Document 4a81gLkqoRVx65g96BJXamyOR

AR226-3023 Study Title 100-Person Hunan Patch Test with H-21275 (Control I ten), H-21273 (Test I ten 1), and H-21274 (Test Item 2) Laboratory Project ID Haskell Laboratory Report No. 447-95 Study Completed On August 24, 1995 Contracting Laboratory Biosearch, Incorporated 3408-50 B Street Philadelphia, Pennsylvania 19134 Author James E. Long for Haskell E. I. du Pont de Nemours and Company Laboratory for Toxicology and Industrial Elkton Road, P. 0. Box 50 Tievark, Delaware 19714 Medicine Study Monitor Gregory S. Ladies Medical Research No. Page 1 of 32 Sanitized. Does not contain T&CA %' Company GENES^ INFORMATION Cont.ol Material DuPont BLO A47-95 Material Tested; Physical Form: Synonyms: Other Codes: Test Material Material Tested: Physical Form; Synonyms i Othar Codes: o H-21273 Test item 1 Material Tested; " sical Form; Synonyms: Other Codes: Stability: Sponsor; Study Initiated - Completed: In-Life Phase Initiated - Completed; Test item 2 In the absence of visible evidence to the contrary, the test materials were assumed to be stable under the conditions of administration. DuPont Specialty Chemicals I. E. du Font de Nemours and Company Wilmington, Delaware 6/21/95 - 8/2A/95 6/21/95 - 7/28/95 2 - Company Sanitized. Does not contain TSCA CM DUPONT CENTRAL RESEARCH AND DEVELOPMENT HASKELL LABORATORY FOR TOXICOLOGY AND INDUSTRIAL MEDICINE DuPont HLO 447-95 J. M. Materniak DuPont Specialty Chemials Jackson Lab August 28, 1995 100-Person Human Patch Test with H-21275 (Control Item), H-21273 (Test Item 1), and H-21274 (Test Item 2) Attached is a report from Biosearch, Inc. (Project No. 95-8267H). in the report are patch test methods, results, and conclusions. Included The purpose of this study was to determine the potential of H-21275 (Control Item), H-21273 (Test Item 1), and H-21274 (Test Item 2) to cause irritation or delayed contact hypersensitivity in humans. During the induction and challenge phases H-21274 of this study, H-21275 (Control Item). (Test Item 2) produced no adverse skin H-21273 responses (Test Item in 100% and 1), and 100X, respectively, of those subjects who were active participants. Based upon the effects observed withandthechtaellsetngmeatpehraiaselss, pnlaeciethderrepHe-2a1t2e7d5ly on the skin during (Control Item). both the induction H-21273 (Test Item 1), nor H-21274 (Test Item 2) are considered skin irritants nor sensitizing agents under the conditions that prevailed in this study. 7^^) O^W Gregory S. Ladies, Ph.D. Research lexicologist 3 - Company Sanitized. Does not contain T8CA CBI DuPcmt HLO 447-95 BIOSEARCH INCORPORATED P.O. Box 8598, Philadelphia, Pennsylvania 19101 Telephone: (215) 739-4499 Fax: (215) 423.9210 PrQ}ecjLNumber: 95-8267H Testing Facility. Biosearch Incorporated 3408-50 "B" Street Philadelphia, PA 19134 Sponsor: Test Article: E.I. du Font de Nemours & Company P.O. Box 50, Elkton Road Newark, DE 19714 H-21273/H-21274 Control Article: H-21275 Test Article Description: Control Article Description: TestArticles Received: 06/16/95 Control Article Received: Study Initiated: Date of Report: lest: Object of Test: Reference: Method of Tert: 06/16/95 06/21/95 Study Completed: 07/28/95 UB/2Z/y5 Modified Draize Repeated Insult Patch Test Study in Human Volunteers To determine the sensitizing properties of the test article. The method employed in carrying out this test was similar to that described in "Appraisal of the Safety of Chemicab in Foods, Drugs and Cosmetics" by J.H. Draize and published by the Association of Food and Drug Officials of the United States. Test Panel: The test involved the application of the test article to the upper arms of a group of 122 volunteer panelists. The panelists ranged from 18 to 67 years of age. One hundred and nine panelists completed the study (see Panelist List, Appendix 1C). Prior to the initiation of the study, all panelists were in good general health and free of any visible skin disease or anomaly in the area to be patched. Each panelist was required to read, understand and sign an infnrmpd consent statement. Page 4 of 32 Company Sanitized. Does not contain TSCA C8? Project Number: 95-8267H DuPont HLO 447-95 E.I. du Font de Nemours & Company - H-21273/H-21274/H-21275 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Method of Test: (continued) Patch Preparation: The control article (H-21275) and the test articles (H21273 and H-21274) were tested as supplied. A portion of each, approximately one inch square, was placed onto a strip of 2" Dermicel hypo-allergenic doth tape (Johnson & Johnson, New Brunswick, NJ 08903). Before applying this strip, each portion of test material was flattened with a gloved finger to insure proper application. This tape strip was then pressed into place on the upper left arm of each panelist at the appropriate test site. Induction Phase: These patches were applied to their designated contact site and remained in place for 24 hours. At the end of this period, the patches were removed and the sites were examined for any dermal