Document JN4eB2bKXJ6wM3jr5BbLK4GjB
APR 7 IVfi
DEPARTMENT OF HEALTH. EDUCATION. AND WELFARE puauc HEALTH SERVICE
POOD AND DRUG ADMINISTRATION WASHINGTON, D.O. MU4
April 1. 1976
^ M. SMfTH
Hr. Albert C. Clark Manufacturing Chemists Assn. 1825 Connecticut Avenue, N.V. Washington, DC 20009
Dear Mr. Clark:
This is to acknowledge receipt of your letter of March 23, 1976, transmitting tho final report entitled, "The Effects of Maternally Inhaled Vinyl Chloride on Embroyonal and Fetal Development in Mice, Rats and Rabbits."
This information vill 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 vhen final regulations are published.
We have not been conducting any animal studies on the potential toxicity of FD&C Red Wo. 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 leva1 of sensitivity of 1 part per billion. We are looking forward to the receipt of further reports of the studies being sponsored by MCA.
Sineerely yours,
J&i*// 9n
Gerad L. McCowln Assistant to the Director Division of Food and Color Additives, HFF-334
XKs
J,
AP00022098
Mom* of tubtlciu*
\ fynonymi '
$P*cit I Strain)
fx;oivi
Sto(i* of xpr imnnt
5. Furfural
Hamster
(CAS teg. No.: 98-01-1; 2-
(Syrian Golden)
Furaldehyde; 2-FUrancarborti1;
o-Furole)
6. Iron oxide
Hamster
(CAS Reg. No. s 1309-37-1; Ferric (Syrian Golden)
oxide; C.I. 77491; Ferric
saquioxide; Jeweler's rouge;
Hematite)
?. Y-Irradiatad chicken
Rat (Wistar)
s. Methylbenzocyanate
Rat (Wistar)
<l. 3-fteth\'lthio-2-butanone-<>` l (Methylarino) carbonyl |oxime
Rat (llistar)
KK N-Nitxoscdiethylaniine
Hamster
(CAS Reg, to.: 55-1B-5;
(Syrian Golden)
Diethyinitroscnine; MU; DE&)
IK Vinyl chloride (CAS Reg. to.: 75-01-4; Chior-
Rat {Wistar)
ethene; Chloethylene; Chlorcr
ethere; Chloroethylene;
Ethylene monochloride; VC; VOi)
12. Yeast (qrcv/n on gas-oil)
Rat Mouse
K>. Yeast fgrcwi on pure n-parnffins) Rat (Wistar)
Mouse
inhalation
histology in progress
i.tr. alone & in ccmbination with Diethylnitrosamine (inhal. & i.tr.)
completed published1
p.o. in the diet
completed to be published
p.o. in the diet
in progress
p.o, in the diet
in progress
i.t.
canpleted published1
p.o. in the diet
& inhal.
in projpsss
p.o. -d i t i cp.o.
/tt
completed -ditto* completed
--i i t t o-
Principal iavattigalorc Feron, V.J. fi Krwysse, A
Fcton, V.J.
Til, H.F. Til, II.P. Til, H.P. Feron, V.J,
Feron, V.J. Til, fl.P. & Kruysse, A.
Feron, V.J.
F~run, V.J.
' See Appendix I
ipijhutMweggsag
t
AP00022099
Nam* el I $ynny<ni I
SO* Span 60 (CAS Peg. No. i 1338-41-6; Sorbitan monostearate)
Spi* (SrralnJ
Mouse (TFI).
