Document z76dM27b2DmQj1Ej8dEma43R

AR226-3057 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 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 I ol'iy Company Sanitized. Does not contain TSCA CBI Material Tested: Physical Form: Synonyms: (iENERAUNFORMATlON- Test Material DuPont HLO 646-96 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 Font 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, DuPoul HLO 646-96 DUPONTCENrRAIrRESEARCH-ANDDEVELOPMENTHASKELL LABORATORY FOR TOXICOLOGY AND INDUSTRIAL MEDICINE ity Chemicals October 8. 1996 100-Person Human Patch Test with H-22056 (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-22056 to cause irritation or delayed contact hypersensitivity in humans. During the induction and challenge phases of this study, H-22056 (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-22056 (Test Item) is not considered to be a skin irritant nor a sensitizing agent under the conditions that prevailed in this study. W u ^ Gregory S. Ladies, Ph.D. Research Toxicologist - 3 "Company Sanitized. Does not contain TSCA CBi l)uPonlllLOfc646-96 ConTox Limited I'.O. Ho\ ViK. I on Washington. Pennsylvania 19034-0368 Telephone: (215 739-4499 lax: (215)423-9210 Project Number: 96-K34211 Testing Facility: ConTox Limited 135S l.yeoming Street Philadelphia. 1A 19124 Sponsor: Test Article: R I. du Font de Nemours & C'ompany P.O. Hex 50. Hklon Road Newark. OF 19714 H-22056 Test Article Description: White woven fabric Test Article Received: 08/13/96 Study Initiated: 08/1496 Study Completed: 09/18/96 Date of Report: lest: 09/30/96 Modified Drai/c Repeated Insult Patch Test Study in Human Volunteers Object of Test: Reference: Method of Test: To determine the sensitizing properties of the test article. The method employed in carrying out this lest was similar to that described in "Appraisal of the Safety of Chemicals in Foods. Drugs and Cosmetics'' by .I.H. Draizc and published by the Association of Food and Drug Officials of the United States. Test Panel: The lest involved the application of the test article to the upper arms of a group of 111 volunteer panelists. The panelists ranged from IX K 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 tree of any visible skin disease or anomaly in the area to he patched. Lach panelist was required to read. understand and sign an informed consent slalemenl. Page 4 Company Sanitized. Does not contain TSCA CBI Project Number: ^1^34211 l)uPonlllLO#64A-% _1:. LiJiLPonLdL.Nemours & Compiiny I l-2205o Modified Dr.ii/.c Repeated Insult Patch Test Study in llumun Volunteers Mcihad-ojL-Lc^l; (continued) P-aldi Prcpumlion: 'I'hc tcsl article was tested as supplied. 'I'he test article was cut into approximately tine inch square portions and placed onto a strip of 2" Dormicel" hypoallergenic cloth tape (Johnson & Johnson, New Brunswick, NJ OKyo?). 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 ol'each panelist at its designated test site. Induction Phase: I'he 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 I'or 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. 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 patch period. This patch was applied on Wednesday following the last scheduled (ninth) induction application on Monday. Challenge Phase: After the th application, a rest period of 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 of irritation or sensiti/.alion. 