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Short-term toxicity to fish

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Description of key information

LC 50 96h > 100 mg/L
NOEC 96h = 100 mg/L

Key value for chemical safety assessment

LC50 for freshwater fish:
100 mg/L

Additional information

The acute toxicity of the test Sulfosuccinate of Lanolin Alcohol to Zebra fish (Danio rerio) was determined in a full 96‑hour static test according to: OECD Guideline for Testing of Chemicals, N. 203.

For this purpose, 7 juvenile fish of the species Danio rerio were exposed, after an acclimation period (59 days), to an aqueous test medium containing the active ingredient at five different concentrations, namely 4.3, 9.4, 20.7, 45.5 and 100.0 mg/L, corresponding to 14.2, 31.3, 68.9, 151.5 and 333.3 mg/L as test item (active ingredient content 30 %).

The obtained experimental results allowed to calculate the LC0, the LC50, the LC100 and the NOEC values at 24, 48, 72 and 96 hours.

The LC50 and NOEC values were determined from the Raw Data by the statistical comparison with negative control, while LC0 and LC100 values at each observation time were directly extracted from the Raw Data.

The LC50 was defined > 100 mg/L of active substance (corresponding to > 333.3 mg/L of test item nominal concentration) at 96 hours, the NOEC 100 mg/L of active substance (corresponding to 333.3 mg/L of test item nominal concentration) at 96 hours.

In the Klimisch 1 GLP study from Kimmel (2013) the acute toxicity of Butanedioic acid, sulfo-, 4-[2-[(2-hydroxyethyl)amino]ethyl] ester, N-C18-unsatd. acyl derivs., disodium salts to zebra fish (Danio rerio) was determined in a 96‑hour semi-static test with daily test medium renewal according to the Commission Regulation (EC) No 440/2008, Part C.1 and the OECD Guideline for Testing of Chemicals No. 203 (1992). The nominal test item concentrations tested were 0.10, 0.32, 1.0, 3.2 and 10 mg as /L.. Additionally, a control group was tested in parallel. In the analyzed test medium samples from the start and end of the first and last test medium renewal periods the measured test item concentrations ranged between 77 and 102% of the nominal value. Consequently, the reported biological results are related to the mean measured concentration, i.e., to 87% as determined in the highest treatment group. In the control and up to and including the highest test concentration with 8.7mg as /L, all fish survived until the end of the test and no visible abnormalities were observed. The 96 hour NOEC and LC0of the test item to zebra fish were both determined to be >= 8.7 mg as/L. The 96 hour LC50of the test item was determined to be > 8.7 mg as/L.

The study was performed at a concentration much higher than the solubility level of the substance and the Critical Micell Concentration, therefore it can be assumed that the representative value of 100 mg/L estimated and confirmed by the similar substance Lanoline sulphosuccinate is reliable