Document BJ669Mmb23vbNmpzG71n15Qw
. s>
I EXHIBIT
I.S
August 3 . 1972
Dr. A lfred V e is s le r , A cting D irector-
D iv is io n o f C o lo r s and C o sm etics T ech n ology
O ffic e of Product Technology
c
Food and Drug A d m in is tr a tio n
Department o f H e a lth , E d u cation and W elfare
W ashington, D. C. 20204
'
'
.
Dear Dr. W eissler
. --
.
E n c lo se d p l e a s e f in d my f i n a l a n a l y t i c a l r e s u l t s on th e m ineral com p osition s of 102 exam ples of stan dard, com m ercial products co n ta in in g t a lc , These in clu d e a l l the specim ens you
s e n t me from W a sh in g to n , e x c e p t f o r a few ( p r i n c i p a l l y h e pharm aceutical specim ens) w hich I w ill rep ort on s e p a r a te ly , as w e l l a s a number' t h a t I p u r c h a se d i n New York and i n B o s t o n .
The a n a ly s e s show th a t 59 o f th e p rod u cts have no d e te c ta b le amounts of any o f the a sb estifcrm m in erals (by th e tech n iq u e em ployed, p rp p o rtio n s by w eigh t of 1-2% or l e s s could'
esca p e d e t e c t io n ) , 20 had sm a ll but d e f in i t e p ercen ta g es o f ' tr e m o lite , 7 had sm all p e r c e n ta g e s o f e h r y s o t ile , 9 had sm a ll p e r c en ta g e s o f b o th tr e m o lite and e h r y s o t ile , and 7 had sub s t a n tia l p ercen ta g es of one or both o f th e se a sb estifo rm m ineral;
I s h a l l r e t a i n and p r e s e r v e t h e o r i g i n a l s p e c im e n s , nd th e
x - r a y d i f f r a c t o g r a a s , u n t i l y o u a d v i s e me o t h e r w is e .
.
With v ery b e s t p e r so n a l r e g a r d s,
S in cerely yours
Seymour is. newin P ro fesso r of Chem istry
INTERNAL 0771
ITA-LG 00200
i
TABULATION OF X-RAY DIFFRACTION ANALYSES OF COMMERCIAL PRODUCTS CONTAINING
' TALC-_______________________
A. P rod u cts having no d e te c ta b le amounts o f a s b e s tifo r s i m in era ls { l i m i t o f G e t s c t a b i l i t j = c a . 1 t o 2% f o r e a c h m in e r a l)
Product
M ineral C om positlon
Talc C h lo rite
P h i 0,i o n i t e c$-Q uarts D o lo m ite O ther
1 70$ 3%
7$
2 100$ n .d . n .d .
3 99$ H# d.* 1$ 4 100$ n .d . n .d .
5 95% 2% O 80$ 2%
7 86$ 7% 8 95% 2% 9 89% 7% 10 93% 3% 11 90% 2%
3$ 5$ 2$
3$ 2$ 2$ 2$
12
130 n .d .
n .d .
13 6o$ n .d .
14
31$
50$
n .d . Ojo9f
15 100$ n.d.. n .d .
16 ----
a ^
17 6o% 3 0 $
4$
18 90% 4$
2$
19 97% 1%
2$
20
35% 60%
. 1$
21
. 67$
25$
2$
22
5.9% 35$
' 1$
23 42$ 50$
2$
24 94$ 1$
2$
25 95% 2$ 26 95% 1$ 2 7 88$ n . d .
3$ 4$ 2$
28 29
94$
1$ 2$
n .d . 2$
3.0
97% 1 $
- 2$
. n .d . n .d . n .d . n .d . n .d . n .d .
3% n .d . 2$ 2$ 4$
n .d . n .d .
10$ n .d .
n .d .
2$ n .d .
4$ . 3$
n.d*. . 3$
3$ n*d. n.d* n .d . n*.d. . n .d . n*d.
