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t i AR226-3023 Study T i t l e 100-Person Hunan Patch Test with H-21275 (Control Item), H-21273 (Test Item 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 E. I. du Pont 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 Medical Research No. 3 Page 1 of 32 Company Sanitized. Does not contain TSGA P iJ Material Tested: Physical Form: Synonyms: Other Codes: Material Tested: Physical Form: Synonyms : GENES ML, INFORMATION Cont.ol Material DuPont BLQ 447-95 Control item Test Material Other Codes: Material Tested: sical Form: Synonyms: Other Codes: Stability: Sponsor: Study Initiated - Completed: In-Life Phase Initiated - Completed: Test item 1 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 E. I. du Pont de Nemours and Company Wilmington, Delaware 6 /2 1 /9 5 - 8/2 4 /9 5 6 /2 1 /9 5 - 7/28/95 Company Sanitized. Does not contain TSCA CBJ DUPONT CENTRAL RESEARCH AND DEVELOPMENT HASKELL LABORATORY FOR TOXICOLOGY AND IND USTRIAL MEDICINE DuPont BIX) 4 4 7 -9 5 J . M. M a te rn ia k DuPont Specialty Chemials Ja ck so n 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). Included in the report are patch test methods, results, and conclusions. 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 of this study, H-21275 (Control Item). H-21273 (Test Item 1), and H-21274 (Test Item 2) 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, neither H ix/3 (Control Item), 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. Gregory S. Ladies, Ph.D. Research Toxicologist - 3- Company Sanitized. Does not contain TSCA CBI DuPont HLO 447-95 BIOSEARCH INCORPORATED P.O . Box 8598, Philadelphia, Pennsylvania 19101 Telephone: (215) 739-4499 Fax: (215) 423-9210 95-8267H Testing Facility: Biosearch Incorporated 3408-50 "B " Street Philadelphia, PA 19134 Sponsor: E.I. du Pont de Nemours & Company P.O . Box 50, Elkton Road Newark, DE 19714 Te st Artide: H -21273/H -21274 Control.Artide- H -21275 Test Artide D eserip tion: Control A rtide Deseription: Test Artides Secami: 06/16/95 Control A rtide R eceiv ed : 06/16/95 3tudy Im tiated: 06/21/95 Study Completed: 07/28/95 Date of Report: OB/2Z/y5 T est: Modified Draize Repeated Insult Patch Test Study in Human Volunteers Qbject of Test: To determine the sensitizing properties of the test article. Reference: The method employed in carrying out this test w as similar to that described in "Appraisal of the Safety of Chem icals 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 arm s 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 III). Prior to the initiation of the study, all panelists w ere in good general health and free of any visible skin disease or anomaly in the area to be patched. Each panelist w as required to read, understand and sign an informed consent statem ent. Page 4 of 32 Company Sanitized. Does not contain TSCA CSi Project Number: 95-8267H DuPont HLO 447-95 E.I. du Pont 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, approxim ately one inch square, was placed onto a strip of 2" Dermicel hypo-allergenic cloth 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 w ere 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, W ednesdays and Fridays until a series of nine applications had been made. Patch applications m ade 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 extrem ely high tem perature 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 L o t# 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 W ednesday. 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 m anner 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- BIO SLARCH, INCORPORATED - P.O. BOX 8598 - PHILADELPHIA, PENNSYLVANIA 19101 Company Sanitized. Does not contain TSCA CBI Etoject Number: 95-8267H DuPont HLO 447-95 E.I. du Pont de Nem ours & 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 sum m ary 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: O perations & Regulatory Affairs Approved by: h :(/ Karl L. Gabriel, V .M .D ., Ph.D. President 6- - BIOSEARCH. INCORPORATED - P .O BOX 859 - PHILADELPHIA. PENNSYLVANIA 19101 Com pany Sanitized. D oes not contain TSCA CBI i-ftcr'1 Project Number: 95-8267H DuPont HLO 447-95 APPENDIX I RESULTS FOR CONTROL ARTICLE C om pany Sanitized. D oes not contain TSCA CBI -7- BIOSEARCH. INCORPORATED -P O. BOX 8598-PHILADELPHIA, PENNSYLVANIA 19101 -J Project Number: 95-8267H