Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

LC50 (96h, Fish) > 100 mg/l (nominal)

EC50 (48h, Daphnia) > 100 mg/l (nominal)

EC50 (72h, Algae) > 100 mg/l (nominal)

EC50 (3h, Microorganisms) > 1000 mg/l (nominal)

Additional information

Data on aquatic toxicty on the substance are not available therefore data on PFAE fumarates were used for the assessment of the toxicity to fish, aquatic invertebrates, algae and microorganisms.

The PFAE fumarates is a robust category with sufficient experimental data collectively covering fatty alcohol carbon numbers from C8 to C22 and total carbon numbers ranging from C12 to C26. Short-term aquatic toxicity data are available for all trophic levels within the PFAE fumarates category. Long-term data are available for algae. The read across approach used for the aquatic toxicity is performed under consideration for the acid chain length in particular, i.e. read across in aquatic toxicology is only performed within this fumaric acid ester category. Furthermore, the available studies cover the outer borders of this category so that the aquatic toxicity endpoints are covered by interpolation (i.e. studies are available for the lower alcohol chain length (C12, C14) and highest alcohol chain length (C18/C22), respectively). Only two constituents, i.e. C8 and C10 fatty acid ester components of 2-Butenedioic acid (E)-, di-C8-18-alkyl esters (CAS 68610-90-2) are not enclosed by the available data but can be covered by extrapolation since no trend in aquatic toxicity is observed due to the insolubility of the category members. Since the water solubility of this UVCB substance is below detection limit (equally to all category members) the influence of both components is regarded as negligible.

Based on the experimental data, all category members exhibit no acute nor chronic toxicity to aquatic organisms up to the limit of water solubility. Therefore, the substance is not expected to be toxic or harmful to aquatic organisms.

In consequence, based on the current data, which are considered adequate for an accurate chemical safety assessment of the category, no category member is classified and labeled for environmental hazard according to the 2nd ATP of the Regulation (EC) No.1272/2008 (CLP).

No effect on microbial respiration or growth occurred for any member of the category. Thus disturbances in sewage treatment plants are not anticipated for any member of the category.

A detailed reference list is provided in the technical dossier in section 13 and within CSR. Furthermore, justification for read across is also given in section 13 of IUCLID.