Document 5bzZqvZqz53KXEEj31qK4QMJ5
t r a d e SF.rRFT
AR226-3095
Study Tide
Laboratory Project ID: HLO-1998-01285
Data Requirements: Author: David Gabriel
Study Completed on: April 17,1998 P erforming Laboratory: ConTox Ltd.
For
E. I Du Pont de Nemours and Company
Medical Research No. o r Work Request No.:
Newark, Delaware 19714-0050
Page 1 o f 33
Company Sanitized. Does not contain TSCA CBI
Materia] TestedHaskell Sample No Svnonvms/rndpgPhysical Form:
DuPont HLO 1998-01285 GENERAL INFORMATTOM
Control Material
23046
Material Tested: Haskell Sample No Svnonvms/Codes: Physical Formr
Test Material
Material Tested:
Haskell Sample No.r Synonvms/Codes-
Test Material 23045
2- -
.
C om pany Sanitized. D oes not co n tain TSCA CB1
Physical Form: Sponsor:
Study Initiated - Completed:
DuPont HLO 1998-1
E. L du Pont de Nemours and Company Wilmington, Delaware January 5,1998 - See cover page
-3Company Sanitized. Does not contain TSCA CM
DuPont HLO 1998-01285
DUPONT CENTRAL RESEARCH AND DEVELOPMENT HASKELL LABORATORY FOR TOXICOLOGY AND INDUSTRIAL MEDICINE
SUE MELETI CHAMBERS WORKS
May 5, 1998
100-Person Human Patch Test with
H-23046 (Control). H-23004 ('test')- and H-2304S (Tbct)
Attached is a report from ConTox Limited (Project No. 98-8412H). Included in the report are patch test methods, results, and conclusions.
The pUrp0Se of this study was to determine the potential of H-23046 (Control Item') H 23004 (Test tom ), and H-23045 (Tea, Bern) to cause tai,alien or delayed c o n i,
93nn4 TTS 4 \ S
m d chaUenge phases of M s study> H-23046 (Control Item), H-
23J (ln n IeSt Item)- H' 23045 (Test Item>produced no adverse skin responses in 100%, 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, neither H-23046 (Control Item), H-23004 (Test
H;h2f 45 ('Eet .Ite^ ) ^ considered skin irritants nor sensitizing agents under the conditions that prevailed m this study.
Gregory S. Ladies, Ph.D. Research Toxicologist
-4 Company Sanitized. Does not contain TSCA CSI
DuPont HLO-1998-01285
ConTox Limited
P.O. Box 368, Fort Washington, Pennsylvania 19034-0368 Telephone: (215) 288-4882 Fax: (610)834-7221
Eroject Number: 98-8412H
Testing Facility:
ConTox Limited
1358 East Lycoming Street Philadelphia, PA 19124
Sponsor.
Test Articles: Control Article: le s t Articles Description:
E. I. du Pont de Nemours and Company Wilmington, Delaware
H-23004
and H-23045
H-23046
Control ArtiV.Ip Description-
le s t Articles Received:
Control Article Received:
Study Initiated-
Date o f Repnrf
Test: Object o f Tost-
Reference:
1/2/98
1/2/98 1/5/98 4/17/98
Sindy Completed: 2/11/98
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
To determine the sensitizing properties o f the test articles.
l lie method employed in carrying out this test was similar to that de-
c ~ . s of
f c " <>
by "
on fF < -
Page 5
Company Sanitized. Does not contain TSC C 3I
Project Number: 98-8412H
^_ T_ DuPont HLO-1998-01285
E.I. du Pont de Nemours & Company - H-23004, H-23045 and H-23046
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
MelhQdiifTesfc -
XssLEmd.: The test involved the application o f the test article to the upper
arms o f a group o f 111 volunteer panelists. The panelists ranged from 18 to 69
years o f age (see Panelist List, Appendix m ). One hundred a!d six p V d i l
completed the study. Pnor to the initiation o f the study, all panelists were in
good general heal* and free o f any visible skin disease or anomaly in the area
be pa*ched Each panelist was required to read, understand and sign an
informed consent statement.
^
Patch Preparation: The control fabric (H-23046) and the test fabric (H-23045) were tested as supplied. The test and control fabrics were- cut into ap proximately one inch square portions. A second test article (H-23004) was prepared as a 4:1 dilution in deionized water (20% w/w). An approximate 0 1 ml portion o f test article was placed onto a 3/4" diameter Lintfrte disk (Filter
^ Gshen In. 46S26)' m d al1 A test ^ c le s were placed onto a
SBrusns4wikck NnJJ 0Z89S03)). ^Beforelearpgp^lymcg this stterippe, e(aJcohhnpsoorntio&n oJfothensstomn'atNereiawl
was secured in place with a gloved finger to insure proper application This
tape strip was then pressed mto place on the upper left arm o f each panelist at
its designated test site.
. Panelist at
Induction Phase.: These patches were applied to their designated contact sites and remained m place for 24 hours. At the end o f this period, the patches were removed and the sites were examined for any dermal response. -Hie panelists were then rested for a 24-hour period after which the skin sites were again ex amined. New patches were then applied to the same sites as previously used The second applications were identical to the first and remained in place 24 hours. This procedure was repeated on Mondays, Wednesdays and Fridays m hl a senes o f 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 necessaiy) for any dermal response at the time o f re moval and again at 48 hours and reported their observations prior to the next application. The same sites were used throughout the study.
