Document G55MeBab65r8E2x0aaRd2e0K7
TO: Jim Sidor AVLTC
March 4, 1992
Subject: FDA Status on Experimental Compounds X150-"168-061-01/ X150-168-061-02/ X150-168-061-03
I reviewed the above experimental compounds for their current FDA
status.
Compounds X150-168-061-01 and 02 look okay.
All the
ingredients have FDA clearance.
Experimental compound X150-168-061-03 has one ingredient (L-21/Stearic Acid) which according to the Supplier, Emery, not have FDA clearance.
does
If I can be of further assistance, please give me a call on ext. 7831.
Connie N. Dillon CND/rm
MAR 0 7 1994
21544001
ISDA. MSF. WORKSHEET
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Flash Point and Procedure________________ ______________LEL
'ihSearch Conducted bv \jyu^r1 l
Phone
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Date
______
__ (Please return this data and attach-
ments to Mark Hross, Oak Tree Blvd. -Cleveland (x-7601))
21544004
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( P0O1R71
BF GOODRICH COMPANY MESSAGE SERVICE
it' 50 A
FROM: P103R360
TO: CLEVMAIN
DOCUMENT: 170006
53 LINES 02/17/92
ROUTE TO: DILLON, CONNIE N
#WK*****:****K*W
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* GEON VINYL TECHNICAL DOCUMENT
KffXtt *XK***X***tt*K**tt*tt KttftK*K*K*X**S**X*K* ***##*#*##*#*##**#***#*** *****> *
R103360
GEON VINYL RECIPE
02/17/92 10:58
GEON 17640 BLUE PWD MU 430
LOC : 12 DEPT :
COMMODITY NO.' 07640 000 4302
EFFECTIVE DATE
SBC NBR 13PM LAB REF:
DELETE FLAG: CMF'R:
BASED ON: 87640 BLUE PMB 430, ISSUE 1, 10/03/89 APPLICATION: BLOK MOLDING NON-TOXIC MB
NO K. SRA1L
( (
PARTS
100.00000 3.00000
10.00000
INGREDIENTS
942710849 F'ARAL.OID BTA 733 ^ 935OOF'05,7 EPOXOL. 9-5 ^ 92100B272 BLUE 5006
SEQ LOC PERCENT
110 12 210 310
88.496
2.655 8.850
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TOTAL
10O.OOO
SPECIFIC GRAVITY 1 .43 ( TYPE SAMPLE USE F'REV. SAMPLE
ISSUED TO ADJUST LETDOWN LEVEL.
MARKETING APPROVAL
(
MI SC CMNT: SEE PAGE 2 FOR F'ROCESSING 6 NOTES
HARDNESS: 0-8< COLOR: 2
21544005
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ROUTE. TO: DILLON, CONNIE N
I*'********#**********#***##**#**##*#**#*****#*#*********#********#**##****#***
* GEON VINYL TECHNICAL DOCUMENT
************************ a#**#******#****#***#*#**-***"****)******##*#**##******' *.
R103360
GEON VINYL RECIPE
02/17/92 10:58
GEON 37640 BLUE: PWD MB 430 COMMODITY NO.: 87640 000 4302
LOC: 12 DEPT: 5694
ISSUE: 002*
EFFECTIVE DATE: 12/26/91
TESTS
LIMITS
FREQUENCY
METHOD
^
NON-TOXIC CLEAN UP REQUIRED.
HENSCHEL MIX CHARGE 6TA-733 AND PIGMENT AT SLOW SPEED ADD P-57, HIGH SPEED,, DROP AT 135F.
