Umweltprobleme durch Arzneimitteln. Literaturstudie

The subject of the study was to examine whether the ecotoxicological hazard potential of pharmaceuticals or their metaboloties should be assessed. In a first step, publications on environmental problems known to be related to pharmaceuticlas were reviewed and evaluated. The data were discussed with concerned interest groups. In a second step, the data required by the 'Arzneimittelgesetz (AMG)' as part of the registration process were assessed under the aspect of suitability for ecotoxicological risk assessment. Additionally, it was evaluated which laboratory tests should be required to perform ecotoxicological risk assessments with pharmaceuticals. Preliminary risk assessments were conducted for different pharmaceutical groups if sufficient data were available. Taking into consideration the legal requirements for chemical notification within the EU, the necessity of further development of the AMG concerning ecotoxicological aspects was emphasized. (orig.)Available from TIB Hannover: RN 8422(1996,60) / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekSIGLEBundesministerium fuer Umwelt, Naturschutz und Reaktorsicherheit, Bonn (Germany)DEGerman

Untersuchungen zum Einfluss der Verfahrenstechnik in Klaeranlagen auf die Eliminierung ausgewaehlter Oestrogene und Xenooestrogene aus dem Abwasser. Teilprojekt 3: Wirkungsuntersuchungen Abschlussbericht

Originator's rep. no. B99006Available from TIB Hannover: F03B1329+a / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekSIGLEBundesministerium fuer Bildung und Forschung, Berlin (Germany)DEGerman

Workshop on Bioaccumulation: sediment test using benthic oligochaetes

The presented report gives a description of the results of the international workshop 'Bioaccumulation: Sediment test using benthic oligochaetes', held at Hochheim/Main, Germany, on April 26-27 1999. Scientists and experts from industry, academia and governmental agencies in the field of assessment of bioaccumulative, sediment-associated contaminants came together for a workshop held in Hochheim/Main, Germany, on April 26/27, to discuss the guideline proposal: Egeler Ph., Knacker Th., Roembke J., Schallnass H.-J., Meller M., Studinger G., Franke C. and Nagel, R. (1997). Bioaccumulation: Sediment test using benthic oligochaetes. Proposal for a draft guideline according to OECD format. 2nd, revised version. German Federal Environmental Agency (Umweltbundesamt) Berlin. Submitted to OECD, Paris, for revision. This draft guideline was based on the results of a research and development project on a standardisable method for the determination of bioaccumulation in sediment dwelling organisms (UBA-F+E 106 03 106/03; UBA Text 2/99) and conducted at ECT Oekotoxikologie GmbH, Floersheim/Main, Germany. The objective of the workshop was to review and refine methodological and scientific aspects of the proposed draft guideline. Questions concerning choice of test species, sediment ageing, duration of the test, and application of the test guideline were discussed. Furthermore, the organisation of an international ring test as well as further steps for the draft test guideline to be implemented in international guideline programs were considered. The proposed method was accepted in general. Recommendations regarding scope and application of the test, test species, and on details of test performance were given and will be included in the revised draft guideline document, which is presented in this report. (orig.)Available from TIB Hannover: RN 8908(99-125) / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekSIGLEUmweltbundesamt, Berlin (Germany)DEGerman

Studie zur Oekologie ausgewaehlter Mikroorganismen

The report consists of a generic part (A) and a special part (B). Part (A) of this literature study gives an overview of the ecological significance of micoorganisms in general. A further focus is the discussion of existing attempts at assessing and evaluating ecological risks which may occur following the release of bacteria with certain properties, e.g. genetically modified bacteria (GMOs). As a possible alternative approach a quantitative evaluation strategy, which is oriented in analogy to the PEC/PNEC-approach for chemicals or pesticides was worked up. The evaluation strategy is characterized mostly that the fate of microorganisms or genes as well as their effect on ecosystem structures and processes for different environmental compartments is quantitied separately. The assessment of the risk for the environment occurs then on the basis of compartment specific dose-effect relationships. Special emphasis was placed here also on the possibilities for standardizable experimental determination of effects (effects on the environment). For this also the existing test guidelines for the ecotoxicological testing of chemicals and pesticides as well as microbial pesticides with respect to their applicability of the testing of GMOs was evaluated. Part (B) of the literature study is a compendium about the ecology of six bacteria species whose release in the context of agricultural or biotechnical application has already occurred or is expected from the stand of research: Bacillus thuringiensis, B. subtilis, Pseudomonas fluorescens, P. putida, Rhizobium leguminosarum and Sinorhizobium meliloti. The information concerning the ecology of these organisms applies to specific living spaces as well as the distribution of the bacteria, their influence on the nutrient status in nature and their role within the biotic system. (orig.)Available from TIB Hannover: RN 8422(1998,64) / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekSIGLEBundesministerium fuer Umwelt, Naturschutz und Reaktorsicherheit, Bonn (Germany)DEGerman

