Document nk6DKRVXVXGX4OrOzrLamMxX8

AR226-3058 Study Title 100-Person Human Patch Test with H-2205S (Test Item) Laboratory Project 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 E. i. du Font de Nemours and Company Haskell Laboratory for Toxicology and Industrial Medicine Elkton Road, P. 0. Box 50 Newark. Delaware 19714 Study Monitor Gregory S. Ladies Page 1 of 19 company Sanitized. Does not contain TSCA CB8 Material Tested: Physical Form: Synonyms: GENERAL INFORMATION Test Material DuPontHLO 647-96 White Woven fabric 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 CB3 7 - . DuPontHLO 647-96 DUPONT CENTRAL RESEARCH AND DEVELOPMENT HASKELL LABORATORY FOR TOXICOLOGY AND INDUSTRIAL MEDICINE October 8. 1996 DuPont Speciality Chemicals TechlabT30+110 100-Person Human Patch Test with H-22055 (Test Item) Attached is a report from ConTox Limited (Project No. 96-8342H). report are patch test methods, results, and conclusions. Included in the The purpose of 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 TSCACBI .1 - DuPont 111.0 #647-% ConTox-Limited P.O. Pox 368. Fort Washington. Pennsylvania 19034-0368 Telephone: (215)739-4499 Fax: (215)423-9210 Pmitfvi.Mumber: 96-834211 Testing Facility ConTox I.imiled 1358 l.ycoming Streel Philadelphia, PA 19124 Sponsor: E.I. du Pont de Nemours & Company P.O. Box 50. Elkton Road Newark. DE 19714 Test Article: H-22055 Test Article Description: White woven fabric TesiArticle Received: 08/13 '96 Study Initialed: 08/14/96 Study Completed: 09/18/96 DaiiLflLReport: Test: 09/30/96 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Object of Test: To determine the sensitizing properties of the test article. Reference: MclhoiLofTesi: 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 Stales. lest.P'anel: The lest 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 II). One hundred and five 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 he patched. Each panelist was required to read. understand and sign an informed consent statement. Page 4 Company Sanitized. Does not contain TSCA CBS Project Nuinhcr: 'Xi-X^I I DuPont I II.() H M7-W __ __________ I--.IT uii-1'oiil-Jc-Ncmours A-Conipany-^l I^O.**.** _ ModiI'lL-d l)r;ii/c Repeated Insull I'ulcli Tc:;( Study in llunian Volunteers Method ul Tcsl; (continued) P'ultAl'rcparalion: The te.sl article was tesied as supplied. The lesi article was cut into approximately one inch square portions and placed onto a strip of 2" DermiccI1' hypoallergenic cloth tape (Johnson & Johnson. New Brunswick. NJ ()}t03). Before applying this strip, each portion ol' test malcrial was secured in place with a gloved linger lo insure proper application. I his tape strip was then pressed into place on the upper left arm ot'each panelist at its designated test site. Induction Phase: The patch was applied to its designated contact site and remained in place lor 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. Hach 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 of 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 palch 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 of 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 of irritation or sensiti/ation. A follow-up examination was conducted at 48 hours after the challenge applications (24 hours alter patch removal). The grading scale used throughout both the induction and challenge phases is shown in Appendix III. -5- ( il|i>\ I iimlL'il - I'd lli>\ IdX. Inn Wllsllin^liin. I'L'IIIIMK.IIII.I ; <m.i.ll IliX Company Sanitized. Does not contain TSCA CBI 1'rojci.i Number: %-S34211 Diil'ont 111.0 ft 647-96 _______ - I -l.