Document 6wvYDx2xL1wgZO82qE40vgmOg
.
e
AR226-3060
Study Title
100-Person Human Patch Test with H-21936 (Test Item)
Laboratory Project ID Haskell Laboratory Report No. 713-96
Study Completed On September 30, 1996
Contracting Laboratory
ConTox Limited 3408-50 B Street Philadelphia, Pennsylvania
19134
Author
David Gabriel
for
E. I. du Pont de Nemours and Company Haskell Laboratory for Toxicology and Industrial Medicine
Elkton Road, P. 0. Box 50
Newark. Delaware 19714
Study Monitor Gregory S. Ladies
^____
--^ ,_
Page I of 19 Company Sanitized. Does not contain TSCA CB^
Material Tested: Physical Form: Synonyms:
GENERAL INFORMATION
Test Material
C?
Clear Water Liquid
DuPontHL0713-96
I
Comnosition: Stability:
Study Initiated - Completed: In-Life Phase Initiated - Completed:
In the absence of visible evidence to the contrary, the test materials were assumed to be stable under the conditions of administration.
DuPont Specialty Chemicals E. I. du Pont de Nemours and Company Wilmington, Delaware
8/14/96 - 9/30/96
8/14/96-9/18/96
QvSSftetfS^ sSfMsiliiAfcttr b'i;.tg& :'.0i vQ't'.i&Kt 'i OfcA Cp(
DuPontHL0713-96
DUPONT CENTRAL RESEARCH AND DEVELOPMENT HASKELL LABORATORY FOR TOXICOLOGY AND INDUSTRIAL MEDICINE
October 8.1996
DuPont Specialty Chemicals Chamber Works
100-Person Human Patch Test with H-21936 (Test Item)
Attached is a report from ConTox Limited (Project No. 96-8342H). report are patch test methods, results, and conclusions.
Included in the
The purpose of this study was to determine the potential of H-21936 to cause irritation or delayed contact hypersensitivity in humans. During the induction and challenge phases of this study, H-21936 (Test Item) produced no adverse skin responses in 100% and 100%. respectively, of those subjects who were active participants.
Based upon the effects observed with the test materials placed repeatedly on the skin during both the induction and challenge phases, H-21936 (Test Item) is not considered to be a skin irritant nor a sensitizing agent under the conditions that prevailed in this study.
Gregory S. Ladies, Ph.D. Research Toxicologist
wfS8j^
Company SanRized. Does not contain TSCA C@i
DuPontHLO#713-96
ConTox Limited
P.O. Box 368. Fort Washington, Pennsylvania 19034-0368 Telephone: (215)739-4499 Fax: (215)423-9210
ErnifieLNumher:
96-8342H
Testing Facility:
ConTox Limited 1358 Lycoming Street Philadelphia, PA 19124
Sponsor:
E.I. du Pont de Nemours & Company
P.O. Box 50, Elkton Road Newark, DE 19714
Test Article:
H-2i936
Test Article Description:
Pale yellow clear liquid
Test Article Received:
08/08/96
^lud^imiiatsd: Date of Report: lesi: Object of Test: Reference:
Method 01-Test:
08/14/96
Study Completed: 09/18/96
09/30/96
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
To determine the sensitizing properties of the test article.
The method employed in carrying out this test was similar to that
described in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" by J.H. Draize and published by the Association of Food and Drug Officials of the United States.
Test Panel: The test involved the application of the test article to the upper arms of a group of 111 volunteer panelists. The panelists ranged from 18 to 70 years of age (see Panelist List. Appendix II). One hundred and five panelists completed the study. Prior to the initiation of the study. all panelists were in good general health and free of any visible skin
disease or anomaly in the area to be patched. Each panelist was required to read. understand and sign an informed consent statement.
Page 4
aBBpeanSyaBRteed. Does no9 contain TSCA GBS
Project Number: 96-8342H I-:. 1. du Font de Nemours & Company - tl-21936
.
DuPont HLO # 713-96
Modified Draize Repealeu Insult Patch Test Study in Human Volunteers
Method of Test:
(continued)
Patch Preparation: The test article was tested as supplied. Approximately 0.2 m'. of the test article was applied to a 3/4" diameter cellulose fiber disc
(Lintine disc. Filter Fabrics, Inc., Goshen. IN 46526) which was attached to a strip of 2" Dermicel* hypoallergenic cloth tape (Johnson & Johnson, New Brunswick. NJ 08903). This tape strip was then pressed into place on the upper left arm of each panelist at its designated test site.
Induction Phase: The patch was applied to its designated contact site and
remained in place for 24 hours. At the end of this period, the patch was removed and the site was examined for any dermal response. The panelists
were then rested for a 24-hour period after which the skin site was again examined. A new patch was then applied to the same site as previously used. Each subsequent application was identical to the first and remained in place 24 hours. This procedure was repeated on Mondays, Wednesdays and Fridays until a series of nine applications had been made. Patch applications made on Friday were removed by the panelists on Saturday.
The panelists examined the sites (with assistance if necessary) for any
dermal response at the time of removal and again at 48 hours and reported their observations prior to the next application. The same site was used
throughout the study.
In the event when one induction application was missed, the panelist was allowed to make it up at the end of the induction patch period. This patch was applied on Wednesday following the last scheduled (ninth) induction application on Monday.
Challenge Phase: After the 9th application, a rest period of approximately 2 weeks elapsed after which a challenge application was applied in the
same manner and to the same site as originally patched. A duplicate challenge application was also applied in the same manner to a virgin site (previously untreated) on the other arm. The challenge applications were removed after 24 hours and the sites were examined and graded for signs
of irritation or sensitization. A follow-up examination was conducted at 48 hours after the challenge applications (24 hours after patch removal).
The grading scale used throughout both the induction and challenge
phases is shown in AppendixIII.
- 5 - (. (inliix l.iniilcil - I'd H"\ IhX. I nrl Wa.shini:ln, Pennsylvania 19034-d.lhX
eoropany SMMS2<i. Does no2 extern TSCA QW
Project Number: %-8342H
DuPon(HLO#713-96
K.l.du Pont deNemours & Company - H-21936.
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Results: Conclusion:
Results obtained with the test article (H-21936) are presented in Appendix I. Individual panelist data are presented in Table I. A summary of the data is presented in Table 2.
From the results obtained with this test panel under the test conditions utilized, the test article does not appear to be a primary skin irritant. The test article does not appear to be a fatiguing agent. The test article does not appear to be a sensitizing agent.
Signatures:
Submitted by ConTox Limited:
^^i/ lu^t^M
Fi;derickUrbach.M.D.
/ Consultant Dermatologist
/XyA<^c/ lU^L^M.^
Ray/mond Mark, M.D. Study Director/Consultant
Approved by:
f / ^ DaTMt*^e
'
k^{ f. ^J.^^J//l^^A/ A,^^ J- .
Karl L. Gabriel. V.M.D.. Ph.D.
President
/o/^/^i. /^Bate''
- 6 - t'nn'liiv l.iinilcil - I'.O Hn.\ JftX. l-'nn Washington. I'clin.si Ivania IWI.M-OJAX
Company Sanitized. Does not contain TSCA CBt
Project Number: 96-8342H
DuPontHLO# 713-96
E.I. diiiPont deNemours ^Company"- H-2T936--- -
----
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
-_--
APPENDIX I RESULTS FOR TEST ARTICLE
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Gomspany Sanitized. Does not contain TSCA CE8
Project N.lumber: 96-8342H E.l.duPont de Nemours & Company - H-219 36. a ssupplied. Modilleci Draize Repeated insult Patch Test St udy n Hunnan V ulunlecrs
DuPont
Tahls' 1 - Individual Panelist E>ata C
InLductign Phase
Ori
Panel ist
1
2
3
4
5
6
7
8
9
10* *
S
Numbel 2448 2422 244S 24 --4S 24 72 244fi 24 -as
1
0
0
0
0
0
0000 00 00 00 ^
0
0
0
0
0
00 00 00 ^
j
0
0
0
0
0
244 24 -4&
IS
0
0
0
0
0
0
0
0
0
24--
0
0
0
0000 A
0
0
0
0
0
0
0
0
0
000000 0000 5
0
0
0
0
0
0
0
0
0
000000 0000 6
0
0
0
000000 0000 00 00 00 7
0
0
0
0000 00 00 00 8
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0000 9
000000 000- 10
00
00
00
0
0
0
0
0
0
0
U
0
0
0
0
0
0
0
0
0 0
0 0
0 0
0000 "
000000 1
0
0
0
0
0
0
0
0
1 -
000000 0000 '- 00 000000 0000 i 13
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
000000 0000 00 00 00 14
15
0000 0
0
0
0
0
0
0
000000 0000 j
16
"1
17
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
000000000000 00000000 5
18
000000
'
000000 0000
20
0
0
0
0
0
0
G 0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
000000 0000 00 00 00 11
21
2
22
0000 a,
23
000000 0000 D
0
0
0
0
0
0
0
0
0
000000 0000
24
0
0
0
s
->5
0000000000 00000000 ^
00 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
0
1 &
<?
24 = Reading 24 hours after application.
48 = Reading 48 hours after application.
- = Missed reading.
1-
72 = Reading 72 hours after application.
:<
* = Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application
U1
day, and the patch series extended unitil 9 induction applications were applied.
>
* = Make-up patch application.
0
D = Discontinued from the study for personal reasons,
B-
-n -
CoxiTox Lhniica - P 0 Pw 368. Fon Wuhbifloii. Paniylvmil 190344I61
Projcci Number: 96-8342H [ I du Pom de Nemours & Company - H-21936. as supplied. Modified Draize Repeated Insult Patch lest Slud\ in Human Volunteers
DuPonlH
Table I - Individual P inelist Data a
IndludifliiEhasi&
Origi
Panelist Number
26 27
1
-^( 48
0
0
0
0
}
-It n
0 0
0
0
3
24 -18
0
0
0
0
4
24 -M
0
0
0
0
5
-i
n
0
0
0
0
6
24 -48
0
0
0
0
7
24. -48
0
0
0
0
8
1A T
0
0
0
0
9
24 18
0
0
0
0
10**
2418
Sit 24
0 0
28
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2*)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
30
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
31
0
D
D
D
U
D D
D D
D D
D D
D D
D D
D
D
^
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
33
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
34
0
0
0
0
0
0
-
0
0
0
0
0
0
0
0
0
0
0
0
35
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
36
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
37
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3S
0
0
0
0
0
*
-
0
0
0
0
0
0
0
0
0
0
0
39
0
0
0
0
0
*
-
0
0
0
0
0
0
0
0
0
0
0
000000 40
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4)
0
0
0
0
0
*
-
0
0
0
0
0
-
0
0
0
0
0
0 0 0 43
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
43
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
44
0
D
D
D U
D D
D D
D D
D D
D D
D D
D
D
45
0
D
D
D D
D D
D
D
D D
D
D
D D
D D
D
D
ss
46
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
N
47
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
48
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
50
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
24 - Reading 24 hours after application.
- = Missed reading.
48 - Reading 48 hours after application.
72 = Reading 72 hours after application.
= Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application
g day. and the patch series extended until 9 induction applications were applied.
* = Make-up p.nch application.
D = Discontinued from the study for personal reasons.
0
-n-
ronTox Limned P 0 Box 36. Fon Wtshmglon. remisylvnr IW)4-0)68
Project Number: 96-834211 1. 1. du Poni do NcnuHirs & C"ompan\ H-21936. as supplied. MoJinnl DraiA' Rcpeatril Insull Patch Icsl Sludy in Human Vtilunlfcrii
DuPont H
Panelist
1
1
Number 2A -JLS ^A TI
^ 1
0
0
0
0
5^
0
0
0
0
53
0
0
0
0
54
0
0
0
0
55
0
0
0
0
56
0
0
0
0
57
0
0
C
0
58
0
0
0
0
59
0
0
0
0
60
0
0
0
0
61
0
0
0
0
3
2A-...AS
0
0
0
0
.)
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Table I - Individual Panelist Data
ln(IDCUOIiPhasie
4
5
6
2A -AS -1,1
0
0
0
J') 2A
1S
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
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
U
0
0
0
0
0
0
0
0
0
0
0
0
0
0
7
2A -AS
0
0
0
0
0
0
0
0
0
0
0
0
0 ,0
0
0
0
0
0
0
0
0
8
1A
-71
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
9
2A 4S
0
0
0
0
0
0
0
0
0
-
0
0
0
0
0
C
0
0
0
0
0
0
10**
.a48
C Orig
S 24
0 0 0 0 0 0 0 0 0 0 0
62
0
0
0
0
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
63
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
64
0
0
0
0
0
*
-
0
0
0
0
0
0
0
0
0
0
0
0
0 0 65
0
0
0
0
0
-
0
0
0
0
0
0
0
0
0
0
0
0
0 0 66
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
67
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
68 60 70
71
n
73 74 75
24 = 48 = 72 =
*
-
** =
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
3
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
0
U 0
0
0
0
0
0
0
0
0
U
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
D
D D
D D
D D
D
D
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
*
- 0 0 0 00
0
Reading 24 hours after application.
