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6. DIMAS Development of an integrated database for the management of accidental spills. Part 2. Global change, ecosystems and biodiversity - SPSDII: final report

Author

Arijs, K., Versonnen, B., Vangheluwe, M., Vanhoorne, B., Cuvelier, D., Vanden Berghe, E., Mees, J., Ghekiere, A., and Janssen, C.R.

Subjects
Chemical spills, Shipping, ANE, Netherlands, Westerschelde, Accidents, ANE, Belgium, Oil spills, Risks, Hazardous materials, Hazard assessment, Modelling
Abstract

DIMAS is a 2-year project executed by three Belgian partners (EURAS, VLIZ and Ghent University) and funded by the SPSD II research program of the Belgian Science Policy (BELSPO). Several shipping accidents in Belgian territorial waters, made the various government agencies involved aware of the need to develop tools to assess the risks and impact on marine resources in the case of an accidental release of hazardous substances. DIMAS aims at the protection of the North Sea and Western Scheldt in case of accidental spills from ships. In the present project, a relational database is developed, providing reliable, easy to interpret and up-to-date information on marine specific issues. The database contains the latest information on effects (acute and chronic), absorption, distribution, bioaccumulation/biomagnification, GESAMP hazard profiles and physico-chemical properties for a selection of priority substances and is publicly available (www.vliz.be/projects/dimas). The selection of the substances is based on criteria such as occurrence on priority lists, volumes transported over sea, frequency of involvement in accidental spills and frequency of transports over sea. The first beneficiaries of this database are the people directly involved in the first phase of a containment plan for an accidental spill. The final indirect beneficiaries are the general public (scientists, journalists, general public, etc.) who will be better informed about the potential impact to man and the environment.

Published
2007

9. Integration RAMA & DIMAS

Author

Volckaert, A.M., Versonnen, B., Arijs, K., and Calewaert, J.-B.

Subjects
ANE, Belgium
Published
2006

14. MERAG: metals environmental risk assessment guidance.

Author

Vangheluwe M., International Council on Mining and Metals., Heijerick D., Van Hyfte A., Van Sprang P., Vandenbroele M., Verdonck F., Versonnen b., Vangheluwe M., International Council on Mining and Metals., Heijerick D., Van Hyfte A., Van Sprang P., Vandenbroele M., Verdonck F., and Versonnen b.

Abstract

The aim of the guidance is to deliver the basic material or building blocks for making metal risk assessments more ecologically relevant while adapting methodologies to different jurisdictions and applications. Metals are introduced as an intrinsic part of the environment, in many cases essential for electron transfer or direct reaction in many enzymatic and metabolic processes, in other cases tolerated by organisms that have adapted or acclimatised to their presence. The toxicity of essential elements is discussed within the framework of setting criteria for environmental quality and the speciation, mobility and bioavailability of metals in the environment is considered at length. The accompanying CD includes eight fact sheets: Risk characterisation - general aspects, 20pp., 11 refs.; Exposure assessment, 48pp., 32 refs.; Effects assessment - data compilation, selection and derivation of PNEC values for the risk assessment of different environmental compartments (water, STP, soil, sediment), 31pp., 41 refs.; Marine risk assessment - use of freshwater data for the derivation of ecotoxicity thresholds for marine species, 13pp., 47 refs.; Bioavailability - water and sediment, 23pp., 29 refs.; Bioavailability - soils, 14pp., 7 refs.; Uncertainty analysis, 22pp., 41 refs.; and Classification - classification for effects on the aquatic environment of metals/metal compounds and alloys, 46pp., 14 refs., The aim of the guidance is to deliver the basic material or building blocks for making metal risk assessments more ecologically relevant while adapting methodologies to different jurisdictions and applications. Metals are introduced as an intrinsic part of the environment, in many cases essential for electron transfer or direct reaction in many enzymatic and metabolic processes, in other cases tolerated by organisms that have adapted or acclimatised to their presence. The toxicity of essential elements is discussed within the framework of setting criteria for environmental quality and the speciation, mobility and bioavailability of metals in the environment is considered at length. The accompanying CD includes eight fact sheets: Risk characterisation - general aspects, 20pp., 11 refs.; Exposure assessment, 48pp., 32 refs.; Effects assessment - data compilation, selection and derivation of PNEC values for the risk assessment of different environmental compartments (water, STP, soil, sediment), 31pp., 41 refs.; Marine risk assessment - use of freshwater data for the derivation of ecotoxicity thresholds for marine species, 13pp., 47 refs.; Bioavailability - water and sediment, 23pp., 29 refs.; Bioavailability - soils, 14pp., 7 refs.; Uncertainty analysis, 22pp., 41 refs.; and Classification - classification for effects on the aquatic environment of metals/metal compounds and alloys, 46pp., 14 refs.

