Registration Dossier
Registration Dossier
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EC number: 939-498-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Additional information
The aquatic hazard assessment of Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and ammonia
was performed using test results of short-term toxicity test for organisms of three trophic levels ( freshwater fish, aquatic invertebrates and algae). The key studies showed a 96h-LC50 of 160 mg/L for fish, a 48h-EC50 of 12.66 mg/L for aquatic invertebrates (Daphnia) and a 72h-EC50 of > 29.1 mg/L for algae. Based on this data the substance is considered to be harmful to aquatic organisms. Aquatic invertebrates are identified as most sensitive organisms.A NOEC value of a long-term toxicity test is available for algae. The 72h-NOEC value is determined to be 5.24 mg/L. Results of long-term toxicity test with fish and Daphnia are not available. In Annex IX, column II (9.1) of Regulation (EC) No 1907/2006, it is laid down that a long-term toxicity test shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on aquatic organisms. The hazard assessment of Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and ammonia reveals that aquatic invertebrates are the most sensitive organisms. However, the 48h-EC50 is measured to be > 10 mg/L indicating that the substance is not acute toxic but harmful to aquatic invertebrates. Given the very fast biodegradation of the substance in the environment (> 50% in 5 days /~ 80% in 15 days) and the very low bioaccumulation potential (log Kow = 1.48) chronic toxicity of the substance in the range of classification is not indicated. An exposure assessment performed using PNECs derived on the basis of the available aquatic short-term toxicity tests (including a conservative assessment factor of 1000) indicate no risk for the aquatic environment. Therefore, it is not considered to be necessary to perform a long-term toxicity test with aquatic invertebrates to improve the safe handling of the substance.
One study investigating the toxicity of Reaction product of fatty acids C14-18/C16-18 unsaturated with dihydrogendioxide and ammonia
to aquatic microorganisms is available. A 3h-EC10 is determined to be > 1000 mg/L. As the substance is readily biodegradable no toxicity was expected for microorganisms. The test result confirmed this assumption. Thus, inhibition of the biodegradation activity of activated sludge in STPs is not anticipated.Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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