=======> PROCESSING INSTRUCTIONS COPIED FROM 876400004302 12 5667 002 <=====*
=======>
ON 12/26/91
<=====
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900W ST2
1 R71 FROM: P103R36
&F GOODRICH COMPANY MESSAGE SERVICE
TO: CLEVMAIN
DOCUMENT: 170005
44 LINES
10:58:1 02/17/92
ROUTE IQ: DILLON. CONNIE N *****************************************************************************
* GEON VINYL TECHNICAL DOCUMENT
if************************************************************************** *
R103360
GEON VINYL RECIPE
02/17/92 10:58
GEON 37640 BLUE PUD MB 430 COMMODITY NO.: 87640 00 4302
SBC NDR: 13PM LAB REF : BASED ON: APPLICATION:
L.OC : 1 2 DEPT :
EFFECTIVE DATE DELETE FLAG CMPR
PARTS
INGREDIENTS
89.14159 2.67424 8.91415
942 710849 PARALOID BTA 733 935 00P057 EPOXOL 9-5 921 00B272 BLUE 5006
SEQ LOC PERCENT
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21544010
Glass Transition Temp..
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Date /-- 2.3
--_____________ (Please return this data and attach
ments to Mark Hross, Oak Tree Bivd. -Cleveland (x-7601))
- SENT BY:UIITCO 8W. U). OAKLAND NJ 02-18-92 03:26PM
216 447 6459 # 1
FAX TRANSMISSION FORM
ARGOS DIVISION, FITCO CORPORATION 8 Fright Fay, Oakland, Han Jersey 07438 Phone; 201-337-2038 FAX Ho. 201-337-3753
Date:
February 18, 1992
To; Hra. Connie Dillon Coapany: B. F. Goodrich
FAX No.; 216-447-6459
Ho. of Pages: %.
Froa:
B.R. Blues'tein
Subject: FDA Status - MARK 3112S
Dear Hrs. Dillon:
Barlier today you requested infornation on the FDA status of HARK 3112S, an Argue product whioh you purohase froa us.
The ingredients in MARK 3112S are inoluded in the FDA Hating of organotin stabilizers whioh nay be safely used alone or in conbination, at speoific levels, in vinyl ohloride plasties. Please see the pages froa 21 CFR 178.2850 (here attached). The approved tin ingredients are listed below
with their CAS numbers.
CAS Numbers 28401-88-5
28401-97-8
Ingredients Acetic aoid, 2,2",2"-[<octylstannylidyne)
trie(thio)]tris-, triisoootyl ester Acetic acid, 2,2'-[(dioetylstannylene)bis
(thio)]bis~, diisooetyl ester
Also, please note that these materials are on the DSL, the Canadian List of Domestic Substances. If there is anything further you need, please let us know.
Sincerely yours,
B.R. Bluestein, Ph.D. Vioe President, Teoh.
FEB 18 '92 15:28
PAGE.001
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________________________LLEEL_ LUEL
Search Conducted by
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I
eiF atochem
ElfAtochem North America Inc.
Thm Parkway, PMwMptta, PA 10102
Tat (213)587-7000
P.02
19 February 1992
Ms. Connie Dillon THE B.F. GOODRICH COMPANY Dept 5458 6100 oalc Tree Blvd. Independence, Ohio 44131 FAX: 216-447-6459
Dear Ms. Dillon,
Per our conversation today, the Elf Atochem North America, Inc. product Thermolite* 890$ is an octyltin stabiliser certified for use in food applications as specified in 21 CFR section 178.2650 Organotln Stabilizers la vinyl chloride plastics when used as specified for finished plastics meeting the restrictions set forth in section (b) (1) .
The exact composition of this product is held as a Trade Secret by Elf Atochem North America, Inc.
If I can be of further assistance to you, please contact me at your convenience (215) 587-7917.
Very Truly Yours,
ELF ATOCHEM NORTH AMERICA, INC.
Karen Br Macho1 Product Safety Specialist
cc: Steve Hulme Tom Bole
21544017
FEB 19 '92 14:04
15
pqrf two
FEB-19-92 WED 14:03
eiFatochem
Elf Atochem North America Inc.
Thre* Parkway, PhfcdtlpNa. PA 10103 Tet (215) 587*7000
P.Ol
ELF ATOCHEM NORTH AMERICA, INC.
THREE PARKWAY
PHILADELPHIA, PENNSYLVANIA
19102
FAX NUMBER: (215) 567*6605
THIS DOCUMENT NAME:
IS TO BE DELIVERED TO: ~ 2/-4.4-'7- 643^
DATE:
/99j?
from:
NUMBER OF PAGES (including cover):
COMMENTS:
If there is a problem With the fax transmission, call (215) 5877917.