E.I. du Pont de Nemours & Company - H-2l275,as supplied. Modified Draize Repealed Insult Patch Tent Study in Human Volunteers Table 1 - Individual Panelist Data Panelist Number 1 2 3 4 5 6 7 OIIB 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 1 24 48 00 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 0u 00 00 00 00 00 00 DD 2 24-7,2 00 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 3 24 48 4 24 48 00 00 00 00 00 0 -* 00 00 00 00 00 00 00 DD 00 00 0 00 00 00 00 00 00 00 DD 00 00 00 00 00 -0 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD Induction Phase 56 24 120 24 48 00 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 0 0 00 00 00 00 00 00 00 00 00 00 00 DD 00 0 00 0 (J 00 00 00 00 00 00 DD 7 24 72 00 00 00 00 00 0D 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 8 24 48 00 00 00 00 0 -* DD 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 9 24 48 00 00 00 00 0 DD 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 10* * 24__72 Challenge Original Virgin Site 24 48 Site M -1B 0 0 0 0 D D 0 0 0 0 0 0 (a) 0 D 0 0 0 0 0 0 0 0 0 0 D 0 0 0 0 D D 0 0 0 0 0 0 D 0 0 0 0 0 0 0 0 0 0 D 0 0 0 0 D D 0 0 0 0 0 0 (a)0 D 0 0 0 0 0 0 0 0 0 0 D 0 0 0 0 D D 0 0 0 0 0 0 D 0 0 0 0 0 0 0 0 0 0 D 24 48 72 120 Reading 24 hours after application < "u m o ai.uei previous application nut 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 of July holidays. 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 on the next scheduled application day, and the patch series extended until 9 induction applications were applied. Make-up patch application. Discontinued from the study for personal reasons. Company Sanitized. Does not contain TSCA CBI DuPont HLO 447-95 Project Number: 95-8267H E.I. du Pont de Nemours & Company - H-21275,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table l - individual Panelist Data (continued) Induction Phase Panelist 1 Mumber 24 48 2 ?4 72 3 24 48 4 24 48 56 24 120 24 48 7 24 72 8 24 48 9 21.48 26 27 28 29 30 31 32 VIO I 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 DD 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 DD 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 -0 00 00 00 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 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 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 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 00 0D 00 00 00 00 00 00 00 00 00 00 0D 00 00 00 00 00 DD 00 00 -0 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 DD 00 00 00 00 00 00 00 DD 00 24 Reading 24 hours after application. 48 Reading 48 hours after previous application but just before next application. .72 = 120 Jr"* I ^ hUrS af^er previous application but just before next application. S Missed3readingUrS previous application but just before next application du< D A Discontinued from the study for personal reasons. Challenge Original Virgin Site Site ',24,48 21J.fi 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 DD 00 00 -0 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 DD 00 00 -0 00 00 00 00 DD 00 to the 4th of July holidays. DuPont HLO 447-95 Company Sanitized. Does not contain TSCA CBI Project Number: 9b-8267H E.I. du Pont de Nemours & Company - H-21275,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 1 - Individual Panelist Data Panelist Number SI 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 1 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 2 24 72 00 00 00 00 00 00 00 00 00 00 00 o- 0 00 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 u 00 00 00 00 00 00 00 00 00 00 4: 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 -0 00 Induction Phase 56 24 120 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 00 00 7 24 72 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 8 24 48 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 -0 00 00 00 00 00 00 00 9 24 M 00 c0 00 00 00 00 00 00 00 00 00 00 -0 00 00 00 00 00 00 00 00 00 00 00 00 Challenge Original Virgin Site Site 24 48 2.1.19 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 on oo oo 00 0o 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 24 48 72 * 120 = 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 previousi application but just before next application due to the 4th of July holidays. Missed reading. DuPont HLO 447-95 Company Sanitized. Does not contain TSCA CBI Project Number: 