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].