In the event when one induction application was missed, the panelist was al
1116lowed to make it up at the end o f the induction patch period. These patches
X TMFrid^Mondayfollowing tetscheduIed^
Challenge Phase: After the 9th application, a rest period o f approximately 2 week, elapsed sdter which a challenge a p p h c c ta w a s a p p M to" l c
r T e f eS described above- A duplicate challenge applica tion was also applied m 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 o f irritation or sensitization.
6- -
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
Company Sanitized. Does not contain TSCA CBI
Project Number: 98-8412H
DuPont HLO-1998-01285
E.I. du Pont de Nemours & Company - H-23004, H-23045 and H-23046
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
(continued) Results;
.Conclusion:
A follow-up examination was conducted at 48 hours after the challenge appli cations (24 hours after patch removal). The grading scale used throughout both the induction and challenge phases is shown in Appendix IV.
Results obtained with the control article (H-23046) are presented in Appendix I. Individual panelist data for the control article are presented in Table 1. A summary o f the data for the control article is presented in Table 2. Results obtained with the test articles (H-23004, H-23045) are presented in Appendix II. Individual panelist data for the test articles are presented in Tables 1 and 3. A summary o f the data for the test articles is presented in Tables 2 and 4.
From the results obtained with this test panel, the test and control articles do not appear to be primary skin irritants. The test and control articles do not ap pear to be fatiguing agents. The test and control articles do not appear to be sensitizing agents under the study conditions utilized.
Signatures:
Submitted by ConTox Limited:
Frederick Urbach, M.D.U Consultant Dermatologist
Study Director/Consultant Approved by:
2--i e y t .
Karl L. Gabriel, V.M.D., Ph.D.
President
Date
V//7 fr
Dati
-7-
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
Company SanRTzecT. Does not contain TSCA
Project Number: 98-8412H
DuPont HLO-1998-01285
APPENDER I RESULTS FOR CONTROL ARTICLE
~5>
8- -
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
Company Sanitized. Does not contain TSC CBS
Project Number: 98-8412H Control Article: 23046 Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix I
Project Number: 98-8412H
E.I. du Pont de Nemours & Company - H-23046
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
lab le I - Individual Panelist Data
Challenge Phase
2 1BJ
W M3
1
ao
g
30
13
3
oo
* r 3 FO?.
p CO guO>' T1 a1
g;
f cauc? < g 5* VoO
5OOOn
Panelist Number
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25
1
24 _ 4 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
2
24 _ 4 S 00 00 00 00 00 00 00 00 00 00 00 00 00 00 .0 0 00 00 00 00 00 00 00 00 00 00
3
24_-2 1 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
Induction Phase
456
24 M __ 24 1 2 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
00 00 00 00 00 00 00 00 00
00 00 00
7
24 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
8
24 __ 48 00 00 00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
9
24_ 00
00
00
00
00 00 00 00 00 00 00 00 00 00 00 00 00
00 00 00 00 00 00 00 00
OO
CNj
*1
10**
Original
Site
24__4S 00 00 00
00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
24 Reading 24 hours after application.
- = Missed reading.
48 Reading 48 hours after application.
D = Discontinued from the study for personal reasons.
72 Reading 72 hours after application.
(a) = Not graded. Next patch applied.
* 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.
ConTox Limited - P.O. Box 368, Foil Washington, Pennsylvania 19034-0368
Virgin
site
2--_4& 00 00 00
00
00 00 00 00 00 00 00 00 00 00 00 00
00 00 00 00 00 00 00 00 00
0o3 > o
sj
DuPont HLO-1998-01285
Appendix I
Project Number: 98-8412H Control Article: 23046 Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix I
Project Number: 98-8412H
E.I. du Pont de Nemours & Company - H-23046
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
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Iahte 1 - Individual Panelist Data
Panelist Number
26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50
1
24___48
00 00 00 00 00 00
00
00
00
00
00
00 00 00 00 00 00 00 00 00 00 00 00 00 00
2
24__ 48
00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
3
24 72
00
00 00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
Induction Phase
6
24___48 24___48 24_..72
0 0 0 0 00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
0 00 00 0 00 00 0 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
7
24___48 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 0 00 00
8
24___48 00 00 00 00 00 00
0 0 0 00 00 00 00 00 00 00 00 00 00 00 00 00 *a 00 00
24_..72
00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
10* * 24___48
00
Challenge Phase
Original Site
24__ 48 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
Virgin
Site
24___48
00 00 00 00 00 00
00
00
00
00
00
00 00 00 00 00 00 00 00 00 00 00 00 00 00
24 - Reading 24 hours after application.
- = Missed reading
48 = Reading 48 hours after application. 72 - Reading 72 hours after application.
D = Discontinued from the study for personal reasons. (a) = Not graded. Next patch applied.
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.
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
DuPont HLO-1998-01285
Appendix I
OQ
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
Project Number: 98-8412H Control Article: 23046 Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Ia h te 1 - Individual Panelist nafa
Panelist Number
51 52 53
54
55 56 57 58 59 60 61 62 63
, 64 -- 65
7 66
67 68 69 70 71 72 73 74 75
1
24 - M 00 00 00 00 00 00 00 00 00 -0 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
2
M __ 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
24 72 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
24 Reading 24 hours after application.
48 72 *
Reading 48 hours after application. Reading 72 hours after application.
