04N-0050
RPT 2
Volumes 9-12

Volume 9

Summary Table of Non-Clinical Safety Studies for Octopirox

Tab 1 - Acute Oral Toxicity to Rats of E2414.01

Tab 2 - Up And Down Procedure For Estimating Acute Oral Toxicity (LD50) in Rats of G0506.01

Tab 3 - Acute Oral Toxicity (LD50) Study in Rats

Tab 4 - Acute Oral Toxicity (LD50) Study in Albino Rats

Tab 5 - Acute Oral Toxicity (LD50) Study in Albino Rats

Tab 6 - Acute Dermal Toxicity of G0539.03 on SKH-HR1 Hairless Mice

Tab 7 - Acute Dermal Toxicity Study in Rabbits

Tab 8 - Acute Percutaneous Toxicity Study in Rabbits

Tab 9 - Acute Dermal Toxicity Study in Rabbits

Tab 10 - OECD Acute Inhalation Toxicity Evaluation

Tab 11 - 12 Day Subchronic Percutaneous Toxicity in Rats

Tab 12 - Primary Eye Irritation Study in Albino Rabbits

Tab 13 - Primary Eye Irritation Study in Albino Rabbits

Tab 14 - Primary Eye Irritation Study in Albino Rabbits

Tab 15 - Rabbit Eye Irritation (Low Volume Procedure) of G0556.01

Tab 16 - Irritant Effects on the Rabbit Eye of E2414.01

Tab 17 - Irritant Effects on the Rabbit Eye of 2414.01

Tab 18 - Primary Skin Irritation Study in Albino Rabbits

Tab 19 - Primary Skin Irritation in Rabbits

Tab 20 - Primary Skin Irritation Study in Rabbits

Volume 10

Notebook #2 - Piroctone Olamine

Tab 1 - Rabbit Skin Irritation Patch Test

Tab 2 - Rabbit Skin Irritation Patch Test

Tab 3 - Evaluation of Skin Irritation Potential of Acetic Acid and Octopirox in the Muta Mouse

Tab 4 - Delayed Contact Hypersensitivity in Guinea - Pigs Modified by Ritz, H. L. and Buehler, E. V. on E-2414.01 (ECM BTS 930) according to P&G Protocol No. C 4, June 1983

Tab 5 - Drosophila Melanogaster Sex-Linked Recessive Lethal Assay of Octopirox, G0539.03

Tab 6 - CHO/HGPRT Mutation Assay

Tab 7 - Clonal Transformation Assay Using Syrian Golden Hamster Embryo (SHE) Cells

Tab 8 - Clonal Transformation Assay Using Syrian Golden Hamster Embryo (SHE) Cells

Tab 9 - Test For Chemical Induction of Mutation in Mammalian Cells in Culture: The L5178Y TK+/- Mouse Lymphoma Assay

Tab 10 - Test For Chemical Induction of Mutation in Mammalian Cells in Culture: The L5178Y TK+/- Mouse Lymphoma Assay

Tab 11 - Studies on the Potential of Octopirox to Inhibit DNA Synthesis in CD-1 Mouse Epidermis In Vivo

Tab 12 - Test For Chemical Induction of Unscheduled DNA Synthesis In Primary Cultures of Rat Hepatocytes (by Autoradiography)

Tab 13 - Effect of Octopirox, Piroctone Acid, and the Iron Chelate of Octopirox on DNA, RNA, and Protein Synthesis in L5178Y Mouse Lymhoma Cells and Syrian Hamster Embryo Cells in Culture

Tab 14 - DNA Synthesis In Mouse Epidermis Following Topical Application of a Test Substance Supplied By Procter And Gamble

Tab 15 - The Mechanism of Cell Growth Inhibition By Octopirox

Volume 11

Notebook #3 - Piroctone Olamine

Tab 1 - Inhibition Of Epidermal DNA Synthesis In Muta Mouse By Octopirox: Time-Course And Dose-Response

Tab 2 - Test of the Potential of Octopirox to Induce Mutation in the Skin of Muta Mouse In Vivo

Tab 3 - Percutaneous Teratology Study in the Rabbit

Tab 4 - 14-Day Range-Finding Study in Rats

Tab 5 - Segment I Study of Fertility in Rats, part 2, part 3

Tab 6-31 - No material submitted

Volume 12

Notebook #4 - Piroctone Olamine

Tab 1 - 14-Day Range-Finding Study in Rats

Tab 2 - A One-Generation Reproduction and Teratology Study of G0539.02, part 2, part 3

Tab 3 - The Effects of Dietary Iron Supplementation on the Toxicity of Octopirox in the Young Growing Rat

Tab 4 - Emetic Study in Beagle Dogs

Tab 5 - No material submitted