Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Overall aquatic toxicity: Acutely harmful to aquatic organisms.

 

Short-term toxicity to fish:

With high probability acutely not harmful to fish.

The toxicity of N,N'-bis(3 -aminopropyl)ethylenediamine (CAS 10563 -26 -5) was studied in a static test according to national standards (DIN 38412, part 11). The test item concentrations were not analytically verified, but are assumed to be stable regarding the sufficient recovery (> 80%) in the chronic study with Daphnia magna (BASF SE, 2014). The 96 -h LC50 was determined to be > 200 and < 460 mg/L., based on nominal concentrations In addition to the not-neutralised test solutions, the highest test concentration of 1000 mg/L was tested in parallel after neutralisation. Mortality was reduced and toxic effects occurred with delay (not neutralised: 100% after 1h; neutralised: 80% after 48 h and 90% after 72 h; BASF AG, 1991; report no. 10F0227/895367).

Long-term toxicity to fish:

No relevant and reliable data available.

 

Short-term toxicity to aquatic invertebrates:

Acutely harmful to aquatic invertebrates.

The acute toxicity of N,N'-bis(3 -aminopropyl)ethylenediamine (CAS 10563 -26 -5) was studied in a static test according to method C2 of Annex V of the EU Directive 79/831/EEC. The test item concentrations were not analytically verified, but are assumed to be stable regarding the sufficient recovery (> 80%) in the chronic study with Daphnia magna (BASF SE, 2014). The 48-h EC50 was determined to be 42.5 mg/L (result based on not pH-adjusted test solutions). In addition to the not pH-adjusted test solutions, the highest test concentration of 200 mg/L was tested in parallel after neutralisation. The toxic effect was similar to the not-adjusted test solution (BASF AG, 1991; report no. 1/0502/2/89 -0502/89).

Long-term toxicity to aquatic invertebrates:

Chronically not harmful to aquatic invertebrates.

To determine chronic effects of N4-Amine N,N’-Bis-(3-Aminopropyl)-ethylenediamine (CAS 10563 -26 -5) on aquatic invertebrates, a GLP-study according to OECD 211 was performed with Daphnia magna (21 d-reproduction test). The test concentrations were analytically verified. The mean measured concentrations for the whole exposure period were within ±20% of the nominal concentration. The NOEC was determined to be 7.2 mg/L (reproduction; nominal) (BASF SE, 2014; report no. 51E0402/04E011). All validity criteria were fulfilled in this study. Based on the NOEC of 7.2 mg/L chronic effects on aquatic invertebrates are not expected.

 

Toxicity to aquatic algae and plants:

With high probability acutely not harmful to aquatic algae.

There is one reliable study available regarding the toxic effect of N,N'-bis(3 -aminopropyl)ethylenediamine (CAS 10563 -26 -5). The study was performed according to OECD 201 under GLP conditions. The test species was Desmodesmus subspicatus. The test concentrations were analytically verified (90 to 100% mean recovery). The 72 -h NOErC was determined to be 50 mg/L, the 72 -h ErC50 was > 100 mg/L (BASF AG, 2005; report no. 60E0402/043218).

 

Toxicity to microorganisms:

The microbial toxicity of N,N'-bis(3 -aminopropyl)ethylenediamine (CAS 10563 -26 -5) was studied in two tests: 1) GLP guideline study, respiration inhibition test with activated sludge, OECD 209; 2) non-GLP guideline study, Pseudomonas putida growth inhibition according to Bringmann-Kühn, German Industrial Standards DIN 38412, part 8.

The respiration inhibition test used activated sludge as inoculum taken from a wwtp treating predominantly domestic sewage. The 3 -h EC10 was determined to be 34 mg/L, the 3 -h EC50 was 720 mg/L (BASF SE, 2012; report no. 08G0402/04G008).

In the growth inhibition test, the test species was Pseudomonas putida. The test concentrations were not analytically verified. The 17 -h EC10 was determined to be 3.97 mg/L, the 17 -h EC50 was 8.8 mg/L (BASF AG, 1990; report no. 1/89/0502). The OECD 209 study was selected as key study since this result was determined under GLP according to an international guideline.

Reasons for data waiving

The results from short-term toxicity tests on fish, Daphnia and algae demonstrate that aquatic invertebrates are the most sensitive trophic level tested. Therefore, it may be concluded that results from a long-term test in fish would not reveal a greater hazard than already determined by the available data. Therefore, and for reasons of animal welfare, a chronic test on fish is not provided. In Annex IX of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity test shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on fish. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or CLP-Regulation (EC) No 1272/2008 or is assessed to be a PBT or vPvB. The hazard assessment of the substance reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment. Moreover, the chemical turned out to be readily biodegradable in an OECD ready test. Therefore, and for reasons of animal welfare, a long-term toxicity in fish is not provided.