FEB 19 '92 14 = 04
PAGE. 001
00
izr.ioc^ ,7S.
J no. /Sro ;/77. szlo O
17&3800
21 CFR Ch. I (4-1-90 Edition) j
Acrylonitrile. Butadiene. a-Methylstyrene. Styrene. Vlnylidene chloride.
(Ill) Polymers Identified in para graphs (aXl) <i) and <U) of this section containing no more than S weight-percent of total polymer units derived by copolymerization with one or more of the following monomers:
and/or copolymers of ethyl acrylate and methyl methacrylate, and not
more than 30 weight-percent of poly, mer units derived from copolymers of methyl methacrylate, a-methylstyrene and acrylonitrile and may optionally
contain up to 15 weight-percent of polymer units derived from butadiene^ styrene copolymers.
(c) No chemical reactions, other than addition reactions, occur among
Acrylic acid.
the vinyl chloride polymers and the
1.3-Butylene glycol dlmethacryl&te. Divlnylbenzene. Methacrylie acid.
modifying polymers present in the polymer mixture used in the manufac
ture of the finished plastic food-con
(iv) Mixtures of polymers identified tact article.
in paragraph (aXl) (i), <ii>, and (ill) of f (d) The finished plastic food-contact
this section; provided that no chemical article, when extracted with the sol
reactions, other than addition reac vent or solvents characterizing the
tions, occur when they are mixed.
type of food and under the conditions,
(2) Polymers identified in paragraph of time and temperature characteriz-*'
(aXl) of this section combined during ing the conditions of Its intended use
their polymerization with butadiene- as determined from Tables 1 and 2 of
styrene copolymers; provided that no 8 176.170(c) of this simpler, yields ex-
chemical reactions, other than addi tractives not to exceed the limits pre^
tion reactions, occur when they are scribed in 8 177.1010 (b) (1), (2), (3);
combined. Such combined polymers and (4) of thio chapter when tested by
may contain 50 weight-percent or \ the methods prescribed in 8 177.1010
more of total polymer units derived ) (c) of this ohapter.^./
*
from the butadiene-styrene copoly mers.
(b) The polymer content of the fin
ished plastic food-contact article con sists of:
(e) Acrylonitrile copolymers identi fied in this section shall comply with' the provisions of $ 180.22 of this chap-
ter. j
(1) Not less than 80 weight-percent
of polymer units derived from the vinyl chloride polymers identified in the introduction to this section and
not more than 5 weight-percent of polymer units derived from polymers identified in paragraph (aXl) of this
section and may optionally contain up
178.3800 Preservatives for wood.
Preservatives may be safely used on
wooden articles that are used or in-^
tended for use in packaging, transport-,
ing, or holding raw agricultural prod^
ucts subject to the provisions of thisjTM
section:
^
to 15 weight-percent of polymer units (a) The preservatives are prepared
derived from butadiene-styrene co from substances Identified in
polymers; or
graph (b> of this section and applied ini
(2) Not less than 50 weight-percent amounts not to exceed those necessary^
of polymer units derived from the to accomplish the technical effect oj
vinyl chloride polymers identified in protecting the wood from decay,
the introduction to this section, not mildew, and water absorption.
more than 50 weight-percent of poly (b) The substances permitted are as'
mer units derived from homopolymers follows;
Ltt of tancM r Hr
Umittfiona thw 50% at ttw aoM*
'si 8
Food and Drug
pwotoum hyOocrtoa copotynwriimion at icycSc. and moraba at oaefcad paMawa
PantKMoropfMnoi and
9178J850 Reuri
Reinforced a as an article o: intended for u factoring, pad porting, or hole provisions of tt
(a) Reinforce leum wax to v certain options its production, sired physical c
(b) The qu&o juvant substan duction of or a does not exce< ably required tended physics any limitation
(c) Any subs production of ing any option: subject of a r 175, 176. 177, I chapter, confer tion in such re*
(d) The subs juvant substsj production of wax include:
(1) Substanc as safe In food.
i(2) Substance
tion for use used in accords or approval.
