Environmental effect assessment for sexual endocrine-disrupting chemicals: Fish testing strategy.

Current standard testing and assessment tools are not designed to identify specific and biologically highly sensitive modes of action of chemicals, such as endocrine disruption. This information, however, can be important to define the relevant endpoints for an assessment and to characterize thresholds of their sublethal, population-relevant effects. Starting a decade ago, compound-specific risk assessment procedures were amended by specifically addressing endocrine-disrupting properties of substances.

Environmental risk assessment of ivermectin: A case study.

The veterinary parasiticide ivermectin was selected as a case study compound within the project ERAPharm (Environmental Risk Assessment of Pharmaceuticals). Based on experimental data generated within ERAPharm and additional literature data, an environmental risk assessment (ERA) was performed mainly according to international and European guidelines. For the environmental compartments surface water, sediment, and dung, a risk was indicated at all levels of the tiered assessment approach.

Environmental risk assessment for the serotonin re-uptake inhibitor fluoxetine: Case study using the European risk assessment framework.

The serotonin re-uptake inhibitor fluoxetine was selected for an environmental risk assessment, using the most recent European guideline (EMEA 2006) within the European Union (EU)-funded Environmental Risk Assessment of Pharmaceuticals (ERAPharm) project due to its environmental persistence, acute toxicity to nontarget organisms, and unique pharmacokinetics associated with a readily ionizable compound. As a widely prescribed psychotropic drug, fluoxetine is frequently detected in surface waters adjacent to urban areas because municipal wastewater effluents are the primary route of entry to aquatic environments. In Phase I of the assessment, the initial predicted environmental concentration of fluoxetine in surface water (initial PEC(SW)) reached or exceeded the action limit of 10 ng/L, when using both a default market penetration factor and prescription data for Sweden, Germany, and the United Kingdom.

A water-sediment screening tool for measuring biodegradation of organic chemicals.

A water-sediment screening tool (WSST) was developed based on OECD guideline 301 C (MITI I; Ministry of International Trade and Industry, Japan) to generate biodegradation data. The WSST and experimental procedures were tested and validated using aniline (CAS No. 62-53-3) and benzoic acid (CAS No.

Targeting the environmental risk assessment of pharmaceuticals: Facts and fantasies.

In contrast to industrial chemicals, pharmaceuticals and pesticides are designed to show specific pharmacological actions or biocidal activities. Despite this difference, the same principles for environmental risk assessment, e.g.

Environmental risk assessment of human pharmaceuticals in the European Union: A case study with the β-blocker atenolol.

β-Adrenergic receptor blockers (β-blockers) are applied to treat high blood pressure, ischemic heart disease, and heart rhythm disturbances. Due to their widespread use and limited human metabolism, β-blockers are widely detected in sewage effluents and surface waters. β-Adrenergic receptors have been characterized in fish and other aquatic animals, so it can be expected that physiological processes regulated by these receptors in wild animals may be affected by the presence of β-blockers.

Toxication or detoxication? In vivo toxicity assessment of ozonation as advanced wastewater treatment with the rainbow trout.

Ozonation as advanced wastewater treatment method is an effective technique for micropollutant removal. However, the application of this method carries the inherent danger to produce toxic oxidation byproducts. For an ecotoxicological assessment conventionally treated wastewater, wastewater after ozonation and ozonated wastewater after sand filtration were evaluated in parallel at an operating treatment plant via the fish early life stage toxicity test (FELST) using rainbow trout (Oncorhynchus mykiss).

A ranking of European veterinary medicines based on environmental risks.

The most likely entry pathways of veterinary pharmaceuticals to the environment are via slurry or manure from intensively reared animals to soil and via dung or urine from animals grazing on pasture. These pathways may result in contamination of surface water via runoff or leaching and drainage. Direct entry into water may occur by defecation by pasture animals or by Scompanion animals.

Direct and indirect effects of pollutants on algae and algivorous ciliates in an aquatic indoor microcosm.

An aquatic indoor microcosm was used to study effects of the pesticides parathion-methyl and prometryn on phototrophic flagellates (Cryptomonas sp.) and predatory ciliates (Urotricha furcata). Parathion-methyl caused effects to flagellates and ciliates at the range of low mg L(-1), regardless of whether the organisms were exposed separately or combined in the multi-species test system.

ECOSAR model performance with a large test set of industrial chemicals.

The widely used ECOSAR computer programme for QSAR prediction of chemical toxicity towards aquatic organisms was evaluated by using large data sets of industrial chemicals with varying molecular structures. Experimentally derived toxicity data covering acute effects on fish, Daphnia and green algae growth inhibition of in total more than 1,000 randomly selected substances were compared to the prediction results of the ECOSAR programme in order (1) to assess the capability of ECOSAR to correctly classify the chemicals into defined classes of aquatic toxicity according to rules of EU regulation and (2) to determine the number of correct predictions within tolerance factors from 2 to 1,000. Regarding ecotoxicity classification, 65% (fish), 52% (Daphnia) and 49% (algae) of the substances were correctly predicted into the classes "not harmful", "harmful", "toxic" and "very toxic".

Estimating the use of veterinary medicines in the European union.

Risk-based ranking is a procedure that ranks active substances according to their potential environmental risk, which can be used to prioritise effort in environmental risk assessment procedures. An important aspect in this procedure is the extent of use of the active substance. However, use volume data for veterinary pharmaceuticals are generally not publicly available.

