Document 3JwXxvdrpxzjoMBMDLYEzZGZ0

BEST COPY AVAILABLE 1663 GK001446 INTEROFFICE MEMORANDUM Datei From: Depti Tel No: 2 0 - Q c t - 1994 ! 1 :0 0 am VMSMail User BUXTONLW B U X T O N L Wd*I S C D C V M 19 C D C IL 1<MF:GAT E TO: k e n n e d v @ h s k :v a x @ m h s a t e Su b j e c t : MP m Sh-a--. m q P r o d u c t r, 4- , t- Clil j ,c*7 ;4' T ; `f CPS A 7A- 7- -I crr.r- -obe-t 7 . Cavanaug Bill p-. t o n . l -P9 R e a Aftr.i'S . -CP-7 ] j -11 ; C iK -j& RMc- L** S h av in 3 p '-odur* <Q Q - O d t f S m e k anneev to comment on seraistsnce or lie n o t a o D r o c ' i a t e for C-S. It doe net sreur-. _-ats iT;c 1 e l i m i n a t e d v e r y s l o w l y 1 2 v -1" V S 3 "*S <* W~ , s u m t o n , D u c,cn t P lu o^ oc n o d u c t s , R e o u l a t o r v A f f a i r s > mail: c'.C .t o. 0 ? 1 2 . W i l m i n g t o n DE 1^SEfO-OT" 2 , US A '' 'dee -none: 3 0 2 -9 9 9 -4 6 5 3 . fax: 3 0 2 -9 9 9 - 4 6 3 8 - * * = -a-'-ci-'t. note f - c n C A V 4 NAP .7-- IS C D C V M 1 1 0 / 20/94 1 0 : 2 8 ** * -r>. v.a p t i 11*-*;-- -1S C D C V M I W A Y N E H M A R T I N B U X T O N L W - - 1S C D C V M 1 L. w i l l i a m ton c rerrr R o b e r t J. C a v a n a u g h 9 9 9 - 4 3 8 5 Subiect: MP in S h a v i n q P r o d u c t .C . J o h n s o n is i n t e r e s t e d in o u t t i n a a m i c r o o o w d e r into E d ge s h a v i n g gel for s m oo th er sh aves, G>"eg and I r e v i e w e d ou r c o n c e r n s w i t h t h en on H F , acid end g - o u p s and C -9 . Th e b e s t g r a d e fo r t h is a p p l i c a t i o n w o u l d be M P - 1 6 0 0 . Do veu have data or the rate of C -8 e l i m i n a t i o n frois/the bo dy ? I was t h i n k i n g that we could ca lc ul at e how m u c h w i l l b i o - a c c u m u a l t f r t o s e e if t h er e is any f e as ib il it y at all of doing this. Th ey will run so me p r e l i m i n a r y tests to see' if thic accroach even works. The assumptions 1 would use are shown below. Do they lock r e a s o n a b l e to y o u "1 T.*{ MP - 1600 T; D T O d U C t 2f ec- C-8 i- hP-ltOC t : ?.ra E c ae se- apolic-ation .'tnev s a v 5 - 1 0 g r a m s is typical) 'lvOIi a b s o r p t i o n of the C - 8 via. skir are v adcition cf C-8 would be 2.0 the elimination rate" lOE-t g r a m s per -'-v C*Cwi David u., De'-'t" '.-.^1,^1 V SiS* ^ 7 BELL En GA- - 1SCDCVM l Sr* r.o i:r 00017^ GK001446 GK001447 m <ci n ----------------------------------------TO P ----------------------------------_________ X ________T --------T -------- T -------- T --------X ---------------T -------- p. HERE IS MY SAMPLE CALCULATION WHICH I THINK SUGGESTS THAT WE MOVE LOWLY INTO THIS APPLICATION. 5 C -3 IN EDGE = 20PPM, OR 200 MICR0 G /10 GRAM EDGE APPLICATION > iOO'i DERMAL TRANSFER EQUALS DAILY DOSE OF 200 MICROG/DAY ' OUR CEG IS 0.0003 MG/M3 ;DAILY AIR EXCHANGE OF 20 M3 PRESENTS 0 .0060MG OR > MICROGRAMS TO THE LUNG. DAILY ALLOWED INHALATION DOSE THEM BECOMES (IF THIS MATH IS RIGHT) ABOUT 30-25 TIMES LESS THAN THE AMOUNT PRESENTED TO THE SKIN IN ONE APPLICATION OF EDGE.' 5 ANOTHER WAY TO LOOK AT THROUGH BLOOD KINETICS E )70K 5 PERSON IS ABOUT 7% B l OOD Oh 5 KG BLOOD t ;--E DOES GET 70 AND STAY IN BLOOD-ASSUME TOTAL TRANSFER FRO* ONE EDS A P P l ICHT ION TO BLOOD- 200 M I C R O G /5 kfi BLOOD <30 MI OF-CG fKF - AO PPR ? >WTt :-* * 1,2 LIFS IN YEARS. SAY 0 AS BEST CURRENT E S T I M A T E ;S'EADY 7 rr w Q u l D BE IN THE PPM RANGE fI L'lD N 'T .CAN 'T DC THAT D A L C U L A T i'jN E `JT 2 DO MI CPC'- /DAY WITH l a T T L s CLEARANCE WOULD Gc jc THE^-t In a HL'PR\ , OU MIGHT 1,.-.Lr-rT T0 0 OYER AND ESS IF THIS MAKES SENSE TO YOU, BUT -- ME CLOSE TO DU T 0 ~ BOUNDS IN A H U R R Y , ( 000180 GK001447