Document xzROmbk2zxjrMVqaM94D3LwQy
AR226-3057
A'
Study Title 100-Person Human Patch Test with
H-22056 (Test Item) Laboratory Project ID Haskell Laboratory Report No. 646-96
Study Completed On September 30. 1996
Contracting Laboratory ConTox Limited 3408-50 B Street
Philadelphia. Pennsylvania 19134
Author .. David Gabriel
for E. 1. 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 I of 19 Company Sanitized. Does not contain TSCA CBI
Material Tested: Physical Form: Svnonvms:
CiENERAl-lNFORMATION Test Material
DuPont HLO 646-96
White Woven fabric
Stability:
Sponsor:
Study Initiated - Completed: In-Life Phase Initiated - Completed:
In the absence o f visible evidence to the contrary, the test materials were assumed to be stable under the conditions of administration.
tn>t|tiPl ^Wnilit tQ/ ^ruvvMi ouliiilA%J/ P hem iralt: 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 CBI
DuPont HLO 646-96 DUPONT CENTRAlrRESEAReHAND DEVELOPMENT
HASKELL. LABORATORY FOR TOXICOLOGY AND INDUSTRIAL MEDICINE
October 8, 1996
Chemicals Tcchlab T30+ 110
100-Person Human Patch Test with H-22056 (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-22056 to cause irritation or delayed contact hypersensitivity in humans. During the induction and challenge phases o f this study. H-22056 (Test Item) produced no adverse skin responses in 100% and 100%, respectively, o f 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-22056 (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
St - 3 'Company Sanitized. Does not contain TSCA CBf
DuPont 111.0 H 646-%
C on T ox Lim ited
P.O. Box >68. Fort Washington. Pennsylvania 19034-0368 Telephone: (215)739-4499 l ax: (215)423-9210
Project Number:
96-834211
Testing Facility:
ConTox Limited 1358 Lycoming Street Philadelphia. PA 19124
Sponsor:
E I. du Pont de Nemours & Company P.O. Box 50. Hlkton Road Newark. I)E 19714
Test Article:
Test Article
Description:
H-22056 White woven fabric
Test Article Received:
08/13.96
Study Initiated:
Date o f Report: Test:
08/14 96
Studv Completed: 09/18/96
09/30/96
Modified Draizc Repeated Insult Patch Test Study in Human Volunteers
Object o f Test: Reference:
To determine the sensitizing properties o f the test article.
rhe 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. Draizc and published by the Association o f Food and Drug Officials o f the United States.
Test Panel: 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 70 years o f 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 o f 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
j
Project Numhcr: %-K342lI
I)uPinl I ILO U 646-%
I l tlu Pont iIl Nemours A Company -11-22056_______________________________________
Modilled Draize Kepeated Insili! Patch 'l'est Studv in I luntan Volunlccrs
Method o l Test; (continued)
Patch 1`rcpuralkm: The test article was tested as supplied. The test article was cut into approximately one inch square portions and placed onto a strip o f 2" Dermicel" hypoallergenic cloth tape (Johnson & Johnson, New Brunswick, NJ 08003). 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 o f 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 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 alter which the skin site was again examined. A new patch was then applied to the same site as previously used. Lach 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 it 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 o f 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 alter 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 aficr patch removal).
The grading scale used throughout both the induction and challenge phases is shown in Appendix III.
-5 -
( , , | | | , ,, I m in a i I ' l l 11,a W.X. I m i \ \ isliiiu'lun I'aiusW i.iiii.i I'XH 1-nW.X
Company Sanitized. Does not contain TSCA CBi
Project Number: %-X342ll
DuPont Ill.O 646-%
l -l^dii lV>l <jc NcnH)urs <fc C
- 11-22056
Modified Drai/e Repeated Insult Patch l est Study in Human Volunteers
Results;
Conclusion:
Results obtained with the test article (11-22056) are presented in Appendix |. Individual panelist data are presented in Iable I. A summary ol the data is presented in I able 2.
I rom the results obtained with this test panel under the test conditions utilized the test article does not appear to be a primary skin irritant. Ihe test article does not appear to be a fatiguing agent. I he test article does not annear to be a sensitizing agent.
Signatures:
Submitted by ConTox l imited:
1 /l A Trederick l Irbach. M.. Consultant Dermatologist
A -
Raymonti Mark. M.D. Studs DirectorConsultant Approved by:
Karl !.. Cabriel. V.M.D.. Ph.D. President
Date
/ o i l /* 7 U Date
- () -
li.X l o ll \V.ishm|!li'ii. IVmiNvIvani.l | `lllM-H<i.X l on f o \ I itm icil M > Hi*\
Company Sanitized. Does not contain TSCA CBI
Ccmoanv Sar>:t:' rl Doe! mnfan TRCA CB!
Project Number: 96-8342H
..\. du Poni de Nemours & Company - H-22056. as supplied.
