Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Acute toxicity to fish

DMAPA is with high probability not harmful to fish.

The key study, originally performed by Hoechst (1980) uses Leuciscus idus as test species in an acute test according to German Industrial Standard DIN 38412 -15 (similar to OECD 203). The exposure duration was 96 h. The stability of the test substance3-aminopropyldimethylamine(CAS 109-55-7) in the test medium has not been analytically verified, but is considered to be stable due to the high water solubility (WS = 1E+06 mg/L), the low Henry´s law constant (uncharged: 6.71E-04 Pa*m3/mol) and the low adsorption potential (log Kow and log Koc < 3) of the substance. The study was performed using not pH-adjusted test solutions. The test substance causes a pH-shift to more alkaline conditions with increasing test substance concentrations, resulting in a maximum pH value of 10.6 in the highest test concentration (500 mg/L). The acceptable pH range for fish given in the OECD TG 203 (pH 6.0 to 8.5) was therefore not kept in all test concentrations. The 96-h LC50 was determined to be 122 mg/L (nominal). Due to the high pH value in the highest test concentration, an influence of the pH value on the toxicity of the substance towards fish cannot be excluded.

 

Long-term toxicity to fish

In Annex IX Section 9.1.6 column 2 of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing on fish 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 3-(dimethylamino)-propylamine 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.  

In Annex XI Section 3, it is laid down that testing in accordance with sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (“Substance-Tailored Exposure-Driven Testing”). In accordance with Annex XI Section 3, it can be demonstrated in the risk assessment that the manufacture and the use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are below 1 for all compartments (see Chemical Safety Report Ch. 9, 10).

Therefore, and for reasons of animal welfare, a long-term toxicity test on fish is not provided.

 

Acute toxicity to invertebrates

3 -Aminopropyldimethylamine is acutely harmful to aquatic invertebrates.

To assess the short-term toxicity of 3 -aminopropyldimethylamine towardsD. magna, a 48-h static non-GLP test was performed according to EEC-Guideline 79/831/EEC method C.2, which is equivalent to OECD 202 (Daphnia sp. Acute Immobilisation Test). The stability of the test substance in the test medium has not been analytically verified, but it is considered to be stable due to the high water solubility, the low Henry´s law constant and the low adsorption potential (log Kow and log Koc < 3) of the substance. The pH values of the test solutions were not adjusted and ranged from 7.9 to 8.6, therefore staying in the limit given by the OECD guideline 202 (pH value 6 to 9). Based on nominal concentrations, the 48-hour EC50 was estimated to be 59.5 mg/L (BASF AG, 1988, report no.: 1/0556/2/87 -0556/87).

 

Long-term toxicity to aquatic invertebrates

The chronic toxicity of 3 -aminopropyldimethylamine was assessed in a semi-static 22-d reproduction test according to OECD 211, usingDaphnia magnaas test species. The test substance concentrations were analytically verified. The initial test concentrations and those after 48 and 72 hours of exposure deviated less than 20% from the nominal concentrations, except for samples of one test concentration on day 19, which deviated more than 20% from the nominal concentration. Therefore, the results are based on time-weighted average concentrations. All validity criteria were fulfilled. After 22 days, a NOEC (reproduction) of 3.64 mg/L was determined, based on time-weighted average concentrations (BASF SE, 2017, report no.: 51E0340/15E017).

 

Toxicity to aquatic algae

DMAPA is acutely harmful to aquatic algae.

The effects of 3 -aminopropyldimethylamine (DMAPA, CAS 109-55-7) on freshwater algae have been assessed using data from a growth inhibition test with DMAPA according to DIN 38412-9 (BASF AG, 1987) and read-across data from three tests with the structurally similar substance 3 -aminopropyldiethylamine (DEAPA, CAS 104-78-9).

In a static growth inhibition test, the freshwater algaePseudokirchneriella subcapitatawas exposed to the read-across substance 3-aminopropyldiethylamine (CAS 104 -78 -9) for 72 hours according to OECD 201 and under GLP conditions. The algae were exposed to nominal concentrations between 4.77 and 50 mg/L. The test item concentrations were analytically verified and the final concentrations were maintained within the designated limit of 80% of the initial concentrations in non-inoculated flasks. Therefore, the effect concentrations and NOEC have been calculated using the nominal concentrations. The 72-h ErC50 and the 72-h NOEC were determined to be 34 and 19.53 mg/L, respectively. The 72-h ErC10 was determined to be 26 mg/L (Arkema, 2000, report no.: 57/99/A. The pH values of the test solutions were not adjusted. They were in acceptable range of 7.6 to 9.3 at the beginning of the test and 8.0 to 9.4 after 72 hours of exposure. Therefore, an effect of the pH level on the toxicity of the test substance can be excluded. The validity criteria of the study were fulfilled. The results were selected as key values for the further risk assessment.