95-8267H E.I. du Pont de Nemours & company - H-2l275,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 1 - Individual Panelist Data Panelist 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 1 Od dfl 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 2 24 72 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 0u 00 00 00 00 00 00 00 00 00 00 00 00 00 -0 00 4 24 48 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 Induction Phase 56 24 120 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 -0 00 00 -D 00 00 00 00 00 00 00 00 00 00 00 00 7 24 72 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 00 00 8 24 48 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00 DD 00 00 00 00 00 00 00 00 00 9 24 48 00 0 00 00 00 00 00 00 00 00 00 00 DD 00 00 DD 00 000 00 00 00 00 000 Original Site 24 M 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00 DD 00 00 00 00 00 00 00 00 00 Virgin Site 24 48 00 00 00 00 00 00 00 00 00 00 00 00 D 00 00 DD 00 00 00 00 00 00 00 00 00 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 previous application but just before next application due to the 4th or July noiioays. Missed reading. Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application day, and the patch series extended until 9 induction applications were applied. Discontinued from the study for personal reasons. DuPont HLO 447-95 Company Sanitized. Does not contain TSCA CB! J Project Number: 95-8267H E. I. du Pont de Nemours u Company - H-2l275,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 1 - Individual Panelist Data Panelist Number 24 48 24 72 24 48 24 48 Induction Phase 6 24 120 24 48 7 24 72 8 24 48 9 24 48 10** 24__ 72 Original Site M .49 Virgin Site M .*8 101 102 103 104 109 106 107 to 108 ! 109 110 111 112 113 114 115 116 117 118 119 120 121 122 00 00 00 00 DD 00 00 00 00 00 00 00 0 -4 00 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 O' 0 00 -0 00 00 00 00 00 00 00 00 00 00 00 0D 00 DD 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 nn {) I) DD 00 00 00 00 00 00 00 00 00 00 00 00 f) 0 00 00 00 00 00 00 DD I) D DD 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 0 0 00 00 nn L> D DD 00 00 0 00 00 00 00 00 00 00 00 00 00 00 00 0 0 00 00 nn DD DD 00 00 00 00 00 00 0c 00 00 00 00 00 00 00 00 00 00 00 00 Dn DD DD 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 l) D DD DD 000 00 00 00 00 00 0 00 00 00 00 00 00 00 00 00 o0 00 00 00 DD DD DD D DD DD 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 0 00 00 24 48 72 120 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 of July holidays. Missed reading. Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application day, and the patch series extended until 9 induction applications w e re applied. Make-up patch application. Discontinued from the study for personal reasons. DuPont HLO 447-95 Company Sanitized. Does not contain TSCA CB Project Number: 95-8267H E.I. du Pont de Nemours 6 Company - H-2l275,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 2 - Summary of Data Induction Phan* 1 21.AS Ql Panelists ; 122 122 Grade 2 24 72 122 122 3 24 48 122 122 4 24 48 122 122 5 24 120 122 122 6 24 48 122 122 7 24 72 122 122 8 24 48 122 122 9 2i_! 122 122 0 118 116 116 118 116 116 U S 116 116 114 110 115 115 113 110 110 108 108 + 00 00 00 00 00 00 00 00 00 1+ 00 00 00 00 00 00 00 00 00 2+ 00 00 00 00 00 00 00 00 00 3+ 00 00 00 00 00 00 00 00 00 4+ 00 00 00 U t) 0 0 00 00 00 - 02 20 21 20 02 60 00 21 33 D 44 4< 4S 56 66 67 7 9 10 11 11 11 10** 24 72 Challenge Original Virgin Site site M-.M 24 48 44 122 122 122 122 43 00 00 00 00 00 00 01 109 109 00 00 00 00 00 109 109 00 00 00 00 00 11 12 12 11 12 12 24 Reading 24 hours after application. 48 72 Reading 48 hours after previous application but just before next application 120 ?iLhurs af*er Previous application but just before next application. U 2 3rSi!SUC9 PreViOUB applio*tlon but b*f" * reliction due to the 4th of July holidy.. ** Make-up patch application. D Discontinued from the study for personal reasons. DuPont HLO 447-95 Company Sanitized. Does not contain TSCA CBI Project Number: 95-8267H DuPont HLO 447-95 APPENDIX II RESULTS FOR TEST ARTICLES ! I -14- bio search , INCORPORATED - P O. BOX 8598 - PHILADELPHIA, PENNSYLVANIA 19101 Com pany Sanitized. D oes not contain TSCA C B I. P r o j e c t N urnbet : 'S 2C7II E.I. du Pont de Nemours & Company - H-21273,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 1 - Individual Panelist Data Induction Phase Panelist 1 Number 24 48 2 24 72 3 24 48 4 24 48 56 24 120 24 48 7 24 72 8 24..,4.8 9 24 48 1 2 3 4 5 6 7 H 9 10 ui t 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 24 48 72 120 00 00 00 00 00 00 00 0 00 00 00 DD 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 o (I 00 00 0 0 0 D 0 0 0 0 0 0 0 0 0 0 D 0n 00 00 00 00 0 -* 00 nu 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 0U -0 00 ii 0 00 00 00 0 00 DD no oo 00 DD 00 00 00 00 00 00 00 U0 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 0 00 0 00 0 00 0 00 0 00 0 0D 0 00 II 0 I) 0 00 0 00 0 00 0 00 0 00 D DD 00 00 00 00 00 00 00 00 00 00 DD 0 00 0 00 0 00 0 00 .* 0 D DD 0 00 0 Oo 0 00 0 00 00 00 0 00 D DD 00 00 00 00 00 00 00 00 00 00 DD Reading 24 hours after application. S a S TM S UrS a!ter Previous application but just before next application Reading 120 hoSrs^ite previ?us application but just before next application. 10* * 2 4 __ 22. Challenge Original Virgin Site site M .4S 24 48 00 00 00 00 DD DD 0 0 0 0 0 0 (a)0 DD 0 0 0 0 3 0 0 0 0 0 D 00 00 00 00 DD DD 00 00 00 00 00 00 (a)0 DD 00 00 00 00 00 00 00 00 00 00 DD Missed heading. c h a l l e S ^ t S . ^ p p l t ^ e ^ H e i n e ' S " " * J"ly hlid*y"' ^ ?h'liT i " f" I" rso" 1 Psneliotwaa patched oh the * Y " * Path 5xte" ted P"" 1 9 induction applications ere applied. D Discontinued from the study for personal reasons. DuPont HLO 447-95 Company Sanitized. Does not contain TSCA C?i Project Number: 95-8267H E.I. du Pont de Nemours & Company - H-21273,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 1 - Individual Panelist Data (continued) Panelist 1 Number M-ii 2 24 72 3 24 48 4 24 48 Induction Phase 56 24 120 24 48 7 24 72 8 24 48 9 24 48 Challenge Original Virgin Site Site 24 48 24 48 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 = 48 72 120 00 00 00 00 00 00 00 00 00 00 00 00 00 0f 00 DE 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 c0 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 n0 00 00 0 1+ 00 00 00 00 00 00 00 00 00 00 DD 00 00 -0 00 00 00 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 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 00 00 00 00 00 00 0 00 00 00 00 00 00 00 00 00 00 00 DD 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 00 00 00 00 00 OD 00 00 00 00 00 00 00 00 00 00 OD 00 00 00 00 0C DD 00 00 -0 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 DD 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 DD 00 00 -0 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 DD 00 00 -0 00 00 00 00 1 D 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. Missed^readingUrS aft6r previous application but just before next application due to the 4th of duly holidays. D Discontinued from the study for personal reasons. DuPont HU) 447-95 Company Sanitized. Doos ,,,,I contain TSCA c m Project Numbei: 9S-.8267H E.I. du Pont de Nemours & Company - H-21273,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 1 - Individual Panelist Data Panelist Number 51 52 53 54 55 56 57 58 59 60 1 62 63 64 65 66 67 68 69 70 71 72 73 74 75 1 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 2 24 72 00 00 00 00 00 00 00 00 00 00 00 00 0. 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 0c 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 4 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 -0 00 Induction Phase 56 24 120 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 l) 0 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 7 24 72 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 8 24 48 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 -0 00 00 00 00 00 00 00 9 24 48 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 Original Site M-M 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 virgin Site 24 48 00 00 00 00 00 00 c0 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 24 * 48 * 72 120 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 of July holidays. Missed reading. se-mra worn Company Sanitized. Does not contain TSCA CBI I P t . .a c t. N um ber : 'J `-p E.X. du Pont de Nemours & Company - H-21273,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 1 - Individual Panelist Data Induction Phase Panelist 1 Number 24 48 2 24 72 3 24 48 4 24 48 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 00 00 00 00 00 00 00 00 00 00 00 00 -* 0 0 0 0 0 0 0 0 0 0 0 0 00 00 00 00 00 00 00 00 00 00 00 00 0 00 00 00 00 00 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 0 00 00 00 00 00 00 00 00 00 0c 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 Reading 24 hours after application. 