Document ndx1azmMZMRz5Kk3MOxRNR9z
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 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
Page 1 of 19 Company Sanitized. Does not contain TSCA CB
Material Tested:
GENERAL INFORMATION Test Material
DuPont H L0 712-96
Physical Form: Synonyms:
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
Companinyv Sanit.izedj . pDnogees n<ot contain TSCA CBS
DuPont HLO 712-96
DUPONT CENTRAL RESEARCH AND DEVELOPMENT HASKELL LABORATORY FOR TOXICOLOGY AND INDUSTRIAL MEDICINE
October 8, 1996
DuPont Specially Chemicals Techlab T3D+ 113-C
100-Person Human Patch Test with H-22033 (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-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%, respecuvely,
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. Research Toxicologist
not contai" TSC A CB
- 3-
S anitize*3- D o e s
Compaq
DuPont HLO # 712-%
C on T ox L im ited
P.O. 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 Lycoming Street Philadelphia, PA 19124
Sponsor:
1.L du Pont e'e Nemours & Company P.O. Box 50, ilkton Road Newark, DF. 19714
Test Article:
H-22033
Test Article Description:
Blue non-woven fabric
Test Article Received:
Study Initiated:
08/08/96 08/14/96
Study Completed: 09/18/96
Date of Report: Test: Object o f Test: Reference:
Method o f 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 years of age (see Panelist List, Appendix 11). 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 CBI
I'rojeel Number: 96-834211
DuPont HLO# 712-96
l l.I. du Pont'de Nemours & (r'ompany - 11-22033 ---------------- ------------------------------------------------
Modified Draizc Repeated Insult Patch Test Study in Human Volunteers
Method ol'-Tesil (continued)
|nfnh Pn>nnrntinn: 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.
inHnrtmn Phase: The Datch 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. Pate applications made on Friday were removed by the panelists on 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 us
throughout the study.
In the event when one induction application was misred, the panelist was allowed to make it up at the end of the induction patch p e n o d jh is patch was applied on Wednesday following the last scheduled (ninth) induction
application on Monday.
TM .i1(.nr Phase: After the 9th application, a rest period o f approximately 2 weeks elapsed after which a challenge application ^ s apphed m th 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 apphcations we removed after 24 hours find 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 remova ).
The grading scale used throughout both the induction and challenge
phases is shown in Appendix III.
-5C-onTov l imited - P.O Hns 3TM. 1" Washington. Pennsylvania ITOM-MMI
Project Number: 96-834211
DuPont HLO # 712-96
!.I. du Pont de Nemours & Company -] 1-22033__________________
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Results obtained with the test article (H-22033) are presented in Appendix I. 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:
Raymnoondn d U... Study Director'Consultant Approved by:
President
6- -
ConTnx I united - 1' O Hox 3ftS. I rt Washington. Pennsylvania IW)J4-(I.168
not contain TSCACBl Company Sanitized. Dos
Project Number: 06-834211
DuPont IILO ft 712-96
----- --I-M. du Pont de Nemours.& Company._-_l.1-2203.3 _____________________________ ______
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
APPENDIX I RESULTS FOR TEST ARTICI E
i
A -7I'onTox l imilo! - PO. Hnx .tftX. I'ort Washington. Pennsylvania iy()34-0.1fi8 TSCA CBl CompanVSanili*4*.Does nci corllaln
Project Number: 96-8342H E.l. du Pont de Nemours & Company - H-22033. as supplied.
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPont HLO * 712-96
Table I - Individual Panelist Data
Challenge Phase
Induction Phase
Original Virgin
Panelist 1
2
3
4
5
6
7
8
9
10** Site
Site
Number 24_JL8 2 4 _ J 1 2 4 _ M
M 24 72 24__M 24__M 24__J 1 24___4S 24__ 48 24__48 24__48
1 00 00 00 00 00 00 00 00 00
00 00
2 00 00 00 00 00 00 00 00 00
00 00
3 00 00 00 00 00 00 00 00 00
00 00 I
4 00 00 00 00 00 00 00 00 00
00 00
5 00 00 00 00 00 00 00 00 00 6 00 00 00 00 00 00 00 00 00
00 00 00 00
II
7 00 00 00 00 00 00 00 00 00
00 00
8 00 00 00 00 00 00 -0 00 00
00 00
9 00 00 00 00 00 00 00 00 00
00 00
10 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
I 00 1
II 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 12 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 13 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
14 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
15 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
I
16 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
17 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
18 0 0 0 0 3 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
19 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
20 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
21 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
22 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
23 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
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
I
Company Sanitized. Does
3O oo3#w*
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
3' HCo>/>
day. and the patch series extended until 9 induction applications were applied.
M = Make-up patch application.
D - Discontinued from the study for personal reasons.