In addition, acute toxicity of the read-across substance toDesmodesmus subspicatuswas investigated according to German Industrial Standard DIN 38412-9. The 72-h ErC50 was determined to be between 100 and 150 mg/L using not pH-adjusted test solutions (BASF AG, 1990, report no.: 02/90/134). The concentrations were not measured in the vessels during the test but the substance is expected to be stable in water as shown in the study mentioned above. Another test with the source substance was conducted according to German Industrial Standard DIN 38412-9. But the stock solution was neutralised with hydrochloric acid to pH 7. In this study, the 72-h ErC10 and the 72-h ErC50 were determined to be 3.45 g/L and 7.12 g/L, respectively (BASF AG, 1990, report no.: 04/90/154). The first two studies were performed without adjustment of the pH as no preferred pH range is described in the guideline. However, in the third study the pH was adjusted, leading to clearly higher effect values. The result of the study suggests that the toxicity of the source substance 3-aminopropyldiethylamine is related to the increase of the medium pH but not to a specific mode of toxic action.

For the target substance 3-aminopropyldimethylamine (CAS 109-55-7), two studies are available, which further support the result of the key study. The 72-h static test withDesmodesmus subspicatuswas performed according to the German Industrial Standard Test Guideline DIN 38412-9. The results were recalculated using ToxRatPro v2.09. The concentrations were not analytically verified but 3-aminopropyldimethylamine is expected to be stable in water due to the high water solubility, the low Henry´s law constant and the low adsorption potential (log Kow and log Koc < 3) of the substance. The re-evaluation showed that the validity criteria of the recent guideline OECD 201 were not fully met, but are in agreement with the above-mentioned results of the structurally similar substance 3-aminopropyldiethylamine. After 72 hours an ErC50 of 64.3 mg/L and an ErC10 of 48.4 mg/L were determined, related to nominal concentration (BASF AG, 1987, report no.: 2/0556/87; BASF SE, 2009).

In an additional marine study performed with 3 -aminopropyldimethylamine according to ISO 10253 using Skeletonema costatum as test species a 72-h ErC50 of 55 mg/L was determined, based on nominal test concentrations (Eide-Haugmo, 2009, 2012).

 

Toxicity to microorganisms

The inhibition of the degradation activity of activated sludge is not anticipated when 3 -aminopropyldimethylamine is introduced in appropriately low concentrations.

In order to assess the toxicity of 3 -aminopropyldimethylamine (DMAPA; CAS 109 -55 -7) to microorganisms there are experimental data for the substance itself as well as for the structurally similar substance 3 -aminopropyldiethylamine (DEAPA; CAS 104 -78 -9) available. In accordance with REACH Guidance Document Ch. R.7b (Version 4.0, June 2017; R.7.8.19.1), to assess the toxicity on STP microorganisms, tests with mixed inoculum are preferred over single species tests. Therefore, the study according to OECD 209 with the read-across substance is selected as key study.

As key study, a study with the structurally similar substance 3 -aminopropyldiethylamine (CAS 104 -78 -9) was selected. The study was performed according to OECD 209 (1993) and GLP to determine the effect of the test substance on the oxygen consumption of microbial-inoculum, compared to the blank control. The test was conducted at concentrations of 0 (control) and 1000 mg/L. The toxicity of the test substance was followed by exposing it to activated sludge from a domestic wastewater treatment plant over 30 minutes. All validation criteria were fulfilled. The pH value of the test solutions was neutralised. Based on the results, the EC20 value and the EC50 value were calculated to be greater than 1000 mg/L (BASF SE 2005, report no.: 08G0264/053084).

The result was supported by a study with DMAPA itself.

A non-GLP test according to German Industrial Standard DIN 38412 was performed with DMAPA using Pseudomonas putida as test organism.The stability of DMAPA in the test medium has not been analytically verified, but is considered to be stable due to the high water solubility, the low Henry's law constant and the low adsorption potential (log Kow and log Koc < 3) of the substance.The EC10 (17h) was estimated to be 69.5 mg/L and the EC50 94.5 mg/L, both related to nominal concentrations (BASF AG, 1987, report no.: 9/0556/87).