Environmental risk assessment of six human pharmaceuticals: Are the current environmental risk assessment procedures sufficient for the protection of the aquatic environment?

Abstract

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.

Sources identification of antibiotic pollution combining land use information and multivariate statistics

“…Concentrations of DOC and OTC were significantly correlated with density of aquaculture (r = 0.74, 0.76, respectively) for June 2010 sampling event. As Nd not detected a (Halling-Sorensen et al 2000) b (Lutzhoft et al 1999) c (Eguchi et al 2004) d (Ferrari et al 2004) shown in Fig. 3, the peak concentrations of DOC and OTC all appeared in East Tiaoxi, where the aquaculture was intensive.…”

Comparison of four different methods for reliability evaluation of ecotoxicity data: a case study of non-standard test data used in environmental risk assessments of pharmaceutical substances

“…The non-standard test data evaluated in this study (presented in Table 2[ [14][15][16][17][18][19][20][21][22]) have been selected for the current analyses since they were either (1) used in risk assessments of active pharmaceutical ingredients within the Swedish environmental classification and information system for pharmaceuticals [[23]; available at http:// www.fass.se] or (2) used in a previous evaluation of this classification system [24]. These selection criteria resulted in a total of nine references that was then evaluated according to the four methods.…”

“…Using the four methods lead to the same evaluation result for two studies only [14,15], both were summarized as studies with unacceptable quality/not reliable. The evaluation result differed by one quality data level, from unacceptable quality/not reliable to acceptable quality/reliable with restrictions, for five studies [16][17][18][19][20] and by two quality data levels, from unacceptable quality/not reliable to high quality/reliable without restrictions, for two studies [21,22] (Table 13).…”

Occurrence and ecological potential of pharmaceuticals and personal care products in groundwater and reservoirs in the vicinity of municipal landfills in China

“…However, limited toxicity information about the PPCPs increased uncertainty in this assessment. Moreover, it has been found that risk assessment based on individual chemicals is often greatly lower than assessments based on chemical mixture (Ferrari et al, 2004;Backhaus and Karlsson, 2014). Therefore, the presence of the PPCPs and the potential ecological risks posed to the groundwater and reservoirs could be a serious issue.…”