title: 28-day repeated dose response study of diglycolic acid: Renal and hepatic effects.
abstract: The acute oral toxicity of diglycolic acid (DGA) was evaluated. Groups of female rats (n = 8 rats/group) received 28 consecutive daily single doses of 0.3, 1.0, 3.0, 10.0, 30.0, 100.0 or 300.0 mg DGA/kg body weight by gastric intubation. One group of animals served as vehicle control. Tissues and blood serum were collected at necropsy on day 29. Select organs were weighed and fixed in formalin for histopathological analysis. Animals from the 300 mg/kg bw dose group were removed from the study after 5 consecutive days of treatment as a consequence of adverse treatment related effects. The animals in the remaining treatment groups survived the exposure period. No adverse clinical signs were observed throughout the exposure period in the surviving animals. No significant differences from controls were observed for feed and fluid consumption or body weight gain in the surviving animals. Lesions were observed in the kidneys, liver, stomach, intestine, thymus, spleen and bone marrow in rats from the 300 mg/kg dose group and signs of renal tubular regeneration were observed only in the 100 mg/kg dose group. These results suggest that high levels of pure DGA would need to be consumed before renal and other forms of organ toxicity are observed.
authors.affiliation: 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: Center for Food Safety & Applied Nutrition, U.S. Food & Drug Administration, Laurel, MD 20708, United States.
authors.forename: Miriam E
authors.initials: ME
authors.lastname: Mossoba
authors.affiliation: 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: 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: Center for Food Safety & Applied Nutrition, U.S. Food & Drug Administration, Laurel, MD 20708, United States.
authors.forename: Sanah
authors.initials: S
authors.lastname: Vohra
authors.affiliation: 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: Center for Food Safety & Applied Nutrition, U.S. Food & Drug Administration, Laurel, MD 20708, United States.
authors.forename: Howard
authors.initials: H
authors.lastname: Toomer
authors.affiliation: Center for Veterinary Medicine, US Food and Drug Administration, 8401 Muirkirk Rd, Laurel, MD 20708, United States.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Stine
authors.affiliation: Center for Veterinary Medicine, US Food and Drug Administration, 8401 Muirkirk Rd, Laurel, MD 20708, United States.
authors.forename: Eric
authors.initials: E
authors.lastname: Evans
authors.affiliation: Center for Food Safety & Applied Nutrition, U.S. Food & Drug Administration, Laurel, MD 20708, United States.
authors.forename: Jessica L
authors.initials: JL
authors.lastname: Sprando
authors.affiliation: Center for Food Safety & Applied Nutrition, U.S. Food & Drug Administration, Laurel, MD 20708, United States.
authors.forename: Martine
authors.initials: M
authors.lastname: Ferguson
mesh_terms: D000825:Animal Structures / Q000187:drug effects / Q000473:pathology; D000818:Animals; D004305:Dose-Response Relationship, Drug; D005260:Female; D006016:Glycolates / Q000008:administration & dosage / Q000633:toxicity*; D007668:Kidney / Q000187:drug effects* / Q000473:pathology; D008099:Liver / Q000187:drug effects* / Q000473:pathology; D051381:Rats; D017207:Rats, Sprague-Dawley; D018675:Toxicity Tests
chemical_list: D006016:Glycolates; C571256:diglycolic acid
keywords: Diglycolic acid; Hepatic toxicity; Oral exposure; Renal toxicity