Document Xw3kEoa278Kr1D3g373RbXaG
AR226-3058
Study Title 100-Person Human Patch Test with
H-2205S (Test Item) Laboratory Protect ID Haskell Laboratory Report No. 647-96
Study Completed On September 30, 1996
Contracting Laboratory ConTox Limited 3408-50 B Street
Philadelphia, Pennsylvania 19134
Author David Gabriel
for b. 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 TSCA CB Page I of 19
m ----------------
Material Tested: Physical Form: Synonyms:
fiF.NRRAL INFORMATION Test Material
r-- a
White Woven fabric
DuPont HLO 647-96
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 Speciality Chemicals E. I. du Pont de Nemours and Company Wilmington, Delaware
8/14/96 - 9/30/96
8/14/96-9/18/96
Company Sanitized. Does not contain TSCA CJ
DuPont HLO 647 % DUPONT CENTRAL RESEARCH AND DEVELOPMENT
HASKELL LABORATORY FOR TOXICOLOGY AND INDUSTRIAL MEDICINE
October 8. 1996
DuPont Speciality Chemicals Techlab T30+ 110
100-Person Human Patch Test with H-22055 (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 o f this study was to determine the potential of H-22055 to cause irritation or delayed contact hypersensitivity in humans. During the induction and challenge phases of this study, H-22055 (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-22055 (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
Company Sanitized. Does not contain TSCA CBI
DuPont 111.0 #647-%
C o n T o x -L im ited ---------------------------------
P.O. Pox 368. l-ort Washington. Pennsylvania 19034-0368 Telephone: (215) 739-4499 Pax: (215)423-9210
Priyeci-Number: h a u n t
Sponsor:
Test Article: Test Article Description: Test Article Received: Study Initiated: Date o f Report: Test: Object of Test: Reference:
M elhoiL ol'Iesi:
96-834211
t'oni'ox Limited 1358 Lycoming Street Philadelphia, PA 19124
E.I. du Pont de Nemours & Company P.O. Box 50. Elkton Road Newark. DE 19714
H-22055
White woven fabric
08/13/96 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 o f the test article.
The method employed in carrying out this test was similar to that described in "Appraisal o f the Safety o f Chemicals in Foods, Drugs and Cosmetics" by J.H. Draize and published by the Association o f Food and Drug Officials o f the United States.
Test Panel: The lest 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 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.
Page 4 Company Sanitized. Does not. contain TSCA CBI
Project Number: `>(-83421I
DuPont III.O H(47-%
I-. It-du-Pont-dc-Ncmours-&-CompanY-=-l.l=220.`5________________________________________
Modi lied Drai/c Repeated Insult Patch lest Study in Human Volunteers
Method of lest; (continued)
I'uldi Preparation: The test article was tested as supplied. The test article was cut into approximately one inch square portions and placed onto a strip of 2" Dermicel* hypoallergenic cloth tape (Johnson & Johnson. New Brunswick. NJ 08903). Before applying this strip, each portion o f test material was secured in place with a gloved linger to insure proper application. This tape strip was then pressed into place on the upper left arm of each panelist at its designated test site.
Induction Phase: The patch was applied to its designated contact site and remained in place for 24 hours. At the end of this period, the patch was removed and the site was examined for any dermal response. The panelists were then rested for a 24-hour period after which the skin site was again examined. A new patch was then applied to the same site as previously used. Fach subsequent application was identical to the first and remained in place 24 hours. This procedure was repeated on Mondays. Wednesdays and Fridays until a series of nine applications had been made. Patch applications made on Friday were removed by the panelists on Saturday. The panelists examined the sites (with assistance if necessary) for any dermal response at the time ol removal and again at 48 hours and reported their observations prior to the next application. The same site was used throughout the study.
In the event when one induction application was missed, the panelist was allowed to make it up at the end of the induction patch period. This patch was applied on Wednesday following the last scheduled (ninth) induction application on Monday.