-dtil'ont dc Ncmtiirs<fc-(-'<'nipany -11-22055____________ Modified Drai/c Repeated Insult Patch Test Study in Human Volunteers Result; CunclusioiL Results obtained with the test article (H-22055) arc presented in Appendix I. Individual panelist data are presented in Table 1. data is presented in Table 2. A summary of the From the results obtained with this test panel under the test conditions utili/.cd. the lest article does not appear to he 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 bv ConTox Limited: Consultant Dermatologist [~IJM^^JLl^u^L (^ ^ Raymoi/dMark, M.D. Date Studv Director/Consultant Approved by: ^J A/LUt/.^ Karl I.. Gabriel. V.M.D., Ph.D. President /f ^A t. Date -6- ('iinl"<"> 1 inincj-i'd Hii< <hX. 1-nrt Washinylnn. 1'cnnsylv.niia IW.l.l-lllhX Company Sanitized. Does not contain TSCA Cffi Project Number: 96-834211 DuPont HLO # 647-96 ---- -14.1. du Ponl-dc Ncmours-A (.'ompany_Jj-22U55^______ _ Modified Drai/.c Repeated Insult Patch 'lest Study in Human Volunteers APPENDIX I RESULTS FOR TEST ARTICLE - 7 - C'iinT(i\ I iiiiilcd - I'.O H>'< )hH. l-'urt Wa-ihinglon. Pennsylvania 1y().14-l).1()S Company Sanitized. Does not contain TSCA CBE I'rojcct Number: 06-K?42H \:.\. du Poni de Ncmours & Cunipain -11-22055. as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers DuPoni Panelist Number 1 > .1 4 ^ 6 7 K 9 10 11 12 13 14 15 16 17 18 19 20 21 ii 23 24 25 1 -> 2i -IS ->4 '72 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 2A.-IS 0 0 0 0 0 0 0 0 0 0 0 0 (1 0 0 0 C 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Table I - Individual Panelist Data luclucliuiifhiiii a 4 5 6 J 4S TA 72 24 1S 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 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 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7 2A -AS 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 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 8 74 72 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1) 24, 48 0 0 0 0 0 0 0 0 0 0 0 U 0 0 0 0 0 0 0 0 0 U 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 10** 24;!!8 C Ori S 24 0 0 0 0(1 0 0 0 1) 0 0 0 0 0 0 0 0 0 0 (1 0 0 0 0 0 24 = 48 = 72 = * = ** = 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 day. and the patch series extended until 9 induction applications were applied. Make-up patch application. D = Discontinued from the study For personal reasons. application Con Tox (.milled P 0 Rox }h8. Fort Washington. Penniylvuir 10014-<WB 0 | U 0) ^ (0 0) 3 K' (0 0. a 0 (1) U) 3 0 0 0" S a 0 > . I'rojcti N iiitihLT: W-834211 1:1.duPont.dc Ncmours& Company -11-22(1 55, a s supp lied. Mud itin1 Drai/.c Kepeaicd Insull Palch Test S udy n Hiirnun V oluniecrs niil'om Tal?l, I Individinal Panelist D nta C Iniduelh,saEbass Ori Panel is 1 2 3 4 s 6 7 8 9 10 * S 2422 2448 NumbejI 26 24JJS -M 24 --IS 74 --Z2 24 -IS 24 AS 2 A 72 21 24 -45 2J 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 000000 28 0 0 0 0 0 0 0 0 0 0 0 0 0 000000 29 0 0 0 0 0 0 0 0 0 0 0 0 0 000000 30 0 0 0 0 0 0 0 0 0 0 0 0 0 000000 31 0 0 D D D U D 1) D D 1) D D D D [> D 1) D 000000 32 0 0 0 (1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1^ .54 35 36 37 3S 39 40 41 42 43 44 45 46 47 48 49 50 24 -48 = 72 - s * a 0 0 0 0 0 0 0 0 0 0 0 0 0 0 (1 0 0 0 0 1) 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 U 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 U 0 0 0 0 1) 0 0 0 0 0 0 0 (1 0 0 0 0 0 0 (100000 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0.0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 * . 