5 24 120 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 6 24 4P 00 00 00 00 00 00 00 00 0 0 00 00 D 00 00 0 0 00 00 0u 00 0 0 0 0 7 24 72 00 00 00 00 00 00 00 00 00 00 00 00 D 00 00 00 00 00 00 00 00 00 00 00 0 8 24 48 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00 D 00 00 00 00 00 00 00 00 0 9 24 48 00 00 00 00 00 00 00 00 00 00 00 00 D 00 00 DD 00 0 00 00 00 00 00 000 Challenge original Virgin fite Site 2i_i 24 48 00 00 00 00 00 00 0c 00 00 00 00 00 DD 00 00 DD 00 00 00 00 00 00 00 00 00 72 120 Reading 72 hauls after S o i s a n S f * ^ 011 Ut jUSt befre neXt *litii. Reading 120 hours a f t e / p r e v i o S s bfore nexfc application. Missed reading. PP lon but ]Ust before next application due to the 4th of July holidays. next scheduled^pplication^ay^and t h e ^ a t c h ^ e ^ ' peronal reasns. Panelist was patched on the Discontinued from the study for persona^reasons*163 extended untl1 9 induction applications were applied. DuPont HL0 447-95 Company Sanitized. Does not contain TSCA CBI Project Number: 95 B2C.7II E.I. du Pont de Nemours & Company - H-21273,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers m Table l Individual Panelist Data Panelist l Number 24 48 2 24 72 3 24 48 4: 24 48 Induction Phase 56 24 120 24 48 7 24 72 8 24 48 9 24 48 10** 24 72 Challenge Original Virgin Site Site 3.4.48 aunt 101 00 00 00 00 00 00 00 00 00 00 00 102 00 00 00 00 00 00 00 00 00 00 00 103 00 00 0D nD DD DD DD DD DD DD DD 104 00 00 00 0D DD DD DD DD DD DD DD 105 DD DD DD DD DD DD DD DD DD DD DD 106 00 00 00 00 00 00 00 00 0- 00 00 107 00 00 00 00 00 00 00 00 00 00 00 10S 00 00 00 00 00 -0 00 00 00 00 00 109 00 00 00 00 00 00 00 00 00 00 00 110 00 00 00 00 00 00 00 00 00 00 00 111 00 00 00 00 00 00 00 00 00 00 00 112 113 00 0 _* O' 0 -0 00 00 00 00 00 00 00 00 00 00 00 00 00 -0 00 00 00 00 00 114 00 00 00 00 00 00 00 00 00 00 00 115 00 0 00 00 00 00 00 00 00 00 00 116 00 00 00 00 00 00 00 00 00 00 00 117 00 00 00 00 00 00 00 00 00 00 00 118 00 00 00 00 00 00 00 00 00 00 00 119 00 00 00 00 00 00 00 00 00 00 00 120 00 00 00 00 00 00 00 00 00 00 00 o121 00 00 00 00 0 -* -0 00 00 00 00 00 00 122 00 00 00 00 0 -* -0 0 00 00 0 0 00 00 24 = 48 = 72 as 120 -- ** ** ss Ds 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 appliclation. Reading 120 hours aftei: previous application but just before next. application due to the 4th of July holidays. Missed reading Panelist missed the scheduled patch application for personal reasons . Panelist was patched on the next scheduled application day, and the patch series extended until 9 induction applications were applied1. Make--up patch application. Discontinued from the study foi personal reasons. DuPont HLO 447-95 C o m p a n y S a n itiz e d . D o e s n o t c o n ta in T S C A CBS Project Number: 95-8267H E.I. du Pont de Nemours & Company - H-21273,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 2 - Summary of Data 1 3-4..48 Total Panelists : 122 122 Grade 2 24 72 122 122 3 24 48 122 122 4 24 48 122 122 Induction Phase 5 24 120 6 24 48 122 122 122 122 7 24 72 122 122 l|i1fCeD CD 24 122 122 9 l i 48 122 122 0 118 116 116 118 116 115 115 116 116 114 110 115 115 113 110 110 108 108 00 00 00 00 00 00 00 00 00 1+ 00 00 01 00 00 00 00 00 00 2+ 00 00 00 00 00 00 00 00 00 3+ 00 00 00 00 00 00 00 00 00 4+ 00 00 00 00 00 00 00 00 00 - 02 20 21 20 02 60 00 21 33 D 44 44 45 56 66 67 7 9 10 11 11 11 10** 24 72 44 43 00 00 00 00 00 00 01 Challenge Original Virgin Site site a * ..i P 24 48 122 122 122 :L22 109 109 00 00 00 00 00 109 109 00 00 00 00 00 11 12 12 11 12 12 24 48 72 120 = a ** = o 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. Missed3readigUrS previous ^Plication but just before next application due to the 4th of July holidays. Make-up patch application. Discontinued from the study for personal reasons. DuPont HLQ 447-95 Company Sanitized. Does not contain TSCA CBf Project Number: 95-8267H E.I. du Pont de Nemours & rompany II 21274,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 3 - Individual Panelist Data Panelist Number 1 2 3 4 5 6 7 8 19 ^ 10 ' 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 