Challenge Phase: After the 9th application, a rest period 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 (previouslv untreated) on the other, arm. lhe challenge applications were removed alter 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-
( i.nli'V I mull'll - I' ll Ilex W,H. I nrt Wuxlimplun. I'cmix>li.ini;i lU -llll.X
Company Sanitized. Does not contain TSCA CBI
Project Number: %-K.'42l I
DuPont 111. # 647-96
i-Tlrdu Pont-de-Nemours-^.-Company--11-22055------------------------------------------------------------
Modi lied Drui/c Repeated Insult Patch Test Study in Human Volunteers
Results: Conclusion:
Results obtained with the test article (H-22055) are presented in Appendix I. Indiv idual panelist data are presented in Table 1. A summary o f 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:
Consultant Dermatologist
Datii l
Study Director/Consultant Approved by:
Karl !.. uaonei, v.ivi.u., r n . u . President
6- -
(in l'i'V I milled - IM I Mux ..1C. In n Washington. IVnnsylvajiiu Idli.U-iiU.K
Company Sanitized. Does not contain TSCA Cffi
Project Number: 96-834211
DuPont HLO # 647-96
-K.-l-.-du- l-onuie Nemours & Company - H-22055 ___________________
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
APPENDIX I RESULTS FOR TEST ARTICLE
-7-
C iin T i'\ I imilL'd - I'.O Itox JhX. I'ort Washington, Pennsylvania 1>0.14-0.1
Company Sanitized. Does not contain TSCA CBfi
a
1 i
Qo
-(/t> O * ow
not contain
I'rojeet Number. t>6-t$342H
ILL du Pont do Nemours & Company - ll-220?5. as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPont II LO = 64"-9i
Panelist Number
1
*>
4
6 7
K
9 10 11
p
13 14
P
16 17 18 19 20 21
n
23 24 25
Table I - IndividualJancM Iiaia
1
2o4___
J
S o
oo
o0
o0
o0
24___ J 2
00 00
00
00
0
00
00
00 00
00
o0 c0
00 00 00
00
00
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
14___ M
00 00 00 00 00 00 00 00
c0
00 00
n0
00 00 00 00 00 00 00 00 00 00 00
00 00
ladueliuaPJtitse
4
u _ _4S
00 00 00 00 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
6
24___ 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
00
00
00
00 00 00
00
00
00
00
00
00
00
00
00
00
00
00
00
00
00
00 00 00
-7I
24____4S
00 00
00 00
0n
00 00
-0
00 00 00 00 00 00
00 00
00 00 00 00 00 00 00 00 00
a8 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
o9 24___A i
00 00
00
00 00
00
0 ft 0 ft 0 ft 0 ft
0 00 00 00
00 00 00 00 00 00 00 00 00 00 00
iInO***
24 48
challenge Phase
Original
Sviitie.24___ i
00
00
00
0- 0 ft 0 0 ft ft 0
00
ft ft
00 00 00 00 00
00 00 00 00 00 00
00 00 00 00 00
VSirigtein 24____415
00
ft ft
00 00
ft 0
00 00 (1 0 00 00
ft 0 c0
00 00 00 00 00
0u
0
0
u
0
ft 0 tl ft
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 schedule app ic o
day. and the patch series extended until 9 induction applications were applied.
** = Make-up patch application.
D = Discontinued from the study for personal reasons.
- 8-
ron rei l imned -P O Bo Jd8. Fon Wattiinpm. PenmyKenio lOOM-niP*
Project Number: 96-834211 i: I. du Pont.de Nemours & t'ompam. -11-22055. ns supplied. Modified Drai/.o Repeated Insult Patch Test Studs in Human Volunteers
DuPont HI.O =
Company Sanitized. Does not contain TSCA CBi
Panelist
Number 26 27
28 29 30 31 32 xt x%
54 35 36 37 38 39
40 41 42 43 44 45 46 47
48 49
50
I
24___48 00 00 0 00 00 0D 00 00 00 00 00 00 00 00 00 00 00 00 0D 0D 0e 00 00 00 00
2
2 4 _ _22 00 0G 00 00 00 DD 00 00 00 00 00 00 0 () 00 00 00 00 00 DD DD 00 00 00
00 00
24__48 00 00 00 00 00 DD 00 00 00 00 00 00 0 0*
00 0*
00 00 DD DD 00 00 00 00 00
24 Reading 24 hours after application. 48 Reading 48 hours after application. 72 Reading 72 hours after application.
lab il I - Individual Panelist nata
Induction Phase
4 24__4S 00 00 00 00 00 DD 00 0 (1
-0 00 00 00 -0
-0 00 -0 00 00 DD DD 00 00 00
00 00
5
24__Z2 00 00 00 00 00 D 1) 00 00
00 00 0 () 00 00 00 00 00 00 00 DD DD 00 00 00 00 00
6
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 b0 00 DD DD 00 00
00
00 00
8 2 4 _ __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 (1 0
00 00 00 00 00 00 00 00 00 00 DD DD 00 00 00 00 00
- Missed reading.