-n-
o03 ConTox Limited 'P O Box 1*8. Fort Washington. Pennsylvania 190144)368
I
vC
I
Oo
3Mo
cWn
V
N
CQD. ao CWD
not contain TSCA CBI
Project Number: 96-8342H E.l. du Pont de Nemours & Company - H-22033. as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPont HLO # 712-96
Table I - Indivisa! panelist nata
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
24---- 48
00 00 00
00
00
0D
00
00
00 00 00 00 00 00 00 00 00 00
0D
0D
00 00 00 00 00
24___ 12
00 00 00 00
00
DD 00 00
00
00 00 00 00 00 00 00 00 00 DD DD 00 00 00
00 00
24 0 0 0 0 0 D 0 0 0 0 0 0 0 0 0 0 0 G D D 0 0 0 0 0
48 0 0 0 0 0 D 0 0 0 0 0 0
*
*
0
0 0 D D 0 0 0 0 0
24 Reading 24 hours after application. 48 Reading 48 hours after application. 72 Reading 72 hours after application.
Induction Phase
456
24__48 24___ 22
00 0 0
00 00 00 00
00 00 00 00 D DD D 00 00 00 00
0 00 00 00 00 00 00 00
0 00 0 00
0 00 0 00 0 0 00 00 00 D DD D D DD D 00 00 00 00 00 00 00 00
00 00
24___48 00
00 00 00 00 DD 00 00
00 00 00 00 00 00 00 00 00 00 DD DD 00 00 00 00 00
7
24___48
00
00 00 00 00 DD 00 00
00 00 00 00 00 00 00
0 00 00 DD DD 00 00 00 00 00
8
24___ 22 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 00 00 DD DD 00 00 00 00 00
9
24___48
00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 00 00 DD DD 00 00 00 00 00
* = Missed reading.
10**
24__ 48
0 0
Challenge Pha<jf
Original Virgin
Site Site
24. 48 00 00 00 00 00 DD 00
24___48
00 00 00 00 00
DD
00
00 00 00 00 00 00 00 00 00 00 00 DD DD 00 00
00
00
00 00 00 00 00 00 00 00 00
DD
DD
00 00
00 00
00 00
00 00
Make-up patch application.
D - Discontinued from the study for personal reasons. -n -
ConToxLimned P O 80 JM . Fon WmKmgwti. Penrayhem , I9 U 4 4 IM
Sanitized. Does not contain TSCA CB
t 0 1
Oo 3Mo 3
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 HLO 712-96
labi I - Individual Panelist Data
Panelist Number
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
2 4 _ .JS 00 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__ 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
3 24___48 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
Induction Phase 456 24__-JH 24__ _I2 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 00 00 00 00 00 00 00 00 00 00 00 00 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 0 0 00DD 00 00 00 00 00 00
78
2 4 _ _48 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 D DD D 00 00 0* - 0
9
24___48 00 00 00 00 000 u0 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00
10** 2 4 _ _4S
00 00
00
Challenge Phase Original Virgin
Site Site
2 4 _ -4 8 24 _48 00 00 00 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 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 DD DD 00 00 00 00
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 Tor personal reasons.
-n-
ConTox Limited- P O Box J6 i. Port Washington. Penm ytvnii 190J4-036S
0
Project Number: 96-8342H E.l. du Pont de Nemours & Company - H-22033. as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers
UuPom HL0 3 7,2.%
Table I Indiv idual 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 _48 00 00 00 00 00 00 00 00
00 00 00 00 0 0. 00 00 00 00 00 00 00 00 00 00
03
00
2
24__ 72 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
3
24__.48 00 00
00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 0* -0 00 00 00 00 00 00
Induction Phase
4 56
24__ -48 24__ JZ2 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 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 -0 00 00 0 D D DD D c0 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
7
2 4 _ .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
8
24__ _Z2 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
9
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
10** 24___48
0o
Challenge Phase
Original Virgin
Site Site
24 48 24 48 00 00
00 00
00 00
00 00
00 0n
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
DD DD
00 00
00 00
00 00
00 00
00 00
00 00
24 = Reading 24 hours after application. 48 = Reading 48 hours alter 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.
Company Sanitized. Does not contain TSC C5I
ConTot Limited P O Bot J68. Fon Washington. Pennsylvania 190)4-0168
Project Number: 96r8342H V..L du Pont de Nemours & Company - H-22033, as supplied. Modified Draize Repeated Insult Patch Test Stud\ in Human Volunteers
DuPont HLO p 712-96
Table 1 - Individual Panelist n.-^
Induction Phase
Challenge Pha^
I hro-
Panelist Number
II 102 103 104 105 106 107 108 109 110 111
1
24__48 00 00 00 00 00 00 00 00 00 00 00
2
2 i _ 72 00 00 00 00 00 00 00 00 00 00 00
3
24L_M 00 00 00 00 00 00 00 00 00 00 00
4
24__ _4S 00 00 00 00 00 00 00 00 00 00 00
5
24__ J 1 00 0D 00 00 00 00 00 00 00 00 00
6
24 M 00 DD
00 00 00 00 0*
G0 00 00 00
7
24__ M 00 DD 00 00 00 00
0 00 00 0* 00
8
24 77 00 DD 00 00 00 00 00 00
00 0
00
9 24 48 0o
DD 0o 0 0o 00 0o 00 0o oo
0G
10** 24 -- 48
00 00
Original Site
21__ 48 00 DD 00 00 00 00 00 00 00 00 00
Virgin
Site
21__ 48 00
DD 00 00 00 00 00 00 00 00 00
I
Oo 3a v03i3-
24 Reading 24 hours after application.
48 Reading 48 hours after application.
72
*
Reading 72 hours after application.