.
n .d . n .d .
n .d . n .d . n .d .
n .d . 2$
n .d .
n .d . n .d .
2$ n .d . n .d .
7$ n .d .
.
6% 2% \
n .d . D.fr.d 3$ 5$ 3$ n .d . n .d .. n .d .
19$ n# d.* 2$ n .d .
ZnO ZnUd
ZnUd ' K ,S
CaC03
* a.
INTERNAL 0772
ITA-LG 00201
Product
T aie
31 s f r 32 80#
33 55% 34 18%
35 78$
36 79$
37 38%
38 87%
39 94$
40 66%
4 l 81%
42 89%
43 '"S6j
44 . .
n .d .
45 65%
46 48$
47 ` 100$
48 88$
49 100$
50 95$
51 100$
52 8 5%
53 90$
54 90$
55 78$ 56 86$
57 58
96$
59 90$
Pagre Z.................... ............
C h lorite
50$ 1% 40$
7% 5% 4$
50$
5% 3% 25$ 8$ 6$ n.d* n .d .
30$ 40$ n .d . 4$ n.d*
5% n .d . 8$ 4$
3% 1 5% 7$ 15$ n .d . n.d*
M ineral C om position
P h lo g o n ite e<-Quartz
2$ 3$
3$
2$
.
2% n.d.
4$ 3$ 2$ 10$ 2$ 15$ 5$ n .d . 4$ 2$
n .d .
1$
4$ 2$ . 1$ n .d . 1$
3%
3% '
2$ n.d.
3% n .d . n .d .
.
n .d .
n .d . 2$
5% n .d . 2$
n.d* n .d . n .d .
n .d . n .d . n .d .
4$ 3% 2% 2% 3% n .d . 2% 5%
2$
1$ n .d .
3% n .d . 4$
n*d.
3$
D olom ite 8$ 8$
3$ 8$
5% ? a .d .
7$ 2$ n .d .
55 5$ 3$ n .d . n.d*
4$ 7$ n .d . 4$ n .d . n .d . n .d . n .d .
2$ 4$ n .d .
2$ 5% n .d . n .d .
Other ZnQ, K
INTERNAL 0773
ITA-LG 00202
B ..... T rod u e t 3 h a v in g s m a ll am ounts o f T r e s o l i t e -*< m ore th a n 1$>
. b u t n o t more th an (5^2 ) $ b y w e ig h t
Product
M ineral Com position
T a le C h lo r it e P h l o s o n i t e &<-Quart2
D olom ite T rem olite
60 615S 30$
n .d .
n .d .
61 35$ 40$
' 2$
3$
62
89$ 2$
- 1$
3$
63 87$ 2$ 64 84$ ' 5$
2$. 4$ U'.5r? c
65
79$ 15$
' n .d .
n .d ,
66 85$ 5$
3$
n .d .
67 75$ 15$
1$
n .d .
68 78$ 15$
n .d .
n .d ,
69 96$ 1$
1$
n .d .
70 2 6 $ 60$
n .d ,
" 5$
71 84$ 10$
n .d .
72 86$ 5$
3$
4$
73
-79$
10$
1$
3$
7^ 92$ rufi.
n .d ..
n .d .
75 75$ 5$
2$
n .d .
76 75$ n .d .
5$
5$
77 91$ n.d,'
4$
2$
78 85$ 2$
1$
4$
79 86$ 5$
4$
nd.
7$ 18$ n .d , n .d .
3$
2$ 5$ 5$ n .d . 7$ n.d*
5$ 5$ 15$ 10$ n .d . 3$ 2$
2$ 2$
5$ 5$ 3$ 2$ 5$ 4$ 2$
2$ 2$
3$ 2$ 2$
3$ 3$ 5$ 3$ 5$ 3$
O . . ~y
INTERNAL 0774
ITA-LG 00203
Cm P r o d u c ts h a v in g 1 s n a i l am o u n ts o f C h ry s b t i l e -- a o r e th a n 1%,
but not aore than
by w eight.
