Document zQ7Qo5pE8YbN5XxakaqzKLxnz

UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE CINCINNATI 19, OHIO KETTERING LABORATORY OP APPLIED PHYSIOLOGY June ll|_, 1950 ' / /-A / a; c. CABLf ADDRESSt KETLAB. CINCINNATI TELEPHONE: UNIVERSITY 2663 Mr. Vm. E. McCormick B.F. Goodrich Company Dept, of Industri al Hygiene and Toxicology Akron, Ohio Dear Maci Enclosed find two copies of our report on VL-60O Resin. Sincerely yours. JFT:RT end. 20473001 BFG03607 The Immediate Toxicity of VL-600 Resin Scope The purpose of this investigation was to determine the immediate toxicity of a resin VL-600 when given orally to rabbits, dogs and a monkey. Conclusions 1. All animals survived without any untoward reactions when given a single oral dose of VL-600 resin. The highest dosages given to rabbits, dogs and a monkey were, respectively, 23,7 g,/kg,, 20.3 g./kg. and 5.95 g./kg. 2# A rabbit survived without any untoward reactions following the oral administration of 5 g. of the resin per kg. of body weight on each of 5 successive days, 3, A dog survived without any ill effects after having been given 2,3 g, of the resin per kg, of body weigjht on each of 6 successive days, if. When given in large doses, this material appears to be poorly absorbed and innocuous. BFG03608 20473002 -2 5. Postmortem examinations of the animals after administration of the resin orally, in single or repeated doses, revealed only minor and apparently irrelevant abnormalities in a few instances. Material Employed VL-&00 Resin is a copolymer of vinyl chloride and vinyldene chloride. It is Insoluble in water. The material employed was a hard, gritty "off-white" powder which was supplied as "spray dried VL-600 Latex," by the Avon Lake Experimental Station of the B.F. Goodrich Chemical Company. Experimental Methods Oral Administration to Rabbits. Because of the insolubility and grittiness of the material, even after being ground in a mortar, a weighed amount of the resin was placed in a large hypodermic syringe and shaken well with 1 per cent aqueous solution of methocel. The syringe was attached to a large catheter (Fl6 or F22) passed through the esophagus of the rabbit. Additional methocel was added to the syringe to wash all of the material into the stomach. BFG03609 20473003 -3- When 5.0 g. of the resin per kg. was given repetitively in 1 per cent methocel to a rabbit, an average of 23.5 ml. of suspension per kg. was given each day (range 21.8 to 2l|..7 ml. of suspension per kg*). Oral Admlnistrat1on to Dogs. The undiluted material was given to dogs in size 000 gelatin capsules by way of the esophagus, whether the material was given on one occasion or on several successive days. Oral Admlnistration to a Monkey. By similar means the undiluted material was given to a monkey in 28 size 0 gelatin capsules. Experimental Results Oral Administration of a Single Dose. The data presented in Table 1 show that 5 rabbits survived when dosages from 7*1 to 23.7 g. per kg. were given as a suspension in aqueous methocel. No significant alteration occurred in their weights (cf. Table l), and no signs of intoxication were apparent. The fecal matter contained considerable gritty material indicating that much of the material was unabsorbed. BFG03610 20473004 k- - Two dogs, given, respectively,. l8.1j. and 20.3 g. of VL-600 resin per kg. (19 and 26 capsules, respectively), survived without any untoward reactions or significant alterations in weight (cf. Table 1). A monkey survived without ill effects when given 5*95 g* Pr kg. (cf. Table 1). Nineteen and one-half hours after the dose had been given, objects that appeared to be the contents of 7 capsules were observed in the fecal matter, the gelatin container having been dissolved away leaving the contents apparently intact in their original shape. Two and three days, respectively, after the dose had been given, the contents of 8.5 and 6,5 capsules were found in similar condition in the feces. Thus 22 of the 28 capsules were evacuated without any obvious evidence of absorption. Postmortem examinations, including histo logic study of the tissues, revealed no lesions in these animals which appeared to have resulted from the administration of the resin. Certain abnormalities were present in occasional animals, and were regarded as evidences of unrelated spontaneous disease; thus. BFG03611 20473005 -5 - two rabbits (F30I4., P328) had slight evidences of degenerative changes in the myocardium, and one of these two (F320) also had slight parenchymatous degeneration of the renal convoluted tubules. In addition, the monkey had moderate fatty infiltra tion of the central zones of the liver