"Route of administration: oral: gavage

Details on exposure: PREPARATION OF DOSING SOLUTIONS:

Dosing solutions were prepared daily before administration Using purified water as a vehicle, solution with a concentration of 30 mg/mL was prepared first. Then, the solution was diluted with vehicle and prepared as solutions with concentrations of 1 and 6 mg/L.

Details on mating procedure: M/F ratio per cage: 1:1

Length of cohabitation: up to 14 days

Proof of pregnancy: Vaginal plug or sperm in vaginal smear referred to day 0 of pregnancy.

Analytical verification of doses or concentrations: no

Details on analytical verification of doses or concentrations:

Because of high volatility of the test article, analytical verification of doses could not be performed.

Duration of treatment / exposure: Male: 42 days including 14-days pre-mating period and mating period

Female: 42-52 days including 14 days pre-mating, mating and gestation periods, and days until lactation day 4.

Frequency of treatment: once daily"

"Administration groups: Control and high dose groups: 7 males and 12 females per dose

Low and mid dose groups: 12 per sex per dose

Recovery groups: Control and high dose groups: 5 per sex per dose

- Dose selection rationale: In 14-days preliminary study, a dose of 500 mg/kg/day tested was proved to be excess because of poor general conditions for the test animals. As a consequence, the top dose in the main study was set down to 300 mg/kg/day. The mid and low doses were set as 60 and 10 mg/kg/day, respectively.

- Rationale for selecting satellite groups: Satellite groups for recovery study were set for control and high dose groups.

- Post-exposure recovery period in satellite groups: 14 days"

F1 Male Crj:CD(SD) Rats