Induction Phase
***4 loo
oc oo
06
9
24 __4& 24 _ 4 S 00 00
2 i _ Z 2 24 00 0
0
24 0
0
24 7? 0o
00 00 00 00 00 0o
00 00 00 00 00 0o
00 00 00 00 00 00
00 00 00 00 00 00
00 00 00 00 00 00
00 00 00 00 00 00
00 00 00 00 00 00
-0 00 00 00 00 00
00 00 00 . 0 00 0o
00 00 00 00 00 0o
00 00 00 00 00 00
00 00 00 00 00 0o
00 00 00 00 00 0o
00 00 00 00 00 00
00 00 00 00 00 00
00 00 00 00 00 00
00 00 00 00 00 00
00 00
0 0
0 0
00 00
0 0
0 0
00 00
0o 00
00 00 00 00 00 00
00 00 00 00 00 00
D 0
DD 00
DD 00
DD 00
DD 00
DD 00
D o
00 00 00 00 00 00
. = Missed reading.
D = Discontinued from the study for personal reasons (a) = Not gmded. Next patch applied
Make-up patch application.
ConTox Limited - P.O, Box 368, Fort Washington, Pennsylvania 19034-0368
Appendix I
Challenge Phacp
Original
Site 24 - M 00 00 00
00 00 DD 00 00 00 00 00 00 00 00 00 00 00
00 00 00 00 DD DD 00 00
Virgin
site
24 _ 4 00 00 00 00 00 DD 00 00 00 00 00 0. 0 00 00 00 00 00 00 00 00 00 DD DD 00 00
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix I
E.I. du Pont de Nemours & Company - H-23046
DuPont HLO-1998-i
Project Number: 98-8412H
o
h--*
N>
Project Number: 98-8412H Control Article: 23046 Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix I
Project Number: 98-8412H
E.I. du Pont de Nemours & Company - H-23046
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
0 1 TaSs 3
33 H 0a ao0m3
0 0
O3
s5.*
HHi 0> O
lable 1 - Individual Panelist Dat^
Zl
oVO loo
Panelist
Number
76
77
78
oo 79 3pH 80 81
i ' 82
# 83
Cl
1
13
84
p 85
COO 86
u> 87
CO 88
i 89
1 cr
'
91
92
f
3
93
O 94
3 95
96
f
S'
97
\o 98
99o o
4*.
o 00O0\J
100
1
24 _ 4 8 00 00 00
00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
2
24 _ 4 8 00 00 00
00
00 00 00 00 00 00 00 00 00 00 00 0. 0 00 00 00 00 00 00 00 00 00
J
24 72 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 000 00 0. 0 00 00 00 00 00
24 Reading 24 hours after application. 48
72
*
Induction Phase
436
24_-48 24 __48 24 3 1
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00
*a
00 00
0 0
0 0
-0 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
24.
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
- = Missed reading
oc 00
24
00
00
00
00
00
00
00
00
00
00
* .
0 0
00
00
00
00
00
00
00
00
00
00
00
00
00
9
24 7? 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
00
00 00 00 00 00 00 00
Make-up patch application.
pa,ch" "- -- * -- < * * --
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
Challenge Phagp
Original Site
2i__48 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
Virgin Site
24 - 4 8 00 00 00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
DuPont HLO-1998-01285
Appendix I
Project Number: 98-8412H
E.I. du Pont de Nemours & Company - H-23046
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Project Number: 98-8412H Control Article: 23046 Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix I
Panelist
Number
101
102
103
104
105
?r 3
106 107
108
e
p
109 110
03 111
1
24__ 48
00
00 00 00
00 00 00 DD DD 00 00
2
24___4
00 00 00
00
00
00
00 DD DD 00
00
lab te 1 - Individual Panp.lkt
3
24__ 22
00
00 00 00 00 00 00 DD DD 00 00
Induction Phase
456
24___48 24___48 24. 72 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 D DD DD D D DD DD D 00 00 00 00 00 00
7
24___48 00 00 00 00 00 00 00 DD DD 00 00
8
24__ 48 00 00 00 00 00 00 00 DD DD 00 00
9
24- ..72 00
00 00 00 00 00 00 DD DD 00 00
10* * 24___48
Challenge Phase
Original
Site
24___48
00
00 00 00 00 00 00 DD DD 00 00
Virgin Site
24___48
00 00 00
00 00 00 00 DD DD
00
00
OJ
I
DuPont HLO-1998-01285
Appendix I
24 = Reading 24 hours after application.
- - Missed reading.
48 = Reading 48 hours after application. ; 72 Reading 72 hours after application.
D = Discontinued from the study for personal reasons, (a) = Not graded. Next patch applied.
I*
Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled aDnlication
day, and the patch series extended until 9 induction applications were applied
scneduled application
Make-up patch application.
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
-I o
> o w
Project Number: 98-8412H Control Article: 23046 Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix I