12. Stearoyl lactic acid, sodium & calcium salt
Rat
Tartrazine
(CAS Reg. No.: 1934-21-0; C.I. Acid Yelled 23, trisodiun salt; 5-Hydroxy-l- (p-sulphophenyl)-4-1 (p-sulphophenyl) -
Mouse (CSI)
azo]pyrazole-3-carboxylic acid, trisodiun salt; C.I. 19140; C.I. Food yellow 4; ID & C yellow 5; Tartar yellow N)
y-Lfrdecalactooe 7CAS Reg. No.: 104-67-6)
Itouse
Vinyl chloride
Rat
(CAS Reg. No.; 75-01-4;
(Kistar)
Chlorethene; Chlorethylene;
/ Chloroethene; Chloroethylene; f Ltliylene mcnochloride; VC;
VOl)
;*
I
& t See Appendix I
Ixpesiilt '
p.o. in the diet
p.o. in the diet
Slag* a( **p*r imml
Principal
histopathological exami nation to be carried out
planned
ocnpleted to be published1
BIBKA staff BIBRA staff
p.o. in drinking water
discontinued in progress
BIBRA Staff
AP00022100
Chemical
Principal Investigator
jfl, ''testosterone & dihyrotestosterone Habib, F.K.
20. Titanium dioxide (CAS Beg. tto.: 13463-67-7; Titanium oxide; Illmenite; Rutiox cr; Titania; Unitane)
Selikoff, I.J. .
* 2U y
Trichloroethylene (CAS Reg. No.: 79-01-6; 1-
Chloto-2,2-dichloroethylene? Ethinyl trichloride; Trichloroethane; Algylen; Germalgene; Trichloran; Triclene; Westrosol)
Axelson, 0.
Vinyl chloride
ttiiess, A.M.
(CAS Reg. "no.7 75*01-4; Chlor-
ethene; Chlorethylene; Qiloro-
. j ethene; Chloroethylene? .
Ethylene ronochloride; VC;
BartalinJ., E.
vol)
Duncan, K.D.
Selikoff, I.J.
Appendix II page v
.
_________________________________________
Name of Department/laboratory 6 Address
Division of Steroid Ehdocrinology, 26-28 Hyde 'terrace, leads 1S2 9IN, UK
Environmental Sciences laboratory, .Haunt Sinai School of Medicine, The City University of New York, 130th Street & 5th Avenue, New York, N.Y. 10029, USA
Department of Occupational Medicine, Regional Hospital, S-70185 Orebro, Sweden
Medical Department, Badische Anilin- uid Sodafabrik, BASF-AG, Brunchstrasse, Ludwigshafen, Federal Republic of Germany
Medicina e Igiene del lavoro, Montedison 4 Consociate, Via A. Appiani, 12, 201212 Milan, Italy
Employment Medical Advisory Service, Health 4 Safety Executive, Baynard's House, Chepstow
Place, tendon W2, UK
Bwircnmental Sciences Laboratory, Mount Sinai School of Medicine, The City University of New York, 100th Street 6 5th Avenue, New York, N.Y. 10029, USA
O M
Og ft.
<
Chemical 22. Cant'd
Principal Investigator Bertazzl, P.A.
23. Vinyl chloride polymers (CAS Peg. No.: PM9002-86-2; Chloroethylene polymer; Poly vinyl chloride; Blacar;
Opalon; Vynon)
Bertaz2i, P.A. Ottevanger, C.F. Duncan, K.D.
24. Vinylldene chloride (CAS Reg. No.s 15-35-4; 1,1-
v Dichloroethylene; asymDichloroethylene)
Pell, S.
Nane of Etepartment/Laboratory Mdress
Clinica del layoro "L.Devoto", University* degli Studi, via S. Bamaba 8, Milan, Italy
Clinica del lavoro **L, Devoto", University* degli Studi, via S. Bamaba 8, Milan, Italy
Department of Industrial Health, Shell Cc., P.O. Box 7000, Rotterdam, The Netherlands
Employment Medical Advisory Service, Health & Safety Executive, Baynard's House, Chepstcv Place, London W2, UK
Medical Division, E.I. du Pent de Nemours 6 Ccr., 11400 Nemours Building, Wibnington, Delaware 19898, USA
........ - '
* ' , r n/y **1F*'*i*ff(5
l