0 0 0 0 0 0 0 0 0 0 0 0 0 000000 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 0000 0 D D D D D D D D D D D D D D D D D D 000000 0 D D D D D D D D D D D D D D D D D D 0 C 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00000000 0 0 0 0 0 0 0 0 0 0 0 0 0 0000 0 0 0 0 0 0 0 0 0 0 0 0 0 00 00 00000000 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 application day. and the patch series extended until 9 induct ion applications were applied. Make-up patch application. . D = Discontinued from the study for personal reasons. C, nfuItm .IrJ -9- Pll llrx ll> hi'n U okhinylon penn)\*nr IWH.Olt.H 1'roivi.l"'-Limber. W-854211 h I.Jul"'oni Jc Scniour-. & I mp.in\ -11-221 )?5.us slipp licil ModideiJ Drai/'; t'.-:ptfiiteil Insull Patch Test ?iluih in liuinan \'iiilunlccrs DuPoniH labl. 1 -Individual Panelist [?aia a Iriduciuinj'bosc Orig Panelis,t 1 2 3 4 ; 6 7 8 9 10' Si 242; -a 2448 Nurnbei 51 ja 24AS y---4S 1.1 --22 24.18 21-- 24 7"1 24 24---4S 24 0 0 0 0 0 0 0 0 0 00 00 00 5^ 0 0 0 0 0 0 0 0 0 0000 55 0 0 0 0 0 0 0 0 (1 00000000 0000 0000 54 0 0 0 0 0 0 0 0 0 0000 55 0 1) 1) 1) 0 0 (1 0 1) 11 0 0 0 0 0 0 0 - 0 000000 0000 56 0 0 0 0 11 0 0 0 0 0 (1 0 0 0 0 ?7 0 0 0 0 0 0 0 0 0 11 11 0 0 0 0 0 0 0 0 0000 58 0 0 0 0 0 0 0 0 0 00 00 00 (1000 59 0 0 0 0 0 0 11 0 0 0 0 0 0 0 0 00 00 60 0 0 0 0 0 0 0 0 0 00 00 00 61 0 0 0 0 0 0 0 (; 0 0 0 0 0 62 0 0 C 0 0 0 0 0 0 00000000 0000 00000000 0-0 63 0 0 0 0 0 0 0 64 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 65 0 0 0 0 0 * - 0 0 0 0 0 0 0 0 0 0 0 0000000 66 0 0 0 0 0 0 0 0 0 67 0 0 0 0 0 0 0 0 0 00000000 0000 68 0 0 (1 0 0 0 0 0 0 0000 0000 W 0 0 0 0 0 0 0 0 0 00000000 0000 0000 70 0 0 0 0 0 0 0 0 0 00 00 00 0000 71 0 0 0 0 0 0 0 0 0 00 00 00 0000 72 0 0 0 o n 0 0 0 0 0 0 00000000 000 000000 73 0 0 0 0 D I) D D D D D D D 0 74 0 0 0 0 0 0 0 0 0 75 0 0 0 * - 0 0 0 0 0 0 0000 0000 0000 0000 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 pa'ch application. D = Discontinued from the study for personal reasons. -10- Cwilm I mined C 0 Bu\ "1 ton Wtitlinguin Pnitilil'tnn KD4-OIM Project N umber: 96-8342H (:.!. Ju Ponl de Nemours & Cuinpanv - 11-22055 . as s upp lied. Moilified Uraize Repeated Insult Patch lest Slui.1\ in hiurman V olunieirrs DuPoni H lahlsILL-Inidiyiih.uLfcmt-lisliAim Chl InidudifMBiiU>c Orig Panelis 1 2 3 4 t 6 7 8 9 10" Sit N umbelr 24AS 2122 24:1S 2A ja 24 76 0 0 0 Tl 24 -A8 .24 -1& 24 0 0 0 0 0 0 73 2A---as 34 48 0 0 0 24 - 0 77 0 0 0 0 0 0 0 0 0 0 0 0 0 00000000 0000 78 0 0 0 0 0 0 0 0 0 0 0 0 0 79 0 0 0 0 0 0 0 0 0 0 0 0 0 000000000000 80 0 0 0 0 0 0 0 0 0 0 0 0 0 00 00 00 81 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 82 0 0 0 0 0 0 0 0 0 0 0 0 0 00 00000000 83 0 0 0 0 0 0 0 0 0 0 0 0 0 84 0 0 0 0 0 0 0 0 0 0 0 0 0 00000000 0000 85 0 0 0 0 0 0 0 0 0 0 0 0 0 00 00 00 86 0 0 0 0 0 0 0 0 0 0 0 0 0 87 0 0 0 0 0 0 0 0 0 0 0 0 0 00000000 0000 88 0 0 0 0 0 0 0 0 0 0 0 0 0 0000 00 89 0 0 0 0 0 0 0 0 0 0 0 0 0 0 90 0 0 0 0 0 0 0 0 0 0 0 0 0 00000000 0000 o 9) sa 92 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00000000 ^ 93 0 0 0 0 0 * 0 0 0 0 0 0 0 0 0 0 0 0 0000 W 00 a) 94 0 0 0 * - 0 0 D D D D D D D D D D D D Si 95 H' (D 96 00000000 0000 p. 97 0 0 98 000000 (D (A 99 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00000000 0000 c^ 100 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000000 0 24 = Reading 24 hours after application. nT 5" 48 = Reading 48 hours after application. a? > 2 0 5 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. ...,1>.