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 111. ( Ulllin I lilllk-.l -5- I'l' lli"> I'.X. lull \\.ls|]|lifl..n l'rl|]ls\l.1111.1 I'llHI-llK.X Company Sanitized. Does not contain TSCA CBB Project Number: %-K34211 Diil'onllll.()(4d-% T Tl-du-l-'onl-de-Neinours-&_tA>'lin'!ij\ -1 l-2205f Modified Drai/e Repealed Insult Patch lest Study in Human Volunteers Refills; Conduiiion; Results obtained with the lest article (11-2205(>) are presenled in Appendix I. Individual panelist data are presented in I able I. data is presented in 'I able 2. A summary of the l-rom tile results obtained with this lest punel under the lest conditions utili/ed. the lest article does not appear to he a primary skin irritant. The test article does not appear to he a fatiguing agent. The test article does nut appear to he a sensiti/ing agent. ^SasslW&si Submitted hv (.'on 1'ox Limited: L j ^ J ^ ^ ^ ^ - ^ ^ yTredcrick I Irbach. M.D. .' Consultant I )ermatologisl i __/^y<t<^.<^- /m^^f) RaymonJ\1ark. M.D. Study Director Consultant ^ f U Dale Approved by: -^^.C.^L-^^^^ KKaarrlll1.... CCiiaahhrriieel.l.VV..MM..ID)....II''hh.D. President 1^ -/P/^/^L> Date t nnl.\ I iniilvil -n- ri> ll.\ li.X liiil \\.ishlll(!lini. 1'ciin^lvaiii.l |')(H.l.llli,x Company Sanitized. Does not contain TSCA CBI ComiMPV Ran't1'0^. OOP'S ""t ^""tain TRCA CB* Project Number: 1 6-8342H h.l. tin Ponide Neincurs & Company - H-2205 6. assupp led. Modified Uraize R cpeulcd Insult Patch Test Sliidy in Hunnan Vtjiunteers UuPout 1 Table 1 - Individual Panelist L)ws C Iniduclio;jLEhase Orig Panelist I 2 3 4 5 6 7 8 9 10* * S 2422 2i45 Number 24 48 1 0 24 -4S 24 72 244,8 24 jm 2 24---48 24 48 24 0 0 0 0 0 0 0 0 0 00000 0000 2 0 0 0 0 0 0 0 0 0 0 00000 0000 3 0 0 0 0 0 0 0 0 0 0 4 0 0 0 0 0 0 0 0 0 0 0000000000 00000000 00 00 5 0 0 6 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0000 7 00000 00000000 8 0 0 0 00 00 0 0 0 0 0 0 ) 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00000 000- 10 0 0 0 0 0 0 0 0 0 0 0 0000000000 0000000 11 0 0 0 0 0 0 0 - 0 0 12 0 0 0 0 0 0 0 0 0 0 0 0 0 0000000 0000 13 0 0 0 0 0 0 0 0 0 0 0000 14 0 0 0 0 0 0 0 0 0 0 00000 0000 15 0 0 0 0 0 0 0 0 0 0 0 0000000000 0000000 16 0 0 0 0 1) 0 0 0 0 0 0 0 0 0 0 17 0000 18 0 0 0 00 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 19 0 0 0 0 0 0 0 0 0 0 00000 0000 20 0 0 0 0 0 0 0 0 0 0 00000 0000 21 0 0 0 0 0 0 0 0 0 0 00000 0000 22 0 0 0 0 0 0 0 0 0 0 00000 0000 23 0 0 0 0 0 0 0 0 0 0 00000 0000 24 0 0 0 0 0 0 0 0 0 0 00000 0000 25 0 0 0 0 0 0 0 0 0 0 0000000000 00000000 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 ap plications were applied. ** = Make-up patch application. D = Discontinued from the study for personal reasons. C w*Tos Lim nrf P 0 -8- Box 168. tan Wihingun. P Biimylswr 19014JOKI Project Number: 96-8342H E.I. du Font de Nemours & Company - H-22056, as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers DuPont H 1rablf; 1 Individual panelist I:?ala a IndiiictioiLChase Orig Panelisi1 1 2 3 4 5 6 7 8 9 1C>** S 2422 Numbci[ 2448 26 2448 2448 24---4S ;24 72 0 0 0 24 M 24 -22 24---48 24---48 24 0 0 0 0 0 0 27 0 0 0 Q 0 0 0 0 0 000000 0000 28 0 0 0 0 0 0 0 0 0 00000000 0000 29 0 0 0 0 0 0 0 0 0 00 0000 0000 30 0 0 0 0 0 0 0 0 0 0000 0000 000000 0000 3 i 1 0 D D D D D D D D D D D D D D D D D D 32 0000 0000 33 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 34 . 