Document jBp5E9VmzRJYZanxbwgjwGrpO

^3 * Report To E. I. DuPONT D eNEMOURS rR-uia.-! ^XA.ZfrtP, (S.'S. 9^, &.1.OeStfliJcc-, Vt. CJHHt C.K1W.V . FUortzo, VT- CJl ij ^C (.P'iASJ 3) ^flsowJL Xft&Ccf?'! 4 *Kii CsH S-w) U-H fftM'iAGr- nBWHftU. w) vs. . .01 ^ VF r The Irritancy and Sensitization Potential of paint components #6237 fc #6238 Submitted By Ivy Research Laboratories Inc. t Philadelphia., Pennsylvania 19101 r y Wr ^k u l OBJECTIVE: STUDY SYNOPSIS To evaluate the hazard potential of an experimental enamel consisting of two parts, #6237 and #6238, SUBJECTS: Forty adult male subjects started the test. Twenty-nine completed the study and eleven subjects did not complete it due to unrelated reasons. MATERIALS: The experimental enamel Was supplied by the Haskell Laboratories of the E. I. DuPont DeNemours & Company and was identified as follows: Part - A - #6237 Part - B - #6238 METHOD: The experimental enamel Was applied to one inch skin sites on Hie volar forearms of all subjects for a total of fifteen applications on alternate days. Before each new application, the dried paint was removed by peeling. Two weeks after the last induction application, the paint was applied to a new skin site and evaluated twenty-four and forty-eight hours later. RESULTS: The results are recorded in the accompanying table. No subject exhibited signs of contact allergy. During Induction, some slight cases of irritation were noted usually slight erythema or mild glazing. Removing the paint each time may have contributed to this slight non-allergic inflammation. There were no reports of itching, burning. Or other subjective symptoms associated With contact allergy. DUP040000872 CONCLUSIONS: This two component experimental enamel did not induce any eases of contact sensitization. The contact sensitization capacity of this paint is very low and not likely to be a significant hazard in actual use. DUP040000873 Subject No. 1 2 3 4 5 6 7 8 9 10 11 .12 13 14 15 16 17 18 19 20 SUBJECT DATA Initials W.M. N. S. J. C. A. M. J. J. W. Mi 0. M, C. J. M.P. F. L. B. T. W.R. W. J. j. McN. J. M. A. G. W. B. J. S. R.A. D. T. Age 21 33 44 33 25 28 30 21 43 51 27 21 31 28 40 37 22 26 25 48 Weight 165 190 220 150 137 165 176 181 140 200 165 170 181 160 195 167 175 200 180 186 Race N N N N W N N N. .N N N W N N N N ' - N N N N DUP040000874 1 -i Subject No, 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 SUBJECT DATA Initials Age Weight R. P. 23 170 T. B, 27 185 W.B. 24 150 L. J. 34 190 C, L. 36 177 A. A, 40 170 J, W. 25 165 J. M. 30 180 R.G. 31 195 B. S. 29 165 P.W. 25 168 G. M. 21 210 R. G. 36 167 W.A. 44 158 S. V. 38 171 B.H. 23 165 C.E. 29 195 E. A, 40 200 R. B. 21 139 J. J. 26 163 Race N N ,N N N N N N* N N N N N N N N N N N N DUP040000875 KEY INDUCTION 0 No Reaction 0 Faint Erythema 1 Brisk erythema 2 3 Erosion 4 Ulceration CHALLENGE 0 No Reaction 1 Erythema, Edema 2 Erythema, Edema, vesicules 3 Erythema, Edema, tired vesicules 4 Erythema, Edema, tired weeping vesicules DUP040000876 TABLE I Induction Exposures Subject No. r 2 3 4 5 6 7 8 9 10 11 12 ' 13 14 15 1 2 3 4 5....... 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 00 0 0 0 0+ 0+ 0+ 0+ 0+ 0+ 0 + 0+ 0+ 0+ 000 0 0 0 0 0 0+ 0+ 0+ 0+ 0+ 04- 0+ 000 000 000 000 0000 0 0 0+ 0+ 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+ 0+ 0 + 0+ 0+ 0+ 0+ 0+ 0+ 0+ 0+ 0+ 0+ 0 + 0 + 000 d is c h a r g e d *- 000 000 000 0 0 0 0+ 0+ 0+ 0+ 0 + 0+ 0 0 0 0 0+ 0+ 0+ 0+ 0+ 0 0 0+ 0+ 0+ 0+ 0 + 0 + 0+ 0 + 0 + 0+ 0 + 0+ 0 + 0+ 1 1 o00 0 0 0 0 0*t 0+ 0+ 0 + 0+ 0+ 0+ 04- 000 00 DISC HARGE d 000 0 0 0 0 0 0+ 0+ 0+ 0+ 0+ 0+ 0+ 000 0000 0 DISCHARGED 00 0 00 0 00 0 00 000 0000 0000 00 00 0 0 0 0 0 + 0+ 0+ 0+ 0+ 0+ 0 4* 04- 0 0 0 o 0 00 00 0 0 0 0 0 0 00 00 0 0 0 0 0+ 0+ 0+ 04" 0 + 0 + 0+ 0 DISCHARGED 0 + 0+ 0+ DUP040000877 TABLE I Induction Exposures Subject Ho. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 __ 15 21 22 23 24 25 26 27 28 29 30 31 32 33 .. 34 . 35 36 37 38 39 40 0 0 0 0 0 0 0 0 04- D I iE C H A R G E D 0 0 0 0 0 0 0 0+ 0+ 04- 0+ 0-f 0 + 04- 04- 0 0 0 0 0 00 0 0 0 000 00 0 0 0 0 0 0 0+ 0+ 04- 0+ 04- 04- 04- 04- 04- 0 0 DISCHARGED 0 0 0 0 0 0 0 0 0 04- 0-f 04- 04- 04- 04- 0 0 0 d is c h ar g e d 0 0 0 0 0 0 0 0 + 04- 04- 04- 04- 04- 04- o-t0 00 0 0 00 0 00 0 0 0 0 0 0 0 0 0 0 0 0 0 04- 0+ 04- 04- 0-i- 04- 04- 0 0 0 0 0+ 0+ 0+ 04- 04- 04- 04- 04- 04- 04- 04- 0 0 0 00 0 0 0 0+ 04- :.0 + 0+ 04- 04- 04- 0 0 000 0 09-+ (04- 04- 0-f 04- 04- 04- 04- 1 0 0 000 0+ 0 + 0+ DISCHARGED 0 0 000 0 0 0+ 0+ 0 + 04- 04- 04- 04- 04- 0 0 0 DISCHARGED 0 0 000 0 0 04- 0-f 04- 04- 0+ 04- 04- 04- 0 0 0 0 0+ 0+ 0+ 04- 04- 0 + 04- 04- 04- 04- 0 + 0 0 0 0 0+ 0 + 0+ 04- 0+ 04- 04- 04- 04- 04- 04- 0 0 0 0 0 + 0+ 0+ 0-f 04- 04- 04- 04- 04- *Oh 0 + DUP040000878 Subject No 1 2 3 4 '"S'" 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 TABLE n Schedule of Challenges 24 Hours 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 48 Hours 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 DUP040000879 Subject No. 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 TABLE n Schedule of Challenges 24 Hours 48 Hours 00 00 00 DISCHARGED 0 0 0 0 0 0 0 0 0 DISC HA R G E D 0 0 0 0 0 DUP040000880