Product
M ineral C om position
P ale C h lorite
Phloy c p ite
o^-Quartz
D o lo i
C h rysotile
80 W - bofi
n .d .
81 80% 7%
1%
8 2 76% 12%
Z%
8 3 S i % 6%
$%
8b 87% k%
1% '
85 83% 5%
2%
86
82% H%
2%
& 6f b% n .d .
n .d . n .d .
n .d . b%
3% b%
3% 8% 4%
k% Z%
m b% 5% 2%
INTERNAL 0775
ITA-LG 00204
r '
D., Produots h avin g sm all amounts o f b oth T r em o lite and h r y s o tile --> . more th a n 1 $ , b u t n o t more th a n ( 5 * 2 ) $ -of ea c h b y w e ig h t .
Product
M ineral C om position
T alc C h lo r ite P h lo g o n lte c^-Quartz D o lo m ite T r e m o lite C h rysote
8 7 2 8 $ 50% 88 61% n .d . 89 68$ 1%
90 55% n .d . 91 23% 1 %
92 6l% n .d .
93 55% 1 % 9^ 4 $ 95 87$ n,d*
n .d . n .d , 3% 3% k% 3%
3% n.d*
h% 1 2 $
h%
&/0T?
5% 25% 8 $ 10 % 5%
5% 5.%
?% 6 %
%6%
6% _
5%
25% 3% 20%
2 5% 35% k%
5% 4$
5% . 5% >$ 2%
5% 5% 5%
5% 2%
.
INTERNAL 0776
ITA-LG 00205
jI
P roducts h avin g s u b s ta n tia l amounts o f C h r y so tlle a n d /o r' T B em o lite -- more th a n i'52)% by w e ig h t .
Product
m ineral C om position
T alc C h lo rite PhloK onite ct-Quarts D o lo site T rem olite C hrysotlle
9976
98
99 100 101 102
' 63375365937816%%%%%$$
n .d .
Xiyi?
n837%%$.d ,
n .d .
333i31*%%%%$:t>
n .d .
b65*o%.%0%% n37%%.d .
62673%%%%5% 15%
1233Oc1%5%%0w2/J%%%
61811%%050%%% 7%n .d .
*
i ii it T 1
r T.
INTERNAL 0777
ITA-LG 00206
NOTES- ? 0 THE TABULATED DATA"
'1, A ll products t e s t e d were standard and com m ercial b ra n d s, purchased in drug sto r e s or the drug departm ents of departm ent '
s to r e s ' or su p e r -m a r k e ts i n t h e c i t i e s o f W a sh in g to n , D. C . , New
York, and B oston. .i
..
2*. A ll data are based upon continuous scan x-ra.y powder '
d iffr a c tio n p a tte r n s. The p r e c is io n , in terms of average d e v ia
t io n , i s of the order o f m agnitude o f
absolute fo r each of
. th e m ineral s p e c ie s r e p o r te d . The d ata are g iv en in u n its o f p er
' centage com position by w eig h t.
3* The lim it s o f d e t e c t a b i l i t y by th e method em ployed a re
o f th e o rd er o f m a g n itu d e o f 1 t o 2% by w e ig h t f o r ea ch o f t h e
m ineral sp e c ie s c it e d .
;
`.
4 A.
Where an a s b e s fc ifc r a m in era l was in d ic a t e d by th e x - r a y
p attern as being presen t to a d e fin ite ly d etecta b le ex ten t, i t s
presence was v e r ifie d by th e use of o p tic a l m icroscopy to d is
c lo s e th e p resen ce o f s ig n if ic a n t numbers o f f ib e r p a r t i c l e s .