Auswertung existierender Organismenlisten bezueglich ihrer Umweltrelevanz Erste Aktualisierung

A comprehensive literature survey on scientific literature concerning the ecology of bacteria was performed. The relevant publications were evaluated and their contents categorized by way of descriptors. The ecologically relevant data were transferred to a database. The database, set up in an earlier study, was updated and now contains 2322 references. The pc-programme ECOBAC which has been developed during an earlier study was modified in order to expand the range of application. The most important modifications are: the possibility to add new data to the database (references and descriptors) by the user of the programme, simplifying the printing of the data sheets and the possibility to add synonyms for taxonomic names of bacteria. (orig.)Mit Hilfe einer umfassenden Literaturrecherche wurden Informationen ueber oekophysiologisch relevante Eigenschaften von Bakterien und ueber die Rolle von Bakterien in der natuerlichen Umwelt zusammengetragen. Die im Rahmen des Vorlaeuferprojektes aufgebaute Datenbank wurde akutalisiert und um 794 neue Literaturzitate erweitert. Sie umfasst gegenwaertig insgesamt 2322 Literaturzitate. Die Literatur wurde mit Hilfe eines eigens erstellten Schlagwortkatalogs (Thesaurus) ausgewertet und verschlagwortet (deskribiert). Der Anwendungsbereich des im Rahmen des vorausgegangenen Projekts in dBASE erstellten Computerprogramms ECOBAC wurde wesentlich erweitert. Die wichtigsten Aenderungen sind: Moeglichkeit zur Eingabe neuer Literaturzitate sowie zur Eingabe von Deskriptoren durch die Anwender, vereinfachtes Ausdrucken der Datenblaetter von Abfrageergebnissen und die Moeglichkeit, synonyme Artnamen eingeben zu koennen. Darueber hinaus wurden verschiedene Befehle des Datenverarbeitungsprogrammes dBASE fuer die Anwender freigegeben. Dadurch sind fuer Anwender mit dBASE-Kenntnissen zusaetzliche Funktionen verfuegbar und so eine Erweiterung des Anwendungsbereichs von ECOBAC moeglich. (orig.)SIGLEAvailable from TIB Hannover: RN 8422(1998,57) / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekBundesministerium fuer Umwelt, Naturschutz und Reaktorsicherheit, Bonn (Germany)DEGerman

Entwicklung eines chronischen Pflanzentests Abschlussbericht

The study describes experiments for the development and tentative application of a chronic toxicity test with higher plants. This test procedure shall form part of an ecotoxicological test battery for the assessment of the quality of contaminated or remediated soils. In comparison to acute plant tests, commonly used in the assessment of chemicals, the chronic plant test includes endpoints relevant for the reproduction of the plants. Also, it was taken into consideration that the test meets the requirements for testing different types of soil. The new test procedure was not fully validated within this research project. Nevertheless, the results were used to draft a test guideline, which has been presented to ISO. The applicability of the chronic plant test was tried out by experiments with soils from different locations contaminated with either, TNT, polyaromatic hydrocarbons or mineral oil hydrocarbons, with biologically remediated soils as well as with one standard and one artificial soil to which the model contaminants TNT or Pyren were added. These tests were designed as dose-response experiments, to evaluate adverse effects on the test plants on the basis of the model contaminant concentration or the mixture ratio of the test soil. In addition, experimental factors like illumination, watering, nutrient amendments, sowing method or pollination were caried to assess their effects on the practicability of the test and the test results. A few uncontaminated reference soils with similar properties to a given test soil, were included in the study as controls and substrate for preparing soil mixtures. In other cases LUFA Sp2.2, a German standard soil, or OECD artificial soil were used for this purpose. The results show, that lack of true control substrates has to be considered when interpreting the dose-(mixture-)response curves. The use of reference soils as a control and substrate for soil mixtures proved to be more problematic than standard or artificial soil with well-known properties. Toxic effects cannot be masked by high levels of nutrients. However, mild adverse effects may be less clearly distinctive when nutrient levels of a test soil are much higher than of the control substrate. Beside nutrients, the water transport capacity of the test soils was of major concern for the practicability of the test. (orig.)SIGLEAvailable from TIB Hannover: F00B1185 / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekBundesministerium fuer Bildung und Forschung (BMBF), Bonn (Germany)DEGerman

