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EC number: 938-575-3 | CAS number: -
In accordance with Annex IX, column 2 (9.4) of Regulation (EC) No. 1907/2006, testing for toxicity to soil organisms is not required since direct and indirect exposure of the soil compartment is unlikely. Furthermore, all members of the PFAE fumarates are unlikely to pose a risk for terrestrial organisms considering the low toxicity as expected for these substances. Therefore, no tests on terrestrial organisms are provided.
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). 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.
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).
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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