Project Number: 98-8412H
E.I. du Pont de Nemours & Company - H-23046
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
IaM e.2-Summary of nata
Challenge Phase
24 _48 Total
Panelists: 111 111
1 Grade
p 0 108 109
X
F* |`
00
CL 1+ 0 0 *T3
p
CD
2+ 0 0
XUO00)n 3+ 0 0
4+ 1
00
24 _48 111 111
109 109 00 00 00 00 00
24 _72 111 111
109 108 00 00 00 00 00
Iaditfition Phase
2
4
_
.. _4S
. 2.4
5
48
66 2.4.. 72
111 111 i n i n 111 111
102 107 00 00 00 00 00
108 108 00 00 00 00 00
108 108 00 00 00 00 00
77 24 _4 111 111
107 107 00 00 00 00 00
88 24 _48 111 111
102 107 00 00 00 00 00
9 24 -22 111 111
108 108 00 00 00 00 00
10** 24 __ 48 22
22 00 00 00 00 00
0riginal Site
24___48
Virgin
Sihte 24___48
111 111 111 111
106 106 00 00 00 00 00
106 106 00 00 00 00 00
ST
-
1 0 .0 0 0 1 5 0 0 0 0 0 1 1 5 0 0 0 0 0
00 00
1a * 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0
v
*aaa0
(a) 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 0
00 00
<5 ia
D
22 22 22 33 33 33 33 33 33 00
55
55
DuPont HLO-1998-01285
Appendix I
a>
S
NmSL
24 Reading 24 hours after application. 48 Reading 48 hours after application.
72 Readin-g 72, hou-r-s--a-f-t-e-r--arppr l-i-c-a--t-io--n-.
Missed reading. D ==Discontinued from the study for personal reasons. (a) = Not graded. Next patch applied.
Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application
3 day, and the patch series extended until 9 induction applications were applied.
8O Make-up patch application.
SS
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
OT
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o
m
Project Number: 98-8412H
DuPont HLO-1998-01285
APPENDIX H RESULTS FOR TEST ARTICLES
- 15-
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
Company Sanitized. Does net contain TSCA CBi
Project Number: 98-8412H
DuPont HLO-1998-01285
E.I. du Pont de Nemours & Company - H-23004
Appendix II
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
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C om pany Sanitized. D oes not contain TSCA CBI
Project Number: 98-84I2H Test Article: 23004
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix II
Project Number: 98-8412H
E.I. du Pont de Nemours & Company - H-23004
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
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Table 1 - Individual Panelist Data
Challenge Phase
Panelist Number
26 27 28
29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50
1
24 48 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 0 0, 00 00
2 24 00 00 00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
3
24_3 1 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
Induction Phase
456
24__ . 24 24 1 2 00 00 00 00 00 00 00 00 00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 -0 00 00
-0 00 00 -0 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
7
24 M 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 000 00
8
24 __ 48 00 00 00 00 00 00 -0 _0 -0 00 00 00 00 00 00 00 00 00 00 00 00 00 *a 00 00
9
2 31 00 00
00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
10** 24 48
00
Original Site
24 48 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 0o 0o
00 0o 0o 0o
00 00 00
Virgin
74 48 0o oo oo oo oo oo 0o o0 0o oo oo 0o 00 0o oo o0 oo oo oo oo oo oo 0o o0 00
24 - Reading 24 hours after application.
- = Missed reading.
48 = Reading 48 hours after application. 72 = Reading 72 hours after application.
D = Discontinued from the study for personal reasons. (a) = Not graded. Next patch applied.
* = 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.
C onto): Limited - P.O. Bo* 368, Fort Washington, Pennsylvania 19034-0368
DuPont HLO-1998-01285
Appendix II
o 3 "so
*3 '
ta
3
N <0 a
a o
g SS 2.
o
3
r**
3* -4
O
^
ProjectNumber: 98-84I2H
Test Article: 23004 Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix II
Table l - IndividuaLEaaelistBala
Challenge Phase
Panelist
Number
51
52
53
o 54
g. 55 X 56
a 57
o1.
"
58 59
p 60
Cd
9
61
U> 62
00 63
I ' 64
Si oo65
K cr
'
66
9 67
68
3? 69
So 70
71 5' 72
VO 73
U) 45k
74
Ou> 0\
75
00
1 24__ 00 00 00 00 00
00 00 00 00 -0 00 00 00 00 00 00 00 00
00
00
00
00
00
00
00
2 24__ M . 00 00 00 00 00 00
00 00 00 00 00 00 00 00 a0 00 00 00
00
00
00
00
00
00
00
3 24_JZ2 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
00
00
00
00
00
00
00
Induction Phase 456
24__ M 00 00 00 00
2 4 .__ 48 00 00 00 00
24_J 2 00 00 00 00
00 00 00 00 -0
00 00 00 00 00
00 00 00 00 00
00 00 00
00 00 00 00 00 00 00 00
00 00 00 00 00 00 00 00
00 00 00 00 00 00 00 00
00
00
00
00
00
00
00
00
00
00
00
00
D DD DD D
00
00
00
00
00
00
7 24__ . 00 00 00 00 00 00 00 00 00
-0 00 00 00 00 00 00 00 00
00
00
00
00
DD
00
00
8 24__ M 00 00 00 00 00 00 00 00 00 00 00 00 00
00 00 00 00 00
00
00
00
00
DD
00
00
9 24__J 1 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
00
00
00
00
DD
00
00
00
fr CN1
Original 10** Site
2 4 .__ 48 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 00 00
00
00
00
DD DD
00
00
24 = Reading 24 hours after application.
- = Missed reading.
48 = Reading 48 hours after application.
D = Discontinued from the study for personal reasons.
72 = Reading 72 hours after application.
(a) = Not graded. Next patch applied.
= 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.
