title: Two new nontoxic, non-pathogenic strains of Sphingomonas elodea for gellan gum production.
abstract: Two new strains of Sphingomonas elodea (designated as PHP1 and PBAD1) were tested for toxicity and pathogenicity in healthy Sprague-Dawley CD(®) IGS rats in separate studies. In each study, twelve rats/sex were administered ≥10(8) viable cells/rat by oral gavage, and four untreated rats/sex served as controls. Blood, feces, and selected organs/tissues collected at various times over the course of the 22 day study were evaluated for the presence of PHP1 or PBAD1 (depending on the study) by a validated method, to determine the potential for survival, propagation, or infectivity of PHP1 and PBAD1 cells in the rat. No mortalities, test substance-related changes in clinical or macroscopic findings, body weight or body weight gain were observed in treated animals compared with controls, indicating a lack of toxicity. PHP1 or PBAD1 were not detected in the tissue, fecal or fluid samples collected from treated animals. Therefore, neither PHP1 nor PBAD1 were pathogenic or acutely toxic under the conditions of the studies.
authors.affiliation: Burdock Group, 859 Outer Road, Orlando, FL 32814, USA. Electronic address: ldolan@burdockgroup.com.
authors.forename: Laurie C
authors.initials: LC
authors.lastname: Dolan
authors.affiliation: Burdock Group, 859 Outer Road, Orlando, FL 32814, USA.
authors.forename: Ray A
authors.initials: RA
authors.lastname: Matulka
authors.affiliation: Burdock Group, 859 Outer Road, Orlando, FL 32814, USA.
authors.forename: Alex L
authors.initials: AL
authors.lastname: LeBeau
authors.affiliation: Product Safety Laboratories, 2394 Highway 130, Dayton, NJ 08810, USA.
authors.forename: Jamie M
authors.initials: JM
authors.lastname: Boulet
mesh_terms: D000818:Animals; D001769:Blood / Q000382:microbiology; D015169:Colony Count, Microbial; D005243:Feces / Q000382:microbiology; D005260:Female; D054884:Host-Pathogen Interactions; D008297:Male; D050296:Microbial Viability; D011135:Polysaccharides, Bacterial / Q000096:biosynthesis* / Q000235:genetics; D017207:Rats, Sprague-Dawley; D018570:Risk Assessment; D020578:Sphingomonas / Q000235:genetics / Q000302:isolation & purification / Q000378:metabolism / Q000472:pathogenicity*; D013997:Time Factors; D014018:Tissue Distribution
chemical_list: D011135:Polysaccharides, Bacterial; C048288:gellan gum
keywords: Gellan gum; Pathogenicity; Rat; Sphingomonas elodea; Toxicity