Document ypzq50kBvvd5yVN6yM963KY43
FOR DU FONT USE ONLY
Skin IrritaKw
AR226-2946
Du Font HLR 112*90
In Rabbits
Study Completed On
March 5, 1990
PerformingLaboratory
Haskell
LEa. bIo.radtouryPofm|si r dTe oNxeicmooluorgsy anandd CIofmldpuansyt,riaInl cM. edicine
Elkt w Road, P. Q. Box 50
Newark, Delaware 19714
Laboratory Project ID Haskell Laboratory Report No. 112-90
Page 1 of 8 company Sanded. Does not contain TSCA CBf
GENERAL INFORMATION
Du Pont HLR 112-90
Material Tested: Medical Research No.: Haskell No.: Hasken Test Code Ho.'. Physical Form; Purity: Composition:
18,267 Amber dispersion
Synonym:
Stability:
Sponsor:
The test material was assumed to be stable under the conditions of administration.
Chemicals and Pigments Department
E. I. du Pont de Nemours and Company,
Milmlngton, Delaware
Inc.
Material Submitted By;
Study Initiated - Completed: In-Life Phase Initiated - Completed:
Teals and Pigments Department
E* I. du Pont de Nemours and Company,
Jackson Laboratory Deepwater, New Jersey
Inc.
2/2/90 - 3/5/90
2/6/90 - 2/8/90
Notebook:
There are 8 pages in this report. Distribution:
2 company Sanitized. Does not contain TSCA CBI
Sk1r> Irr1tatl|onTest with
DU Font HLR 112-90
hn Rabbits
SUNWRY
was evaluated for acute skin Irritation potential In 5 male'rabblts. _ie__te__st Material produced no dermal Irritation In any of th^reated rabolts during the study. Under the conditions of this study,
HUI^hras not a skin Irritant.
Work by:
/.tt^Utft. Ufc/^A Carol Finl^
Technician-
Study Director;
L^^\Jj.oohnnrin^BxyQ.s^AaAr.ve^r \ Technologist
Approved by:
^.B.A^k res E. Maiek, Ph.D.
Research Toxicologlst
Acute and Developmental Toxicology Division
Reviewed and
Approved for Issue:
^.^fiA^^ John lit. Sarver
Study Director
^/r/^o
Acknowledgment:
Cralg Lightcap also participated In the conduct of this
study.
JWS:a1r;HLR39.12
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STUDY DIRECTOR: 2/28/90
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DuPont HLB 112^0
The purpose of Wl
of f
when oppi 1
rabbits. This study w
Laboratory Practice (Dp;
the study records. No
validity of the study.
skin Irritation potential
In of New Zealand NMte
ke applicable EPA Good I lance are documented in niftcantly affected the
l|tttilBll^^^^
A. Animal Husbandry
NWl Young adult male New Zealand White r^l
Marl and, Hewitt, New Jeriify. ^he rabMl^ suspended, stainless stci t, lifye^eslca|l
unique Identification mil iber which was rec
were received from Hare housed singly In
Each rabbit was assigned a >d on a card affixed to the
cage. Purl na Certified I Kflh NNr
ft 9Q325 and water were
available ad llbltua exc pt as noted wrt^r, itocol. Rabbits were
quaranttne'ar weighe'd and observed for oert^ ;neaitn for approximately 2
weeks. Animal rooiiswepi?(i1i1<nedeNit^ ^controlled, 12-hour
Hght/12-hour dark cycle, EnylrenBiental'^i Itlons of the rooms were
targeted for a telBperatu < of 20*C * ? IH'iI relative humidify of SOS +
10%. Any excursions out >1de these Ganges wi |Ne of small magnitude and/or
brief duration and did n<t adversely affect the validity of the study.
B. Protocol
On the day prior to IstudyInitiation, Nlj? hair of 6 male New Zealand
White rabbits was closel, ' clipped to expiose l^ie skin from the scapular to the lumbar region of the back. The rabNtS^^body weights ranged from 2477 to 2733 grams on th day of treatment,
Each rabbit was placed Into a stock ih^%had been fitted with a piece.of rubber sheet1n< ,, approximately ^ ^18". The rabbits remained In the stocks throughoul fne exposureyey^^nd during that time did not have access to food or water. Approxi lately 0.5 mL of 1------frwas
applied directly on the test site beftea'tsh:C^-tnch gauze square that was held In place with non-Irritating t<lpe ^ rubber sheeting was then
wrapped around the animal and securedwflsh ^Ips to retard evaporation
and to keep the test material In contact witn the skin without undue pressure.
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WM^ One rabbit died during
exposure period, ^ross pathological
examination revealed no abnoi attributed to stress associa'
iI lwltf^^hs.^
the ideaftD.of this rabbit was,
le^N ^ restraint. ------
produced no dermal Irritation In any o* the rtiallBing rabbits during the
study. Individual skin Irrit ttion scp'res ape presented In Table II. A
sumnary of responses Is prese ited In the
table.
Summary of Skin Responses
Response No Response
Erythena
zrnr aihr
5/5 . 5/5
Edema
24 hr 48"nr"
5/5
5/5
Under the conditions of wts study.
'was not a skin Irritant.
6 Company Sanitized. Does nol fconlam TSCA CBl
^.a'iW'sH"
Du Pont HLR 112.90
!
TWLC I
PRAIZg1SCALE FORSCORIN6 PRIMARY SKIM IRRITATION
Evaluation of Skin Reactions
Erythema and eschar formation:
No erythena
;
Very slight erythema (barely perceptible)
Well-defined erythena
Moderate to severe erythema
Severe erythema (beet redhess) to slight eschar
formation (Injuries In! depth)
Value
1 (Slight) 2 (Mild)
3 (Moderate) 4 (Severe)
Edema formation:
No edema
Very slight edena (barely perceptible) Slight edema (edgeiss o< f area well defined by
definite raising) Moderate edema (raised approximately 1.0 nm)
Severe edema (raised more'than 1.0 mm extending beyond the area of exposure)
1 (Slight) 2 (Mild)
3 (Moderate)
4 (Severe)
Abbreviations of other
Abraded
Intact
Thickening
Eschar
No Effect
Blanching
dermal effects are: F = (assuring
N = Necrosis G s Fissuring with
(Heeding
S = Epidermal
Scaling
L Sloughing
R
Raw Areas
X Compound Adhered
to Skin SN Superficial
Necrosis
1
Draize, J. H., "Dermal Toxiclty."
Appraisal of the Safety of Chemicals
In Foods, Drugs and Cosmetics, The Editorial Committee of the Association
of Food and Drug Officials Of the United States, Austin, Texas, 1959, pp.
46-59.
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RabMt
^^TirT ^
Number 24565 24566 24567 24568 24569 24570
'
5 5 ^ MUJ&
'^y'^*""'5f F W
Ed
jill hr 48 ftP
9
0
0
0
0
0
0
0
0
0
0
0
^
: 0
0
l
1
j 0
0
-
-
0
0
0
0
Rabbit dieflduring the exposure period.
Company Sanitized. Does not contain TSCA CBI