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Long-term toxicity to aquatic invertebrates

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Description of key information

NOEC (21d, overall threshold effects) = 1.10 mg/l (nominal)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
1.1 mg/L

Additional information

No data is available for the evaluation of the long-term toxicity to aquatic invertebrates of the substance. For this reason, data on Similar Substance 1 -MSA is used. Read Across justification is given in Section 13 of IUCLID.

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: 0.478 - 1.10 - 2.53 - 5.82 - 13.4 mg/l (separation factor 2.3). 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, 9, 14 (0 hours) and in the old media at the end of the exposure intervals on days 2, 12, 16 (48 or 72 hours, respectively) in all concentration levels (with surviving daphnids) and in the control. Since 100% mortality occurred at the highest concentration level 13.4 mg/l, analyses were carried out on days 0, 2, 9 and 12 only. 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 88 to 107% 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 90 to 104% of the nominal concentrations.

The environmental conditions were within the acceptable limits. The validity criteria of the test guideline were met. 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 under the test conditions was 1.10 mg/l (NOEC) and 2.53 mg/l (LOEC) based on the nominal concentrations.

The use of the similar substance 1 -MSA is due to the fact that the effect levels obtained in the long-term toxicity study to aquatic invertebrates is the lowest among the ones available in the category. Following a conservative approach, the results obtained in the long-term toxicity study on acquatic invertebrates on the Similar Substance 1 -MSA will be used for the chemical safety assessment. Moreover the degree of sulfonation and the structural similarity is taken into account.

More details on the results of the other substances in the Category will be provided in the attached document under "Ecotoxicological Information".