Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
Short-term EC50 values for reaction mass of N-butylphthalimide and N-propylphthalimide and N-sec-butylphthalimide are available for three trophic levels of the aquatic freshwater compartment (aquatic invertebrates, algae, fish).
The acute toxicity of reaction mass of N-butylphthalimide and N-propylphthalimide and N-sec-butylphthalimide to Desmodesmus subspicatus was determined in a 72 hours static test according to OECD guideline 201. The median effect concentration with respect to growth rate (ErC50/0–3 days) of reaction mass of N-butylphthalimide and N-propylphthalimide and N-sec-butylphthalimide to Desmodesmus subspicatus was estimated to be 20.7 mg/l based on the measured concentrations. The no observed effect concentration (NOErC) with respect to growth rate was determined to be 6.95 mg/l based on the measured concentrations. The results of the test can be considered reliable without restriction.
The acute toxicity of reaction mass of N-butylphthalimide and N-propylphthalimide and N-sec-butylphthalimide to Daphnia magna was determined in a 48 hours static test according to OECD guideline 202. The median effect concentrations (EC50) of reaction mass of N-butylphthalimide and N-propylphthalimide and N-sec-butylphthalimide on Daphnia magna were estimated to be 9.21 mg/l and 4.64 mg/l measured concentration after 24 and 48 h of exposure, respectively. The NOEC values were determined to be 1.05 mg/l and 0.979 mg/l measured concentration after 24 and 48 h of exposure, respectively. The results of the test can be considered reliable without restriction.
The acute lethal toxicity of reaction mass of N-butylphthalimide and N-propylphthalimide and N-sec-butylphthalimide to Salmo gairdneri was determined in a 96 hours semi-static test according to OECD guideline 203. The median effect concentrations (LC50) of reaction mass of N-butylphthalimide and N-propylphthalimide and N-sec-butylphthalimide on Salmo gairdneri were estimated to be >10 - <100 mg/l nominal concentration after 96 h of exposure. The results of the test can be considered reliable with restrictions.
Conclusion on classification
The environmental classification of reaction mass of N-butylphthalimide and N-propylphthalimide and N-sec-butylphthalimide is currently not harmonised according to the CLP Regulation (EC) 1272/2008. Based on available acute aquatic toxicity data, the lowest valid effect concentration for freshwater aquatic organisms is 4.64 mg/L (EC50 for aquatic invertebrates). Based on the available acute data, the substance should not be classified for acute toxicity following Annex I, table 4.1.0a of the CLP regulation (there are no acute values <=1 mg/L). Based on the available acute data, and the fact that the substance is readily biodegradable, the substance does not need to be classified for chronic aquatic toxicity.
Additional information
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