1 24 48 00 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 c0 00 00 DD 2 24 72 00 00 00 00 00 00 0c 00 00 00 00 00 0 0 DD 00 00 00 00 00 00 00 00 00 00 DD 3 24 48 00 00 00 00 00 0 -* 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 4 24 48 00 00 00 00 00 -0 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD Induction Phase 56 24 120 24 48 00 00 00 00 00 c7 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 00 0 00 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 72 00 00 00 00 00 0D 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD B 24 48 00 00 00 00 0 ~* DD 00 00 00 00 00 00 00 b 00 00 00 00 00 00 00 00 00 00 DD 9 24 dll 00 00 00 00 -0 DD 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 10** 24 72 0D Challenge Original Virgin Site Site 2 -4 I 2 -JI 00 00 00 00 DD DD 00 00 00 00 00 00 (a) 0 - DD 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 DD D 00 00 00 00 00 00 (a)0 DD 00 00 00 00 00 00 00 00 00 00 DD 24 48 72 120 *S ** 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 of July holidays. Missed reading, (a) Challenge patches applied one day late due to an emergency th* schedul*d Patc* 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. Discontinued from the study for personal reasons. DuPont HLO 447-95 Company SanBfced. Does noi coniato TSCA CBI Project Number: 95-8267H E.I. du Pont dw Nemouia u Company - H 21274,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 3 - Individual Panelist Data (continued) Panelist Humber 26 27 28 29 30 31 32 33 ^K3 3I 5t 1 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 1 24 48 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 2 24 72 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 DD 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 DD 00 00 -0 00 00 00 00 00 00 4 24 48 00 00 00 00 00 0a 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 Induction Phase 56 24 120 24 48 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 0 00 00 00 00 00 DD 00 00 00 00 00 00 c0 00 00 7 24 72 00 00 00 00 00 00 00 0 00 00 00 00 00 00 00 DD 00 00 00 00 00 00 00 0D 00 8 24 48 00 00 00 00 00 00 00 00 00 0D 00 00 00 00 00 DD 00 00 -0 00 00 00 00 DD 00 9 24 48 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 DD 00 00 00 00 00 00 00 DD 00 SbaAAfflmw Original Virgin Site Site m .n 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 DD 00 00 -0 00 00 00 00 DD 00 00 00 00 00 00 00 00 00 00 DD 00 00 00 00 00 DD 00 00 -0 00 00 00 00 DD 00 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 previous application but just before next application due to the 4th of July holidays, s Missed reading. D - Discontinued from the study for personal reasons. DuPont HLO 447-95 Company Sanitized. Does not contain TSCA CBI Project Numtifi; 95 H20711 J E.I. du Pont de Nemours & Company - H-21274,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 3 - Individual Panelist Data Panelist Number 51 52 53 54 55 56 57 58 Ns3 59 U 60 61 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 2 24 72 00 00 00 00 00 00 00 00 00 00 00 00 0- 0 00 00 00 00 00 00 00 00 00 00 00 00 3 24 4B 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 4 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 0 0 Indi 'tien Phase c> 24 120 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 00 00 7 24 72 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 8 24 48 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 0 00 00 00 00 00 00 00 9 24 48 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 Sfrallengg Original Virgin Site Site 24 48 2 i_ ii 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 24 Reading 24 hours after application. 48 Reading 48 hours after previous application but just before next application 72 120 Reaning 72 hours after previous application but just before next application Reading 1 20 hours after previous application b u t Missed reading. ju st b e fo re next application due to the 4th of July holidays. DuPont HLQ 447*95 Company Sanitized. Does not contain TSCA CBI w Project Number; 95-82C7H E.I. du Pont de Nemours U Company - H-21274,as supplied. Modified Draize Repeated Insult Patch Test Study in Human Volunteers Table 3 Individual Panelist Data Panelist Number 76 77 78 79 80 81 82 83 84 i M 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 1 24 48 2 24 72 00 00 00 0G 00 00 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 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 0. 