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

27 February, 2019

Daniel J. Caldwella, Vincent D'Acob, Todd Davidsonc, Kelly Kapplera, Richard J.Murray-Smithd, Stewart F. Owene, Paul F. Robinsone,f, Brigitte Simon-Hettichg, Jürg Oliver Straubh, 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  • Previously unpublished chronic effects data for MET were collated for this study.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.

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