B . . Where th e a s b e s t i f o r a m in eral was in d ic a t e d b y -th e x - r a y pattern as being p resen t a t the ju st barely d e tec ta b le le v e l, \ t h is was v e r if ie d (or r e je c te d ) by em ploying th e s te p -s c a n t e c h - ', nique over the reg io n s of th e q u estion ab le d iffr a c tio n peaks.
5* The fo llo w in g m in e r a ls were estim a ted by com paring th e sum o f th e in t e g r a t e d i n t e n s i t i e s a t th e d i f f r a c t i o n a n g le s l i s t e d b e lo w , w it h t h e c o r r e s p o n d in g summed i n t e g r a t e d in t e r n s ! t i e s a t th e same a n g le s o f stan d ard s composed o f th e pure m in era lj
M ineral
T w o-T heta V a lu e s ' Bummed
D olom ite c*~Quartz
C h lorite P hlogopite
31.0 - 31.2; 44.8-45.0.;
.
20.4 - 20.6; 26.6-27jG;v39.3-397 J 6.3-6.5; 12.4-12.8* 19.0-1?..2^ 25.0-25.4
8 .6 -9 .0 ; 2 5 .9-26.I; 2 8 .1 -2 8 .3 V -
. Only two o f th e a sb e stifo r m m in era ls were d e te c te d i n
th e p rod u cts t e s t e d . Each o f th e s e was estim a ted by .comparison..
- w ith sta n d a rd s made up by n tix in g th e pure m in e r a l/w i th pure t a l c
i n v a rio u s p ro p o rtio n s by w e ig h t. For both unknowns and sta n d a rd s,
th e param eter measured was th e r a tio o f th e in te g r a te d in t e n s it y
o f a d i f f r a c t i o n p e a k , r e l a t i v e t o t h a t o f an i n t e r n a l s t a n d a r d .'.
The i n t e r n a l s ta n d a r d em ployed was 5% by w e ig h t o f J2 n (O H )C l. \
The i n t e g r a t e d i n t e n s i t i e s w e r e summed a t t h e f o l l o w i n g d i f f r a c t i o n
angles r
V> V-.
A sb estlform M ineral
. Two-Theta. V a lu e s Bu^merl
:,tv
C h rysotile Trem olite
1 2 .0 - 12,4; 24.3 -2 4 .3
'
1 0 .4 - 1 0 ,6 f 2 7 .4-27.6; 2 9 ,4 -2 9 .7 }
3 0 . 6- 3 0 ,9 1 3 3 .2 - 3 3 * 4
' . .-
fa" 7
i N5' \ -
INTERNAL 0778
ITA-LG 00207
7 T a lc a s d eterm in ed by d i f f e r e n c e .
8 . The fo llo w in g a b b r e v ia tio n s are employed)
n , cU * n o t d e t e c t a b l e
2,h 0 - s in e o x id e
' ..
ZhVd - sin e undeeylenate
' K a k aolin
S n starch
CaCO-j = c a l c l t e
X = phase n o t I d e n t if ie d because deemed
unim portant.
9* I n s e v e r a l i n s t a n c e s , th e san e brand o f p r o d u c t was p u r
chased in d iffe r e n t p la c es a t d iffe r e n t tim es, to check on th e
constan cy of com position o f the m ineral m ixture. C onsiderable
v a r ia t io n s were foiind. S e e p rod u ct numbers 14 and 1 5 ? .2 2 , 22
and 3j^ "irP b ther in s ta n c e s , constan cy w ith in th e p r e c is io n of
th e a n a ly tic a l method was ob served ( e . g . , in th e c a se o f prod
u c t No, .7 ) .