response. The panelists were then rested for a 24-hour period after which the skin sites were again examined. New patches were then applied to the same sites as previously used. The second applications were 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 (obtained 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 sites were used throughout the study. During the third week of the Induction Phase with periods of extremely high temperature and humidity, the test articles patch strips either fell off or were moved out of place in the case of several panelists. When this occurred, additional tape (Micropore 3M, 3M Health Care, St. Paul, MN 55144-1000), was used for the next application. This addition plus using a new Lot# of Dermicel appeared to solve the problem. These few occurrences did not appear to interfere with obtaining valid results from 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. These patches were applied on Friday following the last scheduled (ninth) induction patch application on Wednesday. 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 sites described above. 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 sensitization. A follow-up examination was conducted at 48 hours after the challenge applications (24 hours after patch removal). -5- B10SEARCH. INCORPORATED - P.O. BOX 8598 - PHILADELPHIA, PENNSYLVANIA 19101 Company Sanitized. Does not contain TSCA CB8 Project Number: 95-8267H DuPont HLO 447-95 E.I. du Font de Nemours & Company - H-21273/H-21274/H-21275 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Method of Test(continued) Grading Scale: The grading scale used throughout both the induction and challenge phases is shown in Appendix IV. Results: Results obtained with the control article (H-21275) are presented in Appendix I. Individual panelist data for the control article are presented in Table 1. A summary of the data for the control article is presented in Table 2. Results obtained with the test articles (H-21273 and H-21274) are presented in Appendix II. Individual panelist data for the test articles are presented in Tables 1 and 3. Summaries of the data for each of the test articles are presented in Tables 2 and 4. Conclusion: From the results obtained with this test panel, the test and control articles do not appear to be primary skin irritants. The test and control articles do not appear to be fatiguing agents. The test and control articles do not appear to be sensitizing agents under the study conditions utilized. Signatures: Submitted by Biosearch, Incorporated: s ^ ^ 4 ^ w 'ed- -k Urbach, M.D. bnsul it Dermatologist ig, SC.D. Study Director/Vice President, Laboratory Operations & Regulatory Affairs f;^.4^ Date/ Approved by: i^-i/ ^-/ fc Karl L. Gabriel, V.M.D., Ph.D. President ^ / t-//^ Date -6- BIOSEARCH, INCORPORATED - P.O BOX SS9S - PHILADELPHIA, PENNSYLVANIA 19101 Company Sanitized. Does not contain TSCA CBI i Project Number: 95-8267H DuPont HLO 447-95 APPENDIX I RESULTS FOR CONTROL ARTICLE Company Sanitized. Does noi contain TSCA CBI -7- B10SBARCH, INCORPORATED P.O. BOX BS98 - PHILADELPHIA, PENNSYLVANIA 19101 Proiect Number: 95-8267H E.I. du Pont de N emours & Company - H-2l275,as supplied. Modified Draize R epealcd Inult P.it'ch Tust Study in Human Voluiitrpro Table 1 - Indiv idual Paneli st Data Panelist Number l 3 3 4 5 6 7 1 8 00 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 24 48 72 120 = - a * = ** D = Induction Phase 1 24 48 0 0 23456 0 0 0 0 0 0 0 0 0 C 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0000 0 U 0 0 0 0 0 0 0 0 0 0 0 0 D D 24 72 0000 0000 0000 0000 0000 0000 D00D 0000 0000 0000 0000 0000 DD 24 48 24 48 0000 0000 0000 0000 000-* 00 -0 0000 0000 0000 00 00 0000 0000 D00D D00D 00 00 0000 0000 0000 0000 0000 0000 0000 0000 DD DD 24 120 24 48 0000 00 -0 0000 0000 0000 0000 0000 0000 0000 0000 0000 0000 00 DD D00D 0000 000 0000 0000 0000 0000 0000 0000 0000 0000 DD DD 7 24 72 0 0 0 0 0 0 0 0 0 0 0 D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 8 24 48 9 24 48 0000 0000 0000 0000 0 -* - 0 D D D D 0000 0000 0000 0000 0000 0000 00 00 D D D D 0000 0000 0000 0000 0000 0000 0000 0000 0000 0000 D D D D 10** 2472. 0 D Reading 24 hours after application. Reading 48 hours after previous application but just before next application. Reading 72 hours after previous application but just before next application. Reading 120 hours after previous application but just before next application due to the 4 Missed reading, (a) Challenge patches applied one day late due to an emergency. Panelist missed the scheduled patch application Cor personal reasons. Panelist was patched next scheduled application day, and the patch series extended until 9 induction applicatio Make-up patch application. Discontinued from the study foi puxnonal rraoonn. Company Sanitiz Project Number: 95-B267H E.I. du Pout. de Nemours & Company - H-21275,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table l - Individual Panelist Data (continued) Panelist; Number 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 1 24 48 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 24 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 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 i 24.