Eco-labelling of shampoos, shower gels and foam baths.

Goal, Scope And Background: Environmental issues of personal care products have been met with little attention in the past. Monitoring data as well as preliminary environmental risk assessments indicate that some ingredients in personal care products might be relevant pollutants in the environment. Following the precautionary principle, eco-labelling is proposed as an effective tool for source control of one major group of personal care products, shampoos, shower gels and foam baths (SSBs).

Evaluation of measured and predicted environmental concentrations of selected human pharmaceuticals and personal care products.

Goal, Scope And Background: In the past few years, there was an increasing awareness of the occurrence of pharmaceuticals and personal care products (PPCPs) in surface water and drinking water resources, and measurements in surface water, sediment or waste water were done for a number of PPCPs. In the regulatory context, an environmental risk assessment (ERA) has become essential for new PPCPs. Reliably predicted or measured environmental concentrations (PECs or MECs) of chemicals are essential for the exposure assessment, which is one of the two main pillars of environmental risk assessment (ERA).

Biodegradability of 14C-labeled antibiotics in a modified laboratory scale sewage treatment plant at environmentally relevant concentrations.

For all new pharmaceuticals, an environmental risk assessment (ERA) has to be performed according to guidelines developed by the European Medicines Evaluation Agency. An important factor of this procedure is the assessment of the predicted environmental concentration in the aquatic environment, which is significantly influenced by the biodegradability of pharmaceuticals in sewage treatment plants. Established standardized methods for determining biodegradation under laboratory conditions apply to substance concentrations, which are much higherthan those expected in reality.

The EU-project ERAPharm. Incentives for the further development of guidance documents?

Triggered by the detection of a large variety of pharmaceuticals in surface waters, soils and groundwaters across the world (e.g. Halling-Sørensen et al.

The use of terrestrial and aquatic microcosms and mesocosms for the ecological risk assessment of veterinary medicinal products.

In this paper, we investigate the applicability of experimental model ecosystems (microcosms and mesocosms) for the ecological risk assessment of veterinary medicinal products (VMPs). VMPs are used in large quantities, but the assessment of associated risks to the environment is limited, although they are continually infused into the environment via a number of routes. It is argued that the experience obtained by pesticide research largely can be used when evaluating VMPs, although there are several major differences between pesticides and pharmaceuticals (e.

Bioaccumulation of 14C-17alpha-ethinylestradiol by the aquatic oligochaete Lumbriculus variegatus in spiked artificial sediment.

A bioaccumulation study was performed with the endobenthic freshwater oligochaete Lumbriculus variegatus MULLER exposed to the radiolabelled synthetic steroid 17alpha-ethinylestradiol (14C-EE2) in a spiked artificial sediment. Concentration of total radioactivity increased constantly and almost linearly during 35 days of exposure. The accumulation factor normalised to worm lipid content and sediment TOC (AFlipid/OC) was 75 at the end of the uptake period, but a steady state was not reached.

A rapid method to measure the solid-water distribution coefficient (Kd) for pharmaceuticals and musk fragrances in sewage sludge.

Pharmaceuticals and personal care products are omnipresent in wastewater world-wide. In order to predict their sorption quantities onto sludge in wastewater treatment plants (WWTPs), the solid-water distribution coefficients (Kd values) of selected pharmaceuticals (antiphlogistics, estrogens, lipid regulators, anti-epileptic and cytostatic agents) and polycyclic musk fragrances (HHCB, AHTN) were determined in primary and secondary sludges taken from a German municipal WWTP. For the Kd determination, batches of primary and secondary sludge slurries were spiked with the respective target compounds and slowly stirred under defined conditions (e.

Use of terrestrial model ecosystem data in environmental risk assessment for industrial chemicals, biocides and plant protection products in the EU.

Risk assessment approaches within the regulatory framework of the European Union (EU) based on single species tests were compared to those using data from terrestrial model ecosystems (TMEs). In a case study with the fungicide carbendazim, single species data led to ratios of the predicted environmental concentration (PEC) and predicted no effect concentration (PNEC) of above 1000, depending on available data and related assessment factors, indicating concern for the terrestrial environment. Considering the high degree of realism of the TME studies with multiple endpoints measured, but also residual uncertainty related to higher variability of endpoints, an assessment factor of 5 was applied on TME data.

Ring-testing and field-validation of a terrestrial model ecosystem (TME)--an instrument for testing potentially harmful substances: effects of carbendazim on organic matter breakdown and soil fauna feeding activity.

Organic matter (OM) decomposition and soil fauna feeding activity were integrated as functional endpoints into ecotoxicological tests with intact-soil-core Terrestrial Model Ecosystems (TMEs). Cellulose filter paper served as standardized OM and was either inserted into the top soil or placed on the soil surface for a period of up to 16 weeks. Faunal feeding activity was assessed by the bait-lamina method.

Ring-testing and field-validation of a terrestrial model ecosystem (TME)--an instrument for testing potentially harmful substances: conceptual approach and study design.

During spring and summer 1999 a ring-test and field-validation study with an open, intact Terrestrial Model Ecosystem (TME) was conducted at four different European sites (Amsterdam, The Netherlands; Bangor, U.K.; Coimbra, Portugal; Flörsheim, Germany).