Document EdzQNN48jkBzz36Yre3qzJYBV
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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. O. Box 50 Newark, Delaware 19714
Study Monitor Gregory S. Ladies
Company Sanitized. Does not contain t$CA CB1 Page I of 19
Material Tested: Physical Form: Svnonvms:
r.FNFRAL INFORMATION Test Material
DuPont H L 0 713-96
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 Wilmington, Delaware
8/14/96 - 9/30/96
, 8/14/96-9/18/96
DuPont HLO 713-96
DUPONT CENTRAL RESEARCH AND DEVELOPMENT HASKELL LABORATORY FOR TOXICOLOGY AND INDUSTRIAL MEDICINE
c DuPont Specialty Chemicals Chamber Works
October 8,1996
1(-Person Human Patch Test with H-21936 (Test Item!
Attached is a report from ConTox Limited (Project No. 96-8342H). Included in the report are patch test methods, results, and conclusions.
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
orapany SanRized. Does not contain T S r* r )
ConTox Limited
P.O. Box 368. Fort Washington, Pennsylvania 19034-0368 Telephone: (215)739-4499 Fax: (215)423-9210
Project Number: 96-8342H
Testing Facility:
ConTox Limited 1358 Lycoming Street Philadelphia, PA 19124
Sponsor:
E.l. 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
Received: Study Initiated:
Test: Object of Test: Reference:
Method of Test:
08/08/96 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 o f Food and Drug Officials of the United States.
t est Panel: The test involved the application o f 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 o f 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.
Ooes not contain YSGA 38
Project Number: 96-834211
DuPont HLO # 713-96
du Pont de Nemours & Company -11-21936
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
(continued)
Patch Preparation: The test article was tested as suDDlied. ADDroximatelv 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 annlied to its designated contact site and remained in place for 24 hours. At the end o f 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 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 necessary) for any dermal response at the time o f 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.
rh a lle n p e Phase: After the 9th aDDlication. a rest period o f 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 o f 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.
-5 -
Cnnlnx l imited-I'O Hn\ UiX. Inn Washington. Pennsylvania 19034-03MI
SanlfSsed, Does no! onSain TSCA CBI
Project Number: %-8342H
DuPont HLO U 713-96
-IU. du Pont de Nemours & Company - H*21936 _ _ ___
Modified Draizc Repeated Insult Patch Test Study in Human Volunteers I
Results:
Results obtained with the test article (H-2I936) are presented in Appendix I. Individual panelist data are presented in Table I . A summary o f the data is presented in Table 2.
Conclusion:
From the results obtained with this test panel under the test conditions utilized, the test article does not appear to be a primary skm 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:
/ Consultant Dermatologist
Study Director/Consultant
Approved by:
J
Karl L. Gabriel. V.M.D., Ph.D. President
(o L z J h .
/Z^sB ate' '
6- -
fon'lox lim ited - I'.t) Hn\ J6X. I'orl Washington. I'cnnstlvania
Gofsipany Sanitized. Does not contain TSC OBJ
Project Number: 96-8342H
DuPont HLO # 713-96
E.I. du Pont de Nemours & C om pany-H -21936
.......... "
Modified Draize Repeated insult Patch Test Study in Human Volunteers
APPENDIX I RESULTS FOR TEST ARTICLE
-7 -
Con l'ox l imited - 1*0 llox .168. Fort Washington. Pennsylvania 1<)34-168
Gompany Sanitized. Does not contain TSCA CS
jn 0
Project Number: 96-8342H E.l. du Pont de Nemours & Company - H-21936. as supplied.
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPont HLO 713-96
Table 1 - Individual Panelist Data
Challenge Phase
Induction Phase
Original Virgin
I
00
I
Panelist Number
1
4 5 6 7 8 9
10 11 12
13 14
1
7.4
00 00 00 00
00 00 00 00
00
00
00 00 00 00
2
24__ 72 00 00 00 00 00 00
00 00 00 00 00 00 00 00
3
24 _48 00 00 00 00 00 00
00 00 00 00 00 00 00 00
4
24__
00 00 00 00
00 00 00 00 00 00
00 00 00
00
5
2 4 _ _Z2 00 00 00 00 00 00 00 00 00
00
00 00 00 00
0
24__.48 00 00 00 00 00 00 00 00 00
0
00 00 00 00
/
24__-48 00 00 00 00 00 00 00 -0 00
00
00 00 00 00
0
24__ 72 00 00
00 00 00 00 00 00 00
00
00
00 00 00
24__ 48 00 00 00 00
00 00 00 00 00 00
0 00 00 00
24__ 48
24_-48 00 00 00 00
00 00 00
00
00 00 00 00 00 00
24__ 48 00 00
00 00 00 00 00 00
00 00 00 00 00 00
15 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00
00
16 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 17 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 18 0 0 0 0 0 0 0 0 0 0 0 0 c 0 0 0 0 0 19 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
20 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
21 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 23 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 24 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 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
Sanitized. Does not coniam TSC Gi
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 the study for personal reasons.