Modified Drai/e Repeated Insult Patch Test Study in Human Volunteers
DuPont IILO *>646-96
Panelist Number
1 2
3 4 5
6 7 8 0 10 11 12 13 14 15 16 17 18
t able I - Individual Panelist Data
Induction Phase
34 56 78
_48 24 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 0 00 0 00 0 00 0 00 0
00 0
V
0 0
0 0 0 0 0 0 0 0 0 0 0 0 0
0 0 0 0 0 0 0 0
"M 0 0 0 0 0 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 0 0 0 0 0
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
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
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
24 _48 2 4 _ J 1 00 00 00 00 00 00 00 0 0 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 00 00 00 00 00 00 00 00
0 00 00 G0 00 00 00 00 00 00 00 00 00
00 00
10"
Challenge Phase
Original Virgin
Site Site
2 4 _ .48 00
00
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
Company Sartffizedl Does notontani T&GA Cl
Reading 24 hours after application.
= Missed reading.
Reading 48 hours after application.
Reading 72 hours after application.
. . . ,_
Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled app
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- -
ConTo'iLimited. POBo.)68.FortWuhingBii.Pemoyheme1901*4)16
Project Number: 96-8342H E.l. du Pont de Nemours & Company - H-220S6, as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPont HLO # 646-96
Company Sanitized. Dona nol contain TSCA CB,
Table 1 - Individual Panelist Data Induction Phase
Challenge Phase Original
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 _4S 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
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
2 4 _ _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___48 00 00 00 00 00 [) D 00 00 -0 00 00 00 -0 -0 00 -0 00 00 DD DD 00 00 00 00 00
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
24___4S 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__ - 4 8 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
24___ 2 2 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__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
24__48
00 00 00
24__-4 8 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 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
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 untii 9 induction applications were applied.
Make-up patch application.
D = Discontinued from die study for personal reasons.
-9 -
ConTo* Limited - P O Bo J6I. Fon W adiingm . Pnuuylvain I90J4-0J6
Project Number: 96-834211 E l. du Pom de Nemours & Company - H-22056. as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPont HLO # 646-96
Table 1 - Individual PanelistDala
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
l23
2 4 _ _48 24__ 72 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
0 0 00 00
00 00 00
0 0.0 0 0 0
00 00 00
00 00 00
00 0 04
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 G0
00 00 00
00 00 00
Induction Phase
4 5 6 7 8 9 10**
2 4 _ - i 24___ 22 24___48 24__M . 24__ J 2 24__.48 24__ .48 00 00 00 00 00 00 00 00 00 00 00 00 0U00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 000 00 00 00 00 00 0 0 00 00 00 00 00 0 0 00 00 00 00 0 0 0 0 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 - 0 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
0 0 0 0 D DD DD DD D
00 00 00 00 00 00 0 0 00 00 0 - 0 00 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
00 00
00 00
00 00
00 00
DD 00 00
DD 00 00
Company Sanitized. Does not contain TSCA CB!
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.
- 10-
ConTox Limited P O Box )6ft. Fort Washington. Pennsylvania 190)4-0361
oo 3 o
CO 2. a(ND o o 9tn O3
a8 n> 3
CO >
O JS
Project Number: 96-8342H F I. du Pont de Nemours & Company - H-22056. as supplied. Modified Drai/e Repeated Insult Patch Test Study in Human Volunteers
DuPont HLO 646-96
Table I - Individual Panelist-Data
Panelist
Number 76 77 78 79
80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 9:.
96 97 98 99 100
12
14... _48 24__ 72 00 00
00 00
00 00 0 0 00 00 00 00 00
0G00 0 0 00
00 00 00
00 00 00
0 0.0 0
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
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
4567
24__4S 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 1) 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 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
89
24__.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
D DD D
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 00 00 00 00
DD 00 00 00 00 00 00
10** 24__48
00
Challenge Phase Original Virgin
Site Site
2 4 _ _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
24 = Reading 24 hours after application. 48 Reading 48 hours after application. 72 = Reading 72 hours after application. * 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.
-11-
C'onToa Limited P O But 368, port Washington. Pennsylvania 19034-0368
Project Number. *6-834211 F l. du Pom de Nemours & t'ompan> - H-22056. as supplied. Modified Draize Repealed Insult Patch Test Studs in Human Volunteers
DuPont Hl.O 646-96
Table I - Individual Panelist Data
Panelist
Number 101
102 103 104 105 106 107
108 109 110 HI
1
24_ 48 00 00 00 00 00 00 00
00 00 00 00
2
24_ 7: 00
00 00 00 00 00 00 00 00 00 00
3
24__ 00
00 00 00 00 00 00 00 00 00 00
4
24__ 00 00
00 00 00 00 00 00
00 00 00
5
24__Z2 00 0D 00 00 00 00 00
00
00 00 00
6
24__M 00 DD 00 00 00 00 0* 00 00 00 00
7
24__M 00 DD 00 00 00 00 -0 00 00 0 00
8
24__ _Z2 00 DD
00 00 00 00 00 00
00 -0 00
9
24__M 00 DD 00 000 00 00 00 00 00 00
10** 24.__ 48
00 00
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
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.
