESULTS
H-21095
produced
aild
eonjunctival
redness in the treated unwashed and moderate blood-tinged
eye.
Mild
conjunctiva! redness, observed in
slight cheaosis, the eye washed after
tre&fent.
The treated eyes
dooiffscbthooaxthrigeeriatywbbewrietesrewoebresenrvoerdaadl ubrying4 hthoeursstuadfyte. r Iinndsitviildlautaiol ney. e Nirorictalitnioicnal ssciogrness
are presented in Tables 2 and 3.
Does not conSam TSCfi.
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ou
COREE 0 SS HE
OF
Durst MERHCISECC
comcuuston
was 1 z BE
PelUndertthee ttnconditionsof thisote study, K-110%5v-as il, cransieiw biff |RHE
If these test scores are to be used for EBC/OECD classification, according to the guide to the labeling of dangerous substancesJubiishnd in
7 -
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i available, 4 i
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ETE IRRITATION TEST VITfl B-21095 TABU 1
Mma* SCALE you SCORING OCULAR LESIOHS
(1) Cornea
(A) Opacity-degree of density (area ost dense
taken for reading)
Ho opacity
Scattered or diffuse area, details of iris
.................... clearly visible
Easily discernible translucent areas, details of
................ iris slightly obscured
Opalescent areas, no deiails of iris visible,
............ size of pupil barely discernible
Opaque, iris invisible
..................... (9) Area of cornea involved
One quarter (or less) 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 vhole area
.
.
0
1 (Slight)
2 (Mild) 3 (Moderate) 4 (Severe)
1 (Localized) 2 (SBall) 3 (Moderate) 4 (Generalized)
(2) Iris
(A) Values Norcal Folds above nornal, congestion, swelling, circua-
...................... corneal injection (any or all of these or
combination of any 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) Rednecs (refers to palpebral and bulbar conjunctiva
excluding cornea and it is)
Vesseic noraal
Q
Vessel* definitely Injected above noreal
1 (Mild)
.................. Here diffuse, deeper criason red, individual
. . . . . vessels nut easily discernible
2 (Moderate)
........................ Diffuse beefy red
3 (Severe)
t lDoesrfofes^^^
7 -
Dufoat BLR 271-95
EYE IRRITATION TEST CTTH S-21095 TABLE 1 (Cont'd)
DRAIZE SCALE FOR SCaSSIB OCULAR LBSIOBS
(B) Chcmosis
No svelling Any svelling abo-'e normal (includes nictitating
................... aeBbrane}
Obvious svelling vith partial eversion of
................... lids
Svelling vith lids about half closed
..................... Swelling vith lids about half closed to completely
. . . . . . . closed
.................... (C) Discharge No discharge
Any amount different from normal (does not include
. . . . . . . . . . . . . . . . . . . snail aaounts observed in inner c^nthu'. of
normal animals)
Discharge vith moistening of the lids and
................ just adjacent to lids
Discharge vith moistening of the lids and
. . . . . . . . .......... and considerable area around the eye
hairs hairs,
1 (Slight) 2 (Mild)
3 (Moderate) A (Severe)
0
1 (Miniul)
2 (Moderate) 3 (Copious)
1 Draize, J. H., "Deraal Toxicity." Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. The Editorial Co--it tee of the Association of Pood and Drug Officials of the united States, Austin, Texas, 1959,.pp.
46-59.
^^^^.Does^ eonfafoTSCAGW
8 -
DuPcnt LX 271-95
EYE IRKITATIOM TEST VITB H-21095
TABLg 2
EYE IIUlITATIOti REACTIONS OBSERVED IN TBE
UNWASBBD RABBIT ETE
Rabbit Nunber" 30019
Cornea Opacity Area
Iris
Conjunctiva
Redness
Cheaoiis Discharge
"i----------5-
Hour
Hours
1----------g------------3-
Day
Days
Pays
0
0
0
0
Wzetf. 9 -
Rabbit Nurber 30020
Cornea Opacity Area
1
4
1
i
S
Hour
Hours
Day
Days
Om
0
0
0
0
0
0
0
0
0
C
Iris
Conjunctiva
Redness Cheaosis Discharge
0
0
0
0
0
1
0
0
0
0
1
0
0
0
0
2H+
0
0
0
0
H* - Heaastix* evaluation positive for blood