0 00 00 00 00 00 00 -0 00 4 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 Induction Phase o 24 120 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 0 G0 00 -D 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 DD 00 00 00 00 00 00 00 00 00 p0 00 00 24 48 00 00 0 .0 00 00 00 00 00 00 00 00 00 DD 00 00 DD 00 00 00 00 00 00 00 00 00 24 48 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00 DD 00 000 00 00 00 00 0 00 Challenge Original Virgin Site Site 24 48 21.11 00 00 00 00 00 00 00 00 00 00 00 00 DD 00 00 DD 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 00 00 00 00 00 00 00 24 = Reading 24 hours after application. 46 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 previous application but ~ust before next application due to the 4th of July noiioays = Missed reading. * = Panelist missed the scheduled patch application for personal reasons. Panelist was patched on the next scheduled application day, and the patch series extended until 9 induction applications were applied. D = Discontinued from the study for personal reasons. DuPont HLO Company Sanitized. Does not contain TSCA CBI Project Number: 95-8267H E.X. du Pont de Nemouta u Company H ;u::74,afj supplied. Modified Draize Repeated Insult Patch Test study in Human Volunteers Table 3 - Individual Panelist Data Induction Phase Panelist 1 2-tJ.g 2 24 72 3 24 48 4 24 48 5 24 120 24 48 7 24 72 8 24 48 9 24 48 10** M.__ 72 O rig in al S ite 24 48 101 102 103 104 105 106 107 t-Io 108 109 i 110 111 112 113 114 115 116 117 118 119 120 121 122 oo 00 00 00 DD 00 00 00 00 00 00 00 0 -* 00 00 00 00 00 00 00 00 00 0 0 0 0 D 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 00 0D 00 DD 00 00 00 00 00 00 00 00 00 00 00 00 00 DD 0D DD 00 0 0 0 0 0 0 3 0 0 00 00 00 00 00 00 00 DD DD DD 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 00 DD DD DD 00 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 00 00 DD DD D 0 00 00 00 00 00 00 DD DD DD 0 00 00 00 00 00 00 00 00 DD DD DD 0 00 00 00 00 00 00 0 00 00 00 00 00 00 00 00 00 0 0 00 00 DD DD DD 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 00 24 Reading 24 hours after application. 48 72 Readina ll our pr6V*OUS aPPlition but just before next application. 120 22}" u af*er Previ?us application but just before next application. Mised9readigUrS ***** previous application but just before next application due to the 4th of July holiday. neit'scLSuiefapSncaS'd^i^ peraondl ieaao"s - d e l i s t was patched on the ** Make-up patch application. d th PtCh series extended until 9 induction applications w e re applied. D Discontinued from the study for personal reasons. DuPont HU) 447-95 Company Sanitized. Does not contain TSCA CB1 Project Number: 95-8267H E.I. du Pont de Nemours & Company - H - 21274,as supplied. Modified Draize Repeated Insult Patch Test Study in Human " ,lunteers Table 4 - Summary of Data Induction Phase 1 24 48 Total Panelists : 122 122 Grade 2 24 72 3 24 48 122 122 122 122 4 24 48 122 122 5 24 120 122 122 6 24 48 122 122 7 24 72 122 122 8 24 48 122 .122 9 24 48 122 122 0 118 116 116 118 116 116 115 116 116 114 110 115 115 113 110 110 108 108 + 00 00 00 00 00 00 00 00 00 1+ 00 00 00 00 00 00 00 00 00 2+ 00 00 00 00 00 00 00 00 00 3+ 00 00 00 00 00 00 00 00 00 44- 00 00 00 00 00 00 00 00 00 - 02 20 21 20 02 60 00 21 33 D 44 44 45 56 66 67 7 9 10 11 11 11 10** 24 72 44 43 00 00 00 00 00 01 00 Challenge Original Site Virgin Site auw 2LM. 122 122 122 122 109 109 00 00 00 00 00 109 109 00 00 00 00 00 11 12 12 11 12 12 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 Missed9readigUrS previous apP lication but 3UBt before next application due to the 4th of July holidays. ** Make-up patch application. D Discontinued from the study for personal reasons. DuPont HU) 447-95 Company Sanitized. Does not contain TSCA CB1 Project Number: 95-8267H DuPont HLO 447-95 APPENDIX III PANELIST LIST -27- BiOSEARCH. INCORPORATED - P O BOX 8598 - PHILADELPHIA. Compar^^anitizec.9foes not contain TSCA CBI Project Number: 95-8267H E .I. Du Pont De Nem o, s Sc Company Modified Draize Repeated Insult Patch Test Study in Human Volunteers Appendix III Panelist Number Initials PANELIST LIST Age Occupation Allergies 1 C.C. 49 Homemaker - 2 G.F. 34 Homemaker - 3 D.L. 28 Homemaker * 4 j.M . 5 S.E.A. 6 T.S. 7 P.H. 37 Homemaker 29 Homemaker 39 Homemaker 58 Homemaker Hayfever, Pollen . 