title: Assessing the effect of oral exposure to Paenibacillus alvei, a potential biocontrol agent, in male, non-pregnant, pregnant animals and the developing rat fetus.
abstract: Paenibacillus alvei, a naturally occurring soil microorganism, may be used in the control and/or elimination of human/animal pathogens present on/within produce commodities associated with human consumption. The safety of oral exposure to P. alvei in male, nulliparous females, the pregnant dam and developing fetus was assessed. Adult male and female rats received a single oral dose (gavage) of P. alvei and tissues were collected at post exposure days 0, 3 and 14. To evaluate the effect of the test organism on fetal development, sperm positive female rats received the test organism every 3 days thereafter throughout gestation. As human exposure would be no more than 1 × 103CFU/ml the following dose levels were evaluated in both study phases: 0 CFU/ml tryptic soy broth (negative control); 1 × 108CFU/ml; 1 × 104CFU/ml or 1 × 102CFU/ml. Neither sex specific dose-related toxic effects (feed or fluid consumption, body weight gain, and histopathology) nor developmental/reproductive effects including the number of implantations, fetal viability, fetal weight, fetal length and effects on ossification centers were observed. The test organism did not cross the placenta and was not found in the amniotic fluid.
authors.affiliation: Division of Toxicology, Office of Applied Research and Safety Assessment, Center for Food Safety & Applied Nutrition, U.S. Food & Drug Administration, Laurel, MD 20708, United States. Electronic address: Robert.sprando@fda.hhs.gov.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Sprando
authors.affiliation: Division of Toxicology, Office of Applied Research and Safety Assessment, Center for Food Safety & Applied Nutrition, U.S. Food & Drug Administration, Laurel, MD 20708, United States.
authors.forename: Thomas
authors.initials: T
authors.lastname: Black
authors.affiliation: Division of Toxicology, Office of Applied Research and Safety Assessment, Center for Food Safety & Applied Nutrition, U.S. Food & Drug Administration, Laurel, MD 20708, United States.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Olejnik
authors.affiliation: Division of Toxicology, Office of Applied Research and Safety Assessment, Center for Food Safety & Applied Nutrition, U.S. Food & Drug Administration, Laurel, MD 20708, United States.
authors.forename: Zachary
authors.initials: Z
authors.lastname: Keltner
authors.affiliation: Division of Toxicology, Office of Applied Research and Safety Assessment, Center for Food Safety & Applied Nutrition, U.S. Food & Drug Administration, Laurel, MD 20708, United States.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Topping
authors.affiliation: Division of Public Health Informatics, Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition, United States Food and Drug Administration, Laurel, MD, United States.
authors.forename: Martine
authors.initials: M
authors.lastname: Ferguson
authors.affiliation: Division of Virulence Assessment, Office of Applied Research and Safety Assessment, Center for Food Safety & Applied Nutrition, U.S. Food & Drug Administration, Laurel, MD 2008, United States.
authors.forename: Darcy
authors.initials: D
authors.lastname: Hanes
authors.affiliation: Division of Molecular Biology, Center for Food Safety & Applied Nutrition, U.S. Food & Drug Administration, College Park, MD 20740, United States.
authors.forename: Eric
authors.initials: E
authors.lastname: Brown
authors.affiliation: Division of Molecular Biology, Center for Food Safety & Applied Nutrition, U.S. Food & Drug Administration, College Park, MD 20740, United States.
authors.forename: Jie
authors.initials: J
authors.lastname: Zheng
mesh_terms: D000284:Administration, Oral; D000653:Amniotic Fluid / Q000382:microbiology; D000818:Animals; D061046:Biological Control Agents / Q000008:administration & dosage / Q000633:toxicity*; D001835:Body Weight; D004326:Drinking; D004435:Eating; D005260:Female; D008297:Male; D009929:Organ Size; D056507:Paenibacillus / Q000472:pathogenicity; D011247:Pregnancy; D017207:Rats, Sprague-Dawley; D018675:Toxicity Tests / Q000379:methods*
chemical_list: D061046:Biological Control Agents
keywords: Biological control; Fetus; Oral toxicity; Paenibacillus alvei; Salmonella enterica; Sex differences; Teratology; Tomato