Published
2007

15. List of Contributors

Author

Abdolahi, A., Abdolghaffari, A.H., Abdollahi, M., Achanzar, W.E., Acquisto, N.M., Adatsi, F.K., Adekola, F.A., Agarwal, D., Aizawa, H., Akbar Malekirad, A., Allen, J.A., Allison, B., Alonso Blazquez, N., Altkorn, R., Amanlou, M., Amini, M., Anand, S.S., Andres, S.A., Angelini, D.J., Angelo, G., Api, A.M., Apte, U., Armendáriz, C.R., Asha, S., Atlason, P., Attene-Ramos, M.S., Austin, C.P., Babich, M.A., Badanthadka, M., Baeeri, M., Baer, K.N., Baghaei, A., Bahadar, H., Balali-Mood, B., Balali-Mood, M., Bale, A.S., Ballantyne, B., Banasik, M., Banks, C.N., Banton, M., Baran, K.P., Barata, C., Barefoot, A.C., Barlow, S.M., Barr, D.B., Barrueto, F., Barton, C., Barton, N., Battalora, M., Bayrami, Z., Bazl, R., Beckett, R.D., Bečková, V., Beedanagari, S., Behboudi, A.F., Beilke, L.D., Beltrán, E.M., Benson, A., Bergamo, L., Bergueiro, J., Berman, F.W., Betharia, S., Bhattacharya, S., Biglar, M., Biswas, S., Black, A.T., Bloomhuff, A.B., Bloomquist, J.R., Bolduc, D.L., Bolger, P.M., Bolt, H.M., Bonventre, J.A., Borek, H.A., Borghoff, S.J., Borzelleca, J.F., Botelho, M.C., Boxall, A.B.A., Bradford, H., Brady, P.M., Broderick, M., Brown, D.A., Brown, J., Bruce, R.D., Brugge, D., Brugger, K.E., Bryant, M.A., Bucklin, M.H., Burns-Naas, L.A., Burr, S.A., Caballero, J.M., Cai, Z., Calabrese, E.J., Calvo, M., Cammack, J., Campbell, A., Canedy, T., Cantrell, F.L., Caquet, T., Carbonell, G., Carlson-Lynch, H., Carmichael, N., Carmo, H., Carr, D., Carrington, C.D., Carvalho, F., Carvalho, M., Casa-Resino, I. de la, Cash, L.J., Castranova, V., Cesnaitis, R., Chadwick, K.D., Chakraborty, P., Chan, P.P.K., Chang, S., Chapin, R.E., Chateauvieux, S., Chattopadhyay, A., Chaumot, A., Chen, G., Chen, X., Chesser, R.K., Chilakapati, J., Chojnacka, K., Chou, K., Christoforidis, J., Clark, A.K., Clewell, H.J., Clough, S.R., Coelho, P.C.S., Coggins, C.R.E., Cohen, S.M., Cole, S.D., Corcoran, G.B., Cornu, C., Corsini, E., Cory-Slechta, D.A., Costa, C., Costa, L.G., Costa, S., Covaci, A., Cowden, J., Cumpston, K.L., Curfman, E., Czerczak, S., Daam, M.A., Dahlstrom, D.L., Darracq, M.A., Darwich, A.S., Das, S.R., Davis, J.A., de la Casa Resino, I., de la Torre, A.H., de Lourdes Bastos, M., del Río, E., de Marcellus, S., Demers, P.A., de Peyster, A., Derakhshani, M., Desai, S.N., de San Andrés Larrea, M.I., Descotes, J., Devi, S.S., Devlin, J.J., de Voogt, P., Devriese, L., DeWoskin, R.S., de Zwart, D., Diederich, M., Dieter, H.H., Di Guardo, A., Đikić, D., Dincer, I., Dissanayake, V., DiZio, S.M., Dodd-Butera, T., Doke, D., Dorsey, R.M., Dougherty, M.M., Dourson, M.L., Drake, V.J., Duffus, J.H., Dumancas, G.G., Dumbacher, J.P., DuTeaux, S.B., Dydek, S.T., Dykens, J.A., Eagle, S.R., Eastmond, D.A., Easton, J.D., Eidemiller, B.J., Eisen, E.A., Emami, A., Emami, S., Embry, M.R., Emswiler, M.P., Erraguntla, N.K., Escribano, M., Espín, S., Estevan, C., Estévez, J., Etemad, L., Everson, G.W., Ewers, L.M., Fain, J.H., Fan, A.M., Farris, F.F., Farshchi, A., Fatoki, O.S., Feakes, D., Feasel, M., Fedoruk, M.J., Feitshans, I.L., Fent, G.M., Fernández-Tajes, J., Fernández, Á.J.G., Fernández, C., Fernández