Oral Prenatal and Postnatal Development Study of WR238605 Succinate in Rats. Volume 2 of 2
Abstract
This study evaluated the toxic potential of WR238605 Succinate on the pregnant/lactating female CD* rat (F0 generation) and the survival and development of their offspring (F, generation) consequent to exposure from implantation through weaning. Doses were 2, 6, and 18 mg base/kg/day based on a developmental toxicity study in female CD rats (UIC/TRL Study No. 154) in which decreased body weight gains and food consumption occurred throughout the study at 30 mg base/kg/day while marginal reductions in body weight and food consumption were noted during the dosing period at 10 mg base/kg/day. In the present study, doses of 2, 6, and 18 mg base/kg/day were administered by daily gavage to female CD rats (the F0 generation) for at least 36 days: from gestation day (GD) 0 through postnatal day (PND) 20. The results are summarized in Table 1. There were no mortalities or treatment-related clinical signs or necropsy observations noted in the F generation maternal animals at any dose level. At 18 mg base/kg/day, maternal toxicity was observed as significantly reduced body weights, noted essentially throughout the dosing period (i.e., GD9 - PND21), and significantly reduced food consumption, noted over the gestation period (i.e., GD6 - 20). Significantly reduced food consumption occurred at 6 mg base/kg/day following the initiation of dosing over GD6 - 9; however, body weights were unaffected. Administration of WR238605 Succinate did not affect food consumption or body weights at the low dose. Gestation duration, parturition, and litter size were unaffected by treatment at any dose level. Thus, administration of WR238605 Succinate did not adversely affect the dams' ability to deliver and rear her offspring. Offspring at 18 mg base/kg/day had evidence of growth retardation and slight developmental and functional delays.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 18, 1996
- Accession Number
- ADA640552
Entities
People
- Barry S. Levine
- Debra L. Kirchner
Organizations
- University of Illinois at Chicago