(3) Substance paragraph and tions provided
Erucamid* (erucyfendi W-OiQfOy<8tf|n*
366
cm Ch. I (4-1-90 Edition) ;
food and Dwg Administration, HHS
1713650
frvanf by weight of stfiyttoo propytons 6[on eomplytog wh j 177.1520 at Ms
i of aucti polymers in the lorni in uoiii 0.005 inch.
I parpen by weight of olefin polymare jtnro chapter, under condition* o<(MA
r 2 at f 178.170(C) at Ms chap**. | uaiM by waighT oi polystyrene and . Ut comply Wi 1177.1640 o( Ms chn>-
ju*ysfTana and robbat-modMad polyaly. 1-- condtoons described in | T7-iro(c)
i ccmMons o4 um E through Q.
by weight oi elastomers used in 600 o4 thd chapter.
B ' weight o4 nylon raaina complying tolad, That the finished polymer
at uaa E, F.
6 deathbed to
'
e by weight oi poiycarbonala rerine A tppiar.
t percent by weight oi polystyrene and
Wmers complying wen 9 177.1640 oi Ms Ironed polymer contacts food only under ' F. G. and H described in Table 2 at
b percent by weight of olefin polymers ot ms chapter. asm 1.1. 1.2. or tx percent by weight oi olefin polyriiars
M Ms chapter, dam 2-1. 22. Z3. 3.1. or mpiytog with Earn 2.1. 22. or 2J3 haring n per n*ic centimeter and a thickness - (' nch). shat contact toad orty
F G described in Tebie 2 of
meant by weight oi ethytene-rinyl aceleto 177.1360 of Ms chapter, and that are
tood only under corofitione oi uaa E, F. : oi 1176.170(e) Oi this charter. The ymera in the form in which they contact nritonetar (0.004 inch). : percent by weight of olefin polymers
oi this chapter, item 4. The finished reeter than 0.051 nrifimater (0.002 inch), condkions oi uee E. F. and G described iis chapter.
aroant by weight oi aeryfic and modMed rigid, complying with f 177.lOtO of Mb
0.1 percent by weight oi isobutylene .1420 o> Ms chapter. ) 175.105 of Me chapter,
percent by weight of presets* sensdtwe >.125 of Ms chapter,
percent by weight of cen end cement | l75-300(bK3) (xxri) of this chapter, percent by weight of side seem cement ? 175.300(b)(3) (mdi) of this chaptw. percent by weight ot pefaolem aficycSe i with i 1?S-320(bK3) o* this chapter, parcent by weight el petroleum aficydo hydrogenated produets comptying wdh
rocent by weight oi resins and polymers this chapisr. percent by weight of resins and roeto &2tO(dH3) of Ms chapter. 5 percent by weight ot closures wMt 1177.1210 of this chapter.
0.S percent by weight of peboitoto* and rosin derivative* complying wrih
TrirffrmethyM hydro*y-5-rerMutytphenyt)butan* (CAS Reg. NO. 1843-03-4).
Zinc dbutyidhhiocerbamate (CAS Reg. 14a 13623-2).
2). At levels not to sxceefl 0.5 parcent by weight of rronfoiiod wen
complying wNh ) 1793650. 22. At levels not to exceed 0.5 percent by weight ol olefin copolymer*
complying with f 177.1520(c) of Ms chapter. Mam 3.3 Hie finished pofyraar* may be used to contact with food under conations of gee A through H JuscriLuJ in Table 2 of 1176.170(c) of this chapter.
For use only: 1. At levels not to exceed 02S percent by weight d polymer* used as
provided to f 176.180 of Me chapter. 2. At level* not to exceed 0-25 percent by weight of the lofiowing
polymers when used to articNe tost contact food of Types I, tf. IV-fl. Vl-e, VU-g, and VlN described to Table i of f 176.170(c) of Ms chapter Olefin polymers complying with 1177.1520(c) ol He chapter, items 11. 1.2. 12. 2.1. 22. 22. 3.1. 3A 3.3, or 4 or complying wfih other sectiorro to Pwts 174, 175. 176, 177. 178 wxt 1170.45 of Mi chapter rinyf chloride polymers; end/or rinyl cMoride eopotymam
complying with f 177.1960 of this chapter. 3. At levels not to exceed 0.1 percent by 'might ol the toiowtog
poiymars whan used to articles toat contact food of Types M, tv-A. V.