Rodríguez, M.D., Ferrari, B., Fidalgo, J., Fields, A., Finch, G.L., Finizio, A., Finnveden, G., Fitzgerald, L., Foroumadi, A., Fuentes, D., Gad, K., Gad, S.C., Gad, S.E., Gadagbui, B., Gammon, D.W., García-Fernández, A.J., García Gómez, M.C., Gardner, D.E., Garrard, A., Garric, J., Gautam, G., Geffard, O., Genter, M.B., Gevaart-Durkin, A., Ghafouri, N., Ghazali, A.R., Ghoreishi, K., Ghosh, B., Gilbert, S.G., Giordano, G., Giouleme, O., Gironés, M.C.L.R., Gobba, F., Goel, S., Gohari, A.R., Gohlke, J.M., Golbabaei, S., Gold, S.C., Gómez-López, V.M., Gómez-Ramírez, P., González-Canga, A., González, G.L., Goodman, J.E., Gordon, E., Gordon, T., Gorodetsky, R., Gray, J.P., Green, M.D., Greim, H., Griffiths, J.C., Groth, C.M., Guedes de Pinho, P., Gupta, N., Gupta, R.C., Gutiérrez, A.J., Guy, R.C., Haber, L.T., Hacatoglu, K., Hahn, K., Haines, J.A., Hakkinen, P.J., Hall, E.J., Hall, G.J., Hall, V.R., Hambright, K.D., Handler, J.A., Hansen, D.K., Hanson, K.M., Hanson, M., Hardison, L.S., Hardisson, A., Harper, S.L., Hartmann, A.C., Hartung, T., Hartwig, A., Hassani, S., Hatlelid, K.M., Hayes, A.W., Hayes, A.N., Heidari, M.R., Henderson, J., Henriksen, B., Hernández-Moreno, D., Hertzberg, R.C., Hesterberg, T., Heyndrickx, M., Hicks, D., Hikkaduwa Koralege, R.S., Hilburn, M.E., Hinderliter, P., Hines, E.P., Hirakawa, B., Hirata, C.M., Ho, S., Hobson, D.W., Hoffmann, S., Holloway, A.C., Holstege, C.P., Holstege, E., Hon, S.L., Honeycutt, M., Hong, S., Hoover, M.D., Hopf, N.B., Hopp, A.G., Horiguchi, H., Hosseini-Tabatabaei, A., Hosseini, A., Hostetler, M.A., Hsu, C.H., Huang, F.X., Hulla, J.E., Hultén, P., Hultin, M.L., Hurst, H.E., Iannucci, A., Inayat-Hussain, S.H., Inselman, A.L., Iskander, J., Jabbour, R.E., Jaberidoost, M., Jacobs, M., Jamei, M., Jamison, K.P., Janes, M., Janz, D.M., Jazayeri, S.B., Jenkins, A., Jiang, M., Jin, N., John, K., Jones, L., Jones, P.D., Jordan, S.A., Jurado, A.S., Kalapos, M.P., Kamrin, M.A., Kapp, R.W., Karami-Mohajeri, S., Karanth, S., Karimi, G., Katz, S.A., Kem, W.R., Kempegowda, P., Kennedy, G.L., Kester, J.E., Khaksar, M.R., Kharabaf, S., Khoobi, M., Kiersma, M.E., Kilpinen, J.M., Kim, D.H., Kim, S.T., Kimbrough, R.D., Klein, S.J., Knechtges, P.L., Knuckles, T.L., Knudsen, T.B., Korrapati, M.C., Koshlukova, S.E., Kovacic, P., Kraft, A., Krafts, K., Krishnan, P., Kruger, C.L., Kubic, A., Kulkarni, S., Kwok, E.S.C., Laffon, B., Lagadic, L., Lambert, C.E., Landolph, J.R., Lange, R.W., Lank, P., Lari, P., Lasley, W., Lawana, V., Lazo, C.R., Ledrich, M.-L., Le Goff, F., Lein, P.J., Leung, H.