lobules, and there was a single cyst (parasitic) of the liver. Repetitive Oral Administration. A rabbit showed no ill effects and survived following the oral administration of 5*0 grams of resin per kg. of body weight on each of 5 successive days (given in suspension in aqueous methocel (cf. Table 2). A rough inspection of the fecal matter revealed the presence of gritty material in amounts which did not appear to be equivalent to those administered. A dog survived when given 2.3 grams of the resin per kg. (5 capsules each day) on each of 6 successive days. Ten minutes after the administra tion of the first dose, 2 of the capsules were regurgi tated. Twenty-one hours after the administration of the 3rd dose (which consisted of 2^.9 g. of resin) 13.8 g. of the undissolved gritty particles, assumed to be BFG03612 20473006 6 the resin, were found In the feces. The day following the administration of the 4th dose (25*5 g. of resin) 21.9 g of similar material were found in the feces. There were no lesions in the viscera of the dog. The rabbit was found at autopsy to have coccidiosis of the liver, and microscopically there was moderate interstitial myocarditis. From the Kettering Laboratory in the Department of Preventive Medicine and Industrial Health, College of Medicine, University of Cincinnati, Cincinnati, Ohio. Report and Experimental Work By: Joseph F. Treon, Ph.D. Frederick E. Shaffer, M.S. Frank Dutra, M.D. Tom Gahegan George Neddermann Date June 13. 19SO Approved Cl Robert A. Keiroe, M.D., Director 20473007 BFG03613 xrHs rHH X m 'ad>) T3 > >H 032 CA CVJ I co s oo<r\ r3H ra opOj, 3 \os\ 40 3 3 3 cH$ 1A CsO BFG03614 o s A43 (-! bO<P > COP 3 P CO y c o M ro c PCO 3 cO +3 )3 r--I <h|M Ord 1 03 O Q 43 as 1 X} 0 43 P O M fi > M rH O 43 43 p <P ftM M n 0'S <*H O 0,43 <5 PH < M c -o bos *H O 43 rH 1 cb 03 d bCd 0 C bO M O MO C2 P O 43 r( H tn rl >H PPM P P O ftP K C 3 ft OWIhH flp C rH Oj M +> CMI s c I-1 I i 8EH c0 ,0 51" M 03 43 H p 43 3ro 0H3 P| Co M 1 C op rH 43 M 3) tj> 43 M M _irf CO MS 1 E> bO O O bOsO O 03 01 Q <H C bO 0 c of ft 0 p rH 03 M MH 0 n > 2 CO c Q I 31 <--ll 1 03 43 O <P <H _ HJvOO I I p 03 c (Q <Vh 00 Pp S3 Cp H 0 43 M ,0 c 43 g 0 1 XM) 0 55 p"\ m XS o P tJ r-1 n H >>p M ^H P -d ir\ 'd > M u 0 CO rH O' + 0 C\J I -d" 0 CM CM O UN CM O LfN UN P M > rH 50 C^\ -3 ft 03 d tO3 HUB <H l43 XJ M 5h P W X) -vD d > rH > fa 3 cO c-- 0 1 U\ 0 1 LA rH rH rH rH CO CM 1 1 vO WXD 0(0 PC 20473009 BFG03615 FEDERAL SECURITY AGENCY FOOD AND DRUG ADMINISTRATION WASHINGTON 25. D. C. Dr. William E. McCormick Dept, of Industrial Hygiene and Toxicology The B. F. Goodrich Company Akron, Ohio m 15 1950 Dear Dr. McCormick: Your letter of June 6 requests a written confirmation of the views expressed at the June 5 meeting. Your reports covering the toxicity studies on Geon 202 Resin, Acetyl Tributvl Citrate, and Santicizer B-16, as well as the extraction studies on the finished film using typical food-type solvents indicate to us that there is little chance of any danger resulting from the use of such film for wrapping food. As you know, the responsibility for determining that a food does not become adulterated by being wrapped in a container which may render it dangerous to health is that of the manu facturer or shipper and cannot be shared by this Administration. Very truly yours, Bert J. Vos, M.D. Acting Chief, Division of Pharmacology 20474001 BFG03616 News about B. F. Goodrich Chemical Company raw materials TECHNICAL HELP for manufacturers of vinyl-coated fabrics OVERNMENT requirements are now increasing For products G in which vinyl-coated fabrics are required. For instance, Geon polyvinyl paste resin coated onto cloth resists the action of hazardous chemicals--an important safety factor. Fabrics treated with Geon latex compound help protect the wearer against fire. Garments so treated can be washed or cleaned in any type soap or detergent and still retain their protec tive qualities. The garments are also mildew-proof and, of course, non-toxic and are comfortable to wear. The protective qualities of vinyl-treated fabrics are required in many Military and Navy specifications. Fabric coaters who want technical help on processes for making these protective fabrics should write to Dept. GH-21, B.F. Goodrich Chemical Company, Rose Building, Cleveland 15, Ohio. Cable address: Goodchemco. GEON RESINS GOOD-RITE PLASTICIZERS ...the ideal team to make products easier, better and more saleable. GEON polyvinyl materials* HYCAR American rubber* GOOD-RITE chomleals and plasticizers Proof from The Griswold-Eshleman Co., Cleveland Daily News Record--October 4, 1950 (GH-21) BFG03617 20475001