title: Analysis of the ecotoxicity data submitted within the framework of the REACH Regulation. Part 2. Experimental aquatic toxicity assays.
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.
authors.affiliation: European Chemicals Agency, Annankatu 18, FI-00121 Helsinki, Finland. Electronic address: marta.sobanska@echa.europa.eu.
authors.forename: Jose V
authors.initials: JV
authors.lastname: Tarazona
authors.affiliation: European Chemicals Agency, Annankatu 18, FI-00121 Helsinki, Finland.
authors.forename: Marta A
authors.initials: MA
authors.lastname: Sobanska
authors.affiliation: European Chemicals Agency, Annankatu 18, FI-00121 Helsinki, Finland.
authors.forename: Romanas
authors.initials: R
authors.lastname: Cesnaitis
authors.affiliation: European Chemicals Agency, Annankatu 18, FI-00121 Helsinki, Finland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Sobanski
authors.affiliation: European Chemicals Agency, Annankatu 18, FI-00121 Helsinki, Finland.
authors.forename: Vincent
authors.initials: V
authors.lastname: Bonnomet
authors.affiliation: European Chemicals Agency, Annankatu 18, FI-00121 Helsinki, Finland.
authors.forename: Bram
authors.initials: B
authors.lastname: Versonnen
authors.affiliation: European Chemicals Agency, Annankatu 18, FI-00121 Helsinki, Finland.
authors.forename: Wim
authors.initials: W
authors.lastname: De Coen
mesh_terms: D000818:Animals; D005062:European Union; D005399:Fishes; D015386:Hazardous Substances / Q000633:toxicity*; D007448:Invertebrates; D018570:Risk Assessment; D018675:Toxicity Tests / Q000379:methods*; D014874:Water Pollutants, Chemical / Q000633:toxicity*; D014877:Water Pollution, Chemical / Q000331:legislation & jurisprudence* / Q000706:statistics & numerical data
chemical_list: D015386:Hazardous Substances; D014874:Water Pollutants, Chemical
keywords: Aquatic toxicity; ECHA database; REACH data requirements; Test methods; Test organisms