Registration Dossier

Administrative data

Endpoint:
activated sludge respiration inhibition testing
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is found to be readily biodegradable and the applied test concentrations are in the range of concentrations that can be expected in the influent of a sewage treatment plant
Justification for type of information:
2-ethylhexyl lactate is readily biodegradable even at high concentrations, i.e. 100 mg/L in a respirometry study according to OECD test guideline 301C (MITI (I) test). The microbial inoculum proved to be fully functional at this test concentration, thus lack of toxic effects can be concluded from the biodegradation tests. The NOEC for microorganisms can thus be considered to be 100 mg/L. Toxic effects on the microbial community of STPs are not expected. Most notably, the exposure assessment demonstrates that the predicted influent concentrations in STPs are invariably significantly below the aforementioned NOEC. Therefore, according to REACH Annex VIII, column 2, point 9.1.4, performance of a dedicated study on toxicity to microorganisms is not required.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion