Document 712jXg5qGqk8Vr8ZonyOEXqRj
AR226-3059
Study Title 100-Person Human Patch Test with
H-22033 (Test Item)
Laboratory Project ID
Haskell Laboratory Report No. 712-96
Study Completed On September 30, 1996
Contracting Laboratory
ConTox Limited 3408-50 B Street Philadelphia, Pennsylvania
19134
Author David. Gabriel
for E. I. du Font 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 1 of 19 Company Sanitized. Does nol contain TSCA CB8
Material Tested:
GENERAL INFORMATION Test Material
DuPontHL0712-96
Physical Form: Synonyms:
GreerrFabric
Composition:
Stability:
Sponsor:
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 Wilminglon, Delaware
8/14/96 - 9/30/96
8/14/96-9/18/96
S,n,,,zed.Doe.n>oo".>.^CACa
Company
DuPontHL0712-96
DUPONT CENTRAL RESEARCH AND DEVELOPMENT HASKELL LABORATORY FOR TOXICOLOGY AND INDUSTRIAL MEDICINE
Octobers, 1996
DuPont Specialty Chemicals Techlab T3D+ 113-C
100-Person Hrman Patch Test with H-22033 (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-22033 to cause irritation or delayed contact hypersensitivity in humans. During the induction and challenge phases of this study, H-22033 (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-22033(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
- 3- Coinpany s^."^'00"1""^"3'
DuPontHLO#712-96
ConTox Limited -
1*.(). Box 368. l-'ort Washington, Pennsylvania 19034-0368 Telephone: (215)739-4499 Fax: (215)423-9210
Project Number:
96-8342H
Testing Facility:
ConTox Limited 1358 l.ycoming Street Philadelphia, PA 19124
Sponsor: Test Article:
l.l. du Pont c'e Nemours & Company P.O. Box 50. ^Ikton Road Newark, DE 19714
H-22033
Test Article Description:
Blue non-woven fabric
Test Article Received:
08/08/96
Study Initiated:
08/14/96
Study Completed: 09/18/96
Date of Report: Bat: Object of Test:
Reference:
Method of Test:
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 year*, of age (see Panelist List. Appendix II). One hundred and live 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 Company Sanitized. Does not contain TSCA CB1
Project Number: %-S34211
DuPont HLO # 712-96
-
n.l. <Ju Ponrde Nemours &-C-'ompany--11-22033 - _
__ _
_
Modified Drai/e Repeated Insult Patch Test Study in Human Volunteers
Method ol' Test: (continued)
Patch Preparation: The test article was tested as supplied. The test article was cut into approximately one inch square portions and placed onto a strip of 2" Dermicel* hypoallergenic cloth tape (Johnson & Johnson, New
Brunswick, NJ 08903). Before applying this strip, each portion of test
material was secured in place with a gloved finger to insure proper application. 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 nnd 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 Appendix III.
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^ "'"""'TSCA CB1
Project Number: 96-8342H
DuPontHLO#712-96
1-:.I, du Font dcNcmours&JCompany^ 1-22033
Modified Draiy.e Repeated Insult Patch Test Study in Human Volunteers
Resultsi Conclusion:
Results obtained with the test article (H-22033) are presented in Appendix
1. Individual panelist data are presented in Table 1. 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:
fHuiL^uL.^Uj^ At^
Raymonfl Mark. M.D.
Study Director/Consultant
^/w^
Date
Approved by:
^-i ^ J^^J/ f^o^t
kLaarrll L. Gabrieell..''^^..MM..DD...'PPhh..DD.
/O/z.fq^
"^Date /
President
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Project Number: %-834211
DuPont 111.0 H 1 \ 2-96
_____. ._. - --lU.dii 1'ont dc Neinours-& Company- --11-22033 __ ______
__
Modified Droize Repeated Insult Patch Test Study in Human Volunteers
APPENDIX I RESULTS FOR TEST ARTICI E
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Project Number: 96-8342H E.I. du Pont de Nemours & Company - H-22033. as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPonlH
1Fable 1 Individual Panelist I?ata C
Ind uctioioJBhasfi
Ori
Panelis t
1
2
3
4
5
6
7
8
9
10 **
S
2422 Number idAS 1
2448 24.4fi 24 -U8 ?4 Z2
0
0
0
24 JS ;y
Z2 24 -4S 24 J& 24
0
0 0
0 0
0
000000 0000 2
0
0
0
0000 00 00 00 3
0
0
0
0000 00 00 00 4
0
0
0
00 0000 00 00 5
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
6
000000 0000 00 00 7
00 00000000 00 00 8
00 00 9
0000000- 00 00 00 10
0000 00 00 00 11
i
0000
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
12
000000 0000 CO
0
0
0
000000 0000 i 13
0
0
0
14
000000 0000 15
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
0
0
0
0
0
0
-
0
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0000000000 00000000 0
16 17
00
00
00
0 0
0 0
0 0
0
0 0
0
0
0
0
0
0
0
0
0
000000 00000000 3
18
0
0
0
000030 0000 i
19
000000 0000 *<
20
0
0
0
0
0
0
V)
21
000000 0000 14
0
0
0
000000 000 a5 22
00 00 00 N
23
0000 (0
0000 0000 00 Q.
24
0
0
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0
0
0
25
0
0
0
0
0
0
0
0
0
000000 0000 Q
CD
000000 0000 Ul
3
24 = Reading 24 hours after application.
0
48 = Reading 48 hours after application.
0
<J
72 = Reading 72 hours after application.
3
- = Missed reading.
O?
= Panelist missed the scheduled patch iipplicfition ftirpersonal reasons. Panelist v raspatched onthiinext scheduled a pplication
3"
day. and the patch series extended urltil9iiiducticnap]locations were applied.
-1 0)
** = Make-up patch application.
D = Discontinued from thestudy for)lersonalrca;sons.
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Project Number: 96-8342H E.I. du Pont de Nemours & Company - H-22033. as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPont
Table 1 Individual Panelist Data C
Indijcjio;LCIiasc
Ori
Panelist
1
2
3
4
5
6
7
k
9
10i**
S
2422 Number 2445
26
2448 24-48 24---48 ;Z4 22
0 0
0
2i .48 24 J1 24 -48 24 -48 24
0
0 0
0
0
0
000000 0000 27
0 0
0
0 0
0
0
0
0
0
000000 000 28
0
0
0
0
0
0
0 0
0
000000 0000 29
0
0
0
0
0
0
0
0
0
000000 0000 30
0
0
0 U
0
0
0
0
0
0
0
0
0
31
0
D
D
D D
D D
D D
D D
D D
D D
D D
D
D
000000 32
0 0
0
0
0 0
0
0
0
00 00 00 0000 33
0
0
0
0
0
0
0 0
0
000000 0000 34
-
0
0
0
0 0
0
0
0
000000 0000 35
0
0
0
0
0
0
0
0
0
000000 0000 36
0
0
0
0
0
0
0
0
0
000000 0000 37
0
0
0
0
0
0
0
0
0
000000 0000 0-0 38
0
0 0 0 0 39
0
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 0000 40
0
0
0
0
0
0
0
0
0
000000 0000 41
0
0
0
0
0
*
-
0
0
0
0
0
0
0
0
0
0
0000 0000000- 00 42
0
0
0
43
0
0
0
0
G
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0000 44
0
D
D
D D
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
46
0
0
0
0
0
0
0
0
0
000000 0000 47
0
0
0
0
0
0
0
0
0
000000 0000 4wX
0
0
0
0
0 0
0
0
0
000000 0000 49
0
0
0
0
0
0
0 0
0
000000 0000 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 patchedon the next scheduled iipplication
day. and the patch series extended until 9 iriductkmapplications were applied.
Make-up patch application.
D = Discontinued Horn (he study for personal reasons.
roftTox Urnitfd P 0
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Box 1U. Fon Wohinxom. Piniavh-oni 1903-0tl
Project Number: 96-8342H E.I. du Pom de Nemours & Company - H-22033. as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPom
lable I - Individual Panelist Data C
IndiiidioinPh ase
Orig
Panelis l
1
2
3
4
5
6
7
8
9
10r*
S
000000000000000000000000000000000000000000 000000000000000000000000000000 i
-
000000 000 0 000000 000 '
00000- 000000000 0
0
0000000000 000000 0
0
000000 000 3. 000000 000 w
W
000000000000 000000 N
(D
000000 000 0.
0 0
000000 000 0
w
000000 000 3
00 00 00 2422 244 2448 Number 2448 51
24 -l ;
73
0
0
0
0
34 M 24 -22 24 -4S 24 l8 24
P
0
0
0
0
0
52
0
0
(i
0
0
0 0
0
0
0
53
0
0
0
0
0
0 0
0
0
0
54 55
00
00
00
0 0
0 0
0 0
0 0
0
0 0
0
0
0
0
0
0
0
-
0
56
0
0
0
0
0
0 0
0
0
0
57
0
0
0
0
0
0
0
U
0
0
58
0 0
0
0
0
0 0
0
0
0
59
0
0
0
0
0
0 0
0
0
0
60 61
00
00
00
0 0
0 0
0 0
0 0
0
0
0
0
0
0
0
0 0
0
0
0
62
0 0
0 0
0
0
0
0
0
0
0 0 63
0
Q
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
0
0
0
65
-
0
0
0
0
0 0
0
0
0
0
0
66
0
0
0
0
0
0
0
0
0
0
67 68
00
0
0
0
0
0
0
0 0
0
0
0
0
0
0
0
0 0
0 0
0
69
0
0
0
0
0
0 0
0
0
0
70
0
0
0
0
0
0
0
0
0
0
71
0
0
0
0
0
0
0
0
0
0
72
0
0
0
0
0
0
0
0
0
0
00 00 00 73
0
0
0
0
D
D D
D D
D D
D
D
74
0
0
0 0
0
0 0
0
0
0
75
0
0
0 0
.
0
0 0
0
0
0
0
24 = Reading 24 hours after application.
- = Missed reading.
0 0
48 = Reading 48 hours after application.
ff
72 = Reading 72 hours after application.
3.'
s Panelist missed the scheduled patch iipplicalion ftr personal reasons. Panelist was patched on the next scheduled application
U>
day. and the patch series extended until 9 induction applications were applied.
0
= Make-up patch application.
>
D 5 Discontinued from the study For personal reasons.
-n- 0
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Project N umber: 96-8342H
C.l.duPont de Nemours & Company - H-220 33. as supplie< . Modific( Draize Repeated Insult Patch Test Study in Human Vo lunteers
Du PontH
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0)
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R" (0
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0
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2,
0 0
S S'.
3"
"i 0)
0 > 0 W
Ta ble 1 - Indi yjdual Pan eiN r~)w\ C
lildlltctionPhase
Ori
Panelis
1
2
3
4
5
6
7
8
9
10**
S
44 2422 2448 Numbelr 2448 76
244S 24 -4S 2s -Z2 2. 18 24---4S 24---Z2 24 48
24
0
0
(D 0
0
([)
0
0
0
0
0
0
0
00 00 00 77
0
0
0
0
0
( 0
0
0
0
0
0
0
0
00 00 00 78
0 0
0
0
0
0
0
0
0
0
0
0
0
00 00 00 79
0
0
0
0
0
0
0
0
0
0
0
0
0
80
0
0
0
0
0
0
0
0
0
0
0
0
0
000000000000 81
0
0
0
0
0
0
0
0
0
0
0
0
u
00 00 00 82
0
0
0
0
0
0
0
0
0
0
0
0
0
83
0 0
0
0
0
0
0
0
0
0
0
0
0
000000 84
0
0
0 0
0
0
0 0
0 0
0 0
0
000000 85
0
0
0
0
0
0
0
0
0
0
0
0
0
000000000000 86
0
0
0
0
0
0
0
0
0 0
0 0
0
00 00 00 87
0
0
0
0
0
0
0
0
0
0
0
0
0
00 00 00 88
0
0
0
0
0
0
0
0
0
0
0
0
0
00 00 00 89
0
0
0
0
0
0
0
0
0
0
0
0
0
0000000 00 90
0
0
0
0
0
0
0
0
0
0
0
0
0
0 00 91
0
0
0
0
0
0
0
0
0
0
0
0
0
92
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
000000000 0 93
0
0
0
0
0
*
0
0
0
0
0
0 0
0
0
0
0
ooo 94
0
0
0
*
-
0
0
D
D
D D
D D
D D
D D
D
D
95
C 0
0
0
0
0
0
0
0
0
0
0
0
96
0 0
0
0
0
0
0
0
0
0
0
0
0
000000 97
0
0
0
0
0
0
0
0
0
0
0
0
0
000000 98
0 0
0 0
0
0
0 0
0
0
0
0
0
000000 99
0 0
0 0
0 0
0 0
0 0
0 0
0
000000 .
100
0
0
0
0
0
0
0 0
0 0
0
0
0
0030 00 00 00 00 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.
FonTiK Limmd PO Bat 161 Fon W tlhingmn. PHiiuvlmin 190M-0168
^
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Krojet.l Ss'umbcr: 96-8342H r..i. du pont de Nemours & Company - H-22033, as supplied.
Modifie d Draize Repeated Insult Patch Test Stud\ in HumanV olunteers
DuFoni
7[ablje 1 - Individual Panelist r)ata
Indliiciuan-Phase
Or
Panelis t
1
2
3
4
S
6
7
8
9
1C)*
Mmnhsj 2448 2422 244S 2i -42 .24 22 2448 24 -IS 24-- J2 24 -M 24 -IS 24
101
0
0
0
0
0 0
0
0
0
00000000 0000 00 00 102
0
0
0
D D
D D
D D
D D
D
D
103
0
0
0
0
0 0
0
0
0
000000 0000 104
0
0
0
0
0
0
0
-
0
105
0
0
0
0
0
0
0
0
0
000000000000 00000000 106
0
0
0
0
0
0
0
0
0
107
0
0
0
0
0
*
-
0
0
0
0
0
0
0
0
000000 0000 108
0
0
0
0
G 0
0
0
0
0
0
0
0
000000 109
0
0
0
0
0 0
0
0
0
0 0 0 0 0 0 110
U
0
0
0
0
0
0
0
0
*
-
0
0
0
0
0
0
000000 000000000000 III 00 00 00 0 0 0
0
0 0
0
G
0
0
1^T3
<^S
(0
^
g
p.
0
0 <D (A
3
a
0 0 3
5?
3"
-1 (0 0 >
0 a
24 =
48 =
72 =
=
Reading 24 hours after application.
- = Missed reading.
Reading 48 hours after application.
Reading 72 hours after application.
Panelist missed the scheduled patch appliestion Corpersonal reasons. Panelist w/asp atched onthenext scheduled a pplication
day. and the patch series extended urMil 9 in ductio napplicatii.is were applied.
Make-up patch application.
D = Discontinued from the study for personal reasons.
ConTo
-n-
< 0)
s
I
p.
0
0 a> o> 3 0
(A O o 0
i3
Projecl Number: 96-8342H E.I. du Poni de Nemours & Company - H-22033. as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Dul'oiii
Table 2 Summary of Data
Induction Phase
Or
laiai
Panelifls;
1 2 3 24_AS 24__22 24_AS
ill 111 111 111 111 111
424_AS
111 111
524__22 111 111
6 7 8 9 24_AS 24_4S 24__22 24_4S ill 111 111 111 111 111 111 III
10** 24 48
9 9
.;!
111
Qiade
0
111 108 108 107 107 102 101 107 107 106 105 104 102 103 103 105 104 103
9 9
10
^ 1^
0000000000000000000000000000000000000000
0 0
2+
3r
0000000000000000000000000000000000000000
0 0
4+00000000000000000000 0
* 000000011006700000000001300220001020
0 0
0 033333344566666666 6
24 =
48 =
72 =
*
=
** =
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.
ConTox Limited P 0
-n-
Box 161, FM Widiliqni, Fdmr. Ivmil 19034-P16*
Project Number: ^6-83421 I
DuPoni HLO # 712-96
l-J._duPonjdcNemour.s_&_Company-N-22033
_
Motiined Drai/e Repeated Insult Patcli Test Study in Human Volunteers
APPENDIX II PANELIST LIST
-14-
(nnTu\ l.iinilcil - I'.O. HM ?hK. l-'iin Wnshingltin. Pennsylvania ITO.W-O.ldS
Company Sanded. Does not contain TSCA cm
Project Number: 96-8J42H
DuPontHLO#712-96
_. E.l7du Pont de Nemours & Company - H-22033 -- ___
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Panelist Number
Panelist Initials
1
M.C.
