Document 101EM8K7462LvqdRNQmJEXKGK

V HLOtlSS-^^' Report To E. I. duPont deNemours and Company On The Contact Sensitizing Potential of Paint Samples 2 and 7 5935 - Enamel, White, Polyurethane 9350-350 5936 - Activator 9350-35C 5937 - Promotor 9350-35c 5948-----Enamel* White 183-508 5949 - Thinner. .3810 Submitted By Albert M. Kligman, M. D. Ivy Research Laboratories, Inc. "T1 Philadelphia, Pennsylvania 19101 ca.&.^.SYoWS-......... Unonou- C#r 3 4. Pus. Co^l S "3.0. Anr5 fe-ll.xf?. fttOTyiaii - P ip - C11-5-fcFJ. vvr v -a z ia . . ' DECEIVED. jar i HAStCai LABORATORr STUDY SYNOPSIS OBJECTIVE To evaluate the contact sensitizing potentialities of two paints. MATERIALS The two experimental paints were supplied by die Haskell Laboratories of the E. I. duPont deNemours and Company and were identified as follows: Sample 2 Part A Part B Part C H-5935 H-5936 H-59.37 Sample 7 Part A Part B H-5948 H-5949 SUBJECTS Twenty-five healthy adult males were utilized. METHOD The experimental paints were mixed according to the protocol directions two hours before application each day. The experimental paints were applied to one-inch square skin sites on the volar forearms of all subjects for a total of fifteen applications on alternate days. A cotton tipped applicator was used to apply the paint. Before each new application the dried paints were removed by peeling. Following a two-week rest period the paints were applied to new skin sites and evaluated twenty-four and forty-eight hours later. DUP040000882 RESULTS The results are recorded in the accompanying tables. No subject presented signs of having become sensitized. Daring induction some mild irritation was noted, usually erythema and slight glazing. Removing the paint each time may have contributed to this slight non-allergic inflammation. None of the subjects reported any itching, burning or other subjective symptoms associated with contact allergy. CONCLUSIONS Neither paint sample 2 or 7 induced any cases of contact sensitization. The contact sensitization capacity of these paints is very low and not likely to be a significant hazard under conditions of actual use. Respectfully submitted, - 2- DUP040000883 E. I. duPont deNemours and Company Contact Sensitizing Potential of Paint Samples - Subject Data - je< Initials Age Weight Race 1 A.H. 45 195 2 H. 0. 31 170 3 J. W. 37 167 4 R. C. 23 150 5 Y. B. . ... 26 175 6 G.W. 48 165 7 H. CD 35 192 8 W.B. 30 178 9 S. V, 33 208 10 J. R. 28 159 11 B. H. 23 150 12 E. A, 48 175 13 H.M. 28 149 14 R. B. 34 145 15 B.T, 21 172 16 W.W. 47 180 17 C.E. 35 160 18 P. M. 32 165 N W W W N w N W N N W N N N N 1ST N N DUP040000884 E. I. duPont deNemours and Company Contact Sensitizing Potential of Paint Samples - Subject Data *- Subject No. Initials 19 W. A. 20 C. B. 21 W.H. 22 B. G. 23 P. S. 24 w.c. 25 G. M. Age 33 44 33 43 29 24 33 Weight 157 185 160 170 160 159 180 Race N N N P.R, N N N DUP040000885 PAINT SAMPLE 2 PAINT SAMPLE PAINT SAMPLE PAINT SAMPLE si 4o-> s<D m DUP040000839 w or 55 H co A *# .-. o o o o a.. _ <1 . w ># o 05 o o o o o o o -f + .: V+ lO o . ,; _ O1 O. V - * :v -+ o'.f o - V'" C: :) -+ o. ' `o :;; '1 '-f- .-'.. 4- ; `4* CO o ' P rH o - - - pp:'r + CQ , o ;' 4- ... ' -~-------- rrl ... ' . 4; "f r'` PAINT SAMPLE r** + 4- fcr r- . o: " '". . - !>' 'J` 'l-.* '..~s O r-i p O - + " ., ,,! . P"-' ' . v. ' . .+ , '+ Eh a> . ; - o . . - :;r, . + Q p o " 4: . Q o o o+ O/v O' O o oo 4 o o ( ^ ^_ . Q Ol O .. .O ' 2PS o02 ' Q co O O . : O O . .. O. .. . . .. . ..... 4a<-D> ca co *t< ia . . . t- .. oo r--) 1 DUP040000890 PAINT SAMPLE 7 K E Y- INDUCTION: 0 0+ I. 2 3 4 No reaction Faint erythema Brisk erythema Brisk erythema peeling Erosion Ulceration CHALLENGE: 0 1 2 3 4 No reaction Erythema edema Erythema edema vesicles Erythema edema spreading tiered vesicles Tiered weeping vesicles DUP040000892