"VEHICLE - Justification for use and choice of vehicle (if other than water): Selected vehicle was used to assure proper reproducible dosing of vehicle.

- Concentration in vehicle:

- Amount of vehicle (if gavage): 3mL per kg of body weight"

"TEST MATERIAL

- Amount(s) applied (volume or weight with unit):

- Concentration (if solution): 333mg/mL, 66.7 mg/mL, 13.3 mg/mL

- Constant volume or concentration used: Constant concentrations"

"The formulations were prepared at convenient intervals and were used within the 8 days stability period (established in Charles River Study No. 425881) at 2-8°C in the dark. The test item was formulated by adding the appropriate volume of vehicle (20% TPGS) to required amounts of test item and mixed manually and magnetically stirred until a visibly homogeneous suspension was obtained.

"Duration of treatment / exposure: 4-weeks for males starting 2 weeks prior to mating. The females were dosed once daily from 2 weeks prior to mating then continued until at least Day 4 of lactation; the females were sacrificed with their litters between Days 5 and Day 7 of lactation. Frequency of treatment: daily. Details on study schedule: - Age at mating of the mated animals in the study: [...10 weeks"

"No. of animals per sex per dose: 10

Control animals: yes, concurrent vehicle

Details on study design: - Dose selection rationale: Based upon toxicity data from earlier studies."

P0 Male Sprague-Dawley Rats