Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Based on the substances similarities of the physical and chemical properties and ecotoxicological profile to m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline, a read across has been proposed to fullfil toxicological endpoints where no data is available on the target substance. Please see the relevant endpoint summaries and read across justification document enclosed in Chapter 13.

Short term toxicity from three trophic levels (Daphnia, Fish and Algae) is available for the misomer and for two trophic levels (Fish and Algae) for the p-isomer substance. The results showed that L(E)C50 values to Fish and Algae are very similar (>4.2 mg/L to 5.4 mg/L for Fish and 13 mg/L to 18 mg/L for Algae). Additionally, a chronic study on daphnia reproduction is available on the p-isomer.

Based on the results mentioned above on physico-chemical properties and environmental fate and given that short term toxicity on Fish and Algae species are very similar, it is highly likely that the p-isomer substance will show the same acute toxicity to aquatic invertebrate than the m-isomer and that the m-isomer will have the same chronic toxicity to Daphnia Magna in a reproduction test than the p-isomer. Consequently, we consider scientifically justified to read-across from the m-isomer to the p-isomer and vice versa. For further information, please refer to the read across justification document enclosed in chapter 13.

Additional information

Available Data for

p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline

In the short-term toxicity study on Carp, the LC50 after 96 hours of treatment was 4.2 mg/L with 0% mortality at 3.2 mg/L and 100% mortality at 5.6 mg/L.

In the short-term toxicity study on Daphnia magna, the test substance did not induce significant acute immobilisation of Daphnia magna at 10 mg/L after 48 hours of exposure based on analytically confirmed nominal exposure concentrations. The 48h-EC50 was 18 mg/L based on analytically confirmed nominal exposure concentrations (95% confidence interval between 10 and 32 mg/L)

In the long-term toxicity study on Daphnia magnia, the exposure to the concentrations of 1.7 mg/l and higher induced significant inhibition of the reproductive capacity of the parental daphnids (LOEC for reproduction). The 21d-EC50 for reproduction was 1.4 mg/l and the 21d-NOEC value for reproduction was 0.42 mg/l.

In the toxicity study to fresh water algae on Pseudokirchneriella subcapitata, the substance reduced significantly the growth rate of the algae species at an average exposure concentration of 26 mg/l. The EC50 for growth rate reduction was 13 mg/l, the EC50 for yield inhibition was 7.0 mg/l and the NOEC for growth rate reduction was 4.2 mg/l, while NOEC for yield inhibition could only be estimated to be < 2.5 mg/l.

Toxicity to microorganisms, investigated on Pseudomonas putida led to no inhibition of the growth rate. The EC10 and EC50 values were > 10 000 µg/L.