Registration Dossier

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Studies Klimisch rated reliability 2 based on international guidelines are available for three aquatic trophic levels (algae, aquatic invertebrate and fish) on an analogue substance, METHYL 3-OXO-2-PENTYL-1-CYCLOPENTANE ACETATE (quality High Trans isomer). This read-across substance is a mixture of two diastereomers, approximately 10% cis- and 90% trans-diastereomers of which the cis-diastereomer corresponds to the registered substance. This supporting substance is considered adequate for read-across purposes based on similar physico-chemical properties and readily biodegradability of the registered substance and the analogue material used (see IUCLID section 13).

Among all data available, the aquatic invertebrate, Daphnia magna, is the most sensitive species with a 48h-EC50 at 8.25 mg/L. A chronic toxicity data is also available with a 21d-EC10 for reproduction at 1.86 mg/L. On the fish Oryzias latipes, the 96h-LC50 was determined to be 19 mg/L, and on the algae Pseudokirchneriella subcapitata, the 72h-ErC50 and NOECr (based on growth rate) were determined to be 45.9 mg/L and 11.7 mg/L, respectively. Due to the lower sensitivity of the fish compared to that of the daphnids, a fish chronic study was not considered necessary.

In addition, there is no need to perform an activated sludge inhibition test, in accordance with column 2 of REACH Annex VIII, because the substance is readily biodegradable. The applied test concentration in the key biodegradation study (101 mg/L) is in the range of concentrations that can be expected in the influent of a sewage treatment plant, and no inhibition effects on the activity of microorganisms was observed.

Categories Display