Abstract

A surfactant NP-10 was administered subcutaneously to 7-week-old Jcl:Wistar female rats at dose levels of 2 and 20 mg/kg/day for 15 weeks to assess its effects on their reproductive ability and fetal development, and on the growth, behavior and functions of the offspring they delivered. In the general condition of the F0 dams, changes that were considered to be the local irritation effect of the test substance, such as scab formation and loss of hair at the test substance administration site in the 2 and 20 mg/kg groups and induration of the skin at the test substance administration site in the 20 mg/kg group were observed. Whitish changes of the subcutis were detected at the test substance administration site in the 2 and 20 mg/kg groups and adhesion of abdominal organs in the 20 mg/kg group in the necropsy findings. In addition, an increase was observed in body weight and in food consumption in the 20 mg/kg group. The reproductive ability test failed to reveal any evidence of an effect that could be ascribed to the test substance. The observations at cesarean section or external, visceral and skeletal examinations revealed no effects attributable to the test substance in the F1 fetuses. The observations on the day of birth and during the period of lactation, external examination, physical development test, general condition, body weight and necropsy findings for F1 and F2 offspring and reflex test, open-field test, water-maze test, organ weight and reproductive ability test performed on the F1 offspring failed to reveal any evidence that could be ascribed to the test substance. These results indicate that under the conditions of this study, NP-10 had no effect on the reproductive ability of females or the fetal development or growth, behavior and functions of their offspring.

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