Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

The assessment of the terrestrial toxicity should be based on the outcome of aquatic toxicity testing. Pursuant to ECHA decision on a compliance check CCH-D-2114517125-59-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier and the hazard assessment will be re-evaluated accordingly. Thus, the strategy of terrestrial toxicity will be evaluated later when all aquatic toxicity studies are available.

In accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5, grouping and read-across, the terrestrial toxicity of the PFAE aromatic category members is considered to be negligible based on the results from available acute studies with earthworm and terrestrial plants.

The terrestrial toxicity of the PFAE aromatic category has been tested on the earthworm Eisenia fetida with the category member 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters (CAS No. 90218-76-1). No mortality was observed during the 14-day exposure period at the test concentration of 1,000 mg/kg soil dw. Additionally, data is also available from a test with terrestrial plants for the same substance. The 17-day EC50 value was > 100 mg/kg for all plants tested. All category members are structurally similar and read-across was performed to the structurally most similar category member. The read across is justified due to a) the structural similarity of the category members and b) similar physico-chemical properties (poorly soluble in water (< 0.05 mg/L), high adsorption potential (Koc > 5), high log Kow (> 10) resulting in a similar environmental fate and ecotoxicity profile. There is no convincing evidence that any one of the category members might lie out of the overall profile of this category.

Based on this information, toxicity of the PFAE aromatic category members to terrestrial organisms is not expected to be of concern, and consequently, no further testing is proposed.

Please consider that the originally proposed category approach addressing all Polyfunctional acid esters (PFAE) aromatic is currently under revision and will finally result in an analogue approach for the registration. Therefore, two documents, the category justification and explanatory notes for the analogue approach are provided in Section 13.