Safety assessment of gamma-glutamylcysteine sodium salt.

S D Chandler, M H Zarka, S N Vinaya Babu, Y S Suhas, K R Raghunatha Reddy, W J Bridge

Biospecialties International P/L, 57 Tourle St., Mayfield, NSW, Australia.

Regulatory toxicology and pharmacology : RTP 2012 Oct

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γ-Glutamylcysteine (GGC) is a relatively unexplored option for the treatment of chronic glutathione depletion related disorders that involve down regulation of GGC synthetase. High purity GGC (sodium salt) has only recently become available and, given its reactive capacity, required an investigation of its safety profile. In this report, GGC sodium salt was demonstrated to be safe according to Organisation for Economic Cooperation and Development (OECD) toxicology protocols for acute and repeated doses. No mortalities or adverse effects were observed in Wistar rats following the acute oral (gavage) administration of 2000mg sodium GGC /kg body weight. No animal deaths occurred with daily administration (1000mg/kg sodium GGC) over 90days, with a post trial 28day observation period. GGC had no significant effect on feed consumption, body weights, physical appearance, neurological behaviour and urine chemistry. No consistent significant differences between treatment groups were observed in haematological and clinical chemistry parameters. Similarly, no post-mortem necroscopically identified abnormalities could be attributed to GGC. Based on these observations, sodium GGC can be classed as not acutely toxic at 2000mg/kg, with a no-observed-adverse-effect level (NOAEL) of at least 1000mg/kg/day for systemic toxicology from repeated dose oral gavage administration. Copyright © 2012 Elsevier Inc. All rights reserved.

Citation

S D Chandler, M H Zarka, S N Vinaya Babu, Y S Suhas, K R Raghunatha Reddy, W J Bridge. Safety assessment of gamma-glutamylcysteine sodium salt. Regulatory toxicology and pharmacology : RTP. 2012 Oct;64(1):17-25