-W., Leung, Y.L., Lewandowski, T.A., Li, X., Liesivuori, J., Lim, L., Limaye, P., Lin, H.H., Lin, S.C., Litovitz, T., Liu, F., Liu, J., Lloyd-Smith, M., Lo, J.C.Y., Loccisano, A.E., Logan, P., López, S., Lord-Garcia, J., Lotti, M., Luschützky, E., Mahdaviani, P., Maier, A., Makhaeva, G.F., Malátová, I., Malekirad, A.A., Manayi, A., Mangas, I., Mangino, M., Mangipudy, R.S., Maples, R.D., Marcel, B.J., Marigómez, I., Marraffa, J.M., Martínez-López, E., Mathews, S.M., Maxim, L.D., Maxwell-Stuart, P.G., Mayor, A., McClane, B.A., McCoole, M.D., McCormick, D.B., McGregor, D., McKee, J.M., McMartin, K., Meek, B., Megharaj, M., Mehendale, H.M., Mehrpour, O., Mendes, A., Méndez, J., Menn, F.-M., Meyer, S.A., Michalak, I., Míguez-Santiyán, M.P., Mikulewicz, M., Milanez, S., Mileson, B.E., Miller, G.W., Miller, S.J., Miller, S.M., Millner, G.C., Minarchick, V.C., Miracle, A.L., Mirajkar, N.S., Mirkes, P.E., Mitra, M.S., Mody, V., Mogl, S., Mohammadirad, A., Mojica, E.-R.E., Molander, L., Molina López, A.M., Momen-Heravi, F., Montague, P., Monteiro, J.P., Monticelli, F., Morceau, F., Moreno, M., Morgan, B.W., Mortensen, S.R., Moser, V.C., Moshiri, M., Mostafalou, S., Moyer, R.A., Mumy, K.L., Munday, R., Murdianti, B.S., Murray, A., Murray, T.M., Murta, T.L., Nadri, H., Naidu, R., Naile, J.E., Naistat, D.M., Nakajima, T., Nalliah, R.E., Nance, P., Nathan, S., Navarro, L., Navas, I.M., Nelson, L.S., Nerin, C., Newsted, J., Nikfar, S., Nili-Ahmadabadi, A., Nobay, F., Nony, P., Nurkiewicz, T.R., Oi, M., Okoro, H.K., Oliveira, P.A., Olsen, L.R., Oropesa Jiménez, A.L., Othumpangat, S., Pablos, M.V., Pakulska, D., Pakzad, M., Pallasch, E.M., Pamies, D., Parihar, H.S., Parmar, M.S., Parod, R.J., Paschos, P., Patterson, J., Patterson, T.J., Patterson, T.A., Paulo Teixeira, J., Pawlaczyk, A., Pearson, M.A., Pellerano, M.B., Pellizzato, F., Perales, C.M., Peredy, T., Pereira, J., Pérez-López, M., Peri, R., Persad, A.S., Persson, H., Perwaiz, S., Peterson, M.K., Pham, P.J., Pham, T., Philip, B.K., Pichery, C., Pickett, A.J., Piña, B., Pinkerton, K.E., Pleus, R.C., Podder, S., Poirier, M.C., Pomerleau, A.C., Pope, C., Posthuma, L., Potting, J., Pournourmohammadi, S., Pravasi, S.D., Preston, R.J., Prusakov, P.A., Punja, M., Puran, A.C., Purcell, M.M., Qian, L., Qozi, M., Quintana, P.J.E., Rabiei, M., Radulovic, L.L., Rahmani, N., Rajabi, M., Raman, P., Ramasahayam, S., Ramos-Peralonso, M.J., Rankin, G.O., Rao, C.V., Rao, P.S., Rashedinia, M., Rath, A.D., Ray, D.E., Ray, S.D., Reed, N.R., Remião, F., Rezaee, R., Rezvanfar, M.A., Rezvani, N., Rhomberg, L.R., Riar, N.K., Rice, G., Richardson, J.R., Richardson, R.J., Richter, P., Rider, G., Rivera, H.L., Robbens, J., Roberts, D.J., Roberts, L.G., Robinson, P.J., Robles, H., Rodgers, B.E., Rodgers, K., Rodriguez, Y.R., Rodriguez Fernández, C., Roede, J.R., Rogawski, M.A., Rojo, L., Romano, J.A., Rose, S.R., Rosen, M.A., Rossol, M., Rostami–Hodjegan, A., Rourke, J.L., Roy, R., Roy, S.S., Rozman, K.K., Rubin, A.L., Rubio, C., Ruch, R.J., Rumbeiha, W.K., Rushton, W., Sabzevari, O., Saeedi, M., Saeid, A., Saeidnia, S., Saghir, S.A., Saili, K.S., Salem, H., Salvago, M.R. Moyano, Salvatore, J.R., San