Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

NOEC (21d, overall threshold effects) = 3.04 mg/l

NOEC (21d, reproduction) = 3.04 mg/l

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
3.04 mg/L

Additional information

A reproduction test on Daphnia magna (semi-static, 21 days) was carried out to assess the effect of the test item on the reproductive output of Daphnia magna, according to the OECD Guideline 211. Ten daphnids, held individually, were used per concentration level and control. Nominal concentrations of the test item were selected based on the results of a preliminary range finding test (non-GLP) as follows: 0.429 - 1.20 - 3.36 - 9.41 - 26.3 mg/l (separation factor 2.8) corresponding to the time-weighted mean measured test item concentrations were: 0.398 – 1.12 –3.04 – 8.48 – 23.4 mg/l. The effects on the reproduction capacity and other test item-related effects or parameters such as the intrinsic rate of the natural increase, first appearance of living juveniles, occurrence of aborted eggs and stillborn juveniles, adult mortality, body length and dry weight of the parental daphnids, were assessed. The test item concentrations were analytically verified via HPLC-DAD in the fresh media at the start of the exposure-renewal intervals on days 0, 5, 9, 14 (0 hours) and in the old media at the end of the exposure intervals on days 2, 7, 12, 16 (48 or 72 hours, respectively) in all concentration levels (with surviving daphnids) and in the control. The measured concentrations of the test item in fresh media at the start of the respective exposure renewal intervals (0 hours) were in the range of 79 to 114% of the nominal concentrations. At the end of the respective exposure-renewal intervals (48 and 72 hours), the measured test item concentrations in the old media were in the range of 79 to 100% of the nominal concentrations.

The environmental conditions were within the acceptable limits. The validity criteria of the test guideline were met. The Cochran-Armitage trend-test revealed a significant trend in mortality. The effects on reproduction were evaluated based on the reproduction per introduced parent animal, since this parameter is the ecologically most relevant response variable and is required by the OECD test guideline 211 (2012), when a significant trend in mortality is detected. The overall effect threshold for effects of the test item on daphnid reproduction under the test conditions was 3.04 mg/l(NOEC) and 8.48 mg/l (LOEC) based on the nominal concentrations of the test item.