Study on the ecology of selected micro-organisms

The report consists of a general part (A) and a specific part (B). Part (A) of this literature study gives an overview of the ecological significance of micro-organisms in general. A further focus is the discussion of existing approaches for the assessment and evaluation of ecological risks which may occur following the release of bacteria with certain characteristics, e.g. genetically engineered micro-organisms (GEMs). As a possible alternative to the qualitative risk characterization, a quantitative evaluation strategy that is analogous in orientation to the PEC/PNEC approach for chemicals or presticides was elaborated. The main aspect of this approach is that the fate of micro-organisms or genes as well as their effect on ecosystem structures and functions are quantified separately for different environmental compartments. The risk to the environment is then assessed on the basis of compartment-specific dose-effect relationships. Special emphasis was also placed on the possibilities for standardizable experimental determination of microbial effects on the environment. For this reason, the existing guidelines for the ecotoxicological testing of chemicals and pesticides as well as microbial pesticides were evaluated with respect to their applicability for testing of GEMs. Part (B) of the literature study is a compendium of the data available on the ecology of six bacteria species whose release in the context of agricultural or biotechnical application has already occurred or is pending: Pseudomonas fluorescens, Pseudomonas putida, Bacillus subtilis, Bacillus thuringiensis, Rhizobium leguminosarum and Sinorhizobium meliloti. The information concerning the ecology of these organisms applies to specific habitats as well as the dispersal of the bacteria, their influence on the nutrient balance in nature and their role within the biotic system. (orig.)Summary in GermanSIGLEAvailable from TIB Hannover: RN 8422(1998,65) / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekBundesministerium fuer Umwelt, Naturschutz und Reaktorsicherheit, Bonn (Germany)DEGerman

Evaluation of the different approaches to characterize the environmental risk of contaminated sediments and individual substances for benthic organisms

The aim of the study was to conduct a critical examination of the various approaches discussed in the scientific literature for characterizing the environmental risk of contaminated sediments and of individual substances for benthic organisms. It is shown that the specific properties of sediments and benthic organisms justify treating sediments as a specific environmental compartment. Neither the fate of a substance in sediments nor its effects on benthic organisms can be extrapolated from the fate and effect in the aquatic or terrestrial compartment. It is proposed that an 'ecological approach' be used for the risk characterization of contaminated sediments in order to take into account the complexity of the physico-chemical properties of the sediment and the specificity of the benthic fauna. An assessment based solely on chemical-analytical data is deemed scientifically inadequate. The 'PEC/PNEC approach' is considered to be the most favourable for the prospective ERA of substances in sediments. However, the data for this approach must be derived from tests that are representative of the specific conditions in sediments. Hence there is a need to develop compartment-specific standardized tests to determine the fate and effects of substances in sediments, including aspects of degradation and bioaccumulation. For marine sediments, however, and particularly deep-sea sediments, which can be regarded as the terminal sink for substances, the 'PEC/PNEC approach' is not considered the appropriate tool for conducting ERA. (orig.)Das Ziel der vorliegenden Studie war eine vergleichende Darstellung und Wichtung der in der wissenschaftlichen Literatur diskutierten Ansaetze zur Bewertung des Umweltrisikos, das von kontaminierten Sedimenten oder von einzelnen Stoffen fuer benthische Organismen ausgeht. Es wird gezeigt, dass aufgrund der spezifischen Eigenschaften von Sedimenten und der besonderen Lebens- und Ernaehrungsweise benthischer Organismen, eine Betrachtung als separates Umweltkompartiment gerechtfertigt ist. Das Verhalten und die oekotoxikologische Wirkung von Stoffen im Sediment koennen nicht aus dem Verhalten der Stoffe im Wasser oder Boden und ihrer Wirkung auf pelagische oder terrestrische Organismen abgeleitet werden. Zur oekotoxikologischen Bewertung belasteter Sedimente wird ein oekologischer Ansatz vorgeschlagen, um der physikalisch-chemischen Komplexitaet des Systems und den Besonderheiten der benthischen Fauna gerecht zu werden. Eine ausschliesslich auf der Grundlage chemisch-analytischer Daten durchgefuehrte Bewertung wird als nicht ausreichend angesehen. Der PEC/PNEC-Ansatz wird als eine geeignete Grundlage zur prospektiven Bewertung von Stoffen im Sediment betrachtet. Allerdings muessen die sediment- und benthosspezifischen Eigenschaften bei der Abschaetzung der PEC im Sediment und der PNEC fuer benthische Organismen beruecksichtigt werden. Daher ist die Entwicklung und Anwendung von standardisierten Wasser/Sediment-Systemen erforderlich, mit deren Hilfe das physikalisch-chemische Verhalten, die oekotoxikologische Wirkung sowie Aspekte des Abbaus und der Bioakkumulation von Stoffen im Labor untersucht werden koennen. Fuer marine Sedimente, insbesondere Tiefseesedimente, die als letzte Senke fuer Stoffe fungieren, erscheint jedoch der PEC/PNEC-Ansatz fuer eine Risikoabschaetzung unzureichend. (orig.)SIGLEAvailable from TIB Hannover: RN 8422(1998,54) / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekBundesministerium fuer Umwelt, Naturschutz und Reaktorsicherheit, Bonn (Germany)DEGerman

