Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Daphnia toxicity

In an OECD 202 study, under GLP conditions, the 48 hour EC50 to freshwater invertebrates (Daphnia magna) of 2-Propenoic acid, 2-[[(octadecylamino)carbonyl]oxy]ethyl ester has been investigated is greater than 100% v/v saturated solution. The No Observed Effect Concentration is 100% v/v saturated solution (Envigo, 2016f).

Algal toxicity

In an OECD 201 study, under GLP conditions, the 72 hour EC50 (growth) of 2-Propenoic acid, 2-[[(octadecylamino)carbonyl]oxy]ethyl ester is >100* % v/v Saturated Solution. The NOEC is 32 % v/v Saturated Solution (Envigo 2016g).

 

* It was not possible to calculate an ErC50 value as no more than 50% inhibition of growth occurred at the maximum attainable test concentration of 100% v/v saturated solution

Additional information

In an OECD 105 study the water solubility of 2-Propenoic acid, 2[[(octadecylamino)carbonyl]oxy]ethyl ester was found to be less than 0.00025 mg/L of solution (Envigo, 2016a), thus the substance is considered highly insoluble in water. In the OECD 202 study chemical analysis of the test preparations at 0 and 48 hours showed measured test concentrations of less than the limit of quantification (LOQ) of the analytical method employed were obtained which was determined to be 0.019 mg/L. In the same study, the EC50 was found to be greater than 100% v/v saturated solution. The EC50 can be therefore considered to be at least 0.019 mg/L or above.

As the water solubility measured in the OECD 105 study is approximately a magnitude of ten less than the test concentration measured in the OECD 202 study, it can be assumed that there was no toxicity could be recorded as the EC50 is above the water solubility. According to the ECHA Guidance on the Application of the CLP Criteria (version 4.1, June 2015), an environmental safety net" classification of Chronic Category 4 can be assigned for substances with data that do not allow classification under the CLP criteria but there are nevertheless some grounds for concern (such as poorly soluble substance).

2-Propenoic acid, 2[[(octadecylamino)carbonyl]oxy]ethyl ester is, therefore, classified as aquatic Chronic Category 4. Additional aquatic testing is recommended, potentially long term testing, at the next registration tonnage band to clarify the environmental classification and labelling.