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Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Administrative data

Link to relevant study record(s)

Description of key information

With high probability, acutely harmful to aquatic invertebrates.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC50
Effect concentration:
59.2 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 the N,N-dibutylformamide (CAS 761-65-9) (Q)SAR results were used for the estimation of the acute toxicity to aquatic invertebrates. 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.


The QSAR result is supported by an experimental study (D. magna, DIN 38412 L9; BASF AG, 1989). Further experimental studies are not provided.


 


Assessment


The short-term toxicity on aquatic invertebrates has been assessed using the OECD QSAR Toolbox v4.4. A 48-h EC50 for immobilization of Daphnia magna was derived using a read-across analysis of the standardized workflow for ecotoxicological endpoints as provided by the Toolbox (BASF SE, 2021). The resulting 48-h EC50 was 59.2 mg/L. The Substance is within the applicability domain of the model.


The experimental data from a study according to DIN 38412, L 11 support the key result (non-GLP, equivalent to the OECD guideline No 202). The EC50 value was determined to be 58 mg/L after 48 hours (Daphnia magna, BASF SE, 1989, Report no.: 9.963). All reported results refer to the nominal concentrations. No analytical monitoring was performed during the study; however, the test substance is expected to be stable in water based on its physicochemical properties:


The Substance has a sufficiently high water solubility of 11.8 g/L (BASF SE, 2017, report no.: 17L00357). Adsorption is not expected based on the low log Kow (log Kow = 2, at pH 6, measured, BASF SE, 2017, rep. no.: 17L00358) and log Koc (log Koc = 1.36; estimated; EPI Suite v4.11, KOCWIN v2.00, MCI method; in applicability domain; BASF SE, 2017). The Substance is not expected to evaporate from the test solution based on its low Henry's Law Constant (HLC = 0.041 Pa m³/mol, 25 °C, estimated; EPI Suite v4.11, HENRYWIN v3.20; in applicability domain; BASF SE, 2017) and its moderate vapor pressure (VP = 4.22 Pa @25°C, calculated with EPI Suite v4.11, BASF SE 2017).


 


Based on the available estimated and experimental data N,N-dibutylformamide is concluded to be acutely harmful to aquatic invertebrates.