-n-
ConTox Limited P O Box 368. Fon Washington. Pennsylvania 19034-0368
Project Number: 96-8342H [ I. du Pont de Nemours & Company - H-21936. as supplied. Modified Draize Repeated Insult Patch Test Studs in Human Volunteers
DuPont HLO = 7 13-96
Table 1 - Individual PinelisLPata
Challenge Phase
Induction Phase
Original Virgin
Panelist
1
*>
3
4
56
7
89
IO**
Site
Site
Number 24 48
72 24 _4B 24__ _4S 24__ 72 24__ _48 24___ 48 2 4 _ _ I2 24___48 24___ 48
26 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
27 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
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
24__ _48 00 00 00 00
24__ _48 00 00
00 00
30 0 0 0 0 0 0 0 0 0 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
32 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 DD 00
00 DD 00
33 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00
00
34 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0
00
00
35 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00
00
I 36 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00
00
vC 37 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00
00
I
38
000 0 *
- 0 00 00 00 00 00 00
00
00
39
00 00 0* - 0 0n 00 00 00 00 00
00
00
40 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 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
43 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
44 0 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 46 0 0 0 0 0 0 0 0 0 0 0 0 c 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 0 0 0 0 0 49 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
00 00 00 00
DD
DD 00 00 00 00 00
00 00 00 00 DD DD 00 00 00 00 00
Sanitized. Does not contain TSCA CBS
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 the study for personal reasons.
-n-
ConTox Limited - P O Box 36ft. Fort Washington Pennsylvania 19034-0368
r -- ----------------------- -----------------------------
Project Number: %-8342ll 1:1 du Pont de Nemours & Comparts - H-219.36. as supplied. Moditied I)rai/e Repeated Insult Patch lest Studs in Human Volunteers
DuPont HLO 713-96
\
Table I - Individual Panelist Data
lodns iiQll Phase
Challenge Phase Original Vir&in
I
Panelist
1
2
3
4
5 6789
10** She
Site
Number 2 4 _ 48 24 72 24___ 18 2 4 _ _ 48 24__ __22 2 4 _ _48 2 -A& 24___Z2 2 4 _ _48 2 4 _ _4S 24 _ 48 24 48
51 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00
00
52 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00
00
53 0 0 0 0 3 0 0 0 0 0 0 0 0 0 0 0 0 0
00
00
54 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00
00
5? 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 -
00
00
56 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
57 0 0 c 0 0 0 0 0 0 0 0 0 0 ,0 0 0 0 0
00 00
00 00
I
58 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 c
00
00
59 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
60 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
00 00
i
!
0 1
61 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 0 0 0 0 0 0
63 64
00 00
00 00
00 00
0* -0
00 00
00 00
00 00
00 00
00 00
00
65 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
67 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
68 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 0 0 0 0 0 0 0 0
00
00
00
00 00
0c 00 00
00
00
00 00
00 00
00 00
00
00
I I I
70 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
71 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
72 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
00 00
I
73 0 0 0 0 0 0 0 0 0 0 D D D D D D D D
DD DD
74 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
75 0 0 0 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 day. and the patch series extended until 9 induction applications were applied.
Make-up patch application.
D = Discontinued from the study for personal reasons.