- = Missed reading.
Reading 48 hours after application.
Reading 72 hours after application.
Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application
day. and the patch series extended until 9 induction applications were applied.
Make-up patch application.
D = Discontinued from the study for personal reasons.
C'onlox Limited P 0
-n-
Box lb8. Fon Washington. Penluylvttix {9014.0168
Project Number: 96-8342H E.I. du Pom de Nemours & Company - H-21936, as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPont
Table 1 - Individual Panelist Data
Panelist Number
76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 9! 92 93 94 95 96 97
98 99 100
,
2
T.1 48 34
7^
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
n
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
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
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3
24 -48
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
0
0
0
:
-
0
0
0
0
0
0
0
0
0
0
0
0
0
IndLUCUO1I Phasi*
4
5
6
24 -as 4
0
0
0
72 24 -4fi
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
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
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
0
0
0
.
0
0
0
0
0
0
D
D
D D
D
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
0
0
0
0
7
24 -48
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
0
0
0
0
D
D
0
0
0
0
0
0
0
0
0
0
0
0
8
73
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
0
0
0
0
D
D
0
0
0
0
0
0
0
0
0
0
0 0
9
24 0
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D 0
0 0 0 0 0
10**
48 2448
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
0D 00
0 0 0 0 0 0
C Ori
S 24
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D
0 0 0 0 0 0
24 -- Reading 24 hours after application.
48 = Reading 48 hours after application. 72 = Reading 72 hours after application. * = Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application
day. and the patch series extended until 9 induction applications were applied.
** = Make-up patch application.
COTToi l.imiled P 0 Bo< 161. fon Wuhlngton. PcrmlyKuir IW34-0168
Projeci Number: 96-8342H E.I. du Pont de Nemours & Company - H-21936. as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPontH
Panelist
,
Number 24 15
101
0
0
102
0
0
103
0
0
194
0
0
105
0
0
106
0
0
107
0
0
108
0
0
109
0
0
110
0
0
III
0
0
2
1,1
73
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3
24 ia
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
Table I Individual Panelist Data
ln<ludiu nPha se
4
5
6
24 -48 14
0
0
0
73 24 -4&
0
0
0
0
0
0
D
D
D
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 0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
7
24 -48
0
0
D
D
0
0
0
0
0
0
0
0
-
0
0
0
0
0
0
0
0
8
24 -22
0
0
D
D
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-
0
0
0
9
24 48
0
0
10**
2445
D
D
0
0
0
-
0
0
0
0
000 0
0
0
0
0
0 0
00 00
CI Orig
Si 24
0 D 0 0 0
P
U
0 0 0 0
sf Wt
P-
24 = Reading 24 hours after application.
48 = Reading 48 hours after application.
- = Missed reading.
72 " Reading 72 hours after application.
w
* -= Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application
B
day. and the patch series extended until 9 induction applications were applied.
ft
C
** = Make-up patch application.
D = Discontinued from the study for personal reasons.
3
-8 VI
ft ConTox Limiltd PO Bo< 361. Fon WuhmfKni. PmayKmr 190)4.01U
i
-
LJ '
Q
H H
1p.
0 0
(D 1/1
1^
0
1
(a. 5"
1
0 > 0
a
Project Number: 96-8342H l;.l. du Pont de Nemours & Company - H-219 36. as supplied. Modified Draize Repeated Insult Patch Test S udy in HumanVo)lunteers
DijPontH
lahk'2-Summary of Data C
IndluctiolnEhase
Ori
1
2
3
4
5
6
7
8
9
1C)
S
2448 2422 2442 24---45 <24-- 22 2442 24 -JS 24 -22 24 -48 24 ^S 24
Total
Eanelisisi ill ill 111 111 III 111 111 111 111 III 111 111 111 III 111 111 III 111 9 9
III
Grade
0
III 108 108 107 107 102 101 107 107 106 105 104 102 103 103 105 104 103
9 9
105
+
oooooo 0000 1+
000000 0000 2+ 3+000000000000 00000000 -
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
4+000000 0000 -
0
0
0
0
1 0
7
0
0
0003 *
0 0
0
1
0
6
0
0
0
D033333 05061606 3 4
4
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
0
0
0
0 0
0 0
0
0
2
0
1 2
0
2
0
0
0 0
0
6
6
6
6
6
6
24 = Reading 24 hours after application.