8 A.W.N. 47 Processor - 9 M.S. 10 M.C. 37 Homemaker 48 Homemaker - 11 M.M. 48 Driver Hay fever. Tomatoes 12 F.P.M. 53 Unemployed - 13 R.A.R. 14 A.L. 54 Pastor/Minister 19 Student - 15 K.C. 16 S.S. 17 L.S. 46 Teacher's Aide 58 Homemaker 58 Retired Dust - 18 K.G. 43 Homemaker Penicillin 19 M.S. 29 Unemployed - 20 M.S. 50 Homemaker - 21 L.O. 22 E.W. 39 Homemaker 64 Stock Girl Cats - 23 j.C .C 24 Student - 24 P.M. 32 Homemaker - 25 K.S.B. 26 P.J. 27 B.V. 28 T.P. 29 M.W. 19 Student 48 Homemaker 26 Homemaker 39 Clerk 39 Homemaker - ' 30 J.K. 31 E.A.H. 62 Handyman 47 Homemaker - 32 A.R. 42 Unemployed - 33 J.S. 34 P.P. 59 Retired 31 Homemaker - - 35 M.C. 36 J-J-H. 37 S.B. 38 j.N . 39 B.M. 40 C.M. 41 J.M. 42 B.G. 32 Unemployed - 62 Ambul.Drivcr - 57 Homemaker - 18 Student Penicillin 67 Retired - 29 Homemaker ,- 42 Homemaker Penicillin 43 Homemaker - 43 L.D. 40 Homemaker 44 R.B. 45 E.S. 18 Student 34 Homemaker - 46 F.V . 58 Homemaker 47 v'.P. 34 Homemaker - 48 L.T. 35 Homemaker - 49 P.A. 34 Unemployed * ! 50 M.W. 66 Homemaker - 51 P.M. 55 Food Service 52 G.l. 38 Unemployed i 53 B.H. 40 Homemaker - 9 k 54 J.R. 22 Unemployed Hayfever liil -28BIOSEARCH. INCORPORATED - P.O. BOX 8598 - PHILADELPHIA. PENNSYLVANIA 19101 Company Sanitized. Does not contain TSCA CBI Project Number: 95-8267H E. I. Du Pont De Nem ours & Company Appendix III Modified Draize Repeated Insult Patch Test Study in Human Volunteers Panelist Number *5 06 *7 58 59 60 61 62 63 64 6? 66 67 68 69 70 71 72 /3 73 /.-* 76 77 /8 79 80 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 Initials M.H. T.W. M.S. G.E.S. c.s. M.S. PIK.P. L.O. K.M.D. S.R. L.L.D. A.L.L. D.E. C.C. M.C. T.:a . MM. HR. B.E. MC. 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. J.F. M.A. L:D. E.R. M.D. M.F M.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.S. RS. E.S. D.B. PANELIST MST Age 40 45 55 29 45 20 38 55 35 54 31 47 51 39 22 52 67 53 23 47 29 52 44 43 40 31 48 16 61 27 41 36 68 41 67 28 27 23 43 26 47 63 34 52 48 23 32 44 34 37 18 41 22 22 Occupation Homemaker Forklift Driver Homemaker Unemployed Pretzel Twister Homemaker Homemaker Retired/Homemak Homemaker Homemaker Homemaker Acme (Clerk) Homemaker Homemaker Student Homemaker Retired Homemaker Homemaker Crossing Guard Homemaker Homemaker Homemaker Homemaker Homemaker Homemaker Unemployed Bus Attendent Unemployed Homemaker Homemaker Homemaker Homemaker Umemploycd Homemaker Crossing Guard Homemaker Student Data Entry Homemaker Unemployed Homemaker Homemaker Homemaker Machine Opcr. Homemaker Homemaker Painter Homemaker Homemaker Student Homemaker Homemaker Factory Allergies Hayfever.Grass Ragweed, Pollen Penicillin Codeine Hav lever, Dust, Fish, Nickel Hayfever, _ Sheil fish .. . Blucfish _ .Penicillin . . _ Cat Hair -29BIOSEARCH, INCORPORATED - P O. BOX 8598 - PHILADELPHIA. PI.NNSYL Company Sanitized. Does not oonfain TSCACBl Project Number: 95-8267H E.I. Du Pont De Nemours & Company Modified Draize Repeated Insult Patch Test Study in Human Volunteers Appendix DI Panelist Vumber 109 110 111 112 113 114 115 116 117 118 19 120 121 122 Initials M.F. 5.F. C.L.S. M.S. AG. B.B. E.P. M.F. L.V L.B. M.7. P.W. D.R L.B. PANELIST LIST Age Occupation Allergies 25 Homemaker 23 Student 24 Homemaker 19 Student 63 Homemaker 37 Homemaker 37 Factory Worker 43 Homemaker 33 Homemaker 49 Homemaker 39 Homemaker 44 Homemaker 48 Secretary 1- Homemaker - - - - - - - -30- BIOSEARCH. INCORPORATED - P O BOX 8598 - PHILADELPHIA, PENNSYLVANIA 19101 Company Sanitized. Does not contain TSCA CBS Project Number: 95-8267H DuPont HLO 447-95 ! APPENDIX I\' GRADING SCALE -31- IMOSLARCH. LNCORrORAl LD - r O BOX 8598 - PHILADELPHIA, PENNSYLVANIA 1 9 1 .1 Company Sanitized. Does not contain tsC A CBI Project Number: 95-8267H E.I. du Pont 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 0 -- 1T. 3 4- Interpreta tion n ve suspicious flight erythema well defined erythema ery thema 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 allerg}- 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 f a t i g u e T h i s 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 TOXICITY, p.46-53. Topeka, Kansas: Association of Food and Drug Officials of the United States. .i -32- BIOSLARCH, INCORPORA I h D - P O BOX 8598 PHi!-ADK1.PHIA. PENNSYLVANIA 19101 " Company Sanitized. Does not contain TSCA CB]
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