** ss Make-up patch application.
Virgin Site
24 __48 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 00 00
00
00
00
DD DD
00
00
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-036S
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix II
E.I. du Pont de Nemours & Company - H-23004
DuPont HLO-1998-01285
Project Number: 98-8412H
Project Number: 98-8412H
E.I. du Pont de Nemours & Company - H-23004
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
00 00
00 cn|
Project Number: 98-8412H Test Article: 23004 Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix II
Table 1 - Individual Panelist Data
.Challenge.Phase
Panelist
Number
76
77
78
8 79 80
81
82
ECTl 83
84
p
CgO
85 86
OJ 87
00 88
e3? 1 89
3GE5T
vo '
90 91
i3
92 93
C3T 94 oo 95
<T i
96
3* 97
oo 98
-e 99
uO0>0n 100
1 2 i _ _4S 00 00 00 00 00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
2 24__ A S. 00 00 00 00 00
00 00 00 00 00 00 00 00 00 00
o' 0
00 00 00 00 00 00 00 00 00
3 24__J 2 00 00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 000 00 00 00 00 00 00 00
Induction Phase 456
24__ A S 24__A S 24 J 2 00 00 00 00 00 00 00 00 00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 *a 00 00 -0 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
7
24_-A S 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
8
24__ A S 00 00
00 00 00 00 00 00 00 00 -0 -0 00 00 00 00 00 00 00 00 00 00 00 00 00
9
24_JZ2 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
10** 00
Original Site
24. 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
24 = Reading 24 hours after application.
- = Missed reading.
48 = Reading 48 hours after application.
D = Discontinued from the study for personal reasons.
72 = Reading 72 hours after application.
(a) = Not graded. Next patch applied.
* = 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.
Virgin Site
24 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
DuPont HLO-1998-01285
Appendix II
ConTox Limited - P. 0 . Box 368, Fort Washington, Pennsylvania 19034*0368
Project Number: 98-8412H
E.I. du Pont de Nemours & Company - H-23004
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Project Number: 98-8412H Test Article: 23004 Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix II
Panelist Number
101 102 103 104 105 106 107 108 109 110 111
I
24 00 00 00 00 00 00 00 DD DD 00 00
2
24l_ M 00 00 00 00 00 00 00 DD DD 00 00
labi 1- Individual PanelistData
3
24_3 1 00 00 00 00 00 00 00 DD DD 00 00
Induction Phase
456
24__ 24 . 24 3 1 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 D DD DD D D DD DD D 00 00 00 00 00 00
7
24 M 00 00 00 00 00 00 00 DD DD 00 00
8
24.__ 48 00 00 00 00 00 00 00 DD DD 00 00
9
24 3 1 00 00 00 00 00 00 00 DD DD 00 00
10** 24___48
Challenge Phase
Original Site
24 48 00 00 00 00 00 00 00 DD DD 00 00
Virgin Site
?4 48 00
00 00 00 00 00 00 DD DD 00 00
-20-
ConTox Limited - P.O, Box 368, Fort Washington, Pennsylvania 19034-0368
DuPont HLO-1998-01285
Appendix II
L
aou>
oo
s>
3
0o
>
o
13
24 = Reading 24 hours after application,
- = Missed reading.
48 = Reading 48 hours after application.
D = Discontinued from the study for personal reasons.
72 = R---e-a-d--i-n0g 7, -2-h--o-u--r-s after application.
(a) = Not graded. Next patch applied.
* = 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.
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
Project Number: 98-8412H Test Article: 23004 Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix II
Project Number: 98-8412H
E.I. du Pont de Nemours & Company - H-23004
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Table 2 - Summary of Data
Challenge Phase
l
2 4 _ _4&
Total Eaqeliste. 111 111
2 24___ 4
111 I l l
3 2fL_J 1
111 111
Mastian-Phase
456 2 4 _ .A S 24___ 4S 24 72
111 111 111 111 111 111
78
2i _ _4S 24
111 111 111 111
9 10**
24 _Z2 24__ 4
111 111 2 2
Original Virgin Site Sit
24_ _ 4& 24 _4 &
111 111 111 111
g Grade
gi 0 r*
I
Cl
i-O 1+
108 109 109 109 109 108
00
00
00
00
00
00
102 107 00 00
108 108 00 00
108 108 00 00
107 107 102 107 108 108 00 00 00 00 00 00
2 0 0
2 0 0
106 106 00 00
106 106 00 00
j? 2+
0 0 0 0 0 0 0 0 0 0 0 0 00 00 00 00
00 00
1 3+ 'Ji .
!5* ^H -* 4+
1- 1 s
^a * 73
00 0 0 0 0 0 0 0 0 00 00 00 00 00 00 0 0 0 0 0 0 0 0 0 0 00 00 00 00 10 0 0 0 1 5 0 0 0 0 0 11 50 00 00 0 0 0 0 00 10 00 00 00 10 00 00 0 0 0 0 0. 0 0 1 0 0 0 0 0 0 0 1 0 0 0 0
00 00 00 00 00
00 00 00 00 00
eQs/lj
2. ,, i
22 22 22 33 33 33 33 33 33 00
55 55
9N<D
P*
aaCUi
824 =Reading 24 hours after application. 48 =Reading 48 hours after application.
72 = Reading 72 hours after application.
- = Missed reading. D = Discontinued from the study for personal reasons. (a)= Not graded. Next patch applied.
So3 * = Panelist missed file scheduled patch application for personal reasons. Panelist was patched on the next scheduled application
OO
day, and the patch series extended until 9 induction applications were applied. ** =Make-up patch application.
9s .
