For exposure-response array data display purposes, the following results were coded (control and no effect findings were coded as "0", treatment-related increases were coded as "1", and treatment-related decreases were coded as "-1".

"No effects on histopathology were observed at 5 mg/kg/day in males or females. 6:2 FTOH-related microscopic findings were present in the kidney, nasal cavity, teeth, pancreas and liver at higher doses (Table 7)."

"A minimal increase in apoptosis of pancreatic acinar cells was seen in 2 male and 4 female early death rats at 250 mg/kg and, after 90 days, in 3 rats/group among all 6:2 FTOH-treatment groups for males and at 125 mg/kg/day in female rats. This minimal increase in apoptosis was also observed in a single control female rat. The increase in a few minimal apoptotic acinar cells was also observed in less than 40% of the rats after the 1-month recovery period, and none after 3 months of recovery."

"An increased apoptosis in the acinar cells of the pancreas of male rats at 250 mg/kg/day was observed after 90 days of dosing and in both sexes one month later. This finding was considered to be of negligible toxicological significance, since apoptosis is a normal physiologic process. When paired with normal cell division, it maintains tissue homeostasis in organs such as the pancreas. Therefore, apoptotic bodies are normal findings in the pancreas and are a mechanism of involution of the pancreas. Its occurrence may rep-resent a secondary response to systemic toxicity and body weight decrements."

"Benchmark Dose Analysis (BMD) was performed on the most sensitive endpoints from the 90-day oral gavage study (liver oval cell hyperplasia, pancreatic acinar apoptosis, and teeth ossification)."

Male Crl:CD SD Rat