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International Journal of Toxicology
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Articles

Peri- and Postnatal Developmental Toxicity of Salcaprozate Sodium (SNAC) in Sprague-Dawley Rats

M. Gary I. Riley
Raymond G. York

From the Emisphere Technologies, Cedar Knolls, New Jersey (MGIR); and RG York and Associates, LLC, Manlius, New York (RGY).

Correspondence: Please address correspondence to M. Gary I. Riley, DVM, PhD, DACVP, DABT, Vice President, Nonclinical Development and Applied Biology, Emisphere Technologies, 240 Cedar Knolls Rd, Cedar Knolls, NJ 07929; e-mail:griley{at}emisphere.com.

Salcaprozate sodium (SNAC) (sodium 8-((2-hydroxybenzoyl) amino) octanoate, CAS RN 203787-91-1) is classified as an oral absorption promoter and may be a useful means for improving the absorption of certain nutrients and pharmaceutical agents. Presented herein is a subset of data from a larger study evaluating the potential effects of SNAC on the gestation, parturition, lactation, maternal behavior, and offspring development of rats. Pregnant Crl:CD BR VAF/Plus female rats (F0; n = 25) received SNAC at 1000 mg/kg/d orally (gavage) from implantation through lactation and weaning. F1 pups were exposed in utero and potentially through maternal milk; observations continued through sexual maturity. The study concluded with Caesarean sectioning of F1 dams for litter observations and fetal evaluations. No deaths, abortions, premature deliveries, or gross lesions occurred in (F0) dams. Excess salivation, red perivaginal substance, and slight reductions in body weights, body weight gains, and/or feed intake were noted in late gestation/early lactation. SNAC was associated with a prolonged gestation period, leading to a greater number of dams with stillborn pups, higher number of stillborn pups, and reduced live litter size. Offspring body weights/gains, feed consumption, age of sexual maturation, mating, fertility, behavioral parameters, and organ weights at necropsy were unaffected by SNAC. No gross external changes were observed in F1 or F2 pups. In summary, SNAC administered orally at 1000 mg/kg/d to pregnant rats from gestation to weaning resulted in a slight decrease in maternal body weights (–3.8%) and prolonged gestation, along with an increase in stillbirths, but had no effects on growth and development in surviving offspring.

Key Words: CAS RN 203787-91-1 • rat • salcaprozate sodium • SNAC • developmental toxicity

International Journal of Toxicology, Vol. 28, No. 4, 266-277 (2009)
DOI: 10.1177/1091581809337736
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