- = Missed reading.
d U J'S i *!Ted. ti e SChedu,ed Pa`ch aPP,,ca,ion 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 O Box J6. Fort Washington. Penraytvtma I9034-O36S
Sanitized. Does not contain TSCA CEI
I
#
Project Number. %-8342H E.l. du Pont de Nemours & Company - H-22033. as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPont 111.0 1712-96
Table 2 - Summary of Data
I
24 _4S Total Panelists: 111 111
7 24-- _J2
111 111
3 24-- _48
111 111
Induction Phase 4 56 24___4S 2 4 _ _22 24___J
111 111 111 111 111 111
7 2 4 _ _4S
111 111
8 24__ 72
111 111
9 24___48
III 111
10 24___48
99
Challenge Phase Original Virgin
Site Site 2 4 _ _48 24 _J8
111 111 111 III
Grade 0 + l2+ 3 I4+ . *
D
111 108 108 107 107 102 101 107 107 106 105 104 102 103 103 105 104 103 00 00 00 00 00 00 00 00 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00
00 00 03
00 01 33
10 06 33
70 00 34
00 00 45
00 01 66
30 02 66
20 00 66
12 00 66
99 00 00 00 00 00
105 105 00 00 00 00 00
105 105 00 00 00 00 00
00 00 66
00 00 66
not contain
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-
Conto* Limited - P O B o i 361. Fort WBMflgm. P tim r hienil 190M 4J6I
Project Number: `>6-834211
DuPont HLO # 7 12-96
I'.I. du Pont de Nemours & C'ompany -11-22033__ ____
__ __
Modi lied Draixe Repeated Insult Patch Test Study in Human Volunteers
APPENDIX II PANELIST LIST
.3
3 i
/SVSI .t
-14-
-
{ 'iin'l'iix l imited - I'.O. Hox JhK. tort Washington. Pennsylvania IS034-0368
Company Sanitized. Does not contain TSC CB1
Project Number: 96-8J42H
DuPont HLO # 712-96
E.lrdu Pont de Nemours & Company- H-22033
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Panelist Number
1 2' 3 4' 5 6 7
s
9 10 11 12 13 14 13 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
Panelist Initials
M.C. M.T. C.P. B.R. E.T. B.H. N.R. R.O. J.B. A.B. L.P. M.C. H.D. B.B. A.D. C.M. R.D. C.M. D.P. A.B. M.D. M.M.E. M.A.E. L.D. D.P. L.M. J.C. E.P. A.G. J.W. M.H. N.D. M.C. L.C. S.S. P.W. E.W. L.B. K.M. C.M.
PANELIST LIST
Age Occunation
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 Student 37 Homemaker 38 Homemaker 42 Homemaker 57 Homemaker 34 Homemaker 53 Homemaker
AHereies
Ragweed Penicillin Shellfish, seafood Hayfever
Penicillin, ampicillin, amoxicillin
Penicillin, aspirin Hayfever
- I5 -
ConTox l.imilcd - P.O. Box 368, Fort Washington. Pennsylvania 19034-0368
sn o t contain TSCACBi Sanitized. Ooe Compaq
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.F M.C. D.Y. A.G. A.G. J.F. D.D.
Age
39 31 26 49 20 33 49 35 57 26 37 35 67 31 31 31 33 36 60 62 40 18 29 38 18 26 28 24 21 26 26 47 39 24 50 59 65 64 42 58
PANELIST LIST
Occupation
Day care teacher
H.jmemaker
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-
ConTox I imileii - P.O. Ilox 368. Fort Washington. Pennsylvania l<X>34-03fi8
,,,,t contain TSCA OBI
sanitized. D oes
Project Number: 96-8342H
DuPont HLO # 712-96
E.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
Occunation
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
Allereies
Sulfur
Hayfever Hayfever Penicillin Animal hair
Metals Antibiotics Cats Hayfever
- 17-
ConTox Limited - P.O. Hnx 368, Fort Washington. Pennsylvania 19034-0368
not contain TSCACBI Company Sanitized. Does
Project Number: 46-8342! 1
DuPont HLO ft 712-%
I I . du Pont de Nemours & Company - H-22033
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
APPENDIX III GRADING SCALE
- 18-
ConTox I imiled PO . Ho\ .U18.l'uri Washington. Pennsylvania IWM4-1U6N
Company Sanitized. Does not contain TSCA C81
Project Number: 96-8342H
DuPont HLO # 712-96
E.I. du Pont dej^em ours & Com pany- 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 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 o f 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 o f 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.
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C'onTnx l.imilcil - PCI Box lh8. Fun Washington. Pennsylvania 14111441368
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