Organisation and performance of an international ringtest for the validation of the Enchytraeid reproduction test. Vol. 1 and 2. Organisation und Durchfuehrung eines internationalen Ringtests zur Validierung des Enchytraeen Reproduktionstests. Vol. 1 und 2

The aim of the project was the organisation and performance of an international Ringtest for the Enchytraeid Reproduction Test (ERT) which was developed on behalf of the German Federal Environmental Agency (UBA) several years ago. An existing Draft Guideline presented during a workshop in Bad Soden (Germany) in 1995 was used to run the test. A total of 29 institutions (governmental agencies, universities, contract laboratories, and industry) from 15 different countries participated in the Ringtest. Most participants performed four test. Two of these tests were conducted with the fungicide Carbendazim (Formulation Derosal) and two with 4-Nitrophenol. For each chemical one test was designed according to an ECx approach and the other according to a NOEC approach. Several courses and workshops were organised to inform and train the participants. Six Ringtest newsletters (RTL) were prepared and distributed to all participants during the project. A task force consisting of 6 members supported the organisation of the Ringtest. A major aspect of the project was the detailed statistical evaluation of the test results. Additionally, these results are thought to be an important contribution to the recent discussion on ecotoxicological test design. As a result of the Ringtest, the ERT Draft Guideline, which losely follows formal requirements of the OECD test guidelines programme, was significantly improved. (orig.)SIGLEAvailable from TIB Hannover: RN 8422(1999,4) / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekBundesministerium fuer Umwelt, Naturschutz und Reaktorsicherheit, Bonn (Germany)DEGerman

Entwicklung eines Testsystems fuer die Pruefung des biologischen Abbaus in Oberflaechengewaessern

The study presented here describes the development of a laboratory test system for the determination of aerobic biodegradability of substances at low concentrations in surface water. It was aimed to prepare a draft guideline for a biodegradation simulation test according to OECD format. The experimental approach was based on a literature study conducted within the frame of this project. Further useful information on the possible test design was derived from the German BBA guideline 5-1. Natural water and sediments were collected. Radiolabelled Lindane or 4-Nitrophenol was added. The test vessels (reactors) were aerated and incubated under controlled conditions for up to 92 days. The results showed biological stability of the sediment/water systems even without addition of nutrients and adherence to non-reducing conditions. Mineralisation of 4-Nitrophenol was influenced by the sediment type, the method of aeration and temperature. Factors affecting the mineralisation of Lindane were the method of application and again, the sediment type and temperature. Considerable amounts of the radioactivity were bound to the sediment and were to a large extent unextractable. The potential of a reactor to mineralise a test substance could not be correlated with the biological parameters measured. (orig.)Die vorliegende Studie beschreibt die Entwicklung eines Labortestverfahrens zur Pruefung des aeroben Abbaus niedrig konzentrierter Stoffe in Oberflaechengewaessern. Dabei war es ein Ziel, das Verfahren so weit abzusichern, dass ein Entwurf fuer eine Pruefrichtlinie als Simulationstest im Format der OECD-Richtlinien abgefasst werden konnte. Grundlage fuer die Konzeption war eine zuvoerderst durchgefuehrte Literaturstudie. Hinweise auf ein moegliches Testdesign ergaben sich auch aus der BBA-Richtlinie 5-1. Wasser und Sediment wurden der Natur entnommen und nach Zugabe der radioaktiven Pruefsubstanz Lindan oder 4-Nitrophenol in einem beluefteten Gefaess unter kontrollierten Bedingungen bis zu 92 Tage lang inkubiert. Die Ergebnisse zeigten, dass die Wasser/Sediment-Systeme auch ueber diesen langen Zeitraum ohne Zufuetterung biologisch stabil waren und nichtreduzierende Bedingungen auch im Sediment erhalten blieben. Die Mineralisierung von 4-Nitrophenol wurde vom Sedimenttyp, der Belueftungsart und der Temperatur beeinflusst, die von Lindan von der Applikationsart und ebenfalls vom Sedimenttyp und der Temperatur. Wesentliche Anteile der Radioaktivitaet wurden ans Sediment gebunden und waren zum grossen Teil nicht extrahierbar. Es wird schliesslich diskutiert, dass das Potential eines Sediments, Stoffe zu minimalisieren, nicht mit den gewaehlten biologischen Kenngroessen klassifiziert werden kann. Daraus koennen Probleme bei der Uebertragbarkeit der Ergebnisse auf neue Standorte erwachsen. (orig.)Available from TIB Hannover: RN 8422(1997,13) / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekSIGLEBundesministerium fuer Umwelt, Naturschutz und Reaktorsicherheit, Bonn (Germany)DEGerman