|o* 24__ .48
o0 00 00
Challenge Phn^
Original Virgin
Site Site
24___48 00 00 00
00 00 DD 00 00 00 00 00 00 00 00 00 00 00 00 DD DD 00 00
24___48
00 00 00 00 0 t) 1) D 00 !J 0
00 00 00 00 00 00 00 00 00 00 DD DD 00 00
00 00 00
00 00 00
da>. and the patch seSrCiheesdeUxlCtedndT ed? unatPilP9,iCinad,iu0c"tifo0nr paperpsloicnaatliorcnasswonesre- Paapnpelileisdt Patched on the next scheduled apPPplication
P Patch appl.cat.on,
D = Discontinued from the study for personal reasons -9-
( nio I tmitrJ P O Hox Mt h in Uohm yton Pennstlxtni* I9tm-01<ll
Project Number. 96-834211 P. I. du l*ont de Nemours & l omp.mx - 11-22055. as supplied. Modified Drai/e Repeated Insult Patch Test Studs in Human Volunteers
DuPont HI.O * 647-96
l able 1 - Indisidual Panelist Data
Panelist
I
| |>I|Q
Challenge Phase
Original Virgin
4
56
7
8
9
10** Site
Site
Number 24 _18 51 0 0 52 0 0
21__I2 00 00
2 i_ _18 00 00
21__ 18 21__ _Z2 24___18 00 00 00 00 00 00
21___18 21__ JZ2 2 !_ -1 8 00 00 00
00 00 00
21 _18
21__JS 00
00
2 !_ _1S 00 00
53 0 0 0 0 0 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 55 0 1) 0 0 0 0 0 0 0 (1 0 1) 0 0 0 0 0 -
00 00
00 00
56 0 0 0 0 0 0 0 0 0 0 0 0 u 0 0 0 0 0 57 0 0 0 0 0 0 0 0 0 1) 1) 0 0 0 0 0 0 0
00 00
00 00
58 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
59 (1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
60 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
61 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 (1
00 00
62 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
63 64 65
0 0
0 0
00 00
00 0
00 -0
00 00
0 0
0 0
00 00
00 00
00 00
0
0
00 00 0 * -0 00 0 0 00 00 00 00
00 00 00
00 00 00
O0 3
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
00 ?) 0
00 00
7031 68 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
3< 69 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
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
00 00
72 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
00 00
73 0 0 0 0 0 0 0 0 0 0 D 1) 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
Sanitized. Does not contain TSCA CBI
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 pa ch application.
d = Discontinued from the study for personal reasons.
- 10-
ConTox l imited P O Box IM Fort Washington PcnmxKanta l<)0)4-0)68
Project Number: 96-8342H P I. Ju Pont de Nemours & Compiine -11-22055. as supplied. Modified Draue Repeated Insult Patch lest Studs in human Volunteers
DuPoni HLO = 647-06
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
2 4 _ _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
Table I - Individual Panelist Data
2 7*i
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 24__ A &
56 72 24__ JL8
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 00
00 00 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
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 00 00
00 00 00
78
24__M 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 00 00 00 00 00 00 00 00 00 00 00 D DD D 00 00 00 00 00 00 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
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 DD 00 00 00 00 00 00 00 00 00 00 00 00
Company Sanitized. Does not contain TSCA CB!
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.
- II -
<..lo t 1 mttml P l> lli*x tf*!t frin Wixhinutut' Penns.Kama |*nit4-"WiB
Project Number: 96-834211 E.l. du Pont de Nemours & Compan) -11-22055. as supplied. Modified Drai/e Repeated Insult Patch Test Stud) in Human Volunteers
Table I - Individual Panelist Data
Panelist Number
101 102 103 104
105 106 107 108 109 110 111
1 24__48 00 00 00 00
00 00 00 00 00 00 00
2
24__ _Z2 00 00 00 00 00 00 00 00 00 00 00
3 2 1 _ _48 00 00 00 00 00 00 00 00 00 00
00
Induction Phase
4 56 24__ 48 24__ -12 2 4 _ J A 00 00 00 0 0 0 DD D 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
7
24__-48 00 DD 00 00 00 00 -0 00 00 0* 00
8 24 J 1 00 DD
00 00 00 00 00 00 00 -0 00
9
24__-48 00 DD 00 000 00 00 00 00 00 00
DuPont HLO * 647-96
Challenge Phase Original Virgin
Site Site 24__--48 24__48 00 00 DD DD 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00
Company Sanitized. Does not contain TSCA CBI
24 = Reading 24 hours after application. 48 = Reading 48 hours after application. 72 = Reading 72 hours after application.