. = Missed reading.
48 = Reading 48 hours after application.
72 = Reading 72 hours after application.
* =
** =
Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application
day, and the patch series extended until 9 induction applications were applied.
Make-up patch application.
D = Discontinued from (he study for personal reasons.
-n-
ConT n Lirni]td.PI>Box36.FonWihiiition.l>niiBytviml'iOM<l(>
Projeel Number: %-S34211
DuPont Hl.O # 713-%
1-::1: du I'ont dc Nemours &C'ompan\ -11-21936
ModiHcd Drai/c Repealed Insult I'aich lest Study in Human Volunteers
APPENDIX II PANELIST LIST
- 14-
( nillii\ I .niiird - I'll ll.i\ H.X. Inn Wasllilii;l.i|l. l'cilll'.\lt:llli;i I'fllU-llKiK
Company Sanitized. Does not contain TSCA CB6
Project Number: 96-8342H
DuPontHLO#713-96
LI. <lu Pont de Nemours & Company - H-21936
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Panelist Number
Panelist Initials
M.C.
3'
M.T.
3
C.P.
4'
B.R.
5
E.T.
6
B.H.
7
N.R.
8
R.O.
9
J.B.
10
A.B.
11
L.P.
12
M.C.
13
H.O.
14
B.B.
15
A.D.
16
^-M.
17
K.U.
18
C.M.
19
D.P.
20
A.B.
21
M.D.
ii M.M.E.
23
M.A.E.
24
L.D.
25-
D.P.
26
L.M.
27
J.C.
28
E.P.
29
A.G.
30
J.W.
31
M.H.
32
N.D.
33
M.C.
34
L.C.
35
s.s.
36
P.W.
37
E.W.
38
L.B.
39
K.M.
40
E.M.
PANELIST LIST
Afie
23 33 31 30 41 37 36 41 44 32 36 30 53 29 30 36 49 26 37 31 34 36 55 27 35
3
20 38 52 47 44 34 46
18 37 38 42 57 34 53
Occupation
Supervisor Meat packer Medical assistant Homemaker Dental assistant Homemaker Homemaker Homemaker Newspaper clerk Homemaker Homemaker Homemaker Homemaker Homemaker Salesperson Salesperson Homemaker Homemaker Cashier Laborer Homemaker Homemaker Homemaker Medical Assistant Homemaker Homemaker Student Boxspring maker Homemaker Uemployed Unemployed Student Homemaker S'udent Homemaker Homemaker Homemaker Homemaker Homemaker Homemaker
Allergies
Ragweed Penicillin Shellfish, seafood Hayfcver
Penicillin, ampicillin, amoxiciltin
Penicillin, aspirin Hayfever
- 15-
(.'"n lux l.imitcd -1'.. Hnx 3h. 1-ort Washington. Pennsylvania I'Xl.U-O.WH
(gjfiggiSa^6
.CTO^.n^^
Project Number: 96.8342H
DuPontHLO#713.96
K.I. du Pont de Nemours & Company - H-21936
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Panelist Number
41 42 43 44 45
46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70
71 72 73 74 75 76 77 78 79 80
Panelist
Initials
M.G. S.V. J.H. B.A. H.O. D.G. D.R. P.D. A.T. K.H. V.T. P.A. M.W. T.T. J.N. J.D. J.D. D.K. M.B. J.Z. Y.H. C.R. S.B. H.R. C.R. P.G. C.R. W.C. T.F. R.D. K.A. E.L. M.L. T.E. M.C. D.Y. A.G. A.G. J.F. D.D.
