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EC number: 236-882-0 | CAS number: 13531-52-7
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
Description of key information
The substance is with high probability acutely and chronically not harmful for aquatic algae.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 460.2 mg/L
- EC10 or NOEC for freshwater algae:
- 9.1 mg/L
Additional information
QSAR-disclaimer
In Article 13 of Regulation (EC) No 1907/2006, it is laid down that information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI (of the same Regulation) are met.
According to Annex XI of Regulation (EC) No 1907/2006 (Q)SAR results can be used if (1) the scientific validity of the (Q)SAR model has been established, (2) the substance falls within the applicability domain of the (Q)SAR model, (3) the results are adequate for the purpose of classification and labeling and/or risk assessment and (4) adequate and reliable documentation of the applied method is provided.
For the assessment of N-(2-aminoethyl)-1,3-propanediamine (Q)SAR results were additionally used for the estimation of the toxicity to algae. The criteria listed in Annex XI of Regulation (EC) No 1907/2006 are considered to be adequately fulfilled and therefore the endpoint(s) sufficiently covered and suitable for risk assessment.
Assessment
The toxicity of N-(2-aminoethyl)-1,3-propanediamine against aquatic algae was investigated in a non-GLP study according to DIN 38412, Part 9, with Desmodesmus subspicatus (BASF AG, 1990; Study no. 2/0503/89; 2/w503/89).The study was performed without analytical monitoring, however, it is assumed that the test concentrations remained stable over the exposure period based on the substance's physico-chemical properties and its environmental fate. The test item is completely miscible with water (measured; see IUCLID Ch. 4.8), which is a pre-requisite to the reliable preparation of the test concentrations. The Substance will be evenly distributed in the test medium. In addition, it is highly unlikely that the Substance will precipitate from the test medium. Evaporation of the test item from the test medium is not to be expected based on the low vapour pressure of 0.036 hPa (measured at 20 °C; see IUCLID Ch. 4.6) and the low Henry's Law constant (4.17E-08 Pa*m³/mol, HENRYWIN v3.20; see IUCLID Ch. 5.4.2). In addition, the Substance is ionized at the environmentally relevant pH range (pKa = 10.51; estimated; see IUCLID Ch. 4.21), which further reduces any tendency of the Substance to evaporate into the atmosphere. Finally, loss of the test item from the test medium due to adsorption to the test vessels is unlikely as the Substance has a low adsorption potential (log Kow = -1.67, measured; see IUCLID Ch. 4.7; log Koc = 0.96 at pH 5 to 8, calculated according to Franco & Trapp; see IUCLID Ch. 5.4.1).
Study results were recalculated with ToxRat 2.1 to verify validity criteria (ECT, 2010). The 72h ErC10 was determined to be 9.2 mg/L and the 72h ErC50 was 460.2 mg/L (nominal; not neutralized). In addition to the not pH-adjusted test solutions, selected test solutions were neutralized (7.8, 125, 500 mg/L, nominal). Regarding growth rate and based on a recalculation, no toxic effects were observed (NOErC >= 500 mg/L; LOErC >500 mg/L).
The toxicity of N-(2-aminoethyl)-1,3-propanediamine to algae was additionally evaluated by using ECOSAR v2.2 and the QSAR Toolbox v4.5 calculation model. The substance is withitn the applicability domain of the models.
ECOSAR identified the substance as a member of "Aliphatic Amines". The model estimated a 96-h EC50 of 866 mg/L and a chronic value of 211 mg/L.
Trend analysis was performed with the QSAR Toolbox based on substances which are aliphatic (primary or secondary) amines. Further criteria were applied (see robust study summaries). The trend analysis for determining the EC50 on growth rate resulted in a value of 926 mg/L.The EC10 was determined to be 449 mg/L (BASF SE, 2022).
The QSAR models confirm the low sensitivity of aquatic algae to N-(2-aminoethyl)-1,3-propanediamine.
Based on the available information the substance is with high probability acutely and chronically not harmful for aquatic algae.
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