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Long-term toxicity to fish

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No data from guideline studies on chronic fish toxicity is available. According to Annex IX of the Regulation (EC) No 1907/2006 tests should be proposed if the chemical safety assessment indicates the need to investigate further the effects on fish. The acute data set of Formaldehyde is extensive and complete, covering all trophic levels. Results indicate neither differences between trophic levels nor between marine and freshwater organisms. Since formaldehyde is readily biodegradable it will rapidly disappear from water. A chronic exposure of aquatic organisms is therefore unlikely and testing not necessary.

Nevertheless, a study on the effects of formaldehyde to embryos-larval stages of Danio rerio exposed to five concentrations of formaldehyde is available, investigating the effects of water chemistry to hatching success and survival (Meinelt et al. 2005). Although this study is not accordance with current guidelines (e.g. exposure duration 144 hours), typical endpoints of chronic fish tests are met (e.g. hatching). After 144 hours, most of the embryos in the test medium with natural organic matter (NOM) at lower formaldehyde concentrations hatched, whereas embryos in the test media without natural organic matter (NOM) did not. It was concluded that toxicity of formaldehyde is influenced by water chemistry. Under the experimental conditions applied, the lowest LC50 was 6.9 mg/L.

Furthermore, a juvenile growth test similar to OECD 215 using Oryzias latipes as test organism was conducted (Johnson et al., 1993). Formaldehyde did not cause any target organ pathologies even in the highest exposure concentration (48 mg/L), when tested over a period of 28d. There were also no significant growth or survival effects at this concentration. Therefore, the test can be regarded as a limit test.

In addition, as PNECaqua has been derived by species sensitivity distribution from acute data and an ACR of 10, there is no need for further testing of animals, e.g. chronic toxicity in fish.