Andrés Larrea, M.D., San Andrés Larrea, M.I., Sarazan, R.D., Sardari, S., Sasaki, T., Sawant, S.P., Schaeffer, V., Schep, L.J., Schlesinger, R.B., Schneider, S.M., Schreffler, S.M., Schultz, M.M., Schwartz, M., Schwela, D., Scott, A.L., Scott, B.R., Scribner, K., Seabury, R.W., Seco, B., Seeley, M., Seifert, J., Sellamuthu, R., Serex, T.L., Sexton, K., Shadnia, S., Shafiee, A., Shah, I., Shankar, K., Sheets, L.P., Sheppard, L., Shiotsuka, R.N., Shirley, S., Shojaei Saadi, H.A., Sibbald, K.N., Sidell, F.R., Siegrist, M., Simmons, J.E., Sinal, C.J., Singh, P., Skoglund, R., Skonberg, C., Slaughter, R.J., Sledge, C.L., Slothower, J.D., Smith, M., Smith, M.T., Snider, D.B., Snyman, R.G., Sobanska, M., Sogorb, M.Á., Soler-Rodríguez, F., Solgi, R., Solomon, K.R., Somanathan, R., Sonawane, B.R., Song, X., Soni, M.G., Sorensen, J., Soucy, N.V., Southard, R.J., Spainhour, C.B., Spencer, P.S., Spiller, H.A., Spoelhof, B., Stanard, B., Stanek, L.W., Stapleton, P.A., Stedeford, T., Steidl-Nichols, J., Stephens, M., Steyn, N.P., Stickney, J., Stohs, S.J., Stone, D., Stool, D., Stork, C.M., Strohm, B., Stromberg, P.E., Sullivan, D.W., Sullivan, M.R., Sultatos, L.G., Suryanarayanan, A., Syed, I., Szabo, D.T., Szynkowska, M.I., Takacs, Z., Talaska, G., Talbot, P., Tanguay, R.L., Tarazona, J.V., Teixeira, J.P., Temple, N.J., Temple, W.A., Tena, A., Teuschler, L.K., Thackaberry, E.A., Thakore, K.N., Theodorakis, C., Thompson, R.E., Thornton, S.L., Ting, D., Tirmenstein, M.A., Touwaide, A., Towne, T.G., Traven, S.A., Tritscher, A., Troendle, M., Trosko, J.E., Tsai, W.-T., Tsai-Turton, M., Tsatsakis, A., Tsitsimpikou, C., Tsubura, A., Tsuda, T., Tyl, R.W., Udarbe Zamora, E.M., Utell, M.J., Vahabzadeh, M., Vaidya, V.S., Valdiglesias, V., Valentovic, M.A., Valerio, L.G., Vales, T., Vandenberg, L.N., van den Brink, P.J., van der Kolk, J., Van Vleet, T.R., van Vliet, E., Varga, J., Venkateswarlu, K., Verslycke, T., Versonnen, B., Verstraete, K., Vighi, M., Vilanova, E., Vincent, L., Vincent, M., Visser, R., Volger, B., von Stackelberg, K., Vulimiri, S.V., Wahl, M., Walker, N.J., Walker, T.D., Wallace, D.R., Wang, C., Wang, G.S., Wanna-Nakamura, S.C., Watson, R.E., Wattenberg, E.V., Wax, P.M., Weaver, J.A., Webber, N.R., Weber, J.A., Weber, L.P., Weinrich, A.J., Weiss, B., Wennberg, A., Wernke, M.J., Weston, A., Wexler, P., White, L.D., Whittaker, M.H., Wiedenfeld, H., Wiegand, T.J., Wikoff, D.S., Wild, C.P., Will, Y., Willett, C., Willhite, C.C., Willis, A., Willis, K., Wills, B.K., Wilson, B.W., Wittliff, J.L., Wojcinski, Z.W., Wolfe, M.S., Wood, C.S., Woodall, G.M., Woolley, A., Xia, M., Ximba, B.J., Yan, B., Yanagiba, Y., Yang, D., Yang, N., Yoon, M., Yorifuji, T., Yoshizawa, K., Young, R.A., Zamor, R.M., and Zhao, Q.J.