>1 imilcd.r 11 lh-\ ii.ii t MiUihi niftuf P<nn ).Kn flit-t.utliR Project Number: 96-834211 E.I. du Pont de Nemours &. (.'oinpam -11-22055. as supplied. Modified nrai/c Repented Insult I'.ilcli lest Slud\ in Human Volunteers DuPont H Panelist Number 101 102 103 104 105 106 107 108 109 110 111 , 24 -45 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1A P 0 0 0 0 0 0 (1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 24 -4S 0 0 0 0 0 0 0 0 0 0 f) 0 0 0 0 0 0 0 0 0 0 0 1 able I - Individual Panelist Data In.djjcllonPha ?e 4 5 6 .u 24 T.1 0 0 0 71 24 -13 0 0 0 0 0 0 D D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7 24 -48 0 0 D D 0 0 0 0 0 0 0 0 - 0 0 0 0 0 0 * 0 0 8 34 72 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 0 0 9 10** 24- 48 2448 0 0 D D 0 0 0 - 0 0 0 0 000 0 0 0 0 0 0 0 " 0 0 0 C Orig Si 24 0 D 0 0 0 0 0 0 0 0 0 24 = 48 = 72 = * = ** = 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 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. ronToi Limned P 0 -12- D^ Ihfl. Fnrt Washington. PenMvlvxnr t9014<0)b8 'y / ^ 0 0 S W S N <D a 0 a 0 1 0 -W l 0 > S 5 I'rcjL-Ll Number: %-lt34211 \1. dii Prni dc NcmoursA Compam -11-22 )55. as supplicd. Modified Draizc Repeated Insult Patch lestsStudy in Hu nan V olunteers U uPont Tab!e 2-Summary of Data t ItuduuicinJtiasc Orig 1 2 3 4 ; 6 7 8 < 1C.)* S 2j4S 2472 24i& 24.--48 14 72 2448 24 -12 24.22 2448 24 -45 24 Total Eanslisls. ill III III ill III III III III III III III 111 III III III III III III 9 9 111 tirade 0 III 10S 108 107 107 102 101 107 107 I(K) 105 104 102 103 103 105 104 103 q i) 105 l 0 0 0 0 0 0 0 (I 0 0 0 1) 0 0 0000 1- 0 0 0 0 000000 0000 0000 2'- 0 0 0 0 000000 0000 0000 3- 0 0 0 0 000000 0000 0000 4* 0 0 0 0 000000 0000 0000 10 7 0 0 0 0000 0003 2012 * 0 0 0 3 000303130336 05061606 06060606 D 3 4 4 6 0 0 0 0 0 0 0 0 0 0 0 00 0 0 0 0 6 24 = 48 = 72 = * = ** = heading 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 applic ation day. and the patch series extended until 9 induction ap|flications were applied. Make-up patch application. D = Discontinued fre -n UHestud y for personal reasons. -13- Ci<n V\1im irt-PII Bin IU ^onWuhmrrfl.fWlll<jni> IWDJ-llltil Project Number: 96-8342H DuPont HLO # 647-96 -__ _________ ____ E:Irdu Port deNemours& Company -H-22055--- Modified Draize Repeated Insult Patch Test Study in Human Volunteers APPENDIX II PANELIST LIST -14- ConTox t.imilcd P.O. rhix 368.1-nn Washlnglnn. Pennsylvania 19034-0368 ^"""'"------------------^^CB, Project Number: 96-8342H DuPontHLO# 647-96 E.I. du Pont de Nemburs'&'Company-- H-22055 Modified Draize Repeated Insult Patch Test Study in Human Volunteers PANEUSTLIST *? Panelist Panelist Number Initials Age QccuEation Allergies 1 M.C. 23 Supervisor 2" 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. 8 R.O. 36 Homemaker 41 Homemaker Ragweed 9 J.B. 44 Newspaper clerk Penicillin 10 A.B. 11 L.P. 32 Homemaker 36 Homemaker Shellfish, seafood Hayfever 12 M.C. 30 Homemaker tr 13 H.D. 53 Homemaker 14 B.B. 29 Homemaker 15 A.D. 30 Salesperson 16 C.M. 36 Salesperson 17 R.D. 49 Homemaker 18 C.M. 26 Homemaker 19 D.P. 37 Cashier 20 A.B. 31 Laborer 21 M.D. 34 Homemaker 22 M.M.E. 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 1.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. 