vt-A, vwx vtt-A, and W dasofted to Table t of 1176.170(c) of Me
chapter Olefin polymers complying with f 177.1520(6) of this chapter, items 1.1. 1.2, 1.3, 2.1, 22, 2.3. 3.1. 3.2. 3J. or * or complying wMt other sections in Parts 174. 175. 176. 177. 178 art f 179.45 of MB chapter vinyl chloride poiymars; and/or rinyl chloride copolymers coniplytofl with f 177.1960 of He chapter.
4. As provided in f 175.105 of Ms chapter. 5. At levels not to exceed 04) percent by weight of polystyrene and/or
modffied polystyrene polymers identified in 1177.1640 of Ms chapter. 6. At leva* not to exceed 0-25 percent by weight o> scrytontofie
butadeneistyrene copolymers ussd in contact with nunelrnriufit toads 7. At levels not to exceed 1 parcent by weight of dosurs seafingjisjijn
compositions complying with 1177.1210(b) of this chapter. For use only; 1. At levels not to exceed 02 percent by weight ol ijUrtyter>aiSQpisiis
copolymers complying with f 177.1420 of Ms chapter Prodded. That the finished copolymers contact food only of tot types ilsndfisd in 1176.170(c) of this chapter. Table 1, under Types V, W. Vlk. and DC 2. At levels not to exceed 0-02 percent by weight of polypropylene polymers complying wrth f 177.1520(c). item 1.1 of H chapter.
For use only in rigid polyvinyl chloride and/or in rigid vinyl chloride copolymers corrHymg with f 177.1900 of this chapter Amfcbrf That total saficytetaa (cataiatod as the add) do net exceed 0.3 parcent fay
weight ol such polymers.
1 Copies are ausfiabls from fits American Society lor Tasting and Materials. 1816 Racs Street. PtHadetph**. Pa. 19103.
(42 PR 14609. Mar. IS, 19771
Editorial Notc For Fideral Register citations affecting i 176.2010, see the List of CFR Sections Affected in the Finding Aida section of this volume.
S17&2556 4-Hydroxymthyl-2,&-<U-terfbutylphenoL
4-Hydroxymethyl-2,8-dl-ferf-butyiphenol may be safely used as an anti* oxidant In articles intended for use in contact with food. In accordance with the following prescribed conditions:
(a) The additive has a solidification
point of 140"-141`C. <b) The concentration of the addi
tive and any other permitted antioxi dants in the finished food-contact arti-, cle does not exceed a total of 0.5 milli-i gram per square inch of food-contact'
surface.
176.2660 Organotin stabilizers in vinyl
chloride plasties.
The organotin chemicals identified in paragraph (a) of this section may be
safety used alone or in combination, at levels not to exceed a total of 3 parts per hundred of resin, as stabilizers In vinyl chloride homopolymers and co polymers complying with the provi sions of S 177.1950 or S 177.1980 of this chapter and that are idtffllilledjffQr use
m contact with food oi types n, in,
IV (except liquid milk), V, VI (except malt beverages and carbonated TKftBET-
327
178.2650
21 CFR Ch. I (4-1-90 Edition)
oxide meeting the specifications pre
7coholic beverages). VII, VIII, and IX
described in table 1 of $ 176.170(c) of this chapter/except 101* t'fie orgaflOtln chemical identified in paragraph (aK3)
scribed for dl(n- octyl) tin dichloride or di(n-octyl) tin oxide in paragraph
(a)(1) of this section.