Age
39 31 26 49 20 33 49 35 57 26 37 35 67 31 31 31 33 36 60 62 40 18 29 38 18 26 28 24 21 26 26 47 39 24 50 59 65 64 42 58
PANELIST LIST
Occupation
Day care teacher Homemaker Typist Homemaker Student
Homemaker Homemaker Teaching assistant Bakery worker Homemaker Homemaker Unemployed Homemaker Homemaker Printer Homemaker Homemaker Homemaker Retired Homemaker Homemaker Student Daycare worker Unemployed Student Humemaker Homemaker Student Supermarket worker Unemployed Homemaker Day care teacher Homemaker Homemaker Day care teacher Upholsterer Salesperson Homemaker Unemployed Crossing guard
Allergies
Penicillin
Animals, dust, pollen Hayfever Penicillin, aspirin, tetanus toxoid Hayfever
Animal hair. hayfever Penicillin
Penicillin, aspirin, Darvocet, codeine Dust, grass, trees, pollen, smoke Penicillin
- 16-
ConTnx l.imilcJ - I'O llux .IhH. lort Washinglim. Pennsylvania IW.U-lt.ViH
Project Number: 96-8342H
DuPont HLO# 713-96
. . . LI. duPont de Nemours & Company -H-21936_ _
Modified Draize Repealed Insult Patch Test Study in Human Volunteers
Paneljs) Number
81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110
III
Panelist Initials
H.R. K.B. D.R. A.B. W.M. S.M. J.M. B.M. C.J. A.N. C.C. V.M. N.S. V.S.
J.S. R.S. E.N.
D.H. J.H. O.K. K.N. B.M. V.F. L.T. E.G. M.C. R.F. M.S. R.P. E.D.
J.B.
Age
18 32 31 70 30
26 45
4j
y
48
19 31 37
24 35 52 52 40 49 39 ?3
4H
48 27 43 27 47 38 18 33 28
PANELIST LIST
Occupation
Student
Homsmaker Homemaker Homemaker Waitress Hairdresser Printer Secretary Homemaker Processor Student Student Unemployed Unemployed Homemaker Unemployed Physical therapist Secretary Machine operaor Office worker Accounts payable Homemaker Welder Homemaker Homemaker Laborer Congressional aide Payroll clerk Unemployed Hairdresser Isurance adjuster
Allergies
Sulfur
Hayfever Hayfever Penicillin Animal hail
Metals Antibiotics Cats Hayfever
- 17-
C'nnl'ox l.iiiiilfi) - I'U Hex -IfiK. rirt Washinglnn. Pennsylvania IWM-d.MiK
San^.Do^notoo^TBCACai
Company
I'rojecl Number: %-S34211
Dul'onI HI.O H 713-%
- LI. du Font dc Ncmours &.C'ompany -11-21936
Modified Drai/.e Repeated Insult I'atch lest Study in Human Volunteers
APPENDIX III GRADING SCALE
- 18-
( iiii I..\ I iinili.-J - I'O ll.i\ Ifift. Inn ^ashiiii:liin. I'L'iiiisyliani!! I'lll.M-lllfiX
I'rojcci Number: %-K34211
Dul'ont 111.0 # 713-%
- K.I. du I'oiil ilc Nemours &-Compnny - II^IWi.
Modified Drai/e Repeated InsJl Patch Test Study in Human Volunteers
Appendix III I luman Patch lest Studies Grading Scale
Reading
0
+_
1+ 2+ 3+ 4+
Interpretation negative suspicious slight erythema well defined erythema erythema with induration erythema with ulceration
DHNNITIONS*
Sensitiaition is a phenomenon which manil'ests itself by local effects on either skin or mucous membranes. It differs from primary irritation in that it may also involve tissues remote
from the site of application. These reactions represent an allergy to a chemical which is not obtained on first contact, but requires a number of prior exposures for development.
Repeated patch applications of substances to both man and animals reveal that certain
substances which, at a given concentration, do not produce primary irritation may elicit severe skin reactions after a number of exposures. Nevertheless, these reactions may not be considered
incidents of sensitization since after 10-14 days of rest the skin recovers its original resistance to injury by the substance. For the lack of a better term such reactions have been called "skin fatigue". This latter term is a misnomer in that it does not imply a condition in which the skin has lost significant normal physiological function. This phenomenon consists of a subtle change in
which the skin no longer exhibits its original refractoriness or resistance to the continued or
repeated action of an agent.
* Drai/.c. J.H. 1959. Appraisal of the Safety of Chemicals in Foods. Drugs and Cosmetics. In DI RMAI. TOXICITY, p. 4A-53. Topeka. Kansas: Association of Food and Drug Officials of
the I 'nited Slates.
<50^
-"- v ^^ ^ ^ ^ I .iiilii\ I iniilcil - I'll lln\ ;(.K. i..n ^:islui]!;h'ii. l'L-]ins\li;ini;i Dll.l.l-d.^iX
^Q^.^K.W