--cot o
- 12-
> ConTox Limited - PO Box 361, Fon Wuhington. Peitmylvxnix 19054-0361
o
DO
Project Number: %-8342H K I. du Pont de Nemours & Company - H-22056. as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers
DuPont HLO 646-%
Table 2 - Summary of Data
l
24__JS Total Panelists; 111 111
2 2 i _ _Z2
I I I 111
3 24_-iS
III III
Induction Phase 4 56 24__ 48 24__ JZ2 2 4 _ _4S
7 2 4 _ -48
8 24__ _22
9 24__48
I I I I I I 111 111 111 111 111 111 111 111 111 I I I
10** 24___48
99
Grade 0 Z 1>_
34-
III 108 108 107 107 102 101 107 107 106 105 104 102 103 103 105 104 103 00 00 00 00 00 0 0 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
99 00 00 00 00 00
Challenge Phase Original Virgin
Site Site 24___48 2 4 _ -4 8
I I I 111 I I I 111
105 105 00 00 00 00 00
105 105 00 00 00 00 00
-
00 00
10 7 0
00 00
30
20
12
* 0 0 0 1 0 6 0 0 0 0 0 1 0 2 0 0 00
D 0 3 33 33 34 4 5 6 6 66 66 6 6
00 00 66
00 00 66
Company 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.
-13-
ConTo Limited - P O Bo 3Oft. Fort Washington, Pennsylvania 19034-0368
M odified Draize Repeated Insult Patch Test Study in Human Volunteers
APPENDIX II PANELIST LIST
1
- 14-
C.onTov Limited - P O. Ilox 3ftH, Fort Washington, Pennsylvania 19034-0368
Company Sanitized. Does not contain TSCA CB1
Project Number: 96-8342H
DuPont HLO # 646-96
E.I. du Pont de Nemours & Company - H-220S6_______________________________________
M odified Draize Repeated Insult Patch Test Study in Human Volunteers
Panelist Panelist Number Initials
1 M.C. 2* M.T. * C.P. 4' B.R. 5 E.T. 6 B.H. 7 N.R. 8 R.O. 9 J.B. 10 A.p. 11 L.P. 12 M.C. 13 H.D. 14 B.B. 15 A.D. 16 CM. 17 R.D. 18 C.M. 19 D.P. 20 A.B. 21 M.D. 22 M.M.E. 23 M.A.E. 24 L.D. 25* D.P. 26 L.M. 27 J.C. 28 E.P. 29 A.G. 30 J.W. 31 M.H. 32 N.D. 33 M.C. 34 L.C. 35 S.S. 36 P.W. 37 E.W. 38 L.B. 39 K.M. 40 E.M.
PANELISTLIST
Age Occupation
23 Supervisor 33 Meat packer 31 Medical assistant 30 Homemaker 41 Dental assistant 37 Homemaker 36 Homemaker 41 Homemaker 44 Newspaper c|erk 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
Allergies
Ragweed Penicillin Shellfish, seafood Hayfever
Penicillin, ampicillin, amoxicillin
Penicillin, aspirin Hayfever
- 15 ion'l'ox 1imilcd -1*0 Mux}f>H. l-'uil Washington. Pennsylvania
Company Sanitized. Does not contain TSCA CBi
Project Number: 96-834211
DuPont HLO # 646-96
E.l. du Pont de Nemours & Company - H-22056
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 7! 72 73 74 75 76 77 78 79 80
Panelist Injtiajs
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. MB. 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.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
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
Allereies
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-
l'unTti I iinilcd - 1' It llux ,V>8. Inri Washington. Pennsylvania I'lll.M-tOAX
C ~>pany Sanitized. Does not !onfIn TSCA CBi?
Project Number: 96-8342H
DuPont HLO # 646-96
E.l-du Pont de Nemours & Company_^H-22056------------------------------
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
P A N E L iS T U S T
Panelist Number
81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 lil
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. E.N. D.H. J.H. DI K.N. B.M V.F. L.T. E.G. M.C. R.F. M.S. R.P. ED. 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
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-
( ..n Iox I imilcd -HU Mn\ V.N. I .1 Washington. Pennsylvania IWMAUiH
Company Sanitized. Does not contain TSCA CB1
Project Number: 96-834211
DuPont III.O# 646-96
Ivrl-du-l*onl dc^-Nenuuirs <fe-C-ompuny-^l U22056-------------------------------
Modified Draize Repeated Insult Patch lest Study in Human Volunteers
APPENDIX III GRADING SCALE
- 18 -
< <ti 11 >\ I Miniai * IM * H .n Wth I nri WiishiiiiM.iii l* a iii-0 \iiiiiii l'MII I-M
Company Sanitized. Does not contain TSCA C 8 |
Project Number: `>6-104211
DuPont HLO U646-96
E.l, du Pont de Nemours & Company - H-22056
Modified Draize Repeated Insult Patch Test Study in Human Volunteers
Appendix HI
Iluman 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 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 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". Iliis 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.
* D rai/e. J.II. 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.
- 19-
( o n lo x I m iikil IM) Ho\ W.K. fori Washington. J'cnn>)Ivnnia IWlVI-O.VtK
Company SantBze. D oes n o ttu r n e , T5CACB)
