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Ecotoxicological information

Short-term toxicity to fish

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Administrative data

Link to relevant study record(s)

Description of key information

The substance is with high probability acutely not harmful to fish.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
596 mg/L

Additional information


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. Furthermore according to Article 25 of the same Regulation testing on vertebrate animals shall be undertaken only as a last resort.

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 reaction mass of N1,N3-bis(3-aminopropyl)-2-methyl-cyclohexane-1,3-diamine and N1,N3-bis(3-aminopropyl)-4-methyl-cyclohexane-1,3-diamine (DAP-MCDA) (Q)SAR results were used for toxicity to fish. 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.

Therefore and for reasons of animal welfare, further experimental studies on toxicity to fish are not provided.


This endpoint is not an information requirement for the tonnage band of the substance: 1 - 10 tpa non-intermediate.

However, for the assessment, valid estimated data of the representative constituents of DAP-MCDA were used in a weight-of-evidence approach.

For the reaction mass DAP-MCDA, no experimental data on the acute toxicity to fish are available. In order to assess the acute toxicity to fish, the LC50 value was estimated for two representative constituents of DAP-MCDA (N1,N3 -bis(3 -aminopropyl)-4 -methyl-cyclohexane-1,3 -diamine (BI 858010) and N1,N3 -bis(3 -aminopropyl)-2 -methyl-cyclohexane-1,3 -diamine (BI 858015)) using the model 'Automated workflow for estimation of EC50/LC50 for fish' in QSAR Toolbox v4.3.1.

The 96h-LC50 of both constituents was estimated to be 596 mg/L.

Therefore, it can be concluded that DAP-MCDA is with high probability acutely not harmful to fish.