-n-
C'onlox Limited P O Box J6B. Fort Washington. Pennsylvania 190)4*0368
I I
C om paq Sanitized. Does not contain TSCA CBI
SM iteed. Does not contain TSCA &j
Project Number: 96-8342H E l. du Pont de Nemours & Companx - H-21936. as supplied. Mod.tied Draize Repeated Insult Patch Test Study in Human Volunteers
DuPont HLO 713-96
Table 1 Individual Panelist Data
Panelist Number
76 77 78 79
80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99
100
1
24_- M 00 00 00 00 00 00 00 00 00 00 00
00 0 O' 00 00 00 00 00 00 00 00 00 00 00 00
23
24 _Z2 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 00 00 00 00 00 00 00 00 00 00 0* 0* -0 00 00 00 00 00 00 00 00 00 00 00 00
Induction Phase
456 24__ 24__ 72 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 00 00 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 D D DD D 00 00 00 00 00 00 00 00 00 00 00 00 00 0000 00 00 00
7
24 48 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
DD
00 00 00 00
00
00
24 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
o
0
D
o
o
o
o
o
0
9
_Z2 24 .48 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 0 00 DD D 0 00 0 00 0 00 0 00 0 00
0 00
10** 24___ 48
00
Challenge Phase
Original Virgin
Site Site
24___ 48 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 00
00 00
00 00
00 00
00 00
00 00
DD n D
00
(1 0
00 00
00 00
00 00
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.
ConTo,..united-POBox36.FonWrohington.Pcnroylt.nl>19034-036
II
#
Project Number: 96-8342H E l. du Pont de Nemours & Company - H-21936. as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPont HLO# 713-96
Table I - Individual Panelist Data
Panelist
Number 24__Jl8 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 no 0 0 III 0 0
2L__Z2 00
00 00 00 00
00 00 00
00 00 00
24_. 00 00
00 00 00
00 00
00
00 00
00
Induction Phase
24__48 00
00
00 00 00
00 00 00 00 00 00
5
24 -1 2 00 0D 00 00 00
00 00 00 00 00 00
6
24__48 00
DD 00 00 00 00 0* 00 00 00 00
7
24__48 00
DD 00 00 00 00 -0 00 00 0 00
24__Z2 00
DD 00 00 00
00 00 00
00 -0 00
24__48 00
DD 00 000
00 00 00
00 00 00
10** 24__48
00 00
Challenge Phase
Original Virgin
Site
24 _48 00
Site
24__48 00
DD DD 00 00 00 00 00 00 f' 0 0 0
00 00
00 00
00 00 00 00
00 00
NJ I
Does not contain TSC si
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 the study for personal reasons.
-n-
-ConToxLimited-POBox3b8.FonWashington.PcnrnyKcma190)4-0168
#
Project Number: 96-8342H P I du Pont de Nemours & Company - H-21936, as supplied. Modifed Draize Repeated Insult Patch Test Study in Human Volunteers
DuPont HLO U 713-96
Table 2 - Summary o f Data
I 24__18
Total
Panelists: III 111
24__ 2 2
111 111
3
24__4S
III 111
Induction Phase 456
24_- J 8 24__ 2 2 24_ M
111 111 111 III 111 111
78
24__J8 24_--22
111 111 111 111
9
24_--48
III 111
10**
24__48
99
Grade
Challenge Phase Original Virgin
Site Site
24__48 24__48
III 111 111 111
I I
0 III 108 108 107 107 102 101 107 107 106 105 104 102 103 103 105 104 103 9 9 105 105 105 105
+
00 00 00 00 00 00 00 00 00 00
00
00
1+ 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00
00
I
2+ 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00
00
u--
3+ 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00
00
I
4+ 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00
00
- 0 0 0 0 1 0 7 0 0 0 0 0 3 0 2 0 12
4 0 0 0 1 0 6 0 0 0 0 0 1 0 2 0 0 00
D 03 33 33 34 4 5 66 66 66 6 6
00 00 66
00 00 66
I
Sanitized. Does not contain TSCA CEM
24 = Reading 24 hours after application. 48 = Reading 48 hours after application.
- = Missed reading.
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 the study for personal reasons.
-n-
ConTtnLimitedPOBox368.FonWuhinpon,PcnnsylvaaiaI0344361
I
! I I
Project Number: %-8342ll
DuPont IILO tt 713-%
!:!: du Pont dc Nemours & Company-11-21936
Modi Iled Draize Repealed Insult Pateh Test Study in Human Volunteers
APPENDIX II PANELIST LIST
- 14-
('iin 'ln x I inilltd - I ' U lln \ 1/iX. I nn W;isliiii{ilt>n. IVmisvH:mi:i l `)IIU -(IU iX
Company Sanitized. Does not contain TSCA CBi
Project Number: 96-8342H
DuPont HLO # 713-96
l.I. du Pont de Nemours & Company - H-21936
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Panelist Number
PaneMs; Initials
1 M.C. 2* M.T. 3 C.P. 4' B.R. 5 E.T. 6 BH 7 N.R. 8 R.O. 9 J.B. 10 A.B. II L.P. 12 M.C. 13 H.D. 14 B.B. 15 A.D. 16 C.M. 17 K.D. 18 C.M. 19 DP. 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 E.M.
