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 p-(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

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

A key study and two suporting studies were carried out to determine the acute fish toxicity.

In the key study, the 96h-LC50 was found to be 5.4 mg/L based on the average exposure concentrations (95% confidence interval bewtween 3.6 and 8.1 mg/L) and was already reached within 48 hours of exposure.

The LC50 in both supporting acute fish toxicity test were determined to be 33 mg/L (96 -hour) with 95% confidence limits of 27 - 41 mg/L in the first supporting test and in the second one LC50 has been investigated and gave a 96 -hour LC50 value of 7.5 mg/L.

The log-term toxicity to fish was waived in accodance with REACh (regulation No 1927/2006) Annex IX, long-term toxicity testing does not need to be performed as the chemical safety assessment indicates there is no need to investigate further the effects on aquatic organisms: The substance is neither PBT nore vPvB - as the substance is viscous and not released to the environment - a continuous exposure of the environment is not expected. The substance is used as a monomer and does not migrate out of the polymer because each molecule has three binding sites which makes it very unlikely not to be bound to the polymer.

A key study and two supporting studies on m-(2,3 -epoxypropoxy)-N,N-bis(2,3 -epoxypropyl)aniline were conducted to determined the EC50 to Daphnia magna. In the key study, the 48h-EC50 was found to be 18 mg/L and based on analitically confirmed nominal exposure concentrations (95% confidence interval between 10 and 32 mg/L. The 48h-EL50 in the first supporting studies was found to be 26 mg/L loading rate WAF with 95% confidence limits of 24 -29 mg/L loading rate WAF.. The the seond test, the 48h-EC50 to Daphnia magna was determined to be 7.1 mg/L with 95% confidence limits of 6.1 - 8.2 mg/L.

The key study for long-term toxicity to aquatic invertebrate was performed with the p-isomer of the substance. The test was performed on Daphnia magna under semi-static conditions during 21 days according to the OECD 211. The study was testing the substance at the exposed concentrations of 0.040, 0.096, 0.42, 1.7 and 4.8 mg/L. The 21d-EC50 for reproduction was calculated to be 1.4 mg/L with 95% confidence interval ranging from 0.91 to 2.2 mg/L. Also it was concluded taht p-(2,3 -epoxypropoxy)-N,N-bis(2,3 -epoxypropyl)aniline did not affect reproduction of Daphnia magna at an average concentration of 0.42 mg/L after 21 days of exposure (NOEC).

For the toxicity to aquatic algae, one key study and two supporting studies were performed. In the first supporting study, the effect of the test material on the growth of Desmodesmus subspicatus has been investigated over a 72 -hour period and gave an ErC 50 (0 -72 h) of 15 mg/L, an EyC50 (0 -72 h) of 8.2 mg/L and an EbC50 (0 -72 h) of 8.1 mg/L. The lowest Observed Effect Concentration based on inhibition of growth rate, yield and biomass integral was 8 mg/L and the No Observed Effect Concentration was 4 mg/L. In the second supporting study, the effect of the test material has been investigated over a 72 -h period and gave an EyL50 (0 -72 h) of 27 mg/L loading rate WAF; 95 % confidence limits 24 -30 mg/L loading rate WAF and an EbL50 (0 -72 h) of 32 mg/L loading rate WAF; 95% confidence limits 28 -35 mg/L loading rate WAF. The Lowest Observed Effect Loading Rates based on inhibition of growth rate, yield and biomass integral were 40, 20 and 20 mg/L loading rate WAF respectively, and the No Observed Loadinf Rtaes were 20, 10 and 100 mg/L loading rate WAF respectively.

In the key study experiment, the effect of the test material on the growth of Desmodesmus subspicatus has been investigated over a 72-hour period and gave an ErL 50 (0 - 72 h) of 57 mg/l loading rate WAF; 95% confidence limits 51-65 mg/l loading rate WAF, an EyL 50 (0 - 72 h) of 27 mg/l loading rate WAF; 95% confidence limits 24 - 30 mg/l loading rate WAF, and an EbL 50 (0 - 72 h) of 32 mg/1 loading rate WAF; 95% confidence limits 28 - 35 mg/1 loading rate WAF. The Lowest Observed Effect Loading Rates based on inhibition of growth rate, yield and biomass integral were 40, 20 and 20 mg/l loading rate WAF, respectively. The No Observed Effect Loading Rates were 20 (inhibition) 20 (yield) and 10 mg/l (biomass) loading rate WAF respectively.

A key study was performed to test the toxicity of m-(2,3 -epoxypropoxy)-N,N-bis(2,3 -epoxypropyl)aniline in micro-organisms. The 3h-IC50

was found to be greater than 1000 mg/l.I.