Document np6NE1E6Vxre5Vzmgdp80QZJ8

,January 31 1958 Mr. R. L. Reynolds Solvay Process Division Allied Chemical & Dye Corporation 6l Broadway New York C, New York Dear Mr. Reynolds: Enclosed please find report of our Repeated Insult Patch Test Study with two materials as authorized in your Purchase Order #ES-15-^57-D, dated November l4, 1957* The two materials studied were; 1. Allied Chemical & Dye Corporation - Methylene Chloride 2. Allied Chemical & Dye Corporation - Hair Spray Concentrate The above materials were studied on fifty human volunteers according to the method of Shelanski and Shelanski (Proceedings Of The Toilet Goods Association, Number 19, May, 1953). The Methylene Chloride, supplied as a liquid, was applied directly to the patch. The hair spray concentrate was sprayed directly on to the patches until saturation. During the course of this study none of the subjects reacted at any time to either material. From these results we may conclude that Allied Chemical & Dye Corporation - Methylene Chloride and the hair spray concentrate are neither primary Irritants nor fatiguing agents. We may also conclude with 95# certainty that these materials, if they are sensitizers at all, will be sensitizers to less than 6# of the consumer population. It Is not possible to obtain more significant results with the use of only fifty subjects. If there are any questions concerning this report please let me know and I will be glad to discuss them with you. Thank you for this opportunity of being of service to you. Sincerely, INDUSTRIAL BIOLOGY RESEARCH AND TESTING LABORATORIES, INC. MVS/Id Enc. Morris V. Shelanski, M.D., C.M. Director AS I 000015832 REPEATEDINSULT PATCH TEST WITH ALLIED CHEMICAL & DYE CORPORATION - METHYLENE CHLORIDE ALLIED CHEMICAL & DYE CORPORATION-HAIR SPRAY CONCENTRATE Purpose: To determine the safety of use of Allied Chemical & Dye Corporation - Methylene Chloride and Allied Chemical & Dye Corporation - Hair Spray Concentrate when In contact with the human skin according to the Shelanski Repeated Insult Patch Test Method. Materials: 1. Allied Chemical & Dye Corporation - Methylene Chloride. 2. Allied Chemical & Dye Corporation - Hair Spray Concentrate. Procedure: Patch tests were conducted on fifty human volunteers according to the method of Shelanski and Shelanski (Proceedings Of The Toilet Goods Association, Number 19, May, 1953) . The Methylene Chloride, supplied as a liquid, was applied directly to the patch. The Hair Spray Concentrate was sprayed directly on to the patch until the same degree cf saturation of the patch was attained as with the Methylene Chloride. Results: The accompanying charts show the various reactions after each application. Conclusions: Allied Chemical & Dye Corporation-Methylene Chloride This material In contact with the human skin Is neither a primary irritant nor a sensitizer. It is not a fatiguing agent. It may be considered safe to use in contact with the human skin according to the directions of the manufacturer. Hair Spray Concentrate 00015833 This material in contact with the human skin is neither a primary Irritant nor a sensitizer. It is not a fatiguing agent. It may be considered safe to use in contact with the human skin according to the directions of the manufacturer. Page 1 (Continued) Conclusions: (Continued from Page 1) In using fifty human subjects for these tests we can state with 95# statistical certainty that the material tested will be a sensitizer to less than 6# of the consumer population Inasmuch as none of the fifty subjects showed any sensitizing reactions. MVS:Id INDUSTRIAL BIOLOGY RESEARCH AND TESTING LABORATORIES,INC (Signed) MORRIS V. SHELANSKI,M.D.,C.M Director January 31, 1958 Page 2 KEPEATED INSULT PATCH TEST KITH ALUED CHEMICAL AND DYE CQHPOKATIOW - METHYLENE CHLOKTDE t oooo15833 ALLIED CHEMICAL AND DYE COKPCKATION - METHYLENE CHLCHIDK No. j 2 3 4 5 6 7 8 __ 9 iQ i; i2__ i3 j4 .5___ C 26 0 0 0 o 0 0 0 0 0 0 0 0 0 G G 0 27 0 0 G 0 0 0 0 o 0 0 0 0 0 0 0 0 23 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 29 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 30 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 u o 0 0 0 0 0 0 32 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 33 0 0 0 G 0 0 0 0 0 0 0 0 0 0 0 0 34 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 35 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 J6 0 0 0 o 0 0 0 0 0 0 0 0 0 0 0 0 37 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 38 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 30 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 40 0 0 0 o 0 0 0 0 0 0 0 0 0 0 0 0 -il 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 45 0 0 0 0 0 u 0 0 0 o 0 0 0 0 0 0 44 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 45 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 46 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 47 0 0 0 o 0 0 0 0 0 0 0 0 0 0 0 0 48 0 0 0 o 0 0 0 0 0 0 0 0 0 0 0 0 49 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 50 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 ASI 000015836 'I No. of bubjects showing reactions Number of Application 1 2 3 4 S 6 7 8 9 10 11 12 13 14 IS Sub Total Challenge TOTAL 0 50 50 50 SO 50 50 50 50 50 50 50 50 50 50 50 750 60 800 1+ 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 o 2+ G 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3f 0 0 0 0 0 0 0 0 0 0 0 G 0 0 0 0 0 0 AS I 000015837 No. of subject* negative throughout No. of subjects showing reactions Number of Application l 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Sub Total Challenge TOTAL 0 50 50 50 50 50 50 50 50 50 50 50 50 50 50 50 750 60 800 1+ 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 50 o 2+ 0 0 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 0 0 AS I 000015840