N,N-dimethyl-alkyl-1-amines, reaction products with alkali hydroxide and chloroacetic acid

Long-term toxicity to aquatic invertebrates

Description of key information

NOEC (21 d) = 2.99 mg a.i./L (Daphnia magna, OECD 211, nominal, read-across to EC 931-700-2)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

2.99 mg/L

Additional information

As no chronic study is available for assessing the toxicity of the substance on invertebrates, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 Grouping of substances, a read-across to the structurally related Alkyl Dimethyl betaine (EC-No. 931-700-2) was applied. The read across is justified due to the structural similarity of the analogue substances and similar physico-chemical properties resulting in a similar environmental fate and ecotoxicity profile. Further justification is given in the analogue justification attached to section 13 in IUCLID.

One key GLP study (Kuhl & Frank, 2013) is available in which the effect of the test substance on the survival and reproductive output of Daphnia magna during an exposure period of 21 d was investigated according to the OECD guideline 211. In a semi-static test female Daphnia were exposed to five test concentrations ranging from a nominal concentration of 1.0 - 100 mg test item/L under controlled test conditions. The mortality rate, reproduction and symptoms of intoxication were compared to the control. Since the test item is a UVCB, TOC measurements were conducted to quantify test item concentrations. TOC was measured in freshly prepared as well as in aged test media. The mean recovery of the test item in fortified samples was 97% and the carbon concentrations in freshly prepared and aged media were similar. Therefore, it was concluded that the test item was stable under the test conditions. No particular signs of intoxication were observed during the test but the survival rate of Daphnia magna after 21 d was significantly reduced at the highest, nominal concentration of 100 mg test item/L. The mean reproduction of surviving Daphnia was significantly reduced at the nominal concentration of 32 mg test item/L. The derived 21 d NOEC for reproduction was 2.99 mg a.i./L (10 mg test item/L) and the corresponding 21 d LOEC was 9.57 mg a.i./L (32 mg test item/L). The 21 d NOEC for survival of adults was 9.57 mg a.i./L (32 mg test item/L) and the corresponding LOEC was 29.9 mg a.i./L (100 mg test item/L). The calculated EC50 for reproduction was 9.45 mg a.i./L (31.6 mg test item/L), 7.27 mg a.i./L (24.3 mg test item/L) for the EC20 and 6.31 mg a.i./L (21.1 mg test item/L) for the EC10.