-AS 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 4 24 18 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 l 24- 120. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 6 2 A -4fi 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7 24-12. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D 0 0 8 24 AS. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 ,, 0 0 0 0 0 0 0 0 0 D D 0 0 9 24 4L 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 24 48 72 = 120 " e D Reading 24 hours after application. Reading 48 hours after previous application but just before next application. Reading 72 hours after previous application but just before next application. Reading 120 hours after previous application but just before next application due to the 4 Missed reading. Discontinued from the study for personal reasons Company Sanitized. D ''vsf Pro-iect ^'lumber: ab-8.<i6 7H ? t^&S '^iiiy E.I. du I'ont de Nemours & Company - H-21275,as Esupplied. Modified Draize Repeated I nsult Patch Test Stud}Y in Huma n Volu nteers iFable 1 - Indiv idual Paneli st Datai Induction Phase Panelist Number l 24 48 2 24 72 3 24 48 4 24 48 5 ^24 120 6 24 48 7 24 72 8 24 48 9 24 48 51 52 53 54 55 56 57 58 1 59 5 60 1 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 24 48 72 = 120 = 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0- 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0000 0000 0000 0000 0000 0000 0000 u u 00 0000 0000 0000 0000 00 0000 0000 0000 0000 0000 0000 0on0 oo 0000 0000 0000 0000 - 0 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 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 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 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Reading 24 hours after application. Reading 48 hours after previous application but just before next application. Reading 72 hours after previous application but just before next application. Reading 120 hours after previous application but just before next application due to the 4t Hissed reading. Company Sanitized. D ""^tel %?-- Project Number: SS-8267H E.I. du Pont de Nemours & company - H-2l275,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 1 - Indiv idual P,aneli;Bt 13aita Induction Phase Panelist Number 1 24 4 B 2 24 72 i 24.-18 4 24 18 5 24 120 6 2:4 48 7 24 7 2 8 24 .18 9 24J18 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 24 48 72 120 = SS * D 0000 00 00 0000 00 00 0000 00 00 0000 0000 0000 00 00 0000 0000 0000 0 -* - 0 0000 0000 0000 0000 00 00 0000 0000 00 00 0000 0000 0000 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 - 0 0 0 0 0 0 0 -0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0000 0000 0000 0000 0000 0000 0000 0000 0000 0000 0000 0000 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 0 0 0 0 - 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 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 D D 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 U 0 0 0 G 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 D D 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 - 0 0 Reading 24 hours after application. Reading 48 hours after previous application but just before next application. Reading 72 hours after previous application but just before next appli cation. Reading 120 hours after previous application but just before next appi ication due to the Missed reading. Panelist missed the scheduled pa,tch application for personal reasons Panelist was patched next scheduled application day, and the patch series extended until 9 induction applicatio Discontinued from the study for personal reasons. Company Sanitized Number: 95-8267H E.I. du Font de Nemours & Company - H-.;i2 75,as supplied. Modified Draize Repeated Insult Patch Tea t Study in Human Volunteers Table 1 - I ndiv idual Paneli st Data Induction p base Panelist Number 101 102 103 104 105 1234 24 48 0000 0000 U D 24 72 0000 0000 D U 24 48 0000 0 D D0 0D 24 48 0 0 0 0 P n 0 II D D 5 24 120 0000 r> D 1) U D D 6 2 4 48 0 0 0 0 P n U u D D 7 24 7 3. 0 0 0 0 n n U D D D 8 24 4B 0 0 0 0 1-) n D D D D 9 24 4 1 0 0 0 0 D D D D D D 10** 24 72 106 107 - 108 109 110 111 112 113 114 115 116 117 118 119 120 121 122 24 48 72 120 = = * X D 00000000000000000000000000000000000000000000000000000000000000 00000000000000000000000000000000000 000000000000000000000000000000 0000 0 -* 0' 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 o o -* o -* 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 - 0 0 0 0 0 0 0 0 0 0 0 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 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Reading 24 hours after application. Reading 48 hours after previous application but just before next application. . Reading 72 hours after previous application but just before next application. Reading 120 hours after previous application but just before next