EVALUATION OF SUNSCREENING AGENT 101 Table III Results Subject Number Initials Stripped Skin Study Day 1 2 3 4 5 6 7 8 9 10 1 K.C. 2 L.L. 3 M.W. 4 G.I. 5 L.C. 6 M.R. 7 C.O. 8 E.S. 9 l.c. lO J.R. 0 0 0 0 i 0 0 0 0 0 0 0 i i i 0 0 0 0 0 0 i i 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 i i 0 0 0 0 0 0 0 0 0 i i 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 I I I 0 0 0 0 0 0 0 i I 0 0 0 0 0 'Material: 5 per cent Amerscreen P lotion. Table IV Irritancy Subtotal Inunction for 21 days Subject Day Number Numbers Initials i 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 L.L. 0 0 1 0 0 1 0 0 1 0 0 0 1 1 0 0 0 1 1 0 0 E.S. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 T.S. 0 0 0 0 0 0 0 0 0 0 0 0 i 0 1 0 i i 0 i 0 M.M. 0 0 0 0 i 0 0 0 i 0 0 i 0 0 0 0 0 0 i 0 0 G.S. 0 0 0 0 0 0 i 0 0 0 0 0 0 0 i 0 0 0 0 I 0 J.C. 0 0 0 0 0 0 0 0 1 0 0 1 1 1 0 0 0 1 0 0 0 M.R. 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 1 C.O. 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 1 0 0 0 0 0 T.O. 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 0 1 0 J.D. 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 1 1 0 0 M.W. 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 K.G. 0 0 0 0 0 0 1 0 0 1 1 0 1 0 0 1 0 0 0 1 0 C.J. 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 L.C. 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 1 J.R. 0 0 0 0 0 1 0 0 0 0 1 0 1 0 0 1 0 0 0 0 0 R.J. 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 J.F. 0 0 0 0 0 0 0 0 0 I 0 0 0 0 0 0 0 0 0 0 1 L.I. 0 0 0 0 0 0 0 0 0 0 i 0 i 0 0 0 0 i i 0 0 R.H. 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1t.P. 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0

102 JOURNAL OF THE SOCIETY OF COSMETIC CHEMISTS Table V The Irritancy and Safety of Topically Applied 5 per cent Amerscreen 1 • Lotion DATE Subject # 1, LL. Hematology Hemoglobin-GM per cent 11.5-18.0 GM per cent Hematocrit-VOL per cent 34-52 per cent WBC/MM a 4,000-11,850 Platelets / MM a 150,000-475,000 / M M '• Reticulocytes-per cent 0.4-1.2 per cent Differential (per cent) Neutrophils (polys) 25-70 Lymphoeytes 21-56 Monoeytes 2-8 Eosinophils 0-7 B asophils 0-2 Bands 0-11 Urina]ysis S.C. 1.003-1.035 Albumin 30 MG per cent ( 1+) Sugar Negative (0.1 per cent) WBC/HPF 6 / HPF average RBC/HPF 3/HPF average Casts LPF 4/I, PF average Epith Bacteria Crystals Mucus Threads Chemistry Chosesterol MG per cent 260 MG per cent Bun MGM per cent 7-20 MG per cent Fbs MGM l•er cent 60-100 MG per cent Uric acid MGM per cent 3.0-7.0 MG per cent Sgot U 40 Sigma units Day 0 Day 9.9. 8-6-73 8-9.8-73 14.3 13.3 42 40 4,719 4,O49 Adequate Adequate 0.5 0.6 153 66 45 34 0 0 2 0 0 0 0 0 1.024 1.020 negative negative negative negative 4-8 2-3 0 0 0 0 few fexv 0 0 0 0 0 0 10 12 80 82 32 35 Pretesting-The 5 per cent propoxylated ethyl p-aminobenzoate lotion was pretested on 5 subjects in order to determine whether sodium lauryl su]fate pretreatment was required. A patch of the material was applied to normal sites on the backs for 48 hours under occlusion. No subject had any irritation and it was decided to use sodium ]aury] su]fate (SLS) pretreatment in the test. (5) Subtotal Topical Application, for Irritancy and Toxicity: Repeated massive application of 5 per cent propoxylated ethyl p-aminobenzoate lotion on 20 healthy adult male volunteers substantiates that propoxy]ated ethyl p- aminobenzoate has a very low level of irritancy and toxicity. The lotion was liberally applied to the entire area of the chest, back, shoulders, and face once