Document Dj9gGqa6q1jLMEvJ4k6d6GJ5
AR226-2833
9 w k M m ,' B I O -TEST
1810 FR O N T A G E RO AD NORTHBROOK, ILLINOIS 60062
9m .
i; REPO RT TO
E. I. du PC'iNT de NEMOURS & COMPANY s k in se):NSITIZATION TESTS WITH FOUR SAMPLES IN AT.RINO GUINEA PIGS
A P R IL 12 1973
i
Company Sanitized. Does not contain TSCA CBI
9w $u ibU cil 8 1 0 - T f ST
1810 FRQNfAGf .RjOAgv
NO ?TH:BROOK, I1NQIS ||o 6 2
Dnc.
il 12. 1973
Chief, Oral Toxicology Section E. I. duPont de Nemours <: Company Haskell Laboratory ; Wilmington, Delaware 198j?8
-r i-:
Re: Skin Sensitization T ests with >ur Samples jin Albino Guinea Pigs -
We are submit! ing. herewith onr;laboratory report dated
April 12, 1973, prepared in connection with the above study.
Very truly yours,
^'** -- ***--
J . C. Calandra President:
JCC: sjn
I v|
J
iff
Company Sanitized. Does not contain TSCACBfi !e i
iiiS m m m MM
REPORT TO PO NT de NEMOURS k COMPANY
NSITIZATION TESTS WITH FOUR SAMPLES
ALBINO GUINEA PI0S
APRIL 12, 1973
I. Introduction
At the req u est of E . I du Pont de N em ours & Company, a skin s e n s i
tization te s t w as conducted with each of four sam p les. The sam ples w ere
identified as:
I
1) H-7857 2) H-7858
3) H-7859 4) lk-7860
ii I
Company Sanitized. Does not contain TSCA CBI
2
II. Summary
The resu lts of the sk n sensitization tests in albino guinea pigs are sum m arized below.
T est Materilal
R esu lts
Not a Sensitizer
A Sensitizer
Not a Sensitizer
A Sensitizer
R espectfully submitted,
INDUSTRIAL BIO-TEST LABORATORIES, INC.
Report prepared by:
fj^,. ,j e v earvlleatyr'l TK<Tretchm a rt Technician
Acute Toxicity
Report approved by:
Carmen M astri, B. S. Senior Group Leader Acute Toxicity
bc:psh
Ph.D. f
Company sanitized. Does nof contain TSCA CB/
3
iiiiiSeL
ip p P H iS
htiudal BI O *T E S T JalowiyUel, jiW.
Ill, Investigational Procedure The sam e procedure was followed with each te st m aterial. Ten
albino guinea pigs ranging in body weight from 300-400 gram s w ere used as test anim als. The test procedure was m odeled after that of E. V. Buehler*.
P rio r to the test, the irritation threshold was determ ined for the test m aterial in the appropriate veh icle and the m axim um non-irritating concentration was used for testing, The hair was clipped from the backs and flanks of the te st anim als, and closed patches were applied in the following manner: A W ebril pad containing 0. 5 m l of the test solution was applied near the m idline of the shaved back of each anim al. The W ebril pad was occluded with a standard size E lastoplast coverlet (1 -1 /2 inch x 2 in ch es), and each anim al was placed in a guinea pig re strain er for a six-h ou r exposure period. The anim als w ere insulted in this m anner nine t im e s . T w enty-four and 48 hours a fter the in itia l in su lt and 24 hou rs after the rem a ning eight insults the application site s w ere graded for i r ritation.
* B u eh ler, E . V ., "Delay ed Contact H y p ersen sitiv ity in the Guinea P ig , " Arch, D erm at. 91, February 1965.
Company Sanitized. Does not contain TSCA CB1
*
itviaiUial B I O- T E S T JaityuiUtiei,
TABLE I
Skin Sensitization T est - Albino Guinea P igs
Scoring C riteria for Skin R eactions
R eaction
description
Score
E rythem a Edema Injury in Dep'h
B arely perceptible (Edg ts of area not defined)
P ale red in color and a rea definable
D efinite red in color and area w ell defir ed
Beet c r crim son red in color
Bareljr percepti (Edg es of area not defined)
A rea definable but not raised m ore than 1 mm
A rea w ell defined and ra ised approximately 1 mm
A rea raised m ore than 1 m m
E scharosis, N ecrosis
Maximum Prim ary Skin Irritation Score
2 3 4 1
4 8 8
i
a :1
a tta in tsca CBI
9ttdt<&btial BIO T E S T Jaio'taiyUei,
6
IV. R esults The resu lts of the skin sensitization te sts are presented in T ables
II - XIV.