application due to the 4 Missed reading. Panelist missed the scheduled patch application for personal reasons . Panelist was patched next scheduled application day, and the patch series extended until 9 induction application Make-up patch application. Discontinued from the study for personal reasons Company Sanitize Prolect .HH'nber: 95-8267 H E.I. du Pont de i(temours 6 C'ompaniy - H-21275,as supplied. Modiie<1 Draize I;epe ated In.suit Patch Test Study in Huma n Volumt eers 1 24 4iI Total Panelists: 122 122 Grade 0 118 116 t 0 0 n- 0 0 2+ 0 0 3+ 0 0 4+ 0 0 * < " 0 2 D 4 4 2 24 72 122 122 116 118 0 0 0 0 0 0 0 0 0 0 2 0 4 < Tabi e 2 - Su mmary of E)ata Induction Phaset 3 4 5 34 48 24 46 24 120 122 122 122 122 122 122 6 24 48[ 122 122 7 24 72 122 122 8 24 48 122 122 116 116 11'i 116 116 114 0 0 0000000000 0 0 0000000000 0 0 U 0 00 2 4 5152606062 110 115 0 0 0 0 0 0 0 0 D 0 6 0 6 7 115 113 0 0 0 0 0 0 0 0 0 0 0 0 7 9 110 110 0 U 0 0 0 0 0 0 0 0 2 1 10 11 | 9 2-&& 122 122 108 108 0 0 0 0 0 0 0 0 0 0 3 3 11 11 10'** 24--22 4 4 4 0 0 0 0 0 0 0 24 48 72 s 120 8 ** = D = Reading 24 hours a fter application. Reading 48 hours a fter previous application but just before next application. Reading 72 hours a fter previous application but just before next application. Reading 120 hours after previous application but just before next application due to the 4t Missed reading. Make-up patch appi ication. Discontinued from the study for personal reasons. Company Sanitized Project Number: 95-8267H DuPont HLO 447-95 APPENDIX II RESULTS FOR TEST ARTICLES -14BIOSEARCH, INCORPORATED - P 0. BOX 8598 - PHILADELPHIA, PENNSYLVANIA 19101 Company Sanitized. Does not contain TSCA CBI. Project Numbiii : ''> a<;C711 E.I. du Pent de Nemours & Company - H-2l273,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 1 - Individual Panelist Data Induction Phasel PanelistC Number 1 24 48 2 247S 3 24 48 4 > M, 48 5 24 120 6 2!4 48 7 2J^ E 1 M-4& 9 24 48 10** 2422. I 2 3 4 5 6 7 H 3 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 24 48 72 = 120 = * m ** 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 D0 0D 0000 00 0000 0000 11 0 0000 0000 0 0 D - D - 0 ^ 0000 0000 0 -* 00 11 0 0000 0000 0D- 0D 0 0 0 0 0 0 0 0 0 U 0 0 0 1) o 0 0 0 0 0 0 0 0 0 0 D D 0000 0000 0000 00 n D 0000 0000 D00D 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 11 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 D 0 0 0 1) 0 0 0 0 0 0 0 0 0 0 D D 000 0 0 0 0 0 0 0 0 -* D D 0000 00 - 0 D D 0 0 00 U U 00 0 0 00 0 0 00 0 0 00 0 0 00 0 0 00 D D 0 D 0 D 0 0 00 00 00 00 0 0 00 00 00 00 0 0 00 00 00 00 0 0 00 00 00 00 0 0 00 00 00 00 0 0 00 00 00 0 0 00 00 0 0 00 00 00 0000 0 0 00 00 00 00 0 0 00 00 0000 00 D D no D D oo D D 0 0 0 0 0 0 0 0 0 0 0 0 n 0 0 0 0 0 0 0 D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D D D . . . Reading 24 hours after application. Reading 48 hours after previous a--p--plic-a-tion but just before next application. Reading 72 hours after previous application buc just before next application. Reading 120 hours after previors application but just before next application due to the 4t Hissed reading, (a) Challenge pa tches applied one day late due to an emergency. Panelis t missed the scheduled patch application for personal reasons . Panelist was patched next scheduled application day. and the patch se ries extended until 9 induction applications Make-up patch application. Discontinued from the study for personal reasons , Company Sanitized. D 'wilB Proiect ^lumber: 95-826 7H E.I. du IPont de tiiemours & Compan y - H-21273,as supplied. Modified Draize Brepeated I nsult Patch Test Study in Human Volu nteers Table 1 - Indivi dual Paneli st Dat a (cont inued) Induction Phase Panelist Mumber l 24 48 2 24 72 3 24 48 4 24 48 5 24 120 6 24 48 7 24 72 8 24 48 9 24 48 26 27 28 29 30 31 32 33 1 34 S 3S 1 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 24 = 48 = 72 s 120 s = D s 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 P 0 ( 0 0 D E 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 G 0 0 0 0- 0 0 0 0 0 D D 0 0 00 n 0 00 0 0 00 0 0 00 0 1+ 0 0 0 0 00 0 0 00 0 0 00 0 0 00 0 0 00 0 0 00 0 0 00 0 0 00 0 0 00 D D 00 00 D D 0000 0000 0000 0000 0000 0000 0000 D00D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 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 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D 0 0 0 0 0 0 0 0 0 C D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 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 0000 0000 0000 0000 00 0000 0000 0000 0000 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 0 0 0 0 0 D 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D 0 0 0 Reading 24 hours after application. Reading 48 hours after previous application but just before next application. Reading 72 hours after previous application but just before next application. Reading 120 hours after previous application but just before next application due to the 4t Hissed reading. Discontinued from the study for personal reasons. . Company Sanitized X Pro-ject Number: c^5-826 7H E.I. du Pont de N emours & Company - H-21273,a3 SUpplied. Modified Draize R epeated I nsult Patch Test Stiidy i n Human Volunteers TabIe l - i ildiv idual Paneli st Data Induction P hase Panelist Number 51 52 53 54 55 56 57 58 59 L 60 ^ 1 62 63 64 65 66 67 68 69 70 71 72 73 74 75 1 24 48 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 24 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 3 2-48 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 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 4 24 48 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 o 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 M -1SS. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 6 2. &8 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 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 7 2. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 a 24 .48 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 9 24Jli 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 24 48 72 120 a Reading 24 hours after application. Reading 48 hours after previous application but just before next application. Reading 72 hours after previous application but just before next application. Reading 120 hours after previous applicat ion but just before next applicafcion due to the 4t Missed reading. Company Sanitized. WiiS&ct Niimbtit: '-'-i a^L'/ii E.I. du Font de Merr.ours & Company - H-21273,as supplied. Modified Draize Repeared Insult Patch Test Study in Human Volunteers Table I - Individual Panelint Data Induct ion t'h^me Panel ifit Number 1 24 48 2 24 72 3 24 48 4 24 48 5 24 120 6 24 AS 7 24 72 8 24-Afi S i 24 48 76 77 78 79 80 81 82 83 84 l 85 S30 86 1 87 88 89 90 91 92 93 94 95 96 97 98 99 100 24 = 48 72 120 = - S * 3 D = 000000000000000000000000 000000000000000000000000 000000000000000000000000 000000000000000000000000 0 -* - - 0 000000000000000000000000 000000000000000000000000 000000000000000000000000 000000000000000000000000 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 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 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D 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 0 0 0 0 0 0 0 0 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 D D 0 0 0 0 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 D D 0 0 0 0 D D 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 00 Reading 24 hours after applicati.on. Reading Reading 48 72 hours hours after after previous previous application application but but just before next application. Reading 120 hours Missed reading. after previous application just before next application. but just before next application due to the 4Lh Panelist missed t he scheduled pa tch next scheduled application day, and application the for personal reasons. Panelist was patched o Discontinued from the study for patch serie s personal reasons extended until 9 induction applications Company Sanitized. Do Pro-iect Number: c^ S^f,7ll E.I. du Font de Nerauurs & Company - H-212 7 3, as supplif-ci. Modified Draize Repeated Insult Patch Tes t Study in Human Vol unteers Table 1 I ndi vidual P aneliISC Da ta Induction P las e Panelist Number 101 102 103 104 105 1 2 24 48 00 00 0000 D D 24 72 0000 0000 D D 3 24 48 0000 0 D D00D 4 24 48 0 0 0 0 D D 0 D D D 5 24 120 0000 D D D D D D 6 2A -AS 0 0 0 0 U D D D D D 7 24 7 2 0 0 0 0 D D D D D D 8 24 4 ~ 0 0 0 0 D D D D D D 9 24 4 JS 0 0 0 0 D D D D D D 10** 3422. 106 107 1 108 S 109 ' 110 111 112 113 114 115 116 117 118 119 120 121 122 24 48 72 a 120 = "- as * = ** D 00000000000000 000000000000 0000000000000000 0000000000000000 0 -* 0" 0 - 0 0000000000000000000000000000000000 000000000000000000 00000000000000 000000 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 0 0 0 0 o 0 o o -* o -* 0 0 0 0 - 0 0 0 0 0 0 J 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Reading 24 hours after application. Reading 4B hours after previous application but just before next appli cation. Reading 72 houra after previous application but just before next application. Reading 120 hours after previous application but just before next application due to the 4 Missed reading. Panelist missed the scheduled patch application for personal reasons , Panelist was patched next scheduled application day, and the patch series extended until 9 induction application Make-up patch application. Discontinued from the study foi personal reasons. Company Sanitized. D ' |P Pro-iect Number: 95-82P7H E.I. du Font de Nemours & Company - H-2i273,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 2 - Summary of Data Total Panelists: Induction Phase 12345 24 48 24 72 24 48 24 48 24 120 122 122 122 122 122 122 122 122 122 122 6 24 48 122 122 7 24 72 122 122 8 24 48 122 122 9 24 48 122 122 Grade 0 118 116 116 118 116 115 115 116 116 114 110 115 115 113 110 110 108 108 1+ 00000000000100000000 00 00 00 00 0000 0000 2+ 3+ 00000000000000000000 00 00 00 00 0000 0000 4+ 0000000000 P 0 00 0000 D 02 20 21 20 02 4444455666 60 67 2133 00 79 10 11 11 11 10** 