Document RJyJJpBNEBg2BexRJ68XE4mKn

AR226-2009 AGENDA C-8 REVIEW - APRIL 26. 1990 I. INTRODUCTION - HOWARD SMITH II. TOXICITY STATUS - --'" 0 RESULTS OP HASKELL TESTICULAR EFFECTS STUDY 0 STATUS OF 3M STUDY - NOEL FOR LIVER EFFECTS GERRY KENNEDY III, REVIEW OF ALL PERSOMMEL AXR MONITORING AMtt BLOOD DATA HOWARD SMITH IV. REVIEW OF AIR, WATER, LAND PROGRAMS - - BILL CRAWLEY CALVIM CHIEN (HYDROeeOLOGIST) V, PATH FORWARD HOWARD SMITH HAS/IS 4/3/90 EID924242 INVESTIGATION OF HORMONALMECHANISMS FOR C-8 INDUCED LEYDI6 CELL ADENOMA MARK HURTT & 3QM COOK. HASKELL 0 IN THE TWO-YEAR 3M FEEDING STUDY, A DOSE-DEPENDENT INCREASE IN LEYDIG CELL ADENOMAS (TEST1CULAR TUMORS) WAS OBSERVED. BECAUSE C-8 WAS NEGATIVE IN TWO SHORT-TERM TESTS, THE MECHANISM OP THE TUMOR INDUCTION BY C-8 WAS INVESTIGATED. SPECIFICALLY, THE EFFECT OF C-8 TREATMENT ON THE HORMONAL STATUS WAS EXAMINED. 0 THE RESULTS FROM THE STUDY SUGGEST THAT THE INDUCTION OF LEYDIG CELL ADENOMA BY C-8 IS HORMONALLY MEDIATED. 0 ALTHOUGH THE DATA FROM. THE STUDY WAS FAR FROM FIRM OR COMMANDING, THE STUDY SCIENTISTS DID FEEL IT DID NOT PRECLUDE A HUMAN ROUTE FOR TEST1CULAR TUMORS. 0 THIS STUDY IS SUPPORTIVE OP THE LOW LEVEL BENIGN TEST1CULAR TUMORS IN THE 3M STUDY AND SUPPORTS OUR EXISTING LOW AEL. HASMITH/IS 4/12/90 EID924243 STATUS OF 3M C-8 STUDY NOEL FOR LIVER EFFECTS 0 13-WEEK DIETARY STUDY IN MALE RATS - HAZLETON LABS o START DATE " MARCH 29, 1990 - RESULTS BY DECEMBER 1990 (?) 0 PURPOSE: TO ASSESS THE SUBCHROMXC TOXICITY AND TO EVALUATE REVERSIBILITY OF AMY TOXIC EFFECTS. 0 420 MALE CHARLES RIVER RATS GROUP 1. CONTROL 2. Low 3. , MID-LOW 4. MID-HIGH 5. HIGH 6. PAIR-FED CONTROL DOSE LEVEL (PPM) 0 1 3 10 30 O o STUDY ANALYSIS HASMITH/1S 4/12/90 EID924244