0 0 0 0 0 0 0 0 000000 0000 35 0 0 0 0 0 0 0 0 0 000000 0000 36 0 0 0 0 0 0 0 0 0 000000 0000 37 0 0 0 0 0 0 0 0 0 000000 0000 38 0 0 0 - 0 0 0 0 0 0 0 0 0 0 00000000 0000 39 0 0 0 0 0 * - 0 0 0 0 0 0 0 0 0 0 0000 40 0 0 0 0 0 0 0 0 0 0 0 0 0 41 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 000000 0000 42 0000 000- 43 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 44 0 D D D D D D D D D D D D D D D D D D 000000 0000 45 0 D D D D D D D D D D D D D D D D D D 46 0 0 0 0 0 0 0 0 0 47 0 0 0 0 0 0 0 0 0 000000 0000 48 0 0 0 0 0 0 0 0 0 000000 0000 49 0 0 0 0 0 0 0 0 0 000000 0000 50 0 0 0 0 0 0 0 0 0 00 00 00 00 00 00 00000000 24 = Reading 24 hours after application. = Missed reading. 48 = Reading 48 hours after applkation. 72 = Reading 72 hours after application. * s ** = Panelist missed the scheduled patch applic-itkmfcrpe rsonal reasons. Panelist was patchedon the next scheduled aippiication day. and the patch series extended un tii9iiiductiomapplications were applied. Make-up patch application. D = Discontinued from me study for personal reasons. ronTox Limiud - P 0 -9- Box 161. Fox WohinflMl. Pcniuylviu 190)4-016* Project 1l'umber: 96-8342H E.l.duPoni dc Nemours & Company - H-220 56. as supp lied. Modidetd Draiz.e Repeated Insult Patch Test St udy in HurmanV olunteers DuPont H Tahle 1 - Individual Panelist t?aia Q 11id1uciuaiLEhasc Orig Panelist I 2 3 4 5 6 7 8 9 10** Sit 2422 -a Numhej 2448 51 2448 2448 2i 21 72 0 0 0 24 -42 24 Z2 24 4S 24----48 24 0 0 0 0 0 0 52 0 0 0 0 0 0 0 0 0 000000 0000 53 0 u 0 0 0 0 0 0 0 0 000000000000 0000000 54 0 0 0 0 0 0 0 0 0 55 0 0 0 0 0 0 0 - 0 000000 0000 56 0 0 0 0 0 0 0 0 0 000000 0000 57 0 0 0 0 0 0 0 0 0 000000 0000 58 0 0 0 0 0 0 0 0 0 000000 0000 59 0 0 0 0 0 0 0 0 0 000000 0000 60 0 0 0 0 0 0 0 0 0 000000 0000 61 0 0 0 0 0 0 0 0 0 0 000000000000 0000000 62 00.00 63 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 000000 00000000 g 64 0 0 0 0 0 * - 0 0 0 0 0 0 0 0 00 3 65 0 0 0 0 0 * . 0 0 0 0 0 0 0 0 0 0 0 0 0000 00 13 66 0 0 0 0 0 0 0 0 0 0000 0000 00 ^ 67 0 0 0 0 0 0 0 0 0 S 68 0 0 0 0 0 0 0 0 0 000000000000 00000000 i. 69 000000 0000 8 70 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 P- 71 0 0 0 0 0 0 0 0 0 000000000000000000 00000000 00 72 0 0 0 0 0 0 0 0 0 0 0 (0 (/) /iJi 0 0 0 0 G 0 0 0 0 0 D DD DD DD D D 000000000000 00000000 00 74 0 0 0 0 0 0 0 0 0 <? 75 0 0 0 0 * . 0 0 0 0 ^3 S 24 = Reading 24 hours after application. 48 - Reading 48 hours after application. - = Missed reading. 001 72 = Reading 72 hours after application. > * = Panelist missed the scheduled patch fapplication forpeTsonal reasons. Panelist wvas patched on the next scheduled application 0 03 day. and the patch series extended until 9 induetiona| iplications were applied. 5& * = Make-up patch application. D = Discontinued from the study for personal reasons. -10- c DnTox Liin ittd - P 0 Uai 161. Fon W-hinglon. Penl mylvui 1<M]-CD161 ----^------- v Project Number: 96-8 j42H F.I. ilu Poni de Nemours & Company - H-22056. as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers DuPont HL TnMd-lnrtivirtualfaaeUsLfiaia Ch induction Phase Origi " - ,, ,. , , , 4 5 6 7 8 9 10** Sit =----^^^^^^2^2; ^ uOOOOOOOOOOOOOOOOO S ; 2 I ; S 2 ; 7; o o o o o o o o o o 80 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 0 0 000000000000000000 0 8, 0 C 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 82 8, 0 0 0 0 0 0 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 0 0 0 0 0 0 8. 