Reaction mass of N,N-ethanediylbis- Hexadecanamide, N-[2-[(1-oxohexadecyl)amino]ethyl]-Octadecanamide, Hexadecanoic acid, 12-hydroxystearic acid, reaction products with ethylenediamine, N,N-ethanediylbis-Octadecanamide and Octadecanoic acid, 12-hydroxystearic acid, reaction products with ethylenediamine

Endpoint summary

Description of key information

Short-term toxicity to fish

 

Based on the result of three acute toxicity to fish tests it can be concluded that the registered substance exhibited no acute toxicity to fish.

 

Two studies investigating the acute toxicity of the Read Across Source substance Amides, C16-C18 (even), N,N'-ethylenebis to two different fish species were available. A report from the Japanese Ministry of Environment (MOE, 2002) was chosen as key study. This test was conducted according to OECD Guideline No. 203: Fish, acute toxicity test (1992), using Oryzias latipes as test organism. The results from this study show that after 96 hours exposure to the test substance, no effects were observed up to the highest attainable concentration (0.027 mg/L, limit of solubility). Therefore, the 96-h LC50 was greater than 0.027 mg/L, and no toxicity within the range of water solubility was reported. The test from the supporting study (Bürger and Heyner, 2002), was carried out according to OECD Guideline No. 203: Fish, acute toxicity test (1992), using Brachydanio rerio (Danio rerio) as test organism, under static conditions. Four nominal test concentrations were used, 10, 100, 1000 and 10000 mg/L, and mortality reported after 24, 48, 72 and 96 hours. At the end of the test (96 hours) no mortality was observed up to the highest concentration tested. Therefore, the 96h EC50 was greater than 10000 mg/L. Additional information was collected from the Japanese Ministry of International Trade and Industry (MITI, 1988), regarding a 48 hour test in which N,N’-ethane-1,2 diyldioctadecanamide did not have an effect on Oryzias latipes, being the 48h-LC50 greater than 300 mg/L (nominal concentration).

 

Short-term toxicity to aquatic invertebrates

 

One study investigating the acute toxicity of the registered substance to Daphnia magna is available. The test was carried out according to the OECD Guideline no. 201. At the water-accommodated fraction (WAF) with the nominal loading level of 100 mg/L no biologically significant effect was determined.

 

Two studies investigating the acute toxicity of the Read Across Source substance Amides, C16-C18 (even), N,N'-ethylenebis to Daphnia magna were available. A report from the Japanese Ministry of Environment (MOE) was chosen as key study. The test was equivalent to the one included in the OECD Guideline No. 202: Daphnia sp., Part I- Acute Immobilisation Test (1984). The results show that after 48 hours exposure to the test compound, up to the highest attainable concentration (0.0022 mg/L), no immobilization was observed on Daphnia magna. Therefore, the 48h-EC50 was greater than 0.0022 mg/L and no toxicity was observed within the range of water solubility. The test performed in the supporting study (Heyner, 2002) was carried out according to the OECD Guideline No. 202: Daphnia sp., Part I- Acute Immobilisation Test (1984), but not under GLP conditions. Immobilisation was assessed in daphnids exposed to four (nominal) test concentrations, 10, 100, 1000 and 10000 mg/L, after 24 and 48 hours. At the end of the test (48 hours) the 48h-EC50 was greater than 10000 mg/L.

 

Based on the result of these three acute toxicity to daphnia tests it can be concluded that the registered substance exhibited no acute toxicity to Daphnia magna within the range of water solubility.

 

Toxicity to aquatic algae and cyanobacteria

 

Based on the result of a toxicity to algae test with a read across substance it can be concluded that the registered substance exhibited no acute toxicity to the freshwater algae Pseudokirchenriella subcapitata within the range of water solubility.

 

The toxicity of the read Across Source substance Amides, C16-C18 (even), N,N'-ethylenebis to the freshwater algae Pseudokircheneriella subcapitata was investigated in one study from the Japanese Ministry of Environment (MOE, 2002). This study followed the OECD Guideline No. 201: Algae, Growth Inhibition Test (1984). The results from this test show that after 72 hours exposure to Amides, C16-C18 (even), N,N'-ethylenebis, no effects on growth rate of Pseudokircheneriella subcapitata were observed, up to the highest attainable concentration (0.053 mg/L, limit of solubility). Therefore, the 72h-EC50 was greater than 0.053 mg/L and no toxicity within the range of water solubility was reported.

 

Toxicity to microorganisms

 

The inhibition of the degradation activity of activated sludge is not anticipated (EC10 > 1000 mg/L).

 

The toxicity of the Read Across Source substance Amides, C16-C18 (even), N,N'-ethylenebis to activated sludge was investigated in one study according to OECD 209 (Clariant, 1989). The results from this test show no effects on the respiration rate of activated sludge up to the highest nominal test concentration of 1000 mg/L. Therefore, disturbances in the biodegradation process of activated sludge is not anticipated (NOEC >= 1000 mg/L).