,
j
i
! Company Sanitized. 0es riof contain T8CA CBI
B10 T E S T lnkmkikKt, me.
jga'fc*-. \IS tr
TABLE H
TEST M A T E R IA L ^ B i^ ^ --
H -7857
Skin S en sitiza tio n T e st - Albino Guinea P ig s
R.e su its - R a n g e -F in d in g G roup
S co res Follow ing A pplication
Site 1
Site 2
-
--
Test Gon c
M aterial c a t ra tio n --------------------
--
A nim al N u m b e r --------
------
24 Hours E r .------- E d
r
---------
48 Hours E r , -------E d
24 ,------------- E r .
H
o
ur E
s d
___
48 Hours
V-*
0. 1% (w /v ) A queous Solution
I . 0% (w /v ) A queous Solution 0O 10. 0% (w /v ) A queous Solution 1a 3<
1 2
3 4
5 6
00 00
00 00
00 0o
00 00
00 00
00 00
00 00
00 00
10 00
0o 00
0o 00
0n 00
Key:
Er. = Erythema
f Ed. = Edema
ife.:; iffiSitii
.iiV i ''' it '
-
i ^ l i x , ' .
T A B L E HI
TEST MATERIAL: 1. 0% (w /v ) .^nueous S o lu tio n of H -7857
Skin S en sitization T e st - A lbino Guinea P ig s
R esults - T est Group
Anim al N um ber
S cores Following Initial Application 24 Hours 48 Hours E r . E d.___ E r . E d .
1 2 3 4 5 6 7 8 tf) 9 10
5.
Key:
000 000 0 0 1 000 000 000 600 00 000 000
0 0 0 0 0 0 0 0 0 0
3 Er. = Erythema
8 Ed. = Edema
aa
S cores Follow ing C hallenge A pplications
Insult Site:
V irgin Site*
24 H ours
48 Hours
24 Hours
48 Hours
E r. Ed. E r. Ed. E r. Ed, E r.
Ed.
000 00 00 0 00 00 0 0 00000 00 0 00 0 0 0 0 1000 100 0 .o 0 0 0 0 0 0 o0 00 00 o 00 0 0 0 0 0 00 00 o 0 0 00 00 00
o o
0 0 0 o o o o 0
> o
09 O m iO fe* g1 -7 II S i'l
V.'.'i 'i!
'-is .rMfSii*
oo
hukiihial BI O T E 5T
,%k.
t a b l e iv TEST M A T E R I A L ^ ^ ^ j # | ^ # J | Solution of
A nim al Number
1 2 3 4
Skin S en sitiza tio n T o st - AJfci.no g u in e a P ig s
R esults - Control Group
S c o r e s F'oliow ing C hallenge im p lica tio n
Siite 1 .
'!'v' /?)
Site 2
24 Hours
4$ Hours
24 Hours
48 Hours
Er. Ed.
E r . E d . : .. M r . Ed.
Er. Ed.
00 0 Ot 00 00
00 06 60 q0
00 00 00 00
00 00 00 00
Key:
Er. = Erythema Ed. = Edema
dmftafty
Does not contain t s c a CBI
Dndiiihal BI 0 - T E S T lalMabnieA, /ft
Company Sanitized. Does not contain TSCA CBI
T est M aterial C oncen tratio n 0. 1% (w /v ) A queous S olu tion
1. 0% (w /v) A queous S olu tion
10. 0% (w /v ) A queous S olution'
Key: Er. = Erythema Ed. = Edema
TABLE V
TEST MATERIAL: j4 M M M n jH -7 8 5 8
Skin S en sitiza tio n T e st - A lbino Guinea P ig s
R esults - Range-Finding Group
S cores Follow ing Application
Site 1
Site 2
24 Hours
48 Hours
24 Hours
"E d :------- E t ~.------- E d r
48 Hours
1 2
00 00
00 00
00 00
00 00
3 4
00 00
00 00
00 00
00 00
5 6
00 0
00 00
0 0 0
00 0
:kl
i s a i - o i o jw p w
TABLE VI
TEST MATERIAL; 10. 0% (w /v q u eou s S o lu tio n of H -7858
Skin S en sitiza tio n T e st - Albino Guinea P ig s
Anim al -N'Uinhp-r
Scores Following
Initial Application 24 H ours 48 Hours TTr
R esults - T est Group
Scores Follow ing C hallenge A pplications
,, Insult Site:
24 Hours
48 Hours
V irgin Site:
24 Hours
48 Hours
Company Sanitized. Does not contain TSCA CBI
1 2 3 4 5 6 7 8 9 10
Key:
00 0
00 0
000
00 0
00 0
00 0
00 0
00 0
00 0
10
0
0 0 0 0 0 0 0 0 0 0
0 1 1 1
0 0 0 0
1 1 1 2
0 0 0 0
0 0 0 1
0 0 0 0
0 0 1 1
0 1
0 0
1
2
0 0
0 0
0 0
0 0
1 0 1 1 0 1
0 1 1
0 0
0
1 2
2
0 0 0
0 1 1
0 0 0
0 1
0 0 0 0 0 0 0 0 0 0
Er. = Erythema Ed. = Edema
TABEE VU -: TEST MATERIlJ: 0; % (W v ^ q u g u s Solution of
A nim al Number
1 2 3 4
Skin S ensiti? 3fi^|i T est - Albino Guinea P igs
Re ihilts - Control Group
'Scories Fily/ing C hallenge Application
Site
-"J . S ite 2
24 Hours
4 iHours
-24 H ours
48 Hours
E r. Ed. . Er.;- Ed.
