Document b5gojKm953mjqXen8XDvKo1ay

SHORT-TERM STUDY PROTOCOL SHEET MR NUMBER: MK-35^0-001 HASKELL NUMBER: 13,257 NAME & SYNONYM: Paint, Dulux Enamel TYPE TEST: SK-MISC - 5r>' DOSAGE LEVELS : / ^ PROPOSED STARTING DATE: /*/*/?? PROPOSED COMPLETION DATE: 1-- DISPOSAL OF WASTE MATERIALS: ', ^ . ^ SPECIAL SAFETY HANDLING PROCEDURES: FOR ADDITIONAL PROTOCOL INFORMATION SEE THE STANDARD OPERATING PROCEDURE FOR THE ABOVE TEST TYPE.* VARIANTS FROM THE STANDARD OPERATING PROCEDURE FOR THIS TEST: / Clyv&r/q/Ui'Y . / /O*-/ SIGNATURE OF STUDY DIRECTOR ^ S'/? ? /DATE OF''APPROVAL *ADDITIONAL REFERENCE: HASKELL LABORATORY REPORT NO, 206-75 IENTRAL RESEARCH AND DEVELOPMENT DEPARTMENT HASKELL LABORATORY FOR TOXICOLOGY AND INDUSTRIAL MEDICINE wi nranstnaB SHORT-TERM STUDY PROTOCOL SHEET MR NUMBER:. 3540-001 HASKELL NUMBER; 13,257 NAME & SYNONYM: Paint, Dulux Enamel TYPE TEST: Skin-Misc. ,, tf-/3,/0 DOSAGE LEVELS : !/>yJi 'Wf4''** PROPOSED STARTING DATE:3/4/J 3_ PROPOSED COMPLETION DATE0*?' - DISPOSAL OF WASTE MATERIALS: vJ 4^3 . SPECIAL SAFETY HANDLING PROCEDURES: ^ i' dh/& /H V 4 ^ FOR ADDITIONAL PROTOCOL INFORMATION SEE THE STANDARD OPERATING PROCEDURE FOR THE ABOVE TEST TYPE.* VARIANTS FROM THE STANDARD OPERATING PROCEDURE FOR THIS TEST: IS THIS STUDY INTENDED FOR THE FDA? Q YES 43 NO _________ (fK^>______ SIGNATURE OF STUDY DIRECTOR DATE OF ''APPROVAL " ADD.IT IONAL REFERENCE: HASKELL LABORATORY REPORT NO. 206-75 Revised 12/5/79 DUP040002360 PROTOCOL FOR 15-DAY SKIN ABSORPTION STUDY WITH (H-13,257) PAINT, DULUX ENAMEL AND (H-13,163) LEAD NAPHTHANATE Test Materials: H-13,257 - Paint, Dulux Enamel containing 0.415% of 24% Lead Naphthanate Solution H-13,163 - 24% Lead Naphthanate Solution Test Animals: 30 male New Zealand albino rabbits will be taken from stock after they have been quarantined for approximately 10-14 days. The rabbits will be weighed prior to the start of the test and every 5 days thereafter. The animals will be arranged in 3 groups of ten with the average weight of each group being approximately the same. Group I - Control (water) Group II - H-13,257 and H-13,163 (Paint, Dulux Enamel containing 1,2% Lead Naphthanate by weight) Group III - H-13,257 and H-13,163 (Paint, Dulux Enamel containing 6% Lead Naphthanate by weight) Treatment and Preparation of Stock Suspension: A. The control group (I) will be administered 1.0 ml of distilled water on the shaved intact skin of their backs per treatment. Treatments will be administered once/day for 10 consecutive days. The test material will not be washed off of the animal at any time during the study. The treated area will be covered with a small (~1-1/2" x 1") plastic shield, then covered with Saran Wrap and secured with adhesive wrapping. B. For Group II, a stock suspension of H-13,257 containing 1.2% h -13,163 will be made in the following manner (on a weight % basis): 1. Weigh out 4.604 g of Lead Naphthanate (H-13,163). 2, Add to it 95.396 g of Paint, Dulux Enamel (H-13,257) containing 0,415 wt, % Lead Naphthanate, This suspension will be applied to Group II test animals using the procedure in A and wrapped accordingly. DUP040002361 2 C. For Group III a stock suspension of H-13,257 containing 6% H-13,163 will be made in the following manner (on a weight % basis): 1. Weigh out 24.687 g of lead Naphthanate (H-13,163). 2. Add to it 75.313 g of Paint, Dulux Enamel (H-13,257) containing 0.415 wt. % Lead Naphthanate. This suspension will be applied to Group III test animals using the procedure in A and wrapped accordingly. All animals will remain wrapped for 6 hours after treatment. Parameters: Blood will be taken from a vein in the ear of all 3 groups of rabbits on day 0. Blood will be taken in the same manner from test groups II and III on days 5 and 10. On day 15, blood will again be taken from controls and the 2 test groups. All blood analyses will be done by the Analytical Section of the Technical Services Division at Haskell Lab. PA:seg 1/31/80 Prepared By: Approved By O. Louis Dashiell ; Supervisor, Toxicology Division Neil D. Krivanek Consultant, Industrial Hygiene DUP040002362 ATTAUH.i'OBlNT Technical Time = $57/hr. Other = $26/hr. BUDGET - $12,000.00 Expenses Analytical Expenses Lab Assistants Shaving Holding Technical Bleeding Treating Report Pretest Work Other (Technicians) Bleeding Pretest Work Cost of animals per die m Estimated Total Cost $5,250.00 260.00 875,00 484.50 570.00 200.00 -800.00 442.00 156.00 420.00 (14 .00 ea. - 30) (1. 05/day/animal) $9,768.50 DUP040002363