Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Short-term toxicity to fish

With high probability, acutely not harmful to fish

A 96 -h acute toxicity study was conducted with 3,3'-iminodi(propylamine) (CAS 56 -18 -8) according to the German industrial test guideline DIN 38412, Part 15 (BASF AG 1979, report no. 79/42). The test was conducted with Leuciscus idus exposed to concentrations ranging from 100 to 464 mg/L in a static test system. The pH values of the test solutions were not adjusted. In addition, a test concentration of 500 mg/L was tested for 72 h with neutralised test solutions. The LC50 for the non-neutralised test solutions was determined to be between 215 and 316 mg/L. After 72 h, the concentration of 500 mg/L showed no mortality after neutralisation with H2SO4. Hence, observed effects were caused by the pH shift in the test medium.

The concentrations were not analytically verified during the test, but 3,3'-iminodi(propylamine) is expected to be stable in water, as the substance is miscible in water (Gestis database 2012), its vapor pressure is moderate (VP = 1.26 Pa @20°C, BASF AG 1987, report no. 187.0002.1) and its Henry's Law Constant is low (HLC = 5.54 E-08 Pa m³/mol @ 25°C, calculated with HENRYWIN v3.20, not in applicability domain, BASF SE 2017).

 

Long-term toxicity to fish

In Annex IX of Regulation (EC) No 1907/2006, it is laid down that chronic tests 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, 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. Considering the possibility for the prediction of relative species sensitivities according to the REACH Guidance Document R.7b, chapter R.7.8.5.3, further testing on fish would not contribute to improve the current knowledge of the substance and/or its associated risk when released to the aquatic compartment. This conclusion is based on a factor of greater than 10 for fish to aquatic invertebrates.  Long-term toxicity testing is not triggered by the results of the exposure assessment and the risk characterization. The  risk-characterisation ratios (RCR) do not indicate a risk for the environment (RCR < 1). Therefore, and for reasons of animal welfare, a chronic test in fish is not provided.  

 

Short-term toxicity to aquatic invertebrates

Acutely harmful to aquatic invertebrates

To determine the short-term toxicity of 3,3'-iminodi(propylamine) (CAS 56 -18 -8) to aquatic invertebrates, a static 48 -h acute Daphnia magna toxicity study was conducted according to EU Method C2 (BASF AG 1989, report no. 1/0499/2/89). The nominal test concentrations ranged from 7.81 to 500 mg/L. The pH value of the test solutions was not adjusted. The 48 -h EC50 was estimated to be 37.4 mg/L, based on nominal concentrations.The highest test concentration of 500 mg/L was also tested after neutralising the test solution, but no significant differences to not-neutralised conditions were found.

The concentrations were not analytically verified during the test, but 3,3'-iminodi(propylamine) is expected to be stable in water, as the substance is miscible in water (Gestis database 2012), its vapor pressure is moderate (VP = 1.26 Pa @20°C, BASF AG 1987, report no. 187.0002.1) and its Henry's Law Constant is low (HLC = 5.54 E-08 Pa m³/mol @ 25°C, calculated with HENRYWIN v3.20, not in applicability domain, BASF SE 2017).

 

Long-term toxicity to aquatic invertebrates

Based on the GHS, no chronic toxicity is anticipated at an NOEC or EC10 > 1 mg/L.

Experimental data on the chronic toxicity of 3,3'-iminodi(propylamine) (CAS 56-18-8) on aquatic invertebrates are not available.

Read-across data on long-term toxicity are available from a GLP study according to EU method C.20 (Daphnia magna reproduction test) with the structural analogous substance DETA (CAS 111-40-0). The 21-d NOEC was determined to be 5.6 mg/L (nominal; Akzo, 1991). The concentrations were not analytically verified during the test, but DETA is expected to be stable, due to a high water solubility (miscible), a moderate vapour pressure (VP = 0.35 Pa @20°C, measured) and a low Henry's Law Constant (HLC = 3.14 E-08 Pa m³/mol @ 25°C, calculated with HENRYWIN v3.20, not in applicability domain).

The key study is supported by an OECD 211 GLP-guideline study (recorded in the ECHA database) with the structural analogous substance 1,2 -Ethanediamine, N,N'-bis(2 -aminoethyl)- (CAS 112 -24 -3), providing a 21-d EC10 of 1.9 mg/L.

 

Toxicity to aquatic algae

With high probability, not harmful to aquatic algae and cyanobacteria.

A study was performed according to the German industrial test guideline DIN 38412, Part 9 regarding the toxic effect of 3,3'-iminodi(propylamine) (CAS 56 -18 -8) towards the algal species Desmodesmus subspicatus (BASF AG 1989, report no. 01/0499/2/89). The endpoint were recalculated using the program ToxRatPro (v2.10; BASF SE 2011). The study is considered valid. Based on growth rate, the 72h-ErC50 was determined to be 1494.5 mg/L, and the ErC10 was determined to be 294.3 mg/L (nominal; values based on neutralised test solutions).

The concentrations were not analytically verified during the test, but 3,3'-iminodi(propylamine) is expected to be stable in water, as the substance is miscible in water (Gestis database 2012), its vapor pressure is moderate (VP = 1.26 Pa @20°C, BASF AG 1987, report no. 187.0002.1) and its Henry's Law Constant is low (HLC = 5.54 E-08 Pa m³/mol @ 25°C, calculated with HENRYWIN v3.20, not in applicability domain, BASF SE 2017).

 

Toxicity to microorganisms

Depending on local conditions and existing concentrations, disturbances in the biodegradation process of activated sludge are possible.

The assessment of the toxicity of 3,3'-iminodi(propylamine) (CAS 56 -18 -8) to aquatic microorganisms is based on experimental data from a respriation inhibition test according to OECD 209, performed under GLP conditions(BASF SE 2011, report no. 08G0696/05G004).Domestic activated sludge was used as inoculum. The 3h-EC50 was determined to be 410 mg/L, the 3h-EC20 was 20 mg/L and the 3h-EC10 was 4 mg/L, based on nominal concentrations.

The result is supported by two additional studies with sludge microorganisms:

In a growth inhibition study with Pseudonomas putida performed according to the German industrial test guideline DIN 38412, Part 8, an 17h-EC50 of 33 mg/L was measured (BASF, 1989, report no. 9/89/9/0499).

In a short term respiration study with industrial activated sludge performed similar to OECD 209, an EC50 of > 750 mg/L was observed (BASF, 1979, report no. 559).

In all three tests, the concentrations were not analytically verified, but 3,3'-iminodi(propylamine) is expected to be stable in water, as the substance is miscible in water (Gestis database 2012), its vapor pressure is moderate (VP = 1.26 Pa @20°C, BASF AG 1987, report no. 187.0002.1) and its Henry's Law Constant is low (HLC = 5.54 E-08 Pa m³/mol @ 25°C, calculated with HENRYWIN v3.20, not in applicability domain, BASF SE 2017).