0 000000000000000000000000000000000000 0 86 87 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00.0000000000000000 88 0 0 0 0 0 0 0 0 89 0 0 0 0 0 0 0 0 0 0 0 90 91 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 oooooooooooooooooo n I0 9, o o o o o o o o o o o o o o o o o o o 1 ^0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 - OOO*-OOUDUDDDDDDDD D ^ 94 ,4 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 o ,(,000000000000000000 1: 0 ,7000000000000000000 0 S 99 ,8000000000000000000 o g OOOOOOOOOOOOOOOOOO 100 o o o o o o o o o o o o o o o o o o 3 2- 24 = Reading 24 hours after application. S 48 -E Reading 48 hours after application. ...,., 72 = Reading 72 hours after application. 5- * = panelist missed the scheduled patch application for personal reasons. Panelist was patchedon the next scheduled apprlica.t.ion (3 day. and the patch scries extended until 9 induction applications were applied. 2 ** = Make-up patch application. 0 n" Ra fonTo Limittd P " B>. )M. l-'on Winhmimiii PcnwylvBlit 1W1+016S ------------- Project Number: tb-K.^II F..1. du Pom de Nemours & Company - H-22056. as supplied. MoJifieJ Drai^e Repealed Insult Patch Test Stud> in Human Volunteers DuPoni Table 1 - Individual Panelist Data C Induction Phase Ori 1 2 3 4 5 6 7 8 9 Panelist 10** S Number 101 102 000000000000000000 HAS .a22 2448 2448 2472 2445 2448 2422 2442 OOOOOOOOODDDDDDDDD 244B 24 0D 103 104 105 106 00000000000000000000000000000000000000000000000000000000000000000000000- 00 00 107 108 104 110 00000000000000000000000000000000000000000000000*00-0000 000-000000000000 00 00 00 00 111 000000000000000000 0 0 0 3 0 D) ^ 01 01 3 S Q" o S !^ 1 (U 5" -COI 0 te, , i 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 sched uled application day. and the patch series extended until 9 induction applications were applied. ** = Make-up patch application. D = Discontinued from the study for persona! reasons. ' . -I2I - ConTox Limittd P 0 Box Ml, Foil Wuhinpon. tamylvuil 140144161 I'rojecl Number: *M)-834;H F 1. du Font de Nemours & Compan\ - H-22056. as supplied. Modified Drai/e Repealed Insult Patch Test Study in Human Volunteers DuPoni H Table 2 . Summary of Data Cb y;1a 23456789 Ida) Eanelias; 111 111 2472 III 111 2448 111 III Induction Phase 2448 III 111 2422 111 111 2448 111 III 2442 2422 III 111 III 111 244S 111 111 10* 2442 9 9 Orig Sit 244 III Grade 0 111 108 108 107 107 102 101 107 107 106 105 104 102 103 103 105 104 103 9 9 105 ; 1- 00 00 00 00 00 0000 CO 00 00 000000000000000000 00 00 23- 000000000000000000000000000000000000 00 00 00 4- 00 00 00 00 00 00 00 0000 00 0 9 0) <3 000000011006700000000001300220000102 0 0 11 D 033333344566666666 6 S 24 -- Reading 24 hours after application. = Missed reading. 0 48 = Reading 48 hours after application. t? 72 = Reading 72 hours after application. 0 3. * = Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next sche< luted application B). day, and (he patch series extended until 9 induction applicationswere applied. 3 ** - Make-up patch application. D = Discontinued from the study for personal reasons. W ^ 0 S -13- ConTo Lmilled . P 0 Box Ibl. Fon Wishmgttn. Pttimylvtrin 19014068 Project Number: 96-8342H DuPont HLO # 646-96 E.I. du Font de Nemours & Company - H-22056______________________ Modified Draize Repeated Insult Patch Test Study in Human Volunteers APPENDIX II PANELIST LIST -14- (onTox Limited PO llox fhH. hid Waihinglon. Pennsylvania 1<H)}4-036R Company Sanitized. Does not contain TSCA CBS Project Number: 96-8342 H DuPontHLO# 646-96 E.I. du Font de Nemours & Company - H-22056 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Panelist Number 1 ' ^ . 