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Ecotoxicological information

Toxicity to terrestrial plants

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Description of key information

waiving

Key value for chemical safety assessment

Additional information

In accordance with Annex IX, column 2 (9.4) of Regulation (EC) No. 1907/2006, testing for toxicity to terrestrial organisms is not required since direct and indirect exposure of the soil compartment is unlikely. Furthermore, considering all available related data combined in an expert statement as presented below all members of the PFAE fumarates are unlikely to pose a risk to terrestrial organisms in general.

Intrinsic properties and fate/ exposure

All members of the PFAE fumarate category are either readily biodegradable or readily biodegradable, but failing 10-day window. According to the Guidance on information requirements and chemical safety assessment, Chapter R.7b, readily biodegradable substances can be expected to undergo rapid and ultimate degradation in most environments, including biological Sewage Treatment Plants (STPs) (ECHA, 2012b). Furthermore, indirect application of the substances via sludge application can be excluded, as the sludge will be incinerated. Therefore for all category members indirect exposure to soil can be excluded. In addition, available use information as presented in chapter 3.5 of the technical dossier and chapter 9 and 10 clearly show that direct exposure to soil can be excluded as well.

Aquatic ecotoxicity data

The PFAE fumarates is a robust category with sufficient experimental data for the aquatic toxicity. Short-term aquatic toxicity data is available for all trophic levels within the PFAE fumarate category. Long-term data is available for aquatic algae. Based on the experimental data, all category members exhibit no toxicity to aquatic organisms up to the limit of water solubility. The category members are thus not expected to pose a risk to terrestrial organisms as well.

Metabolisms/Bioaccumulation

After absorption, members of the PFAE fumarate category are expected to be enzymatically hydrolysed in vivo by the ubiquitary enzyme carboxylesterase, yielding the corresponding alcohols and fumaric acid. QSAR estimations using BCFBAF v3.0 support the expected rapid biotransformation of this substance with BCF/BAF values of ≤ 10 l/kg, respectively (Arnot-Gobas estimation including biotransformation, upper trophic).

The metabolism of the hydrolysis products: alcohol (e.g. Dodecanol) and dicarboxylic acid (i.e. fumaric acid) is well established and not of concern in terms of bioaccumulation (for further information see chapter 5.3 of the technical dossier).

Conclusion

All members of the category PFAE fumarates are unlikely to pose a risk for terrestrial organisms based on

a) the lack of direct exposure based on identified uses,

b) lack of indirect exposure due to ready biodegradation,

c) metabolism via common pathways, leading to expected low bioaccumulation potential and low toxicity.