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Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Short-term toxicity to fish

Two studies were supplied to address this data point. The study from CECA, 2005, has a Klimisch rating of 1 and is identified as the key study. It has been decided that the study from AkzoNobel, 1990 will be used as the supporting study as its Klimisch rating is 2.

The 96-hour LC50 of N-[2-(piperazin-1-yl) ethyl]C18-insaturated-alkylamide to D. rerio under semi-static conditions was 0.33 mg a. s. /L.

Long-term toxicity to fish

For the PNEC calculation, it is considered unlikely that fish toxicity will be critical for N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide. Hence any additional toxicity testing with fish will not add scientific value to the ecotoxicity profile of N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide other than for obtaining a lower assessment factor. It is therefore concluded that for scientific reasons and in accordance to REACH legislation further testing on fish has to be avoided for reasons of animal welfare.

Toxicity to invertebrates

Short and long-term tests are available for assessing toxicity of N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide to aquatic invertebrates.

The determination of the inhibition of mobility (acute toxicity) of the freshwater Daphnia magna exposed to the test item N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide for a duration of 48 hours was performed following the method C2 described in Directive 92/69/EEC of the European Commission and in the guideline 202 (part I) of the OECD (Gancet, 2004).

The 48-hour EC50 of N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide to D. magna under static conditions was 0.44 mg a.s./L (median lethal concentration).

A study by Kean determined the long-term toxicity of N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide to Daphnia magna. The study was carried out in accordance with OECD Guideline 211. Daphnia magna were exposed to the following nominal concentrations of the test material: 0, 0.011, 0.036, 0.12, 0.37, and 1.2 mg/L. A first test has been performed in 2010 but due to physical effects accurate determination of the endpoints was not possible. Therefore, a test was repeated in 2011 with a bulk approach. Based on all endpoints the NOEC for this substance is 0.37 mg/L. Due to no partial responses occurring an accurate EC10 could not be determined. This may be reported as > 0.37 mg/L and < 1.2 mg/L. Interpolation between these two endpoints was not considered accurate.

Toxicity to aquatic algae

Gancet, C.et al., 2005: Exponentially growingP. Subcapitatawas exposed to N-[2-(piperazin-1-yl) ethyl]C18-insaturated-alkylamide at nominal concentrations of 0, 20, 40, 90, 210, 450 and 1000 µg/L in a static 72 -hour toxicity test. 

The 72 -hour ErC50 (growth rate) and EbC50 (integrated biomass) endpoints determined by probit analysis for P. subcapitata exposed to N-[2-(piperazin-1-yl) ethyl]C18-insaturated-alkylamide under static conditions were 0.037 and 0.016 mg/L respectively. The corresponding 72 -hour NOECs based on inhibition of specific growth rate and integrated biomass were both 0.011 mg/L respectively.

Toxicity to Microorganisms

The toxicity to activated sludge was determined in accordance with OECD Test Guideline 209, and in compliance with the OECD principles of Good Laboratory Practice.

The toxicity of N-[2-(piperazin-1-yl) ethyl]C18-insaturated-alkylamide to activated sludge was determined at a contact time of 3 hours, using various concentrations of the test substance. The EC50 of N-[2-(piperazin-1-yl) ethyl]C18-insaturated-alkylamide for activated sludge after 3 hours contact time is 228 mg/L with 95% confidence limits of 132 and 566 mg/L. The EC10, EC20 and EC80 are 90, 124 and 420 mg/L, respectively.

N-[2-(piperazin-1-yl) ethyl]C18-insaturated-alkylamide is therefore considered not harmful to activated sludge.

No effects were observed in a sewage treatment simulation (CAS) test at an influent concentration of 50 mg/L.