Document Rpdd38yYLR35NLR135zDM8q3B

AR226-2009 AGENDA C-ft REVIEW - APRIL 26, I. In t r o d u c t i o n II. To x i c i t y Status - ' o Re s u l t s o f Ha s k e l l t e s t i c u l a r EFFECTS STUDY o St a t u s o f 3M s t u d y - NOEL FOR LIVER EFFECTS . Ho w a r d Sm i t h * Ge r r y Ke n n e d y III. Re v i e w o f a l l Pe r s o n n e l Ai r Mo n i t o r i n g a n d B l o o d Da t a Ho w a r d Sm i t h IV. Re v i e w o f Ai r , Ma t e r , La n d Pr o g r a m s Bi l l Crawley Ca l v i n Ch i e n (Hy d r o g e o l o g i s t ) V. Pa t h Fo r w a r d Ho w a r d Sm i t h HAS/is 4/3/90 EID924242 AJP001661 INVESTIGATION OF HORMONAL MECHANISMS FOR C-8 INDUCED LEYDIG CELL ADENOMA MARK HURTT & JON COOK. HASKELL o I 3Mn t h e t w o -y e a r f e e d i n g s t u d y , a d o s e -d e p e n d e n t INCREASE IN LEYDIG CELL ADENOMAS (TESTICULAR TUMORS) WAS C-8o b s e r v e d . Be c a u s e w a s n e g a t i v e i n ,t w o s h o r t -t e r m TESTS, THE MECHANISM OF THE TUMOR INDUCTION BY C-8 WAS INVESTIGATED. SPECIFICALLY, THE EFFECT OF C-8 TREATMENT ON THE HORMONAL STATUS WAS EXAMINED. o Th e RESULTS FROM THE STUDY SUGGEST THAT THE INDUCTION OF LEYDIG CELL ADENOMA BY C-8 IS HORMONALLY MEDIATED. o Al t h o u g h t h e d a t a f r o m .t h e s t u d y w a s f a r f r o m f i r m o r COMMANDING, THE STUDY SCIENTISTS DID FEEL IT DID NOT PRECLUDE A HUMAN ROUTE FOR TESTICULAR TUMORS. o This s t u d y is s u p p o r t i v e o f t h e l o w l e v e l b e n i g n TESTICULAR TUMORS IN THE 3M STUDY AND SUPPORTS OUR EXISTING LOW AEL. AJP001662 HASm i t h /i s 4/12/90 iJ EID924243 STATUS OF 3M C-8 STUDY NOEL FOR LIVER EFFECTS o 13-Week Di et ar y Study in Ma le Rats - Hazleton La b s o Start Da t e - March 29, 1990 - Results by December 1990 (?) o ToPu r p o s e : Assess t h e Subchronic Toxicity and to Ev al ua t e Reversibility of a n y Toxic Effects, o 420 Ma l e Charles River Rats Group Dose Level (ppm) 1, Co n t r o l 2, Lo w 0 1 3. ,, Mi d -l o w 3 4. Mid-high 10 5. High 30 6. Pa i r -fe d Co n t r o l 0 o St u d y A n a l y s i s HASm i t h /i s 4/12/90 AJP01663 EID924244