2"
M.T.
3
C.P.
4'
B.R.
5
E.T.
6
B.H.
7
N.R.
S
R.O.
9
J.B.
10
A.B.
11
L.P.
12
M.C.
13
H.D.
14
B.B.
15
A.D.
16
C.M.
17
R.D.
18
C.M.
19
D.P.
20
A.B.
21
M.D.
22
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
C.M.
PANELIST LIST
A&e
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 39 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 Home-naker Homemaker Homemaker Homemaker Homemaker Salesperson Salesperson Homemaker Homemaker Cashier Laborer Homemaker Homemaker Homemaker Medical Assistant Homemaker Homemaker Student Boxspring maker ilumemaker Uemployed Unemployed Student Homemaker Student Homemaker Homemaker Homemaker Homemaker Homemaker Homemaker
Aljergies
Ragweed Penicillin Shellfish, seafood Hayfever
Penicillin, ampicillin, amoxicillin
Penicillin, aspirin Hayfever
-15-
ConTox l.imllcd - P.O. Box 368, Fort Washinglon. I'ennsylvania 19034-036B
TSCACBl
SanW^d.OoesnAoc' ontain Comp^
Project Number: 96-8342H
DuPoniHLO#712-96
H.L du-Pont de Nemours & Company - H-22033
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.R 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
nay care teacher Hjmemaker 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
Homemaker 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 D-st, grass, trees, pollen, smoke Penicillin
-16-
ConTnx I imileil - P.O. llox 368. Port Wnshingtnn. Pennsylvania.I SI1WTOMa3-4On-J(WftiKB.i.e-.O"------6_0,./"13rR"l'^"8
Company
Project Number: 96-8342H
DuPuntHLO#712-96
R.I. du Pont de Nemours & Company - H-22033
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Panelist Number
81
82 83 84 85 86 87 38 89 90 91 92 93 94 95 96 97 98 99 100
101 102 103 104 105 106 107 108 109 110 111
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. D.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 43 39 48 19 31 37 24 35 52 52 40 49 39 33 48 48 27 43 27 47 38 18 33 28
PANELIST LIST
Occupation
Student Homemaker 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 Congressio dl aide Payroll clerk Jnemployed Hairdresser Isurance adjuster
Allergies
Sulfur
Hayfever Hayfever Penicillin Animal hair
Metals Antibiotics Cats Hayfever
- 17-
CtinTox Limited P.O. llux 368. l-'ort Washington. Pennsylvania 19034-0368
S^annititiizzeedo. 0u 035 not contain TSCACB1
Company
Project Number: 46-834211
DiiPont HLO ff 712-96
I-:. 1. du Pent de Nemours & Company - H-22033
Modi tied Draize Repeated Insult Patch Test Study in Human Volunteers
APPENDIX III GRADING SCALE
-18-
ConTox I iinilei) - I'O H< .KiS. 1-iirt Wil'.liintiliiil. I'tfnnsylvmii.l mi!.U-ll.hll
C^p,S3n..,z.d.Oo,sn,,con,.,nTSCACB,
Project Number: ^-S.^H
DuPont HLO # 712-96
EJ.d^ Font deNemours^ company-_H^22033
_.,,_
___
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
,_.__
.___..
Appendix III
Human Patch Test Studies Grading Scale
Reading 0 1+ 2+ 3+ 4+
Interpretation negative suspicious
slight erythema well defined erythema erythema with induration erythema with ulceration
DEFINITIONS*
Sensitization is a phenomenon which manifests 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 thai 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.
* Draize. J.H. 1959. Appraisal of the Safety of Chemicals in Foods. Drugs and Cosmetics. In DERMAL TOXICITY, p. 46-53. Topeka. Kansas: Association of Food and Drug Officials of
the United States.
-
19 -
ConTnx l.imiird P(i Hn\ ItiS. Fiin Washinalon. I'ennsylvania l*i).W-<13()8
Company Sanitized. Does net contain TSCA CB1