H ConTox Limited P.O. B ox 368, Fort Washington, Pennsylvania 19034-0368
Cf*
O >
O
DuPont HLO-1998-01285
Appendix II
Project Number: 98-8412H Test Article: 23045 Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix II
Project Number: 98-8412H
E.I. du Pont de Nemours & Company - H-23045
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
labte 3, r. Individuai Panelist Pate
Challenge Phase
Induction Phase
Original Virgin
Panelist 1
2
34
5
67
8
9
10** Site
Site
Number 24__ 24__ 24__3 2 24__ 24___4 24__3 2 24___4S 24__ _4& 24 72 1 00 00 00 00 00 00 00 00 00
00
s
24.__ 4& 24.__ 48 00 00
2 00 00 00 00 00 00 00 00 00
00 00
3 oo 4
00 00
00 00
00 00
00 00
00 00
00 00
00 00
00 00
00 00
00 00
00 00
5
Pi
t-*
6
00 00
00 00
00 00
00 00
00 00
00 00
00 00
00 00
00 00
00 00
00 00
37
00 00 00 00 00 00 00 00 00
00 00
at. 8 " 9
00 00
00 00
00 00
00 00
00 00
00 00
00 00
00 00
00 00
00 00
00 00
pCO g
10 11
ua>s 12
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
13 oa 1 14
00 00
00 00
00 00
00 00
00 00
00 00
00 00
00 00
00 00
00 00
00 00
| SH5
00 00 00 00 00 00 00 00 00
00 00
1 16 0 0 o- 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
fa o
17 18 19
00 00 00 00 00 00 00 00 00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
00 00 00
00 00 00
< gS '
20 21 22
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
NoO 23
00 00 00 00 00 00 00 00 00
00 00
t 24
00 00 00 00 00 00 00 00 00
00 00
a
as 25
oo
00 00 00 00 00 00 00 00 00
00 00
o
24 = Reading 24 hours after application.
- = Missed reading.
3 48 = Reading 48 hours after application.
D = Discontinued from the study for personal reasons.
O*#> 72 = Reading 72 hours after application.
(a) = Not graded. Next patch applied.
8 * = Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application
3f-e> ,
day, and the patch series extended until 9 induction applications were applied.
3' ** =Make-up patch application.
C3 O ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034*0368 >
O
1
DuPont HLO-1998-01285
Appendix II
Project Number: 98-8412H Test Article: 23045 Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix II
Project Number: 98-8412H
E.I. du Pont de Nemours & Company - H-23045
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Table 3 - Individual Panelist Data
Challenge Phase
Induction Phase
Original
Panelist 1
2
3
4
5
6
7
89
10** Site
N u m b e r 24_ _ 4S 24 _ 4 24_ --72 24 26 0 0 0 0 0 0 0
0
24_ _48 24_ _ Z 2 24 _48 24__ J 00 00 00 00
24 _Z2 24__4S 00
27 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
oo
28 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 29 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 31 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
3 32 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 0 0
aff. 33 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
o 35 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
g 36 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Uas) 37 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Tri
g5, t1o
^ U)
38 39 40
00 00 00 00 00 00 00 00 00 00 00 00 - 0 00 00 00 00 00 00 Q0 00 - 0 00 00 00 00 00
2 4 _ _4& 00 00
00 00 00 00 00 00 00 00 00 00 00 00 00
Sgr 41 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 42 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
o
P
S'
43 44
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
*(<a *< <
ss s0
INS!
O
soo ft
45 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 46 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 47 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 - * a 0 0 0 0 49 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
sa 0 0 0 0 0 0 0 0Os
50 0 0 0 0
aoQU) 24 = Reading 24 hours after application.
00 00 00 - = Missed reading.
00 00 00 00 00 00 00 00 00 00
3O oo
3
48 = Reading 48 hours after application.
D = Discontinued from the study for personal reasons.
72 = Reading 72 hours after application.
(a) = Not graded. Next patch applied.
* = Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application
S3.
day, and the patch series extended until 9 induction applications were applied. ** = Make-up patch application.
-4
0)
O
> ConTox Limited - P.O, Box 368, Fort Washington, Pennsylvania 19034*0368
o
Virgin Site
24__48 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
DuPont HLO-1998-01285
Appendix II
Project Number: 98-8412H
E.I. du Pont de Nemours & Company - H-23045
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Project Number: 98-8412H Test Article: 23045 Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix II
oq 30 3
FT 0a uo(9
3 O*- 0a SJ 3'
Table 3 - Individual Panelist Data
Challenge Phase
Panelist
Number
51
52
53
? 54
55
1 r
56
3 57
8Cu 58
V 59
b 60
w
g
61
OJ 62
00 63
^4 3 .65
S' fS3
1 66 67 68
69
*< 70 <g 71 S' 72 VpO 73
74 UOONO) 75
1 24__ A S 00 00 00 00 00 00 00 00 00
-0 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
2 24__ A S 00 00 00 00 00 00 00 00 00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
3
2A_J 2 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
Induction Phase 456 24 AS 24 48 24_JZ2 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 -0 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 D DD DD D 00 00 00 00 00 00
7
24__ A S 00 00 00 00 00 00 00 00 00 -0 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00
8
24__ AS 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00
9 24__JZ2 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00
oc C4l
Original 10** Site
2 L __4S 00 00 00
00 00 DD 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 DD DD 00 00
24 = Reading 24 hours after application.
= Missed reading.
48 = Reading 48 hours after application.
D = Discontinued from the study for personal reasons.
72 = Reading 72 hours after application.
(a) = Not graded. Next patch applied.
* - 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.