PANELIST LIST
Age Occupation
23 Supervisor 33 Meat packer 31 Medical assistant 30 Homemaker 41 Dental assistant 37 Homemaker 36 Homemaker 41 Homemaker 44 Newspaper clerk 32 Homemaker 36 Homemaker 30 Homemaker 53 Homemaker 29 Homemaker 30 Salesperson 36 Salesperson 49 Homemaker 26 Homemaker 37 Cashier 31 Laborer 34 Homemaker 36 Homemaker 55 Homemaker 27 Medical Assistant 35 Homemaker 39 Homemaker 20 Student 38 Boxspring maker 52 Homemaker 47 Uemployed 44 Unemployed 34 Student 46 Homemaker 18 S'udent 37 Homemaker 38 Homemaker 42 Homemaker 57 Homemaker 34 Homemaker 53 Homemaker
Allergies
Ragweed Penicillin Shellfish, seafood Hayfever
Penicillin, ampicillin, amoxicillin
Penicillin, aspirin Hayfever
- 15-
.'nn lux I.mitcd - I'.i llux 36K. I;ml Washington. Pennsylvania l`M)J4-03h8
not co' Ooe gat"
Project Number: %-8342H
DuPont HLO # 713*96
K.l. du Pont de Nemours & Company - H-21936
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Panelist Number
Panelist Initials
41 M.G. 42 S.V. 43 J.H. 44 B.A. 45 H.O. 46 D.G. 47 D.R. 48 P.D. 49 AT. 50 K.H. 51 V.T. 52 P.A. 53 M.W. 54 T.T. 55 J.N. 56 J.D. 57 J.D. 58 D.K. 59 MB. 60 J.Z.
61 Y.H. 62 C.R. 63 S.B. 64 H.R. 65 C.R. 66 P.G. 67 C.R. 68 W.C. 69 T.F. 70 R.D. 71 K.A. 72 E.L. 73 M.L. 74 T.E. 75 M.C. 76 D.Y. 77 A.G. 78 A.G. 79 JT. 80 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 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 Dust, grass, trees, pollen, smoke Penicillin
- 16-
Con l iix l imited - I' O Hux IftH. l ull Washington. Pennsylvania IWM4-0.16K
Project Number: 96-8342H
DuPont HLO # 713-96
E.l. du Pont de Nemours & Company- H-21936_
_ ____ ______ ______ ______
Modified Draize Repealed Insult Patch Test Study in Human Volunteers
Panelist Number
Panelist Initials
81 HR. 82 K.B. 83 D.R. 84 A.B. 85 W.M. 86 S.M. 87 J.M. 88 B.M. 89 C.J. 90 A.N. 91 C.C. 92 V.M. 93 N.S. 94 v .s . 95 J.S. 96 R.S. 97 E.N. 98 D.H. 99 J.H. 100 D .K . 101 K.N. 102 B.M. 103 V.F. 104 L.T. 105 E.G. 106 M.C. 107 R.F. 108 M.S. 109 R.P. n o ED. III J.B.
Age
18 32 31 70 30 26 45 4j 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 Congressional aide Payroll clerk Unemployed Hairdresser Isurance adjuster
Allergies
Sulfur
Hayfever Hayfever Penicillin Animal hair
Metals Antibiotics Cats Hayfever
- 17-
C'nnl' I.mill'd - PO. lit WiH. In n Washington. Pennsylvania IW4-(UhX
Sanitized. Does not contain Company
Project Number: %-83421l
Dul'ont III.O H 713-%
+ l-.l. du Pont de Nemours & .Company -11-21936
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
APPENDIX III GRADING SCALE
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Project Number: 96-834211
DuPont 111.0 # 713-%
H.l. dii Pont ile Nemours .Company -11-21936. . .
Modillcd l)rai/c Repeated Insult Patch lest Study in Human Volunteers
Appendix III
Reading
0 +
1+
2+ 3+ 4+
Interpretation negative suspicious slight ery thema 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 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.
* Draize. J.H. 1959. Appraisal of the Safety of Chemicals in Foods. Drugs and Cosmetics. In DI RMAI. TOXICITY, p. 46-53. Topeka. Kansas: Association of Food and Drug Officials of the 1 nited States.
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