Environmental risk assessment of six human pharmaceuticals: are the current environmental risk assessment procedures sufficient for the protection of the aquatic environment?
In this study, exposure and ecotoxicity data of six human pharmaceuticals (carbamazepine, clofibric acid, diclofenac, ofloxacin, propranolol, and sulfamethoxazole) were collected, including our own experimental data and literature data. From this data collection, the two-tiered European draft guideline on the environmental risk assessment of human pharmaceuticals was tested. Measured environmental concentrations in effluents from France and in effluents and surface waters from Germany were compared to the predicted environmental concentrations (PECs) in both countries. In a similar manner, predicted no-effect concentrations (PNECs) derived from acute data and PNECs derived from chronic data were estimated for each pharmaceutical and corresponding PEC/PNEC ratios then were compared in both countries. Globally, results demonstrated that all environmental concentrations (predicted or measured) for each considered pharmaceutical exceeded the 10-ng/L cutoff value, which requires the implementation of the second-tier assessment based on ecotoxicity data. Moreover, the six pharmaceuticals showed a relatively limited acute toxicity, and carbamazepine and propranolol were inaccurately identified as having negligible risks under the current European draft procedure. Such results lead to discussion of the actual procedure on pharmaceuticals, especially on the need of appropriate ecotoxicity tests.
Ferrari
Benoît
B
Laboratoire d'ecotoxicologie, Institut F.-A. Forel, 10 route de Suisse, CH-1290 Versoix, Switzerland.
Mons
Raphael
R
Vollat
Bernard
B
Fraysse
Benoît
B
Paxéus
Nicklas
N
Lo Giudice
Roberto
R
Pollio
Antonino
A
Garric
Jeanne
J
D000818:Animals; D002220:Carbamazepine / Q000009:adverse effects; D002995:Clofibric Acid / Q000009:adverse effects; D004008:Diclofenac / Q000009:adverse effects; D064420:Drug-Related Side Effects and Adverse Reactions; D004784:Environmental Monitoring; D005602:France; D005858:Germany; D006801:Humans; D015242:Ofloxacin / Q000009:adverse effects; D004364:Pharmaceutical Preparations / Q000032:analysis; D011433:Propranolol / Q000009:adverse effects; D018570:Risk Assessment / Q000379:methods / Q000592:standards; D013420:Sulfamethoxazole / Q000009:adverse effects; D018675:Toxicity Tests / Q000379:methods / Q000592:standards; D014874:Water Pollutants, Chemical / Q000032:analysis* / Q000633:toxicity
D004364:Pharmaceutical Preparations; D014874:Water Pollutants, Chemical; D004008:Diclofenac; D002220:Carbamazepine; D002995:Clofibric Acid; D011433:Propranolol; D015242:Ofloxacin; D013420:Sulfamethoxazole