2412 4 4 0 0 0 0 00 00 01 24 = 48 = 72 = 120 = = ** = D = Reading 24 hours after application. Reading 48 hours after previous application but just before next application, Reading 72 hours after previous application but just before next application. MReisasdeindgre1a20dinhgo.urs after previous application but just before next application due to the 4 Make-up patch application. Discontinued from the study for personal reasons. Company Sanitized. Pro-iect Number: 95-8267H E.I. du Font de Nemours & fomptiny 11 ^1274,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 3 - Individual Panelist Data Inducticw Phase Panelist Number 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 1 24 18 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 2 24 J 12. 0 0 0 0 0 0 0 0 0 0 0 !.' 0 C 0 0 0 0 0 0 0 0 0 0 0- 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 3 2i 48 0 0 0 0 0 0 0 0 0 0 0 -* 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 4 24-i18 0 0 0 0 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 5 24 ISO 0 0 0 0 0 0 0 0 0 0 C ^ 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 6 24 4JB 0 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 D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 7 2<.22 0 0 0 0 0 0 0 0 0 0 0 D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 8 21- 48 0 0 0 0 0 0 0 0 0 -* D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 9 24 18 0 0 0 0 0 0 0 0 - 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 10** 24 72 0 D 24 Reading 24 hours after application. 48 Reading 48 hours after previous application but just before next application. 72 Reading 72 hours after previous application but just before next application. 120 Reading 120 hours after previoas application but just before next application due to the 4t Missed reading, (a) Challenge patches applied one day late due to an emergency. Panelist missed the scheduled patch application for personal reasons. Panelist was patched ** Mneaxkte-uspchpeadtuclhedaapppplilcicaatitoionn. day, and the patch series extended until 9 induction application D Discontinued from the study Cor personal reasons. Company Sanitized. Does Hy ~' ^gy Project Number: 35-8267H E.I. du I'oiiL d>.' Nemoutu t< Company - H J 1274, as supplied. Modified Draize Repeated Insult Patch Test Study in Hum-in Volunteers Table 3 - Individual Panelist Data (continued) Inciuction Phase Panelist Number 36 27 28 29 30 31 32 33 1 34 N3 M 35 ' 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 1 24 48 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2, 24 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 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 24 48 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 4 24 48 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 c 24 J^O 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 6 2.1 -18 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 c 0 0 0 0 0 7 24 7 2, 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D 0 0 8 24 48. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 - 0 0 0 0 0 0 0 0 0 D 0 0 0 9 24 i8 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 24 48 72 120 = D Reading 24 hours after application. Reading 48 hours after previous application but just before next application. Reading 72 hours after previous application but just before next application. Reading 120 hours after previous application but just before next application due to the 4th Missed reading. Discontinued from the study for personal reasons Company Sanitized. Do Prefect tiuinLt.-t ; 9S B-iC 711 E.I. du Ifont de Nemours & Company - H-21274, as supplied. Modified Draize Repeated I[nsult Patch Test S tudy in Huma n Voluinteers Table 3 - Indiv idual P aneli st Data Indi. tion Phase Panelist Number 1 24 48 2 24 72 3 24 48 4 24 48 5 24 .1.20 (l 24 48 7 24 72 8 24 48 9 24 48 51 52 53 54 55 56 57 58 ^ ,59 OJ 60 ' 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 24 48 72 s 120 a 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0- 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0000 0000 0000 0000 0000 0000 0000 0000 0000 0000 0000 0000 00 0000 0000 0000 0000 0 0 0000 0000 0000 0000 0000 0000 0000 - 0 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 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 o 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 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Reading 24 hours after application. Reading 48 hours after previous application but just before next appli cation. Reading 72 hours after previous application but just before next appli cation. Reading 120 hoursB after previous application but -just hffore nexl- Ippi ic-iitioii due to the 4t Missed reading. Company Sanitized. Doss n Pro-iect Number: 95-82C 7H E.I. du Pont de N emours 61 Compan y - H-212' 4,as supplied. Modified Draize Repeated I nsult Patch Test- Study in Human VQlL-inteers Table 3 Indi\/idual P anelisSt E3atLa Induction Phasea Panelist Number l 24 48 2 24 72 1 21 4H 4 2-1 A1 S 24 120 6 -Z,4 48 7 24 7 2 8 24 A18 9 