of this section, which may be used In (3) Alkyl mercaptoacet&tes re
contact with food of types I through action products with dichlorodloctyi-
IX at temperatures not exceeding 75 stannane and trichlorooctylstannane
C (167 *F), and further that the or- (CAS Reg. No. 83447-69-2) is an organ
ganotin chemicals identified in para otin chemical mixture having 10.8 to
graphs (a) (5) and (6) of this section 11.8 percent by weight of tin (Sn) and
may be used in contact with food of having 8.0 to 8.6 percent by weight of
types I through IX at temperatures mercapto sulfur. It is made from a
not exceeding 66 *C (150 *F>, condi mixture of di(n-octyl)tin dichloride
tions of use D through G described In and (n-octyl)tin trichloride which has
table 2 of 1 176.170(c) of this chapter, an organotin composition that is not
and further that dodecyltin chemicals less than 95 percent by weight di(n-
identified in paragraph (a)(7) of this octyDtin dichloride/(n-octyl)tin tri
section which may be used in contact chloride. and not more than 1.5 per
with food of types I, II, III, IV (except cent by weight of tri(n*octyl)tin chlo
liquid milk), V. VI (except malt bever ride. The alkyl radical in the mercap
ages and carbonated nonalcoholic bev toacetate is derived from a mixture of
erages), VII, VIII, and IX described in saturated n-alcohols which has a com
table 1 of I 176.170(c) of this chapter position that is not less than 50 per
at temperatures not exceeding 71 *C cent by weight tetr&decyl alcohol, and
(160 *F), in accordance with the fol that is not more than 50 percent by
lowing prescribed conditions:
weight total of decyl alcohol and/or
T3J purpose of this section, dodecyl alcohol, and/or hexadecyl al
the organonn chemicals are those cohol.
L1XUH1 ill l&ragraphs (a) (1), (2), (3), (4) (n-Octyl)tin S,S'S" trlsdsooctyl-
(4), (5), (6), and (7) of this section.
mercaptoacetate) is an octyltin chemi
(1) Di(n-octyl)tln S,S'-bis(lso-oc- cal having the formula n-
tylmer-captoacetate) is an octyltin C.HiiSn(SCHtCOsCHu h (CAS Reg.
chemical having 15.1 to 16.4 percent No. 26401-86-5) having 13.4 to 14.8
by weight of tin (Sn) and having 8.1 to percent by- weight of tin (Sn) and
8.9 percent by weight of mercapto having 10.9 to 11.9 percent by weight
sulfur. It is made from di(n-octyl)tin of mercapto sulfur. It is made from (n-
dichloride or di(n-octyl)tin oxide. The octyl)tin trichloride. The isooctyl radi
isooctyl radical in the mercaptoacetate cal In the mercaptoacetate is derived
is derived from oxo process lsooctyl al from oxo process isooctyl alcohol. The
cohol. Di(n-octyl)tin dichloride has an (n-octyl)tin trichloride has an organo
organotin composition that is not less tin composition that is not less than 95
than 95 percent by weight of dl(n- percent by weight of (n-octyl)tin tri
octyl)tin dichloride and not more than chloride and not more than 5 percent
5 percent by weight of tri(-octyl)tin by weight of tri(n-octyi)tIn chloride.
chloride. Di(n-octyl)tin oxide has an (5) Bis( beta-carbobutoxyethyl)tln
organotin composition that is not less bisdsooctylmercaptoacetate) (CAS
than. 95 percent by weight of dl(n- Reg. No. 63397-60-4) is an estertln
octylHin oxide and not more than 5 chemical having 14.0 to 15.0 percent
percent by weight of bis[trl(n- by weight of tin (Sn) and having 7.5 to
octyUtin] oxide, and/or mono h-octyl- 8.5 percent by weight of mercapto
tin oxide.
'
sulfur. It is made from bis(beta-
(2) DKn-octyl) tin maleate polymer carbobutoxyethyDtln dichloride. The
is an octyltin chemical having the for lsooctyl radical in the mercaptoacetate
mula [(C.Hit)sSnC.H0]l (where n is is derived from oxo process primary
between 2 and 4 inclusive), having 25.2 octyl alcohols. The bis(6ea-
to 26.6 percent by weight of tin (Sn) carbobutoxyethyDtin dichloride has
and having a saponification number of an organotin composition that is not
225 to 255. It is made from di(n- less than 95 percent by weight of
octyDtln dichloride or di(n-octyl)tin bls( bea-carbobutoxyethyl)tin dichlo-
328
21S44C2Z