Published
2014
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16. From Bioavailability Science to Regulation of Organic Chemicals.

Author

Ortega-Calvo JJ, Harmsen J, Parsons JR, Semple KT, Aitken MD, Ajao C, Eadsforth C, Galay-Burgos M, Naidu R, Oliver R, Peijnenburg WJ, Römbke J, Streck G, and Versonnen B

Subjects
Biological Availability, Risk Assessment, Soil chemistry, Soil Pollutants analysis, Organic Chemicals chemistry
Abstract

The bioavailability of organic chemicals in soil and sediment is an important area of scientific investigation for environmental scientists, although this area of study remains only partially recognized by regulators and industries working in the environmental sector. Regulators have recently started to consider bioavailability within retrospective risk assessment frameworks for organic chemicals; by doing so, realistic decision-making with regard to polluted environments can be achieved, rather than relying on the traditional approach of using total-extractable concentrations. However, implementation remains difficult because scientific developments on bioavailability are not always translated into ready-to-use approaches for regulators. Similarly, bioavailability remains largely unexplored within prospective regulatory frameworks that address the approval and regulation of organic chemicals. This article discusses bioavailability concepts and methods, as well as possible pathways for the implementation of bioavailability into risk assessment and regulation; in addition, this article offers a simple, pragmatic and justifiable approach for use within retrospective and prospective risk assessment.

Published
2015
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17. Analysis of the ecotoxicity data submitted within the framework of the REACH Regulation. Part 3. Experimental sediment toxicity assays.

Author

Cesnaitis R, Sobanska MA, Versonnen B, Sobanski T, Bonnomet V, Tarazona JV, and De Coen W

Subjects
Ecotoxicology legislation & jurisprudence, Ecotoxicology standards, Environmental Monitoring methods, Risk Assessment, Water Pollutants, Chemical toxicity, Environmental Monitoring legislation & jurisprudence, Environmental Policy, Geologic Sediments chemistry, Hazardous Substances toxicity, Toxicity Tests standards
Abstract

For the first REACH registration deadline, companies have submitted registrations with relevant hazard and exposure information for substances at the highest tonnage level (above 1000 tonnes per year). At this tonnage level, information on the long-term toxicity of a substance to sediment organisms is required. There are a number of available test guidelines developed and accepted by various national/international organisations, which can be used to investigate long-term toxicity to sediment organisms. However instead of testing, registrants may also use other options to address toxicity to sediment organisms, e.g. weight of evidence approach, grouping of substances and read-across approaches, as well as substance-tailored exposure-driven testing. The current analysis of the data provided in ECHA database focuses on the test methods applied and the test organisms used in the experimental studies to assess long-term toxicity to sediment organisms. The main guidelines used for the testing of substances registered under REACH are the OECD guidelines and OSPAR Protocols on Methods for the Testing of Chemicals used in the Offshore Oil Industry: "Part A: A Sediment Bioassay using an Amphipod Corophium sp." explaining why one of the mostly used test organisms is the marine amphipod Corophium sp. In total, testing results with at least 40 species from seven phyla are provided in the database. However, it can be concluded that the ECHA database does not contain a high enough number of available experimental data on toxicity to sediment organisms for it to be used extensively by the scientific community (e.g. for development of non-testing methods to predict hazards to sediment organisms)., (© 2013.)

Published
2014
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18. Analysis of the ecotoxicity data submitted within the framework of the REACH Regulation: part 4. Experimental terrestrial toxicity assays.

Author

Versonnen B, Tarazona JV, Cesnaitis R, Sobanska MA, Sobanski T, Bonnomet V, and De Coen W

Subjects
Ecotoxicology legislation & jurisprudence, Ecotoxicology standards, Environmental Monitoring methods, Risk Assessment, Water Pollutants, Chemical toxicity, Environmental Monitoring legislation & jurisprudence, Environmental Policy, Geologic Sediments chemistry, Hazardous Substances toxicity, Toxicity Tests standards
Abstract

This paper summarises the terrestrial ecotoxicity data submitted in the REACH registration dossiers and disseminated by ECHA. The analysis describes both the guidelines and the test species mostly used by registrants. REACH information requirements in relation to the effects on terrestrial organisms encompass three trophic levels; invertebrates, plants and micro-organisms, and the study of both long and short-term exposure. The results observed for soil invertebrates showed that on one hand there was a clear prevalence for testing on the species recommended by the standard test guidelines. On the other, the reporting included a large variety of species from very different families, demonstrating the feasibility for conducting toxicity tests on a number of relevant groups e.g. for species sensitivity distribution approaches. Standard toxicity testing with terrestrial plants under REACH follows a different approach and requires simultaneous testing on several species, using the same test conditions, adapted to each species, if needed. The test methods used to conduct the studies were only reported for 30% of cases. The most extensively reported test guidelines for terrestrial plants were OECD 208, ISO 11269-1 and ISO 11269-1. Information requirements for soil micro-organisms under REACH are related to the analysis of functional endpoints instead of on species or taxa. As recommended in REACH, OECD 216 and OECD 217 were the most often used test methods for soil micro-organisms. But overall, the test method was reported for only about 40% of the experimental studies. Moreover, it is noted that information on potential effects on soil micro-organisms is available for a limited number of REACH registered substances. The assessment suggests that providing waiving justifications and collecting available information, which in many cases might be well used for covering standard REACH data requirements, have been the main approaches used by registrants for the first REACH registration deadline., (© 2013.)