E r. Ed.
Er. Ed.
10
00
Q0
0 0 4 'i r o '
0
0 0
0. 0
0
0 ; /. Or
o
rb 0
00 00 00 00
Key:
Er. = Erythema Ed. = Edema
Company Sanitized. Does not contain TSCA CBl
V
TA BLE VIII
TEST MATERIAL:
H-785 9
Skin S en sitization T e st - A lbino Guinea P ig s
R esults - R ange-Finding Group
T est M aterial C o n cen tra tio n
A nim al N um ber
0. 1% (w /v ) A queous Solu tion
1 2
?.:, 1- 07# (w /v ) A queous S olu tion
oo
3tsu<s 10. 0% (w /v ) A queous Solution
0) O3J -
N(0 Key:
a.
oaw 3
Er. Ed.
= Erythema = Edema
3 4
5 6
S cores Follow ing A pplication
Site 1
Site 2
24 Hours
48 Hours
24 Hours
48 H ours
E r. Ed.
E r. Ed.
Er. Ed.
Er. Ed.
00 00
00 00
00 00
00 00
00 00
10 10
00 00
10 10
00 10
00 10
10 10
1 0' 10
M V -i
S 'il
"'H .vfj
to
lot contain TSCA CB1
i~i^ gkii'n}3t
mm
m
Unduittial BI 0 - T E ST Ja&yiaktici, Ate.
TA BLE IX
TEST MATERIAL: 1% (w /v ) A q u eo u s Solu tion of M M M H lN H -7 8 5 9
Skin S en sitization T est - Albino Guinea P ig s
R esults - T est Group
r --
1
Anim al 24 Hours 48 Hours
; N um ber E r . Ed. E r . E d .
Scores Follow ing Insult No.
5
4
24 Hours 24 Hours 24 H ours
Er. Ed. E r. Ed. Er. Ed.
5
24 Hours Er. Ed.
6
24 Hours Er. Ed.
7
24 Hours Er. Ed
l:
r;Vv
9 3
N'
; a. 1 5`
Poa 8
a3
roo*
S' 3* (/) O> h-o^
1
0010
2 02 0
2
l 010
2 010
3
0 00 0
2 010
4
0000
-
__
5
l 010
2 o2 0
6
q010
2 0 10
7
0000
2 0 10
8
l 010
2 02 0
9
0000
1010
10
0010
102 0
1 000 1010 1010
_
1010 1010 1 0 10 0010 1010 0010
10 20 10
10 10 10 20 10 10
10 20 1 0
11 20 20 20 20 20
Key: E r. = Erythema Ed. = Edema
- = Animal died.
N ote. T e s t m a te r ia l con cen tration w as red u ced to 0. 01% p rio r to in s u lt N o. 4 and th e in su lt s it e w as ch an ged due to increased irritation. The anim als were insulted seven tim e s rather than nine in order to m in im ize skin fatigue.
ii i
TEST MATERIALyjG^O ^ K v/v^ Q aeQ ub Solution of
. 1 /' ' ; i(iA" ' Skin Sensitization T e st - Albino Guinea P igs
B e s ulte. * T e s t G roppi;,
A nim al Number
1 2 3 4 5 6 7 8 9 10
S co res Following^ Chsijllenge A pplication
Insu;It S ite
Virgin Site
.
