Reaction mass of N,N’-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide), Octadecanamide, 12-hydroxy-N-[2-[(1-oxooctadecyl)amino]ethyl]- and Octadecanoic acid, 12-hydroxy-, 1-hexyl-12-[[2-[(12-hydroxy-1-oxooctadecyl)amino]ethyl]amino]-12-oxododecyl ester

Endpoint summary

Description of key information

Four acute toxicity studies are available for the test substance (bisamide multi) and read-across bisamide substance representing three trophic levels of aquatic organisms. All studies are carried out in accordance with guideline methods and to GLP. No acute toxicity was observed at the limit of solubility of the test substances. The study by Dickinson (2013) reported no toxicity at the limit of solubility of the read-across substance to fish (Oncorhynchus mykiss). The LL50 was reported to be greater than 10 mg/l nominal loading rate. The study by Dickinson (2013) reported no toxicity at the limit of solubility of the read-across substance to aquatic invertebrates (Daphnia magna). The LL50 was reported to be greater than 10 mg/l nominal loading rate. Similarly, the study by Dickinson (2013) reported no toxicity at the limit of solubility of the read-across substance to algae (Pseudokirchneriella subcapitata). The EbC50, ErC50 and EyC50 were reported to be greater than 100 mg/l nominal loading rate. No toxicity was observed at the limit of solubility of the test substance. The study by Vryenhoef (2018) reported no toxicity at the limit of solubility of the test substance (bisamide multi) to the algae Pseudokirchneriella subcapitata. The results are based on nominal % v/v saturated solutions. Under the conditions of the test the EL50 (growth rate) was determined to be >100% v/v saturated solution.

New studies are available for assessing the long-term potential toxicity to aquatic organisms. All studies were carried out to guideline methods, GLP and using the test substance (bisamide multi) or the read-across substance CAS 100545-48-0. In a fish early life study (FELS) no toxicity was observed at the limit of solubility of the test substance, reported as a NOEC greater than the limit of quantification of 0.00046 mg/l (Sacker, 2018). A chronic reproduction study with Daphnia magna using the read-across substance CAS 100545-48 -0 reported no effects at the limit of solubility and a NOELR of >10 mg/l nominal loading rate (Chastenet, 2018). The two algal studies also provided no effect information. Vryenhoef (2018) reported a NOELR calculated to be 12.5% v/v saturated solution (equivalent to 1.25 mg/l nominal loading rate), although this is greater than the limit of solubility of the test substance (bisamide multi). The NOEC (nominal loading rate of the read-across substance) reported by Dickinson (2013) for algae was greater than the loading rate of 100 mg/l.

The aquatic microbial study is waived on the basis that no toxicity is anticipated at the limit of solubility.