Environmental risk assessment of metformin and its transformation product guanylurea II

Environmental risk assessment of metformin and its transformation product guanylurea: II. Occurrence in surface waters of Europe and the United States and derivation of predicted no-effect concentrations

Daniel J. Caldwell^a, Vincent D'Aco^b, Todd Davidson^c, Kelly Kappler^a, Richard J.Murray-Smith^d, Stewart F. Owen^e, Paul F. Robinson^e,f, Brigitte Simon-Hettich^g, Jürg Oliver Straub^h, JoanTellⁱ

^a Johnson & Johnson, 410 George Street, New Brunswick, NJ, USA
^b BSI EHS Services and Solutions, 1187 Main Avenue, Clifton, NJ, USA
^c Bristol-Myers Squibb, 1 Squibb Drive, New Brunswick, NJ, USA
^d Regulatory Science Associates, Inverkip, United Kingdom
^e AstraZeneca, Alderley Park, Cheshire, United Kingdom
^f Dr. Knoell Consult Ltd., 22 Cathedral Road, Cardiff CF11 9LJ, United Kingdom
^g Merck KGaA, Frankfurter Str. 250, U009/101, 64293 Darmstadt, Germany
^h F. Hoffmann-La Roche, CH–4070 Basle, Switzerland
ⁱ Merck Sharp & Dohme, 2000 Galloping Hill Road, Kenilworth, NJ, USA

Highlights

• Previously unpublished chronic effects data for MET were collated for this study.
• A PNEC for MET was derived by deterministic procedures using these data.
• Chronic studies were conducted to derive a PNEC for GUU.
• PECs for MET and GUU were modeled and MECs were retrieved from literature.
• Risk characterization ratios were <1, indicating no significant risk for MET or GUU.

Dowload your free copy from here.