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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

The most sensitive organism regarding exposure to 2 -dibutylaminoethanol (CAS 102-81-8) was Pseudokirchneriella subcapitata (72 -h ErC10 = 6.9 mg/L).

Short-term toxicity to fish:

With high probability acutely not harmful to fish.

Reliable results from two studies on the acute toxicity of 2 -dibutylaminoethanol (CAS 102 -81 -8) towards fish are available. A 96 -h acute toxicity study was performed under static conditions according to German Industrial Standard DIN 38412, part 15, using Leuciscus idus as test species (BASF AG, 1987, report no. 10F0432/865014). The 96 -h LC50 was determined to be 31.6 mg/L (nominal; geometric mean; pH not adjusted). The toxicity was significantly reduced in pH-adjusted test solutions which resulted in an LC50 of 224 mg/L (geometric mean of LC0 = 100 mg/L and LC100 = 500 mg/L). The test concentrations were not analytically verified, but are assumed to be stable over the exposure period, as it was verified in other studies (see for example IUCLID Chapter 6.1.5, NITE 2004), and as the substances' water solubility is 4000 mg/L (BASF SE 2012, report no. 11L00536), its vapor pressure is moderate (VP = 0.05 hPa @20°C, BASF SE 2012, report no. 11L00536) and its Henry's Law Constant is low (HLC = 0.217 Pa m³/mol, calculated with the VP/WS method, BASF SE 2017).

 

The results were supported by a GLP-study according to OECD 203, performed with Oryzias latipes as test species. The guideline OECD 203 advises a pH adjustment if there is a strong change in the pH of the water after addition of the test substance. The pH strongly increased in this test after addition of the test substance (pH of fresh test solutions 10-100 mg/L: pH 8.5-9.8). The pH of the fresh test solutions was outside the recommended pH-range according to OECD 203 (pH 6.0 to 8.5). Therefore it cannot be excluded that the test substance is less toxic after neutralization. Without pH adjustment, 2-(dibutylamino)ethanol is acutely harmful to fish according to this test. The 96 -h LC50 was determined to be 29.2 mg/L (analytically verified, not pH-adjusted; NITE, 2004).

In another short-term acute toxicity test according to OECD 203, the 96 -h LC50 was determined to be 32 mg/L (nominal; not pH-adjusted) with Oryzias latipes as test species. This test was performed as a ranging-finding test within a bioaccumulation study according to OECD 305 and GLP (NITE, 2001). The test concentrations were not analytically verified but are assumed to be stable based on the assumptions given above.

The acceptable pH range for fish is given in the OECD TG 203 as pH 6 to 8.5. Without pH-adjustment the pH values exceeded this range; therefore, the data from these tests (BASF AG, 1987, without pH-adjustment; NITE, 2001; NITE, 2004a/2011) with fish should not be considered in the assessment of the DBEA as otherwise pH-effects cannot be distinguished from the inherent toxicity of DBEA to fish.

It is reasonable to conclude that DBEA is with high probability acutely not harmful to fish after pH-adjustment (96-h LC50 > 100 mg/L; BASF AG, 1987).

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 CLP-Regulation (EC) No 1272/2008 and its second adaptation 286/2011 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.

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. 10).

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.

The acute toxicity of 2 -dibutylaminoethanol (CAS 102 -81 -8) was studied in a semistatic test equivalent to OECD 202 using Daphnia magna as test species (Danish EPA, 2000, report no. 11531). The concentration of the stock solution was analytically verified. The 48 -h EC50 was determined to be 73.7 mg/L (measured; nominal: 81.0 mg/L).

The results were supported by an acute toxicity study according to OECD 202 using Daphnia magna as test species. The 48 -h EC50 was determined to be greater than 108 mg/L (analytically verified; NITE, 2004).

Long-term toxicity to aquatic invertebrates:

Chronically not toxic to aquatic invertebrates.

Regarding chronic toxicity to aquatic invertebrates a test performed by the Japanese National Institute of Technology and Evaluation (2004) was identified as the key study. The test is performed according to OECD guideline 211 under GLP conditions. The NOEC for reproduction of Daphnia magna after 21 days of exposure is 4.4 mg/L. The 21-d EC50 is 9.0 mg/L. All concentrations were analytically verified.

 

Toxicity to aquatic algae and plants:

Acutely harmful to algae.

The toxic effect of 2-dibutylaminoethanol (CAS 102 -81 -8) was tested in a GLP-guideline study according to OECD 201 using the algal species Pseudokirchneriella subcapitata as test species (NITE, 2004).

The concentrations were analytically verified. The 72 -h ErC50 was determined to be 21.6 mg/L, the 72 -h ErC10 was 6.9 mg/L, the 72 -h NOErC was 3.2 mg/L (results obtained from J-Check database and revalidated in 2014 by BASF SE). The ErC10 is the preferred effect value according to REACH Guidance Document R.7b (v4.0, June 2017) and will be used for the assessment of the sensitivity of algae to DBEA as well as for deriving the PNEC.

Toxicity to microorganisms:

The inhibition of the degradation activity of activated sludge is not expected when introduced in appropriately low concentrations.

The assessment of the toxicity of Dibutylethanolamine (DBEA; CAS 102 -81 -8) to aquatic microorganisms is based on experimental data from a respiration inhibition test according to OECD 209, performed under GLP-conditions (BASF SE 2005, report no. 08G03286/053095). Non-adapted activated sludge from a municipal wastewater treatment plant was used as inoculum. The pH of the test solutions was adjusted. The 30 -min EC20 was determined to be greater than 1000 mg/L, based on nominal concentrations, indicating that no effect on the degradation activity is anticipated for activated sludge if DBEA is introduced in appropriately low concentrations.

The data for the key study are supported by the results of a non-GLP study conducted according to OECD 209 (BASF AG 1985, report no. 1120). Activated slugde from an industrial wastewater treatment plant was used as inoculum. The 30 -min EC20 was determined to be > 1000 mg/L (nominal).

In both studies, the concentrations were not analytically verified during the test, but DBEA is expected to be stable in water, as it was verified in other studies (see for example IUCLID Chapter 6.1.5, NITE 2004), and as the substances' water solubility is 4000 mg/L (BASF SE 2012, report no. 11L00536), its vapor pressure is moderate (VP = 0.05 hPa @20°C, BASF SE 2012, report no. 11L00536) and its Henry's Law Constant is low (HLC = 0.217 Pa m³/mol, calculated with the VP/WS method, BASF SE 2017).