Virgin
Sit 24 AS 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 DD DD 00 00
DuPont HLO-1998-01285
Appendix II
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
Project Number: 98-8412H Test Article: 23045 Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix II
Project Number: 98-8412H
E.I. du Pont de Nemours & Company - H-23045
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
oc
" B5 g *aS
cf t 3
N
(0 Os
ao<9
U>
3
oo
a
,
3
-4
0> O >
o
Table 3 - Individual Panelist Data
Challenge Phase
Panelist
Number
76
77
78
o
79 80
81
s' 82
C<U
*0
83 84
pCgu0>0
85 86 87 88
IS:
' 89 U90
' 91 $ 92
93
94
I
%
95
<R 96
5* 97
soC-ou0fo>c0\.
98 99 100
12 2 i _ _48 2 i _ _4& 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 0 0 O' 0 00 00 00 00 00 00
00 00
00 00
00 00 00 00 00 00 00 00
3 2i_-2 2 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 000 00 00 00 00 00 00 00
Induction Phase
456
24 - M 2 i _ _4S 24__Z2
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
0*
0 a
0 0
0 0
0 0
0 0
-0 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
7
24_ 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
8
2 !_ _42
00
00
00
00
00
00
00
00
00
00
-
-
0 0
00
00
00
00
00
00
00
00
00
00
00
00
00
9
24__Z2 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
10** 2 ! _ 48
00
Original Site
24__48 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
24 = Reading 24 hours after application.
- = Missed reading.
48 = Reading 48 hours after application.
D = Discontinued from the study for personal reasons.
72 = Reading 72 hours after application.
(a) = Not graded. Next patch applied.
* ss 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.
Virgin Site
24 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
DuPont HLO-1998-01285
Appendix II
Project Number: 98-8412H
E.I. du Pont de Nemours & Company - H-23045
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Project Number: 98-8412H Test Article: 23045 Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix II
Xabk.3.-.Indivjdu3l Panelist Pate
Panelist Number
101 102 103 104 105 106 107 108 109 110 111
1
24
00
00 00 00
00 00 00
DD
DD 00 00
2
24 AS
00 00 00 00 00 00 00 DD DD 00 00
3
24_JZ2
00 00 00 00 00 00 00 DD DD 00 00
Induction Phase 456
24___4S 24 AS 24_JZ2
00 00 00 00 00 00 00 00 00 00 00 00
00 00 00 00 00 00 00 00 00 D DD DD D D DD DD D 00 00 00 00 00 00
7
24__-4S
00 00 00 00 00 00 00 DD DD 00 00
8
24__-4S
00 00 00 00 00 00 00 DD DD 00 00
9
24_1 2
00 00 00 00 00 00 00 DD DD 00 00
10**
24__ 4S
Challenge Phase
Original - Site
24.__4S
00 00 00 00 00 00 00 DD DD 00 00
Virgin Site
24 __ 4S
00 00 00 00 00 00 00 DD DD 00 00
-26-
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
DuPont HLO-1998-01285
Appendix II
24 Reading 24 hours after application.
- = Missed reading.
48 Reading 48 hours after application.
D = Discontinued from the study for personal reasons.
72 Reading 72 hours after application.
(a) = Not graded. Next patch applied.
* 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.
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
Project Number: 98-8412H
E.I. du Pont de Nemours & Company - H-23045
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Project Number: 98-8412H Test Article: 23045 Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix II
Table 4 - Summary of Data
1
Total
24 _ 1
Panelists; 111 111
2
24 __4&
111 111
3
24__22
111 111
4 2 --
Induction Phase 56
2_
2__Z2
7
2 !_ _ !8
111 I l l 111 111 111 111 111 111
8
24 _4 8
111 111
9
2d__Z2
111 111
10**
24 _4&
22
Challenge Phase
Original Site
24 _ 4 8
Virgin Site
2 d _ _AS
111 111 111 111
o Grade 2
go
I
sQ. * 1+ b is 2+ QX &00 3+
o i 4+
1'
I*
I (a)
1- D g
108 109 109 109 109 108
00
00
00
00 00 00
00 00 00
00
00
00
00 10
00
o- 0
00 01
00 00 00
00
00
00
22
22
22
102 107 00 00 00 00 00 50 10 01 33
108 108 00 00 00 00 00 00 00 00 33
108 108 107 107 102 107 108 108
00
00
00
00
00
00
00
00
00
00
00
00
00
00
00
00
00
00
00
00
00
11 50
00
00
00
10
00
00 00 0 100
33
33
33
33
2 0 0 0 0 0 0 0 0 0
2 0 0 0 0 0 0 0 0 0
106 106 00 00 00 00 00 00 00 00 55
106 106 00 00 00 00 00 00 00 00 55
DuPont HLO-1998-01285
Appendix H
U)448
Reading. 24 hours after application. Reading 48 hours after application.
- = Missed reading. D = Discontinued from the study for personal reasons.
72 Reading 72 hours after application.
(a) = Not graded. Next patch applied.
* 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.
ConTox Limited P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
Project Number: 98-8412H
DuPont HLO-1998-01285
APPENDIX HI PANELIST LIST
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ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
Company Sanitized. Does not contain TSCA CBf
Project Number: 98-8412H E.I. du Pont de Nemours & Company Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPont HLO-1998-01285 Appendix III
Panelist List
Panelist # 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45
Initials
R.H. S.D. W.C. J.M. M.R. E.K. K.K. T.R. J.L. W.M. L.S. E.S. B.R. D.P. E.T. J.H. V.F. B.C. A.M. I.M. B.M. A.S. M.T. L.H. C.W. C.W. S.A. B.B. N.B. J.B. C.O. L.W. L.M. J.S. T.T. S.D. J.W. M.G. M.S. R.S. C.L. M.B. M.B. L.D. P.A.