INTERNAL 0779
ITA-LG 00208
KEY TO PRODUCT MAKES
P roduct Number
P r o d u c t Name
1 AHMENS POWDER, MEDICATED
2 AMOLIN DEODORANT POWDER
3 AQUAMARINE COOLING SPRAY BATH
POWDER
4 BAGATELLE AMBER DUSTING POWDER
BOURJOIS BATH POWDER
CALDESENE MEDICATED POWDER
CASHMERE BOUQUET BODY POWDER
8 CHANEL NO. 5 BATH POWDER
$ COUNTESS ROCHEAU CAKE DUSTING . POWDER
10 . CREPE DE CHINE DUSTING POWDER,
KILLOT
11 CREPE DE CHINE POUDBE MIST,
MILLOT
:
12 CDTTCURA TALCUM POWDER
13 DESENEX 14 DESITIN BlffiY POWDER
1165
: DESITIN BABY POWDER DIAPAREHE BABY POWDER
1
17 ; DOROTHY GRAY ''SECRET OF THE SEA"
' DUSTING POWDER
18 ' EMERAUDE TALCUM POWDER
19
ENGLISH LEATHER
'
2 0 FABERC-E TKSIC DUSTING POWDER
21 : FRIENDSHIP GARDEN DUSTING POWDER
22 : FRIENDSHIP GARDEN DUSTING POWDER
23 . FRIENDSHIP GARDEN DUSTING POWDER
24 HEAVEN SENT AEROSOL BATH POWDER
= MIST
2265
HEAVEN SENT BATH POWDER HELEN PRESS! LITTLE LADY11
m ISPOHTA, SPAIN MENS TALC '
j IS IS FLORAL TALCUTi -POWDER
29 ; JOHNSON3 BABY POWDER
j JOHNSON AND JOHNSON MEDICATED,
i POWDER
31 ! KOSCOT BEAUTY DUST-- OIL OF MINK 32 ; LANVIN ARPEGE DUSTING POWDER
33 f LANVIN ARPEGE EOWDERED MIST
! LANVIN ARPEGE TALC
35
t LEWIS BA3Y POWDER
'
'
36 i LOVES FRESE LEMON C-LOSSY POWDER
37 i MACY'S SCENTED BOBATED TALCUM
$8 i MACY'S TALCUM, APPLE
39 I MAECELLB DUSTING POWDER, HYPO-
I ALLERGENIC
`
40 MARY CHESS PERFUMED DUSTING
POWDER ' ,
.
Further I d e n tlflo a tlo a
B r is to l-M y e r s (No* IF 25) Norwich
Revlon (143) Corand (DCH)
Fennw alt (5274) C olgate-P alm ollv
Jergens
''
House o f F ragrance (L1132'
House o f Fragrance
Pures: (07170)
WTS-Pharmacraf t
P fiz e r (1139Z) (3 /2 9 /7 2 )
P fiz e r (115) (5 /1 0 /7 2 )
B reon (EIQUQ)
Coty (355-^ 010)
Mem
'
(2891) Shulton (3 /2 7 /7 2 )
Shulton (5 /9 /7 2 )
Shulton (7 /1 3 /7 2 )
R ubinstein R ubinstein
(028Q) ( 3612)
(1288)
Manley & James (2K4)
INTERNAL 0780
ITA-LG 00209
Strafter i-TOduor Name
.... F u r t h e r I d e n t i f i c a t i o n
41 MEWNEN BABY MAGIC POWDER
42 KENNEN QUIUSANA FOOT1 POWDER
(B 1 1 2 ) (H202)
43 MERCK TALC, PRODUCT NO. 6 4 6 0 , LOT
! HO, 6 4 6 0 )
{8039301)
44 HEXSANA 238?-D MEDICATED POWDER P lou gh
45
46
OLD SPICE BODY TALCUM PERSIAN LILAC DELUXE DUSTING
S h u lto n
<
I POWDER
A p r il Show ers (LFN)
4? PERSIAN LILAC SPRAY BATH POWDER A p r il Show ers (B200B)
48 POND*3 PERFUMED TALC BODY
. DEODORANT DREAM FLOWER
(115B)
49 PRINCE MATCHABELLI BELOVED SPRAY
POWDER
50 QUEST DEODORANT POWDER
51
BEPLIQUS SPRAY BATH POWDER -
Parfums R aphael (004)
52 SIVIAPIA FOODS - ITALIAN STEARIN TALC F o r R ic e
53 SEPTEMBER KORN BY POND'S
' . (19B)
54
SEVEN WINDS AFTER BATH TALC
DuBarry
(021033)
55 U S P TALC
56 VASELINE INTENSIVE CARE BABY POWDER
(I 209)
5? YVES SAINT LAURENT RIVE GAUCHE SPRAY TALC
58
I B T BABY POWDER
'
(E l021)
59
ZEASORB SUPER ABSORBENT MEDICATED POWDER
S tie fe l
60 AMBUSH-DANA DUSTING POWDER 61 APRIL- SHOWERS
(9.884)
62 AVON UNFORGETTABLE PERFUMED TALC
63 BELOVED PERFUMED DUSTING POWDER, PRINCE MATCEABELLI
64 COTY PACE POWDER RACHEL
65
DESERT FLOWER SPRAY BATH PONDER
S h u lto n (F 1 BXI)
66 EMEEAUDE DUSTING POWDER
Coty
6687
EMEEAUDE SPRAY DUSTING POWDER
Coty
( 1 AEY)
FA3ERGE FLAMBEAU DEODORANT SPRAY POWDER ' (37 WBF)
69
JEAN HATE SPRAY BATH POWDER
'
(1 H 247)
70 JERIS TALC, FLESH
71 JCLIE KADAJiE DUSTING POWDER, BALMAIN
72.
LADY ESTHER FACE POWDER, RACHEL '
"
4&X -FACTOR FACE POWDER, EACHELLE
"
U
MEDICATED COMFORT POWDER.
. Parke-D avls
GHi d a LONDON TALC
' lard ley
(498)
71
TO KNOW KB IS TO LOVE ME - TIHKSRBSLL
? 02H F i e l d s , L td .
77
^OUCH AND GLOW PACE POWDER, CREAMY PEACH
R evlon
78 TOUJOURS KOI BATH POWDER
Corday
-79 YARDLSY APRIL VIOLETS
(4905)
80
CHANTILLY DUSTING POWDER
V Houbigant
51 .CASHMERE BOUQUET
82 JEAN NATE TALC
'
83
hehhes shave talc
.
.
(B 81)
f
w
SHOWER TO SHOWER EP'DY POWDER
' J ohnson & J ohnson ' ( 55C7BC ;
85
PURE BABY POWDER, DART DRUG
.>
(E :IIC )
86
POND'S -DREAR FLOWER PERFUMED TALC
. (0 13D)
10 INTERNAL 0781
ITA-LG 00210
P ro d u ct Number
87 88 89
90
91 92, 93 94 95
P r o d u ct Name
Further Id e n tifica tio n
AIKAY HYPO-ALLERGENIC FACS POWDER
CONSTANCE CARROLL, BOUQUET TALC
DJEH-K1SS TALCUM
FLAMINGO LUSTING POWDER, TUSSY
LANDER LILACS AND ROSES TALC
MAVIS TALCUM
MAVIS BODY PONDER
TAHGEE
0
ZBT BABY POWDER
K erkoff (L I 04-7)
Vvaudou V ivaudou L u ft-T a n g ee (B0048)
96 BLANCHARD'S DUSTING PONDER
97 BOHN WILD DUSTING POWDER
D el Labs
98 LANDER GARDENIA AND SWEET PEA TALC
99 LANDER LILACS AND ROSES DEODORANT BODY TALC
100 .MISS DIOR DUSTING POWDER
101 TAI WINDS SPRAY TALC
(Avon (DCC 12 7 2
2 - 1 4 - 7 2 , EWS)
102 TOSCA DUSTING POWDER
? 11
INTERNAL 0782
ITA-LG 00211