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U.S. Department of Health and Human Services

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TITLE:  A No Observable Adverse Effects Level (NOAEL) for pigs fed melamine and cyanuric acid
AUTHORS:  Stine CB;Reimschuessel R;Gieseker CM;Evans ER;Mayer TD;Hasbrouck NR;Tall E;Boehmer J;da Costa GG;Ward JL;
YEAR:  2011
JOURNAL ABBREV:  Regul Toxicol Pharmacol
JOURNAL FULL:  Regulatory toxicology and pharmacology : RTP
END PAGE:  372
KEYWORDS:  adverse effects;Crystal;Cyanuric acid;Feed;Food;Infant;Kidney;Melamine;Milk;NEPHROPATHY;pigs;RENAL-FAILURE;Research;SEDIMENTS;STONES;urine;veterinary;Veterinary Medicine;
ABSTRACT:  Ingesting melamine adulterated milk products led to kidney stones in many infants in 2008. This differs from the renal failure caused by intratubular crystal formation after co-ingestion of melamine (MEL) and cyanuric acid (CYA) in adulterated pet foods in 2007. To better understand the potential risk of developing crystal nephropathy following co-ingestion of MEL and CYA, we fed 16 weanling pigs 0, 1, 3.3, 10, 33, or 100 mg/kg bw/day of each MEL and CYA, or 200 mg/kg bw/day of either compound individually for 7 days. Crystals were found in the renal medulla and cortex and urine sediments of all pigs fed both MEL and CYA each at 10 mg/kg bw/day (or greater). Crystals were also found in one of the two pigs fed 200 mg/kg bw/day MEL-only. In a 28 day study, 36 weanling pigs were fed 0, 1, or 3.3 mg/kg bw/day of MEL and CYA or 200 mg/kg bw/day MEL-only. Only one of the 3.3 mg/kg MEL and CYA pig kidneys contained crystals. The no-observed-adverse-effect level (NOAEL) for pigs fed MEL and CYA for 28 days was concluded to be 1.0 mg/kg bw/day corresponding to 25 mg/kg (ppm) MEL and 25 mg/kg (ppm) CYA in dry feed
AFFILIATIONS:  Center for Veterinary Medicine, USFDA, Laurel, MD 20708, USA. cynthia.stine@fda.hhs.gov