Registration Dossier
Registration Dossier
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EC number: 209-406-4 | CAS number: 577-11-7
Endpoint summary
Administrative data
Description of key information
Daphnids were the most sensitive trophic level with an geometric mean EC50 of 15.2 mg Docusate Sodium/L and an 21 day-EC10 (mortality) of 9.0 mg/L. This value of 9.0 mg/L will be used as worst case scenario for the risk assessment of aquatic organisms.
Additional information
The environmental hazard assessment for (fresh-) water organisms and sediment habitats is supported by several acute studies (pelagic compartment), a chronic Daphnia reproduction study and by using scientific argumentation (sediment dwelling organisms).
For the environmental hazard assessment of Docusate Sodium acute toxicity studies for freshwater fish, daphnids, freshwater algae and STP microorganisms are available. In addition, a long-term Daphnia reproduction study is available. A long-term study for fish is waived since a longtern study is available for the more sensitive group, e.g., the daphinds.Experimental information about toxicity on marine organisms is not available.
Some of the above studies were conducted with test materials which contained the submission substance at > 80%. The majority of the acute aquatic studies, however, was performed with Docusate Sodium containing formulations. These test materials contained typically between 64 and 70 % Docusate Sodium. For the assessment of all available studies it was assumed that neither synergistic nor antagonistic effects influence the toxicity of Docusate Sodium and - as worst case scenario - the toxicity observed for the test material is only due to the toxicity of Docusate Sodium. The concentration of Docusate Sodium in the respective test materials was used to calculate the effect concentrations for Docusate Sodium.
The short-term EC50/LC50 valuesfor fish, Daphnia, algae and microorganismswere 49, 15.2, 82.5 and 164 mg Docusate Sodium/L,respectively. The EC10 (mortality) obtained in a 21 day chronic daphina reproduction study was 9.0 mg/L. The reproduction of Daphnia was not affected at concentrations up to 11 mg/L, a concentration at which mortality was relevant.
Docusate Sodiumis ready biodegradable, has a log Pow of < 3, has a low Koc resulting in a low likelihood to partition to sediment and is only moderately toxic to pelagic aquatic organisms. Therefore,Docusate Sodiumis not expected to cause adverse effects on sediment organisms. Consequently sediment toxicity tests do not need to be conducted to assess the risk for sediment-dwelling organisms.
The daphnids were the most sensitive trophic level with a geometric mean EC50 of 15.2 mg Docusate Sodium/L and an 21 day-EC10 (mortality) of 9.0 mg/L. This value of 9.0 mg/L will be used as worst case scenario for the risk assessment of aquatic organisms.
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