4' 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 2526 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. E.M PANELIST LIST Age Occupation 23 Supervisor 33 Meat packer 31 Medical assistant 30 Homemaker 41 DentuI 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 Homemuiier 38 Homemalier 42 Homemaker 57 Homemaker 34 Homemaker 53 Homemaker Allergies Ragweed Penicillin Shellfish, seafood Hayfever Penicillin, ampicillin, amoxicillin Penicillin, aspirin Hayfever -15(onTo< I imilcil - I'f Hi< Ihll. hut WiKhinplnn. 1'cnn.sylvania IWM-OIMI Company Sanifeed. Does not contain TSCA CBft Project Number: 96-834211 DuPont HLO # 646-96 E.I. 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 71 72 73 74 75 76 77 78 79 80 Panelist Imtiajs 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.S. J.Z. Y.H. C.R. S.B. H.R. C.R. P.O. 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 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 - 1Penicillin /Animals, dust, pollen IHayfever FPenicillin, aspirin, tetanus toxoid tHayfever Animal hair, hayfever Penicillin Penicillin, aspirin. Darvocet, codeine DDust, grass, trees, pollen, smoke Pienicillin - (6. 1'iinTtK I imilci) -I'll HIIK M'K. l-'nn Washington. I'cnnsvlvaniu l'"H4-(l>H C. TOy Sanitized. Doss no, confab TSCA ^ Project Number: 96-8342H DuPontHLO# 646-96 -K;l^duPontdeNemours&Company^H-22Q56_ Modified Draize Repeated Insult Patch Test Study in Human Volunteers Panelist Number 81 82 83 84 85 86 87 88 89 90 9) 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.I 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 PANELJST.UST 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 Congressionalaide Payroll clerk Unemployed Hairdresser Isurance adjuster AJler&ies Sulfur Hayfever Hayfever Penicillin Animal hair Metals Antibiotics Cats Hayfever -17- ( on I ^ I mined - P l' Hi" r'H. I"" WiKhinslnn. Pennsylvania |W<4-".W>X Company Sanitized. Does not contain TSCA CB hoicct Number: %-K34211 DuPont 111.0 # 646-Wi -l;7l-Jii-l*<>nide-Ncm(Uirs<fe-C-'onipany-^ll-22(5A_________________________ Mudil'ied Dmi/.e Repealed Insult I'alch lest Study in Human Volunteers APPENDIX III GRADING SCALEi - IS- 1 riil,", I iiiiiicil-l'u H.'i ll'l' Irn W;isliiiirl.iiil'ciiirJ;iiii.i I'llll.l-nll.K Company Sanitized. Does not contain TSCAC8| Project Number: 96-(n421 1 DuPont HLO # 646-96 I-:.!, du Font de Ncmours & Company - 11-22056_________________________ Modillcd Drai/.c Repeated Insull Patch Test Study in Human Volunteers Appendix HI Human Patch lest Studies Grading Scale Reading 0 + 1+ 2+ 3+ 4+ Inlerpretation 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 of application. These reactions represent w 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 ofsensitization since after 10-14 days of rest the skin recovers its original resistance to injury by the substance. For the lack of a better term such reactions have been called "skin fatigue". This latter term is a misnomer in that it does not imply a condition in which the skin has lost significant normal physiological function. This phenomenon consists of a subtle change in which the skin no longer exhibits its original refractoriness or resistance to the continued or repeated action of an agent. * Drai/c. J.I I. 1959. Appraisal of the Safety of Chemicals in Foods. Drugs and Cosmetics. In DI:RMAI. TOX1CII Y. p. 46-53. Topuka. Kansas: Association of Food and Drug Officials of (he United Slates. - 19( iilii\ I iiinlL-il -I'd lli>\ KiK. Inrl Wilsliuit!liiii. rmn-.i.k.ini.l I'MIU.II.'fiK Company Saoitizeff. Does not<;ontain TSCAC