Study room: The study room was maintained under conditions of positive airflow relative to a hallway and independently supplied with a minumum of ten changes per hour of 100% fresh air that had been passed through 99.97% HEPA filters. room temperature and humidity were monitored constantly throughout the study. Room temperature was targeted at 66F to 77 F; relative humidity was targeted at 30% to 70%.

Housing: Rats were individually housed in stainless steel, wire bottomed cages. All cage sizes and housing conditions were in compliance with the GUIDE FOR THE VARE AND USE OF LABORATORY ANIMALS.

Lighting: An automatically controlled fluorescent light cycle was maintained at 12-hours light: 12-hours dark, with each dark period beginning at 1900 hours EST.

Sanitization: Cage pan liners were changed at least three times weekly. Cages were changed approximately every other week,

Feed: Rats were given ad libitum access to Certified Rodent Diet #5002 (PMI Nutrition International, Inc., St Louis, Missouri) in individual feeders. Feed was removed the evening prior to scheduled sacrifice.

Feed Analysis: Analyses were routinely performed by the feed supplier. No contaminants at levels exceeding the maximum concentration for certified feed or deviations from expected nutritional requirements were detected by these analyses. Copies of the results of the feed analyses are available in the raw data and in APPENDIX G.

Neither the Sponsor nor the Study Director was aware of any potential contaminants likely to have been present in the feed that would have interfered with the results of this study.

Water: Local water that had been processed by passage through a reverse osmosis membrane (RO water) was available to the rats ad libitum from an automatic watering access system and/or individual water bottles attached to the cages. Chlorine was added to the processed water as a bacteriostat.

Water Analysis: The processed water is analyzed twice annually for possible chemical contamination (Lancaster Laboratories, Lancaster, PA) and monthly for possible bacterial contamination (Analytical Laboratories, Inc., Chalfont, PA). Copies of the results of the water are available in the raw data and in APPENDIX G. Neither the Sponsor nor the Study Director was aware of any potential contaminants likely to have been present in the water that would have interfered with the results of this study.

F1 Male Sprague Dawley Rat