24 Houys
48 Hours
'24 Hours
48 Hours
Er, Ed
Er/:. Ed %..'^.;|Sr. Ed.______E r . Ed.
1 0 .. ,# ; 0 - :- I 1 0
1
0' 1
' o
0
10
2 : -.0:1 l l i i l o
0
--
-
10
2Q 20
2 0 I li 0
2 ,d , I: .i? 1
0
20
10
10
20
10
10
1
2 0 . "2 : 0 : l
0 0
..1*5
00 00 10 4
10 10 10 10 10 20
Key:
Er. = Erythema Ed. = Edema
- = Anim al Jied.
-SiIt
!-vt.|{l
i M II
`Sjjfct
via
Comparty Sanitized. Does not contain TSCA CBI
<%!
A nim al Number
1 2 3 4
Skin Sensitizsaftion T est * Aibaho to r n e a P ig s
'
.
. 'ey*"
R eiu lts - Control rouJ>
S cores Follow ing Challenge Application
Slf 1
.
- Site 2
24 Hours E r. Ed.
48 'Hours ' 24 H ours
E r. Ed. Mr. Ed.
48 Hours Er. Ed,
10
10
:-i 0
2
2 b - fill
0
1
10
i0
1 0 :' 1 0
i0
10 10 10 00
Key:
Er. = Erythema Ed. = Edema
-Ir:-#he 4 i H;5 Ih
:';MVT-j
'/iifl ``43
v;:'u25i i!S9
- -.0% "PM
ai p
3.ri&TA
c mpany Sanitized. Do
fefnrsCACB/
PsiytffiiftrP-'y
'*'*C 'MityMoyo? 1 s 3 1 * O IQ 7z?vr,,/ w^'
T est M aterial C o n cen tra tio n
0. 1% (w /v) A queous Solution
1. 0% (w /v ) A queous Solution
'>x3m3<> 10. 0% (w /v) A queous Solu tion 30w) Key: M % Er. = 00oo)) E d . = O3 Oo
3
:
S53'
T A B L E XII
TEST MATERIAL:
H -7860
Skin S en sitization T e st - A lbino Guinea P ig s
R esults - R ange-Finding Group
S cores Follow ing A pplication
Site 1
Site 2
24 Hours
48 Hours
-E r ------- E d .-------- E * , E d .
24 Hours
48 Hours
Er.-- E d ; ------- E r , E d .
1 2
00 00
00 00
00 00
00 00
3 4
00 00
00 00
00 00
00 00
5 6
00 00
00 00
00 00
00 00
StuLiit/dal BI O- T E S T JaiMafotw, fa .
Company Sanitized. Does not contain TSCA CBJ
T A B L E XIII
TEST MATERIAL: ^ 10. Q% ( w / v ^ q u eo u s S olu tion of t a i l l i a t f H-786 0
Skin S en sitization T est - Albino Guinea P ig s
Anim al -Num ber
Scores Following
Initial Application
24 Hours 48 Hours
F .r. EM
__ ^d
1
000
0
2
0 0 .0
0
3
00 0
0
4
000
0
5
00 0
0
6
000
0
7
o' 0 0
0
8
000
0
9
000
0
10
00 1
0
R esults - T est Group
Scores Follow ing C hallenge A pplications
Insult Site:
V irgin Site:
ZA H ou rs
48 Hours
24 Hours
48 Hours
zE r. Ed. Err Ed. E r . ~ Ed. ~ E r .-- ---- En
0 1 0 1 1 0 0 1 1
0 0 0 0 0 o 0 o 0
0 1 0 1 1 0 1 1 1
0 0
0 0 0 0 0 0 0
0 0 0 0 0 0 0 0 0
0 0 0 0 0 0 0 0
0 0 0 0 0 0 1 0 1
000 00 0 G
0 0 0 0 0 0 0 o 0 0
Keys
Er. = Erythema Ed. = Edema
00
in ^ riti.
TEST M ATERIAL:_J0, Q% (w /v^A queous Solution of IM H-7860
Skin Sensit .zation T est - Albino Guinea P ig s '. "
le suits - Control Group
|| 'S |
A nim al Number
1 2 3 4
Key:
Scores Following Challenge Application
Site 1
'I S ite 2
24 Hours Er. Ed.
48 H ours ':7: 24 H ours
Er. Ed.
Er. Ed.
48 Hours Er. Ed.
10
00
00
00
00
00
00
00
00
00
00
00
..
..... ^
:
00 00 00 00
J '-ii
| 1
j .j
| 1
' Vi[4
> Er. = Erythema Ed. = Edema