37 Homemaker 36 P.W. 38 Homemaker 37 E.W. 42 Homemaker Hayfever 38 L.B. 57 Homemaker 39 K.M. 34 Homemaker 40 E.M. 53 Homemaker -15- ConTox l.imilcd P.O. Rex .168. l-'ort Washington. Pennsylvania IWM-036B Company Sanitized. Does not contain TSCA CBi Project Number: 96-8342H DuPont HLO # 647-96 -E.l;du-PontdeNemours& Company--H-22055___. Modified Draize Repeated Insull 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. 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. O.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.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 Occupation Day care teacher Homemaker Typist Homemaker Student Homemaker Homemaker Teaching assistant Bakery worker Homemaker Homemaker Unemployed Hcmemaker 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 Penicillin Animals, dust. pollen 1Hayfever 1Penicillin, aspirin, tetanus toxoid 1Hayfever Ai nimal hair, hayfever IPenicillin FPenicillin, aspirin. Darvocet, codeine IDust, grass, trees, pollen, smoke P enicillin - 16- ( un lux I iniilL-il - I' (l llux ihK. l-'iirl Washin('lnn. Cunnsylvaniu I'tlM-IIViH Company Sanitized. Does not contain TSCA CBJ Project Number: %-8342II RuPont HLO # A47-96 l^l^du l*ontdcNi;mt>urs_&_('qinrany- [1-22055 Modified Drai/e Repealed In-sull Patch 'lest Study in Human Volunteers Panelist Number 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 106 107 108 109 110 III 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. I..T. I:.G. M.C. R.F. M.S. R.P. L.D. J.B. PANEUST LIST 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 2K Occupation Student Homcmaker Homemaker Homcmaker Waitress Hairdresser Printer Secretary Homemaker Processor Student Student Unemployed Unemployed Horn "maker Unemployed Physical therapist Secretary Machine operaor Office worker Accounts payable Homemaker Welder llomemaker Homemaker Laborer Congressional aide Payroll clerk Unemployed Hairdresser Isurance adjuster Allergies Sullur Hayfever Hayfever Penicillin Animal hair Metals Antibiotics Cats Hayfever Project Number: 96-834211 DuPont HLO # 647-96 -H.I. du Pont de NemoursA-Gompany - H-22055-- ------------- Modified Draize Repeated Insult Patch Test Study in Human Volunteers --- - --- ----- APPENDIX III GRADING SCALE - 18- C'onTox I imilnl - I'.O Hnx JIM. Fort Washington. Pennsylvania |Q(V4-0.1Mt Company Sanitized. Does not contain TSCA CB| Project Number: %-834211 Dul'ont 111-0 # 647-96 U. du Font uiTNemours-A Company--11-22055_ Modified Drai/c Repeated Insult Patch Test Study in Human Volunteers Appendix 111 Human Patch Test Studies Grading Scale Reading 0 +_ 1+ i{- 3+ 4+ Inlerpretation negative suspicious slight erythema well defined erythema erythema with induration erythema with ulceration DEFINITIONS* Sensilization is a phenomenon which manifests itself by local effects on either skin or mucous membranes. It ditTers from primary irritation in that it may also involve tissues remote from the site of 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, suhsunces 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 sensilizalion since after 10-14 days of rest the skin recovers its original resistance to injury by the substance, l-'or the lack of a heller 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 repealed action of an agent. W). * Draiy.e. J.H. Appraisal of the Safety of Chemicals in Foods. Drugs and Cosmetics. In DKRMAL 1OXKTTY. p. 46-53. Topeka. Kansas: Association of Food and Drug Officials of the I Inited States. - l1)( nl\ I ii'iilL-d -I'd II.\ t'.K. l..n %:isliiiit!liin. l'i:nnsil\.uii;i I'MIU-IIXiK C^ww Sanitized. Does not contain TSCA CB