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".

"There was 1 out of 10 couples (male no. 28 and female no. 68) treated at 300 mg/kg without successful mating, and 1 out of 10 couples (male no. 33 and female no. 73) treated at 1000 mg/kg without pregnancy despite proof of mating. No cause for the absences of offspring could be established from the sections examined. Based on the low incidences (within / background incidence of rats of this strain and age) and absence of related histopathology changes in the reproductive organs, these failures to produce offspring were considered to be unrelated to treatment with the test material. There were no morphological findings in the reproductive organs of either sex, which could be attributed to the test material.

Mating Index: There were no differences in the mating index in the treated groups compared to the controls. One female treated at 300 mg/kg (no. 68) showed no evidence of mating. This incidental unsuccessful mating, which occurred in absence of related histopathology changes in reproductive organs or a dose-related trend, was considered to be unrelated to treatment.

Precoital time: There were no differences in precoital time in the treated groups compared to the controls. All females with evidence of mating were mated within 4 days, except for one female each in the low dose and high dose group for which it took 14 days before mating could be confirmed. At the isolated incidence and in the absence of a dose-related trend, it was considered to be unrelated to treatment. Number of implantation sites: There were no differences in the number of implantation sites in the treated groups compared to the controls.

Fertility and Conception index: There were no differences in fertility and conception indices in the treated groups compared to the controls. Except for one female treated at 1000 mg/kg (no. 73), all mated females were pregnant. This incidental non-pregnancy without related histopathology changes in reproductive organs was considered to be unrelated to treatment."

P0 Male Crl:WI(Han) Rats