- = Missed reading.
* = 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.
- 12-
ConToi Limited . P O Dnt 3Ml. Fnn Washington. Pennsylvania 19034*0308
Project Number: 96-834211 du Puni de Nemours & Comparu -11-22055. as supplied.
Modified Draize Repeated Insult Patch l est Study in Human Volunteers
DuPont HLO 647-%
fable 2 - Summary of Dalit
Ifiial
Panelists:
1 24___ 48
111 III
Grade
1
24_JL2
111 111
3
24__ 48
III 111
Induction Phase 4 56 24__ 48 24___Z2 24__48
III 111 III III III III
7
24_.48
III III
8
24__ 72
III in
9
24_-48
III III
10**
24.__48
99
0 111 108 108 107 107 102 101 107 107 106 10? 104 102 103 103 103 104 103 9 9
-. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
1*
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00
00
2-1-
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00
00
3-*- 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
4*
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00
00
-
00 00
10 7 0 0 0 0 0
30 20
12
* 0 d 0 1 0 6 0 0 0 0 0 1 0 2 0 0 00
D 0 3 33 3 3 34 4 5 6 6 66 6 6 66
Challenge lh,.s.. Original Virgin
Site Site 24__48 24 _48
III III in III
105 105 00 00 00 00 00
105 105 00 00 00 00 00
00 00 66
00 00 66
Company Sanitized. Does not contain TSCA CBl
24 Reading 24 hours after application.
48 Reading 48 hours after application.
72 *
Reading 72 hours after application.
- = Missed reading.
" t - r SCheduled K 1*aPP|ication fcr personal reasons. Panelist was patched on the next scheduled application ay. and the patch senes extended until 9 induction applications were applied
Make-up patch application.
D = Discontinued fa n the study for personal reasons.
- 13-
i fo i I untied P l I B w \b* Fon
Penimi* jnia
Project Number: 96-8342H
DuPont HLO# 647-96
E L du Pont de Nemours & Company- H-22055--------------------------------
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
APPENDIX II PANELIST LIST
-14-
ConTox l imited - P.O. Box 368. Fort Washington, Pennsylvania 19034-0368
C-"PanySa,, ife6(f. D(Jes,,ot(;M ia|nT sc flcB |
Project Number: 96-8342H
DuPont HLO # 647-96
E.I. du Pont de Nemours & Company - H-22055
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
PANELISTLISJ
if
Panelist Panelist Number Initials
Age Occupation
Allergies
1 M.C.
23 Supervisor
V M.T. 33 Meat packer
3 C.P.
31 Medical assistant
4' B.R.
30 Homemaker
E.T. 41 Dental assistant
6 B.H.
37 Homemaker
7 N.R. g R.O. 9 J.B.
10 A.B. 1J L.P.
36 Homemaker 41 Homemaker 44 Newspaper clerk
32 Homemaker 36 Homemaker
Ragweed Penicillin Shellfish, seafood Hayfever
12 M.C. 13 H.D.
30 Homemaker 53 Homemaker
tr
14 B.B.
29 Homemaker
IS A.D. 16 C.M. 17 R.D. 18 C.M.
30 Salesperson 36 Salesperson 49 Homemaker
26 Homemaker
19 D.P.
37 Cashier
20 A.B.
31 Laborer
21 M.D. 22 M.M.E.
34 Homemaker 36 Homemaker
23 M.A.E. 24 L.D.
55 Homemaker 27 Medical Assistant
Penicillin, ampicillin, amoxicillin
25' D.P.
