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Short-term toxicity to fish

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Description of key information

LC50 for freshwater fish (rainbow trout) = 960 mg/L

Key value for chemical safety assessment

LC50 for freshwater fish:
960 mg/L

Additional information

For the data endpoint “Short-term toxicity to fish” in total 2 studies on freshwater fish are available: one Klimisch 2 key study and one disregarded study with Klimisch 3 score.

 

The non-GLP study from Cytec (Cooke 1990) was classified as Klimisch 2 key study. The study was conducted according to the appropriate guidelines, without major deviations in the in-life phase but without dose verification analysis. In this study the acute toxicity of a formulation containing 80 % Sodium di(1.3-dimethylbutyl) sulfosuccinate to rainbow trout, Oncorhynchus mykiss was determined in a static test. The non-GLP test was performed according to OECD 203. The acute toxicity of the test material containing 80% Sodium di(1.3-dimethylbutyl) sulfosuccinate, 15% water and 5% ethyl alcohol to rainbow trout, Oncorhynchus mykiss, was determined in a static test. The test was performed with a control and nominal 250, 500, 1000, 2000 and 4000 mg test material /L corresponding to 200, 400, 800, 1600 and 3200 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L. For each test group, 2 replicates with 5 fish were set up. During the study, the temperature of the test solutions ranged within 15 +/- 2°C. After 96 hours of exposure, 0, 0, 0, 1, 10 and 10 out of 10 fish had died in the control, 200, 400, 800, 1600 and 3200 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L treatment groups. The 96 h LC50 was determined to be 960 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L. The concentrations were based on nominal concentrations. Since this study represents the technically and scientifically best study, it is considered reliable and relevant for the risk assessment of Sodium di(1.3-dimethylbutyl) sulfosuccinate.

 

Beside the key study, one disregarded Klimisch 3 study is available for this endpoint. This study is considered not to be relevant for the risk assessment but added for informational purposes here since no dose verification was performed and major deviations to the guidelines were observed, i.e., the oxygen concentration declined to 2.0 mg/L at the highest treatment level.

 

The Cytec study from Bowman (1987) was classified as Klimisch 3 study. In this study the acute toxicity of the test material containing 80% Sodium di(1.3-dimethylbutyl) sulfosuccinate, 15% water and 5% ethyl alcohol to bluegill sunfish, Lepomis macrochirus, was determined in a static test. The test was performed according to OECD 203. Deviations to the guideline other than the time and dose dependent decline of the dissolved oxygen concentration to 2 mg /L in the highest treatment level were not reported. The test was performed with a control and nominal 100, 180, 320, 560 and 1000 mg test material /L corresponding to 80, 144, 256, 448 and 800 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L. For each test group, 1 replicate with 10 fish was set up. Fish weighed on average 0.30 g and had a mean length of 24 mm. Dose verification analysis was not performed. During the study, the temperature of the test solutions ranged within 22 +/- 1°C. After 96 hours of exposure, 0, 0, 0, 0, 0 and 1 out of 10 fish had died in the control, 80, 144, 256, 448 and 800 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L treatment groups. A dose- and time -dependent decrease in dissolved O2 was noted: it ranged from 6.4 (control) to 3.1 mg/L (448 and 800 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L) at 48 hours and 5.9 (control) to 2.0 mg/L (800 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L) at 96 hours.The 96 h NOEC was determined to be 448 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L. The 96 h LC50 was determined to be > 800 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L. The concentrations were based on nominal concentrations.

The results of this study are considered to be reliable. However, the dose dependent decline of the oxygen concentration may have confounded the test material based mortality in the test solutions. Hence, this study has strong restrictions for the risk assessment.

Both studies demonstrate that the test material and hence Sodium di(1.3-dimethylbutyl) sulfosuccinate has only a low toxicity to fish. Hence, the study with the best test design and scientifically most sound results was selected as key study. Therefore, the acute LC50 of 960 mg Sodium di(1.3-dimethylbutyl) sulfosuccinate/L from the key study will be used for the further risk assessment.