Document gadZpRbjj7d89NGbVweepb069

PROTOCOL CHRONIC INHALATION TOXICITY STUDIES ON Ti02 AND TiCl^ Approved for Pathology: /V/ty / ,, G; Aft?osmis, DVM Approved for Biochemistry: Approved for Toxicology: Barnes, Ph.D. 8/31/77 DRAFT PRELIMINARY PROTOCOL* FOR TWO_YEAR INHALATION STUDY FOR TITANIUM DIOXIDE AND TITANIUM TETRACHLORIDE INTRODUCTION This study is designed to evaluate the potential chronic toxicity and carcinogeneity of titanium dioxide and titanium tetrachloride, respectively, in rats, by inhalation. The two test compounds will be started simultaneously utilizing one common control. MATERIALS TO EE TESTED Titanium dioxide (TiO^, Titanium Oxide) is a crystalline and amorphous powder with the following properties: Form: White solid, Median Particle Size ~1.0|j Molecular Weight: 79.9 . Melting Point: Specific Gravity (water = l): Decomposes at l640C 3-8-4.2 Solubility: Insoluble in water; soluble in sulfuric acid or alkali Titanium tetrachloride (TiCl^) is a liquid at room temperature and has the following properties: Specific Density 1.7 g/ce Molecular Weight 189.73 Boiling Point a.t "j60 mm Rg 137 C Color APHA-40 Vapor Pressure at 25C 15 mm Hg Solubility > 10$ in water; reacts with acetone, ethanol, dimethylsulfoxide and vegetable oil DUP050447991 CENTRAL RESEARCH & DEVELOPMENT DEPARTMENT HASKELL LABORATORY FOR TOXICOLOGY AND INDUSTRIAL MEDICINE DATE March 5, 1979 fcFR/BCM. JGA' FAB JRG QNH INP6 TO: W. H. DARNELL CHEMICALS, DYES & PIGMENTS DEPARTMENT B-17366 REVISED ------------------------ MEDICAL RESEARCH PROJECT MR-2929 PART I TITLE: CHRONIC INHALATION TOXICITY STUDIES ON TiOz AND TiCl4 Authority is requested to undertake the investigation identified above and described as follows: This revised proposal is written to cover the costs of chronic inhalation toxicity studies on Ti02 and TiCl^ in rats. A detailed protocol and cost estimate is attached. The cost estimate below is based on 3 test concentrations/compound with shared control group exposed for 24 months. This estimate reflects operating cost increases sustained since submittal of the preliminary proposal and includes-an' allowance for projected cost increases through 1982. Amount requested_________ $588,205 Previously authorized $667,179 Expended to date_______________ 0________ Account to be charged 18225.0<y6r Work to be started 2nd Quarter 1979 Request for study made by discussions between R. Salemi and Haskell personnel, June, 1977. __________ If this request meets with your approval, please enter the account to be charged, have two copies authorized and return them to Haskell Laboratory, Control Section. The additional copies may be retained for your informa'tionand distribution. Proposed b -'--eider, Jr. --"igations Approved by_ PWS/cgs N 30820.01 CENTRAL RESEARCH & DEVELOPMENT DEPARTMENT HASKELL LABOPsATORY FOR TOXICOLOGY AND INDUSTRIAL MEDICINE DATE August 17, 1977 TO: DR. ROBERT SALEMI PIC-MENTS DEPARTMENT MEDICAL RESEARCH PROJECT MR- 2929 PART I TITLE: CHRONIC INHALATION TOXICITY STUDIES ON TiOg AND TiCl^ Authority is requested to undertake the investigation identified above and described as follows: This proposal is written to cover the costs of chronic inhalation toxicitystudies on Ti02 and TiC14 in rats. A detailed protocol and cost estimate is attached. The cost estimate below is based on 3 test levels/compound and a. common control group exposed for approximately 18 months (followed by a 6-month holding period). If exposure beyond 18 months is necessary, a Part II to this project will be written. A cost estimate'for an additional six months' exposure is included in the attachment. Amount requested $667.170________ Previously authorized_______0______ Expended to date _______________ _ Account to be charged 8225-066 Work to be started 1st Quarter 1T7Q Request for study made by rH gcngglnns between R. Salemi and Haskell personnel, June 1977. If this request meets with your approval, please enter the account to be charged, have two copies authorized and return them to Haskell Laboratory, Control Section. The additional copies may be retained for_ your^in-f&rma-fion and distribution. Proposed by r> ivt f i fir / *' Approv, **'!/*' Authorized Is .... /!,(,. DUP050447993