Age 45 30 47 48 36 38 27 54 41 31 51 49 32 26 42 38 50 29 35 31 24 32 34 50 29 42 37 42 46 29 45 34 31 31 33 35 47 50 41 49 57 33 57 34 36
Occupation Homemaker Waitress Laborer Meat Wrapper Homemaker Homemaker Cement Worker Bartender Secretary Waitress Printer Laborer Secretary Hairdresser Dental Assistant Homemaker Welder Laborer Unemployed Homecare Nurse Homemaker Baker Meatpacker Waitress Hostess Homemaker Homemaker Homemaker Homemaker Insurance Adjuster Homemaker Homemaker Homecare Nurse Homemaker Homemaker Homemaker Painter Homemaker Homemaker Laborer Homemaker Homemaker Homemaker Homemaker Laborer
Allergies Penicillin Penicillin
Animal Dander, H ayfever
Penicillin Hayfever
Hayfever Hayfever Hayfever Hayfever Hayfever
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ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
Company Sanitized. Does not contain TSCA CO
Project Number: 98-8412H E.I. du Pont de Nemours & Company Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPont HLO-1998-01285 Appendix HI
Panelist List
Panelist# 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 81 82 83 84 85 86 87 88 89 90
Initials M.A. C.A. V.P. J.B. P.P. R.W. S.B. M.W. J.K. J.P. D.R. A.E. J.G. K.W. M.B. L.P. M.D. L.P. T.H. HJ. P.M. L.M. P.L. D.D. L.B. T.W. J.G. D.R. L.M. D.R. S.L. E.L. L.B. M.C. M.W. J.C. P.C. K.K. M.W. K.B. T.S. T.S. M.G. D.G. S.M.
AgS 69 37 37 27 33 43 59 42 64 42 51 45 52 36 61 37 35 28 29 45 58 63 59 60 58 44 18 20 40 35 40 49 29 51 51 63 47 35 44 33 45 43 59 32 57
Occnpation
School Aide
Homemaker
Homemaker
Homemaker
Office Worker
Laborer
Homemaker
Homemaker
Laborer
Clerk
Homemaker
Homemaker
Factory Worker
Homemaker
Retired
Daycare Worker
Homemaker
Homemaker
Salesman
Homemaker
Homemaker
Retired
Security Guard
Crossing Guard
Homemaker
Shipper
Unemployed
Factory Worker
Homemaker
Homemaker
Store Clerk
Daycare Teacher
Homemaker
Daycare Teacher
Daycare Teacher
Retired
Homemaker
Homemaker
Homemaker
Homemaker
Security Guard
Retired
`
Homemaker
Homemaker
Homemaker
Allergies
Penicillin Hayfever Penicillin Hayfever
Penicillin Penicillin Hayfever Penicillin
-30-
ConTox Limited - P.O . Box 368, Fort Washington, Pennsylvania 19034-0368
Compaq
,,,,oUonlaMTSCACBI
Project Number: 98-8412H E.I. du Pont de Nemours & Company Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPont HLO-1998-01285 Appendix HI
Panelist # 91 . 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 111
Initials B.M. E.K. C.J. S.L. S.S. L.S. M.A. BCD. M.C. P.H. J.H. M.B. P.C. S.M. Y.H. H.R. C.T. V.M. N.S. M.F. H.S.
Age 69 44 41 41 61 60 68 26 37 57 40 41 51 28 42 40 35 33 38 27 40
EanelistJiat
Occupation Retired Homemaker Homemaker Homemaker Homemaker Retired Homemaker Childcare Worker Homemaker Homemaker Homemaker Homemaker Teacher Hairdresser Homemaker Laborer Homemaker Nursing Aide Homemaker Homemaker Childcare
Allergies Hayfever
-31 -
ConTox Limited - P.O . Box 368, Fort Washington, Pennsylvania 19034-0368
Company Sanitized. Does not contain TSC CBS
Project Number: 98-8412H
DuPont HLO-1998-01285
APPENDIX IV GRADING SCALE
-32-
ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
not contain Sanitized. DoeS
C om ply
Project Number: 98-8412H E I. du Pont de Nemours & Company
DuPont HLO-1998-01285 Appendix IV
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Reading
0
+
1+ 2+ 3+ 4+
GRADING SCALE
Human Patch Test Studies
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 o f application. These reactions represent an allergy to a chemical which is not obtained on first contact, but require a number o f prior exposures for development.
- Repeated patch applications o f substances to both man and animals reveal that certain substances which, at a given concentration, do not produce primary irritation but may elicit severe skin reactions after a number o f exposures. Nevertheless, these reactions may not be considered incidents o f sensitization since after 10-14 days o f rest the skin recovers its original resistance to injury by the substance. For the lack o f 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 o f a subtle change in which the skin no longer exhibits its original refractoriness or resistance to the continued or repeated action o f an agent.
* Draize, J.H. 1959. Appraisal o f the Safety o f Chemicals in Foods, Drugs and Cosmetics. In DERMAL TOXICITY, p. 46-53. Topeka, Kansas: Association o f Food and Drug Officials o f the
United States.
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ConTox Limited - P.O. Box 368, Fort Washington, Pennsylvania 19034-0368
Company Sanitized- 3 e s ROt
