Registration Dossier
Registration Dossier
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EC number: 948-816-4 | CAS number: -
Short-term toxicity to fish
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
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. 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.
Assessment:
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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