Document 9L4bjrY7BDx6qyv3nB7XgxJw7
O Primedica
Argus Division j 905 Sheehy Drive, Bldg. A ! Horsham, PA 19044
Tel 21 5.443.871 0 | Fax 2 15.4 43.8587
_________
fhi I I S [ M l
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
Pnmedica Corporation ! www.prime
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.
/- O C T - 0 O
RaytWond G. York, PHT3., DABT Associate Director of Research and Study Director
Date
J y)>': ./i/ C'ali 2 T , cn Nancy J. Gongliewski
/ OC -CO Date
J Manager of Regulatory Compliance
PROTOCOL 418 009: COMBINED ORAL (GAVAGE) FERTILITY, DEVELOPMENTAL AND PERINATAL/POSTNATAL REPRODUCTION TOXICITY STUDY OF N-EtFOSE IN RATS
MAlE
Acclimation M Day*
Cohabitation 14 Days
Ptiaimacokineiic Sample Collection S'gioup
F0 Male Rais
Sacrificed
JS r Q Mal Hals Dosage Gioup Attive
ai Testing facility
Closing Penod 8egms foi Male Rais
Acciimalion 14 Days
Estiuus Evaluation iVgruup
Cohabitation 14 Days
DO 10
C Sectioning lU/giuup
Dosing Period Ends loi Male Rais
3b F ! Female Rais Dosage Gioup Attive
al Tailing Facility
Dosing Period Begins For Female Rats
FI GENERATION
F t Dosing Peiiod Begins Day I
isl Possible Delivery |DG 21)
Lesi Possible Oeliveiy |0G 25)
t
PARTURITION Udatlon Day 1 (01 t)
Dosing Penod Ends lot Female
Rets (DL 20)
Pharmacokinetic Sample
Collection
IS'gioup
Day ol Sacrifice IOC 21)
Possible Delivery (OG 21)
last Possible Oeliveiy (DG 2S)
418-009: PAGE 1-4 REVISED PAGE
