Document 2qOQDamvXmeRzpE6pZz0XqV77

department of health, education, and welfare PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION WASHINGTON. D.C. 20ICH April 1, 1976 APR 7 m/f) Hr. Albert C. Clark Manufacturing Chemists Assn. 1825 Connecticut Avenue, tl.W. Washington, DC 20009 Dear Mr. Clark: This is to acknowledge receipt of your letter of March 23, 1976, transmitting the final report entitled, "The Effects of Maternally Inhaled Vinyl Chloride on Embroyonal and Fetal Development in Mice, Rats and Rabbits." This information will be considered in our evaluation of the use of vinyl chloride polymers in contact with food. Accordingly, as you are aware, it may be necessary to place this report on public display at the Hearing Clerk when final regulations are published. \e have not been conducting any animal studies on the potential toxicity of FD&C Red No. 2. We have been analyzing various samples of PVC coatings, gasket material, plasticized film, and flexible tubing. To date, we have been unable to detect any migration of vinyl chloride from these types of articles at a level of sensitivity of 1 part per billion. We are looking forward to the receipt of further reports of the studies being sponsored by MCA. Sincerely yours Gerad L. McCowin Assistant to the Director Division of Food and Color Additives, HFF-334 rv*: * t* * ASI 00022238 Horn* of lubilonc* Synonym! 1 S p t c i t [ Srratnf Furfural (CAS Ifk;. No. : Furaldehyde; a-Furole) 98-01-1; 22 - Furanca rbona 1; Hamster (Syrian Golden) Iron oxide (CAS Peg. No.: 1309-37-1; Ferric od.de; C.I. 77491; Ferric sr-qu Lex ide; Jewel er' s rouge ; Hero-; i to) Hamster (Syrian Golden) ?. y-Irradfated chicken Rat (Wistar) Me thv lbe n zoc vana t e Rat (Wistar) 3 --fie thy 1 thi c--2 - bu tar,one -O T~ (f tl vy 1 a; ni no) c a rloonyTTozirre Rat (Wistar) N-Nitrosc diethyl amine ""(CAS Reg. No. : 55-18-5; Diethyl nitrosamine; DEW; DENA) Hamster (Syrian Gcilden) 7 7 Vinyl chimride (CAS Reg. No,: 75-01-4; Chlor- Rat (Wistar) ether.e; Chloethyiene; Chloro- e there; Chlcroe thy ler.e ; Ethylene monochloride; VC; VCM) 7 ^ Yeest (crown on qas-oil) Rat Mouse Yeast (gram on pure n-purafins) Rat (Wistar) Mouse Expoiurtt inhalation S I a a of * x r 'meni hinistporoioggrJey-r ss co CM CM COM o o *m<-> Principal inv^iUgatori Feron, V.J. R Kruysse, A i.tr. alone & in examination with Diethylnitrosz;,i Lno (inlial. 5, i.tr.) p.o. in the diet p.o. in the diet p.o. in the diet i. t. completed published1 completed to be published in progress in progress canpleted published1 F<eron, V.J. Til, H.P, Til, H.P, 111, H.P. Feron, V.J. p.o. in the diet & inhal. in progress Feron, V.J. Til, H.P. S> Kruysse, A. p.o. -d i t t op.o. -d i t i completed -d i t t o~ completed -d i t i o- Feron, V.J. Feron, V.J. Sro Amend !:; I Norat of iub|lon< ; Syncnymi ) Span 60 (CAS Reg. No.: 1338-41-6; Sorbitan memos tearate) Sp9 c i* 1 1 Srrain} Mouse (TFI) Stearoyl lactic acid, sodium & calcium salt Fat Tartrozine Mouse '(CAS Reg. No.: 1934-21-0; (CSI) C.I. Acid Yellcw 23, trisodium salt; 5-Hydroxy-l- (p-sulpho- phenyl}-4-[ (r-sulphophenyl)- azo]pyrazole-3-carboxylic acid, triscdium salt; C.I. 19140; C.I, Food yellcw 4; FD & C yellcw 5; Tartar yellcw N) -Undecalactane (CAS Reg. No.: 104-67-6} Mouse r--.y 1 chloride ;C-'C Fog. No. : 75-01-4; Chlorethene; Chlorethylene; Cb i croc thene; Ch lorce thylene; butylene nanochloride; VC; 'At'.) Rat (Wistar) P-o. in the diet P-o- in the diet Principal in v i figa fort histopathological exami nation to be carried.out planned completed to be published1 BIBRA staff BIBRA staff p.o. m drinking water discontinued m progress BIBRA staff icasW W .' Appendix I Chemical Principal Investigator jo. Testosterone & dihyxotestosterone Habib, F.K. 2 \ Titanium dioxide (GAS Reg. No.:' 13463-67-7; Titanium oxide; Illmenite; Rutiox or; Titania; Unitane) Selikoff, I.J. 2i, Trichloroethylene (CAS Peg, No.: 79-01-6; 1Chloro-2,2-dichloroethylene; Ethinyl trichloride; Tri ed loroe there; Algylen; Germalgene; Trichloran; Triclene; Westrosol) Axelson, 0. 22. Vinyl chloride Thiess, A.M. (CAS Reg. No.: 75-01-4; Chlor- e there; Chlorethylene; Chloro- / ethene; Chloroethyiene; Ethylene monochloride; VC; Bartalini, E. \GM) Duncan, K. D. Selikoff, I.J. Appendix I1 page v CsJ Csl C-J O O Name of Department/Laboratory & Address --------------------------------------------------------------------- -------- oHnH Division of Steroid Endocrinology, 26-28 ^ Hyde Terrace, Leeds LS2 9LN, UK Environmental Sciences Laboratory, Mount Sinai School of Medicine, The City University of New York, 100th Street & 5th Avenue, New York, N.Y. 10029, USA Department of Occupational Medicine, Regional Hospital, Sr70185 Orebro, Sweden Medical Department, Badische Anilin- und Scdafabriic, BASF-AG, Brunchstrasse, Ludwigshafen, Federal Republic of Germany Medicina e Igiene del Lavoro, Montedison & Conscciate, Via A. Appiani, 12, 201212 Milan Italy Employment Medical Advisory Ser\'ice, Health f Safety Executive, Baynard's House, Chepstow Place, London W2, UK Environmental Sciences Laboratory, Meant Sina School of Medicine, The City University of New York, 100th Street & 5th Avenue, New Yor N.Y. 10029, USA Ch erica1 .22. Cant'd Principal Investigator Bertazzi, P.A. 23. / Vinyl chloride polymers TCAS Reg. No.: PM9002-S6-2; Chloroethylene polymer; Poly vinyl chloride; Blacar; Cpalon; Vyr.on) Bertazzi, P.A. Ottevanger, C.F. Duncan, K.D, OO `if * Vinvlidene chloride TCAS Reg. No.: 75-35-4; 1,1" Dichloroethyler.e; asynDichloroethylene) Pell, S. Name of Departmcmt/Laboratory & Address Clinica del Lavoro "L.Devoto", Universita degli Studi, via S. Bamaba 8, Milan, Italy Clinica del Lavoro "L. Devoto", Universita degli Studi, via S. Bamaba 8, Milan, Italy Department of Industrial Health, Shell Cc., P.0. Box 7000, Rotterdam, The Netherlands Employment Medical Advisory Service, Health & Safety Executive, Bavnard's House, Chess t;' Place, London W2, UK Medical Division, E.I. du Pont de Nerrours i, 2 11400 Nemours Building, Wilmington, De1awar, 19898, USA