35 Homemaker
26 L.M.
39 Homemaker
27 J.C.
20 Student
28 E.P.
38 Boxspring maker
29 A.G.
52 Homemaker
30 J.W. 31 M.H.
47 Uemployed 44 Unemployed
Penicillin, aspirin
32 N.D.
34 Student
33 M.C.
46 Homemaker
34 L.C.
18 Student
35 S.S. 36 P.W.
37 E.W.
37 Homemaker 38 Homemaker 42 Homemaker
Hayfever
38 L.B.
57 Homemaker
39 K.M.
34 Homemaker
40 E.M.
53 Homemaker
]
i
1
-15-
ConTox limited - PO Box .168. Port Washington. Pennsylvania IWM-0368
Sanitized. Does not contain t s c a c b s Company
Project Number: 96-8342H
DuPont HI.O U647-96
-- E.h-du-Pont de Nemours & Company - H-22055------------------------------------------------------------
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Panelist Number
41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80
Panelist Initials
M.G. S.V. J.H. B.A. HO. D.G. D.R. P.D. AT. 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. ML. T.E. M.C. D.Y. A.G. A.G. J.F. D.D.
Age
39 31 26 49 20 33 49 35 57 26 37 35 67 31 31 31 33 36 60 62 40 18 29 38 18 26 28 24 21 26 26 47 39 24 50 59 65 64 42 58
pan elistlist
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
- 16t onTu 1intilcd - !1IIIIX Ih*. l'uri Woshinplim. IVnnsylvania l`l.l4-n.l6S
Company Sanitized. Does not contain TSCA CBI
Project Number: 06-834211
DuPont H1X) # 647-%
I-l-d u P o n t do Nemours_&_('omp:iny - 11-22055___________________
Modified Drai/e Repeated Insult Patch Test Study in Human Volunteers
Panelist Number
81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99
too
101 102 103 104 105 106 107 108 109
no
III
Panelist Initials
HR. 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. fc.N. D.H. III. D.K. K.N. B.M. V.F. I..T. H.G. M.C. R.F. M.S. R.P. L.D. J.B.
p a n e l is t l ist
Occupation
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
IS 33 28
Student Homemaker Homemaker Homemaker W aitress H airdresser Printer Secretary Homemaker Processor S tu d e n t S tu d e n t Unemployed Unem ployed H orn'`m ak er Unemployed Physical therapist
Secretary M achine operaor O ffice worker A ccounts payable Homemaker W elder 1loin em ak er Homemaker Laborer Congressional aide
Payroll clerk Unemployed H airdresser Isurance adjuster
Allergies
Sulfur
H ay fev er H ayfever Penicillin Animal hair
M etals A ntibiotics C ats H ayfever
- 17-
{ '(in'lc\ I imilcd - 1' <> M..X u,K. I o n W ashinplm i. I'cn asylvan ia l ` H 4 -0 W.S
Company Sanitized. Does not contain TSCA CBl
Project Number: 96-8342H
DuPont HLO # 647-96
----- E.l. du Pont de Nemours &-C-ompany - H-22055------------------------------
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
APPENDIX III GRADING SCALE
- 18-
CnnTcix l imited - IMI llnx .MX. Fort Washington. Pennsylvania 190.14-0.168
Company Sanitized. Does not contain TSC CBI
Project Number: %-8342ll
DuPont !Il.O # 647-96
~ T 7l d u i'oifi ile'N cnrours-& C o m p an y - 11-22055-------------------------------------
Modified llrai/o Repeated Insult Patch l est Study in Human Volunteers
Appendix 111 I li,mnn Patch lVst I n d i e s G rading S cale
Readinn 0 + 1+ 7*3+ 4+
Interpretation negative suspicious slight erythema well defined erythema erythema with induration ery thema with ulceration
d e fin it io n s * , - mnn;frets itself by local effects on either skin or
Repeated patch applications o f SUbS substances which, at a given concentration o ^
w Son^eH c" ' ^ ^ reactions may not be considered
skin reactions after a number o incidents o f sensitization since a
of rcst the skin recovers its original resistance to ^ ^ jic r tcnn such reactions have been called "skin
IhtigucVIlds latteTtem is ^misnomer in
repeated actitn tit an agent.
.
of a suW ^change'tn
" ,o ,he co" ,inue<, or
ihe United Stales.
- l `>-
.
U.K. I i>n \ t tisliiiijtlttii. IVtttisy lytini.
|i||)U-IHhX
( ,inli>\ I ii'iilvd - I'* ' **"'
t>?vapsnv Sanitized. Does not contain TSCA CBJ