24 4 a 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 24 48 72 a 120 - S * = 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 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 -- 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Q 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 0 0 0 0 0 0 0 0 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 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0000 0000 0000 0000 0000 0000 00 10 0000 0000 0000 0000 0000 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 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 D D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 P 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 D D 0 0 0 0 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 D D 0 0 0 0 D D 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 - 0 0 Reading 24 hours after applicati on. Reading 48 hours aft.er previous application but just before next appli cation. Reading 72 hours after previous application but just before next application. Reading 120 hours after previous application but- -ust before next appi ication due to the 4 Missed reading. Panelist missed the scheduled pa tch application for personal reasons Panelist was patched next scheduled application day, and the patch series extended until 9 induction applicatio Discontinued from the study for personal reasons. Company Sanitized. Doe Protect Number: 95-8267H E.I. du Font de tiemouia & Company 1< -;1 .;7^,^.^.3 uupplif.-d. Modifiec3 Draize R epeated Insult Patch Te st Study in Human Volu nteers Table 3 - Indivadual P aneli st Data Induction Phase Panelistt Number 1 24 48 2 24 72 3 24 48 4 2.4. 48 5 24 120 d 2.4 48 7 24J2. 8 2JLJA 9 21-3.a 10** 2422 101 102 103 104 105 106 107 108 j 109 ' 110 111 112 113 114 115 116 117 118 119 120 121 122 24 48 72 120 * = ** a 0 0 0 0 0 0 0 0 0 D D 0000 0000 D D 0000 0 D D0 0D 0 0 0 0 D D 0 D D D 0000 D D D D D D 0 0 0 P U U D D D D 0 0 0 0 D D D D D D 0 0 0 0 D D D D D D 0 0 0 0 D D D D D D 0 0 00 00 00 0 0 00 00 00 0 0 00 00 00 0 0 00 00 00 0 0 00 00 00 0 0 00 00 00 0 0 00 00 0 -* 00 00 0 0 00 00 00 00 0 0 00 00 00 0 0 00 00 00 0 0 00 00 00 0 0 00 00 00 0 0 00 00 00 0 0 00 00 00 0 0 0000 0000 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 0 0 0 0 0 0 0 0 0 0 0 -* 0 -* 0 0 0 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 - 0 - 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 Reading 24 hours after application. Reading 48 hours after previous application but just before next application. Reading 72 hours after previous application but just before next application. Reading 120 hours after previous application but just before next application due to the 4t Missed reading. Panel lat missed the ucheduled p c*Lch appliuaLlun l.oi peroondl leaoons . Panelist was patched next seneduled application day, and the patch selies extended until 9 induction application l'IaKG"'Up o^--af--cewh kaknjfa^lM1.-o.kaut-h1.--r>nv Discontinued from the study for personal reasons Company Sanitized. Does Pro-ject Number: 95-826 7H E.I. du Pont de ^temo urs & Compa ny - H-21 2 74, as suippi:Led. Modified1 Draize I lepe ated I nsult Patch Te S t Study in iluman1 "JUint<sers r Fable 4 - Suininar^' of t lata l 24 4 iI Total Panelist.a: 122 1:22 Grade 2 24 72 122 12 2 3 2,&-i8 12 2 122 4 2,4 &a 12 2 122 Induellion Phase> 5 2 4i;i0 6 24 48\ 12 2 1;22 1 22 12'2 ^ f 24 22. 122 122 8 M -&s 122 .122 0 118 1:16 116 11 8 11 6 116 11 5 116 11 6 1:14 1 10 11 5 115 113 110 110 ^ 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 2+ 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3+ 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 U 0 0 0 0 0 1 9 aa i8 122 122 108 108 0 0 0 0 0 0 0 0 0 0 - 0 2 2 0 2 1 2 0 0 2 6 0 0 0 2 1 3 3 D 4 4 4 4 4 5 5 6 6 6 6 7 " 9 10 11 11 11 10* * 2A--2 4 4 0 0 0 0 0 0 0 24 48 72 120 z * a D Reading 24 hours after applicati on. Reading 48 hours after previous appiicat ion but just before next application. Reading 72 hours after previous applicat ion but just before next application. Reading 120 hours afte r previous application but just before next application due to the 4t Missed ]reading. Make-up patch applicat ion. Discont:Lnued from the study or personal reasons company Sanitized. Does n Project Number: 95-8267H DuPont HLO 447-95 APPENDIX III PANELIST LIST BiOSEARCH. 