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. 2016 Feb 16;6(2):33. doi: 10.3390/nano6020033

Table 1.

Information requirements according to Annex II of the Biocidal Product Regulation for ecotoxicity testing, including corresponding test methods as set out in Regulation EC 440/2008 (CDS = Core Data Set, ADS = Additional Data Set, TG = Test Guideline). Data from [4,17].

Test Specification Data set Test method according to regulation EC 440/2008 [17]
Toxicity to Aquatic Organisms
Short-term toxicity testing on fish CDS * Test method C1
Short-term toxicity testing on aquatic invertebrates Test species: Daphnia magna CDS Equivalent to OECD TG 202 (2004)
Other species ADS
Growth inhibition study on algae Effects on growth rate of green algae CDS Equivalent to OECD TG 201 (2006) **
Effects on growth rate of cyanobacteria or diatoms CDS Equivalent to OECD TG 201 (2006) **
Bioconcentration Estimation methods
Experimental determination
CDS *** Equivalent to OECD TG 305 (1996)
Inhibition of microbial activity CDS Method C.11.
Further Toxicity Studies on Aquatic Organisms ****
Long term toxicity tests on Fish Fish Early Life Stage (FELS) test;
Fish short term toxicity test in embryo and sack fry stages
Fish juvenile growth test
Fish full life circle test
ADS (b) Equivalent to OECD 212 (1998)
(c) Equivalent to OECD TG 215 (2000)
Long term toxicity testing on invertebrate Daphnia growth and reproductive study
Other species reproduction and growth (e.g., Mysid)
Other species development and emergence (e.g., Chironomus)
ADS (a) Equivalent to OECD TG 211 (1998)
Bioaccumulation in any appropriate aquatic species ADS
Effects on any other specific, non-target organisms Non-target organisms: flora and fauna believed to be at risk ADS
Studies on sediment-dwelling organisms ADS
Effects on aquatic macrophytes ADS

Notes: * Data element not required if a valid long-term study on fish is available. ** From EC 761/2009 amending EC 440/2008 [17]. *** Data element not required if it can be demonstrated (on the basis of physical-chemical properties (e.g., logKow < 3) or other) that the substance has low bioaccumulation potential. **** If the results from the ecotoxicity studies on fate and behavior and/or the intended use(s) of the active substance indicate a risk for the aquatic environment, or if long term exposure is expected, then one or more of the tests mentioned as ADS in the table must be conducted [4].