Document 9J85G3w6Znrozzn11dNqVVgrL
FOR DU FONT USE ONLY
AR226-2959 Pu Pent BLR 325-91
Skin Irritation Test vit
in Rabbits
I
Author
! John S. Server
Study Completed On i June 3, 1991
Parforming Laboratory
Haskell
E. I. du Ifont de Nefflours and Company
Laboratory for Toxicology and Industrial Elkton Road, P. 0. Box 50
Newark, Delaware 19714
Medicine
Laboratory Project ID Haskell Laboratory Report No. 325-91
Page 1 of 9
Company Sanfdzed. Does not contain TSCA CBI
In the absence of visible evidence to the contrary, the test material was assumed to
be stable under the conditions of administration.
Du Font Chemicals
E. I. du Font de Nemours and Company
Wilmington, Delaware
Company Sanifesd. Does not contain TSCA CBII-
Material Submitted By;
Study Initiated - Completed; In-Life Phase Initiated - Completeds
Notebook;
There are 9 pages in *':is report). Distribution:
Du pwt flex aa^i
ours and Coapany
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TSCACBI
Company Sanded. . nDoes nn ot contain
Du Font Bill 325-91
>n potential in 3 male md
> mild erythema by 24 and ght erythema was observed.
'as a mild skin irritant.
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Study Director:
L^3 - QQAA^g^y
3wn V. Sarver
l&achnologist
Approved by:
-N--a^np^-',C- ., ^k iCi hir.o.ffley,(/Ph.D.
Manager
Acute Toxicology
Reviewed and Approved for Issues
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Study Director
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Acknowledgements: C. Finlay ^Iso participated in the conduct of this study.
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Company Sanrfrzerf. Does not contain TSCA CBJ
STUDY: H# 18, Skin Irritation 'Test with
AUDITS: Item Audited
Protocol, Conduct Records, Report
SHORT-TERM AUDIT REPORT NUHBERy--------J
DATE FINDINGS REPORTED TO0,'i MANAGEMENT AND STUDY DIRECTOR: 5/20/91
Vicik^^Date Reported by: n^-ff\jCL>\, G xfipJL, 'Deborah A. I Quality Assurance Auditor
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Company Sanitized. Does not contain TSCA CBl
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Du Font W^m^
The purpose of (Nfi A;^ ofi--------hen applied to t rabbits. This study va9 'f^wS^
Laboratory Practice Regulations.
study records. No deviations
skin irritation potential
n of Nev Zealand Unite applicable EPA flood
liance are documented in the the validity of the study.
A. Animal Husbandry
i
Young adult male andl female Nev Zealand White rabbits were received from Hare Maryland, Sewitt, New Jersey. TAe rabbits were housed singly in suspended, stainless siteel, wire-mesh cagejs- Each rabbit was assigned a unique ident-iiicatlon number yhlch was recoided on a card affixed to the cage. Purina Certified High Fiber Rabbit^Chow81 15325 and water were available ad libituro except as noted unlife JgSj>tocol. Rabbits vere
quarantined, weighed, and observed for g^ei^ health for approximately 2
weeks. Animal rooms were maintained on a tiaer-controlled 12-hour light/12-hour dark cycle.i Environmental conditions of the rooms were targeted for a temperature of 20C 2c and relative humidity of 50% 10?. Any excursions outside these ranges were of small magnitude and/or brief duration and did nojt adversely affect tfte validity of the study.
B. Protocol
On the day prior to tr< atment, the hair of 3 male and 3 female New Zealand White rabbits was losely clipped to expose the skin from the
scapular to the lumbar reg: on of the back. the body weights of the rabbits ranged from 2415 t( 2708 grams on the day of treatment.
Each rabbit was placedjinto a stock which had been fitted with a
piece of rubber sheeting, Approximately 8" x 18". The rabbits remained in the stocks throughout the exposure period and <m->ng*ha*- n'jy did not have access Co food or watrr. Approximately 0,5 mL of|P----rtywas
applied directly to a 2-inch gauze square that vas then placed on the
^
test site. The patch was lield in place with non-irritating tape. The
rubber sheeting was then wrapped around the animal and secured with clips
to retard evaporation and ':o keep the test material in contact with the
skin without undue pressure.
Company Sanftizecf. Does not contain TSCA CB&
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rubber sheeting^w squares was ai^^l^i'3"''
vere then rfflo^|!.''.,^ _
^^^=i^|@^ to remove exc^'^iBpl:'i^|^(^^^^.
animals vere r^rnea
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Approximately 2A, 48, and I'aiipeiB
material, the tept sites vei'4? ^w|a^
evidence of dermal effects and ''were;
(Table I). The adjacent areas p^ .it%e
comparison.
application of the teat
rythena, edea and'other cording to the Draize scale
tied skin vere used for
C. Records-KeteHtion
i
All raw data and the final report wlH be stored in the archives of
Haskell Labor-1 wy for Txicoiogy and Ildu,st|Fial Medicine, E. I. du Font
de Nemours and Company, tevark., Delaware or In the Du Font Records Management Center, Viliniigton, Delaware.
RESULTS AND CONCLUSIONS
II. UIHUHyroduced slight jerythema in 2 rabbits and aild erythema in
rabbit by 24 hours after application. By 48 hours, slight erythema was
observed in 3 rabbits, and mild erythema in i. A nodule measuring
approximately 2 mm in diameter was observed uss the test site of 1 rabbit. By
72 hours, slight erythema va6 observed in 2 rabbits. The nodule was not
piir. esseennit.. Niiuo eedueemuiaa was o<UbUsBetirlvveedu tinhrruouuggHhOouuti tmhee study. Individual skin
irrrriitation scc;ores aa re pp resennteed in Table
A summary of skin responses is
presented in the fo lHloowiinng ts. iibbilcea.
Sunuioary ( .f Sikin Resp onses t
Response
24 hr
Er ytheroa 48 hr
72 hr
24 hr
Edema
48 hr
72 hr
No Response
3/6
2/6
4/6
6/6
6/6
6/6
Slight
2/6
3/6
2/6
0/6
0/6
0/6
Mild
1/6
1/6
0/6
0/6
0/S
0/6
Under the conditions of this study,H|BiBI was a mild skin irritant.
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Company Sanitized. Does not contain TSCA CBS
Du Font BUt 325-91 TABLE I DRAIZEl SCALE FOR SCORING PRIMARY SKIN IRRITATION
Evaluation of Skip Reaetiong
Erythema and eschar foraatloh: No erythema Very slight erythema (bajrely perceptible) Well-defined erythema ; Moderate to severe erytheaa Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Value
1 rslight) 2 (Mild)
3 (Moderate) 4 (Severe)
Edema formation:
No edema
Very slight edema (barely perceptible) Slight edema (edges of area veil defined by
definite raising)
Moderate edema (raised approximately 1.0 BB) Severe edema (raised mor^ than 1.0 mm extending
beyond the area of exposure)
1 (Slight)
2 (Mild) 3 (Moderate)
4 (Severe)
Abbreviations of other
A = Abraded
I = Intact
T = Thickening C = Eschar
- = No Effect
B = Blanching
dermal effects are: F = Fissuring
N = Necrosis G = Fissuring with
.Bleeding S = Epidermal
Scaling
L
Sloughing
R
Raw Areas
X
Compound Adhered
to Skin
SN Superficial
Necrosis
Draize, J. H., "Dermal Toxicity." 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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Romany SanH^oe^
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