Published
2014
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19. Analysis of the ecotoxicity data submitted within the framework of the REACH Regulation. Part 2. Experimental aquatic toxicity assays.

Author

Tarazona JV, Sobanska MA, Cesnaitis R, Sobanski T, Bonnomet V, Versonnen B, and De Coen W

Subjects
Animals, European Union, Fishes, Invertebrates, Risk Assessment, Water Pollution, Chemical statistics & numerical data, Hazardous Substances toxicity, Toxicity Tests methods, Water Pollutants, Chemical toxicity, Water Pollution, Chemical legislation & jurisprudence
Abstract

This paper summarises the aquatic ecotoxicity data submitted in the REACH(1) registration dossiers and disseminated by the European Chemicals Agency (ECHA(2)). The analysis describes both the guidelines and the species mostly used by registrants. Non-OECD guidelines have been extensively used, in particular in covering of fish and aquatic invertebrate studies, but the main concern is that in 22-36% of the cases, depending on the endpoint, no information on the methodological approach and potential equivalences to test guidelines has been provided. As expected, most studies were conducted with those species typically used in laboratory ecotoxicity testing; nevertheless, the database provides a broad range of available species, covering the most relevant taxonomic groups for both freshwater and marine systems, although most are just occasionally used. This species diversity is essential for higher tier testing strategies, including the use of Species Sensitivity Distribution approaches. The assessment suggests that collecting available information has been the main approach used by registrants to fulfil their REACH information requirements for this first REACH registration deadline. Many studies are disclosed for the first time, and all are available through searchable web tools., (Copyright © 2013 Elsevier B.V. All rights reserved.)

Published
2014
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20. Analysis of the ecotoxicity data submitted within the framework of the REACH Regulation. Part 1. General overview and data availability for the first registration deadline.

Author

Sobanska MA, Cesnaitis R, Sobanski T, Versonnen B, Bonnomet V, Tarazona JV, and De Coen W

Subjects
Ecotoxicology, Toxicity Tests, Databases, Chemical, Environmental Policy, Environmental Pollution legislation & jurisprudence, Hazardous Substances toxicity
Abstract

REACH(1) entered into force in June 2007 and has hence been operational for six years. With the first registration deadline in November 2010, the European Chemicals Agency (ECHA(2)) has received a large amount of scientific and administrative information related to chemical substances. In order to understand what type of data on ecotoxicity endpoints was submitted under the REACH framework a detailed analysis of the availability and content of relevant information was performed. To avoid unnecessary testing, the REACH Regulation provides registrants with the possibility to build testing strategies and to adopt the standard information requirements based on the specific conditions listed in the regulation. The types of information submitted by registrants to fulfil data requirements for aquatic, sediment and terrestrial toxicity endpoints were analysed. The REACH database analysis confirms large differences in the availability of experimental aquatic versus sediment and soil ecotoxicity data. Information requirements on aquatic organisms are mainly covered by experimental data, while those for sediment and soil are mostly waived., (© 2013.)

Published
2014
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21. Identification of chemical hazards for terrestrial plants in the regulatory context: comparison of OECD and ISO guidelines.

Author

Tarazona JV, Cesnaitis R, Herranz-Montes FJ, and Versonnen B

Subjects
Environmental Policy, Hazardous Substances standards, Soil Pollutants standards, Environmental Pollution legislation & jurisprudence, Hazardous Substances toxicity, Plants drug effects, Soil Pollutants toxicity
Abstract

Standardized test protocols are used in the regulatory context for identifying the hazardous properties of chemicals, wastes, and contaminated materials. This paper compares the relevance of two guidelines measuring effects on terrestrial plants, the OECD TG 208 and the ISO TG 22030 and presents the scientific basis for a recent decision of the European Chemicals Agency (ECHA) under the European chemicals regulation REACH. If there are no specific phytotoxicity alerts, both guidelines are considered suitable for assessing long-term hazards, providing that a sufficient number of species is included in the OECD protocol, the recommended minimum number is six, which offer a reasonably broad selection of species to account for interspecies sensitivity. The proposed methodology, based on a combination of probabilistic assessments using Monte Carlo analysis, can be adapted for supporting similar decisions under specific regulatory processes; for example, for assessing contaminated soils or pesticides' applications.