1NCORPORATLD - P 0 -27- BOX 8598 - nmjSOSilPWA, rENNSYl-^ANIA J9U11 Company Sanitized. Does no,t co^ntasin TfSaCfAA tc*aWi L Project N umber: 95-82671H E.I.DUPoat De Nemo. s>&Company Modified Draize Repeated1 Insult Paitch Test Study iin Human Volunteers Appendix HI Panelist Number 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 B 2 324 y 25 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 51 52 53 54 Initials C.C. G.F. D-L. J.M. S.E.A. T.S. P.H. A.W.N. M.S. M.C. M.M. F.P.M. R.A.R. A.L. K.C. S.S. L.S. K.G. M.S. M.S. L.O. E.W. J.C.CP.M. K.S.B. P.J. B.V. T.P. M.W. J.K. E.A.H. A.R. J.S. P.P. M.C. JJ-H. S.B. J.N. B.M. CM. J.M. B.C. L.D. R.B. E.S. H.V. \'". L.T. P.A. M.W. P.M. G.I. B.H. J.R. Age 49 34 28 37 29 39 58 47 37 48 48 53 54 19 46 58 58 43 29 50 39 64 24 32 19 48 26 39 39 62 47 42 59 31 32 62 57 18 67 29 42 43 40 18 M 58 34 35 34 66 55 38 40 22 PANELIST U ET Occupation Allergies Horoemaker Homemaker Homemaker Homemaker Homemaker Homemaker Homemaker Processor Homemaker Homemaker Driver Unemployed Pastor/Minister Student Teacher's Aide Homeinaker Retired Homemaker Unemployed Homemaker Homemaker Stock Girl Student Horncmaker Student Homemaker Homemaker Clerk Homemaker Handyman Homemaker Unemployed Retired Homemaker Unemployed Ambul.Drivcr Homemaker Student Retired Homemaker Homemaker Homemaker Homemaker Student Homemaker Homemaker Homemaker Homemaker Unemployed Homemaker Food Service Unemployed Homemaker Unemployed - Hayfever. Pollen - Hay fever. Tomatoes - Dust - Penicillin - Cats - Penicillin - Penicillin - Hayfever -28- BIOSEARCH, INCORPORATED - P.O BOX 8596 - PHILADELPHIA. PENNSYLVANIA 19101 Company Sanitized. Does not contain TSCA CBI Project Number: 95-8267H E.I. Du Font De Nemours & Company Appendix HI v Mivloudaiifnieeda Duraize RKepeatreda Iinsult Praatrcchn Tleest Study imn Human Vvolunteers Panelist Number Initials PANELIST LIISS1Tr Age Occupation Allergies "5 36 ?7 58 59 60 61 62 63 frt 65 66 67 68 69 "0 1 i 3 4 "^ 76 77 B 7 879 80 !i;B'' K1 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 M.H. T.W. M.S. G.E.S. C.S. M.S. P.t. K.P. L.O. K.M.D. S-R. L.L.D. A.L.L. D.E. C.C. M.C. T.:-l. M.M. H.R. B.E. M.C. L.V. M.A. C.G. K.G. L.C J.S. D.C. H.C.R. N.V. C.S. E.W. B.S. ).F. M.A. L.D. E.R. M.D. M.IM.D. M.C.T. R.J. K.W. R.C.G. J.H. K.D. B.S. J.W. D.N. M.E.O. R.A.SRS. E-S. D.B. 40 Homemaker 45 Forklift Driver 55 Homemaker 29 Unemployed Hayfever.Grass - - Ragweed, Pollen 45 Pretzel Twister - 20 Homemaker - 38 Homemaker - 55 Rctired/Homernak - 35 Homemaker - 54 Homemaker - 31 Homemaker - 47 Acme (Clerk) Penicillin 51 Homemaker - 39 Homemaker - 22 Student - 52 Homemaker - 67 Retired - 53 Homemaker Codeine 23 Homemaker - 47 Crossing Guard 29 Homemaker 52 Home-iaker 44 Homemaker 43 Homemaker 40 Homemaker 31 Homcmdkcr H.-.'.lcvc;-. Dust, Fish, Nickel 48 Unemployed Vs Bus Attcndcnt 61 Unemployed H^yfcver, Dust, Dog Hair 27 Homemaker 41 Homemaker 36 Homemaker 68 Homemaker 41 L'mcmploycd 67 Homcrnakcr 28 Crossing Guard 27 Homemaker - 23 Student Shell fish 43 Data Entry - 26 Homemaker 47 Unemployed 63 Homemaker - 34 Homcniakcr - 52 Homemaker Blucfish 48 Machine Opcr. - 23 Homemaker 32 Homemaker - 44 Painter - 34 HomciTiakcr Penicillin 37 Homcrnakcr - 18 Student - 41 Homemaker - 22 Homcniakcr - 22 Factory Cat Hair .<iSiii^ -29B10SEARCH. INCORPORATED - P 0. BOX 8598 - PHILADELPHIA. PIA'NSYi-VANIA 19101 Company Sanitized. Does no! 6onlam TSCA GUI Project Number: 95-8267H E.I. Du Font De Nemours & Company Modified Draize Repeated Insult Patch Test Study in Human Volunteers Panelist Kumbcr 109 110 111 112 113 114 115 lib 117 118 119 120 121 '22 Initials M.F. S.F. C.L.S. M.S. AC. B.B. E.P M.F. L.V L.B M.7. P.\V. D.R L.B. PANELKT LIST Age Occupation Allergies 25 Homcmaker 23 Student 24 Homcmaker 19 Student 63 Homcmaker 37 Homcmaker 37 Factory Worker 43 Homemaker 33 Homemaker 49 Homcmaker 31 Homcmaker 44 Homemaker 48 Secretary Homcmakcr Appendix m BIOStARCH. 1NCORPORATCD - P 0 BOX 8598 - PHll.ADtl.PHIA, PENNSYLVANIA 19101 Company Sanitized. Does not contain TSCA COS Project Number: 95-8267H DuPont HLO 447-95 APPENDIX IV GRADING SCALE -31IllOSLARrH. INCORrORATLD-rO BOX 85W - Pmi.ADU.PHIA. PENNSYLVANIA Hl.-I Company Sanitized. Does not contain TCA 688 Project Number: 95-8267H E.I. du Font de Nemours & Company - H-21273/H-21274/H-21275 Modified Draize Repeated Insult Patch Test Study in Human Volunteers Appendix IV GRADING SCALE Human Patch Test Studies Reading U _ Interpretation n vc suspicious slight erythema well defined erythema (."vthema with induration ervthema with ulceration DEFINITION'S* 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 an allergy to a chemical which is not obtained on first contact, but requires a number of prior exposures for development. Repeated patch applications of substances to both man and animals reveal that certain substances which, at a given concentration, do not produce primary irritation may elicit severe skin reactions after a number of exposures. Nevertheless, these reactions may not be considered incidents of sensitization since after 10-14 days of rest the skin recovers its original resistance to injury by the substance. For the lack of a better term such reactions have been called "skin fatigue". This latter term is a misnomer in that it does not imply a condition in which the skin has lost significant normal physiological function. This phenomenon consists 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. * Draize, J.H. 1959. Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. In DERMAL TOX1CITY, p.46-53. Topeka, Kansas: Association of Food and Drug Officials of the United States. BIOSLARCH. 1NCORPPRA I bD - P 0 -32- BOX 8598 - PHIiADKI.PHIA. n-.NNSYl.VANIA 19101 Company Sanitized. Does not contain TSCA CBJI