Registration Dossier
Registration Dossier
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EC number: 301-097-5 | CAS number: 93981-14-7
Endpoint summary
Administrative data
Description of key information
Additional information
Studies were conducted on a formulated product containing 44.7% of the registered substance (6-[(p-Tosyl)amino]hexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)) to determine the acute toxicity of the product to marine fish, marine algae and marine, aquatic invertebrates. A calculation was performed to estimate the toxicity of the registered substance based on the toxicity of the formulated product, assuming a linear relationship between dose and response. Using this method, the registered substance was found to be non-toxic to aquatic invertebrates or fish, however, the substance was found to be toxic to aquatic algae, with an estimated 72 hour EC50 (growth rate) of 10.28 mg/l, and as such requires classification as Aquatic Chronic 3 according to EU CLP criteria. In addition, the triethanolamine component of the registered substance was not found to be toxic to aquatic invertebrates, fish or aquatic algae. A study was conducted on the carboxylic acid component (6-[(p-Tosyl)amino]hexanoic acid) of the registered substance to determine the effect of the substance on the respiration rate of Sewage Treatment Plant (STP) microorganisms. This activated sludge, respiration inhibition study found a 3 hour EC50 of >5000 mg/l for the carboxylic acid, demonstrating that the carboxylic acid component of the registered substance is not toxic to STP microorganisms. It is considered justified to read-across from the carboxylic acid component of tosyl salt to the tosyl salt itself as the acid remains chemically unchanged upon salt formation, and the carboxylic acid and triethanolamine components of the tosyl salt dissociate completely in water and essentially act as independent substances. In a literature study conducted to determine the toxicity of triethanolamine to STP microoganisms (OECD 209), an IC50 of >1000 mg/l was found. Based on the findings of the activated sludge, respiration inhibition studies on the carboxylic acid and triethanolamine components of the tosyl salt it can be concluded that the registered substance is not toxic to STP microorganisms and is not expected to inhibit the respiration rate of STP microorganisms at the concentrations used in the environment.
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