Published
2013
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22. Experimental parameters affecting sensitivity and specificity of a yeast assay for estrogenic compounds: results of an interlaboratory validation exercise.

Author

Dhooge W, Arijs K, D'Haese I, Stuyvaert S, Versonnen B, Janssen C, Verstraete W, and Comhaire F

Subjects
Chemistry Techniques, Analytical methods, Estrogen Receptor alpha chemistry, Humans, Reproducibility of Results, Sensitivity and Specificity, Solvents chemistry, Time Factors, Estrogens analysis, Saccharomyces cerevisiae chemistry
Abstract

In vitro assays are considered as the first step in a tiered approach to compound screening for hormonal activity. Although many new assays have been developed in recent years, little attention has been paid towards assay validation. Our objective was to identify critical experimental parameters in a yeast estrogen screen (YES) that affect its sensitivity and specificity. We investigated the role of incubation time, solvent type, yeast inoculum growth stage and concentration on the outcome of the YES. Compounds tested included new and established agonists, antagonists and negative controls, and results were evaluated according to prefixed statistical criteria. In addition, we assessed the assay's performance in a blind interlaboratory validation exercise (IVE). An incubation time of five days was necessary to positively identify the estrogenic properties of all agonists tested, when dissolved in DMSO. Longer incubation times were required when using an ethanol protocol. Similar estrogenic activity was reported for benzyl butyl phthalate, bisphenol-A, methoxychlor, permethrin and genistein in the IVE. One out of the three laboratories did not classify alpha,beta-endosulfan, dissolved in DMSO, as an estrogen. The same was true for 4,4'-DDE and lindane, dissolved in ethanol, a result that might be attributable to an inappropriate yeast start concentration and/or growth stage. These validation experiments show that under appropriate experimental conditions the YES yields sensitive, specific and reliable results. Therefore it fulfills the requirements as a first step screening assay to evaluate the capacity of chemicals to interact with the estrogen receptor.

Published
2006
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23. Induction of vitellogenesis in 17alpha-ethinylestradiol-exposed rainbow trout (Oncorhynchus mykiss): a method comparison.

Author

Verslycke T, Vandenbergh GF, Versonnen B, Arijs K, and Janssen CR

Subjects
Animals, Oncorhynchus mykiss, Vitellogenesis physiology, Ethinyl Estradiol pharmacology, Vitellogenesis drug effects, Vitellogenins blood
Abstract

Juvenile rainbow trout, Oncorhynchus mykiss, were exposed to the synthetic estrogen 17alpha-ethinylestradiol (EE(2)) through injection (1, 10, 25 and 50 microg EE(2)/g fish/week) and via water exposure (1, 10 and 100 ng EE(2)/l). After seven (injection and water exposure) and 14 days (only for water exposure), blood and plasma vitellogenin concentrations were quantified using indirect endpoints, i.e. plasma alkaline-labile phosphorus (ALP), plasma protein and plasma calcium. In addition, the relative gonad (GSI) and liver weight (HSI) were recorded. Actual plasma vitellogenin concentrations were measured with an enzyme immunoassay. Only fish injected with 50 microg EE(2)/g fish had a significantly higher gonad weight. No concentration-dependent changes in the HSI were detected in fish exposed via the water, but a significant dose-dependent increase of the HSI was observed in fish injected with EE(2). Exposure of rainbow trout to EE(2) had a significant effect on all tested plasma parameters. Plasma protein, phosphoprotein and calcium concentrations were significantly higher after two weeks exposure to 100 ng EE(2)/l. Fish injected with 10, 25 and 50 microg EE(2)/g fish exhibited increased plasma protein concentrations after 1 week. Compared to the controls, plasma ALP and calcium levels were significantly higher in all injected fish. A significant and positive correlation was observed between all three plasma parameters and between these indirect parameters and the actual plasma vitellogenin concentrations. These findings indicate that both the plasma ALP and the plasma calcium assay have a similar sensitivity as that of available antibody-based assays (EIA), at least in EE(2) exposure studies, and thus these assays can provide a rapid, simple and cost-effective alternative to available immunoassays.

Published
2002
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