Document 6xwOELk5pLQeDDxg97dZnZbE

iff CPrimedica f t f i2 A - 0 ? U Argus Division j 9 0 5 Sheehy Drive, Bldg. A j Horsham, PA 19044 Tei 2 ! 5 . 4 4 3 . 8 7 1 0 | Fox 2 ) 5 . 4 4 3 . 8 5 8 7 ff SS(WS ORIGINAL Y OCT 1 3 2000 y) October 12, 2000 Marvin T. Case, D.V.M., Ph.D. 3M Toxicology Services 3M Center, Building 220-2E-02 St. Paul, Minnesota 55144-1000 Telephone: (651)733-5180 Telefax: (651)733-1773 RE: Protocol 418-009 - Combined Oral(Gavage) Fertility, Developmental and Perinatal/Postnatal Reproduction Toxicity Study of N-EtFOSE in Rats Dear Dr. Case: Enclosed is a copy of the issued final Report Amendment 1 to the above-referenced protocol. If you have any questions, please do not hesitate to contact me. Sincerely, RGY.rg Enc. Associate Director of Research and Study Director fe-rOa CO O ZZZ --ca 3; ron ~'i m ;S yO rrso> XI? Primedica Corporation www.primedico.ee Primedica Argus Research Laboratories. Inc 905 Sheehy Drive. Building A Horsham, PA 19044 Telephone: (215) 443-8710 Telefax: (215)443-8587 REPORT AMENDMENT 1 12 OCTOBER 2000 PROTOCOL 418-009 COMBINED ORAL (GAVAGE) FERTILITY, DEVELOPMENTAL AND PERINATAL/POSTNATAL REPRODUCTION TOXICITY STUDY OF N-ETFOSE IN RATS FINAL REPORT Attached is the corrected Text Figure 1 to the above-referenced final report. This change reflects the addition of a notation for the dosage administration of the FI generation rats and did not affect the results of the study. Associate Director of Research and Study Director ;O t.Zsj2& Date C c t - C O .Ck Nancy J. Gongliewski Date J Manager of Regulatory Compliance PROTOCOL 418-009: COMBINED ORAL (GAVAGE) FERTILITY, DEVELOPMENTAL AND PERINATAL/POSTNATAL REPRODUCTION TOXICITY STUDY OF N-EIFOSE IN RATS Acclimation 14 D iff Estious Evaluation 15/group ta/iaWraliofl 14 Days C. Svdtimtnq Ki/giuup 35 Ftl Famal# R ill Doug Gioop A im * ftatyI foiling Doling Panod Bogins Fm fsm a it flats 0G0 O G 10 tsi PosuWa D(DatG/v2a1ry) last PossiW* Oa&vary (DG 25) t P A R T U R IT IO N lactation O a r ) (CM. l| Dosing Pno4 Ends tor farnale (0f1la2t0s ) Pharmacokinetic Sample CoUaction 5/group 1 (01?t|Oar t Sacrifice 418-009 :PAGE REVISED PA b