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Environmental fate & pathways

Bioaccumulation: aquatic / sediment

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Description of key information

Bioaccumulation in organisms is not to be expected.

Key value for chemical safety assessment

BCF (aquatic species):
2.41 L/kg ww

Additional information

Waiving argument

According to Annex IX, column 2 of REACH, the study does not need to be conducted as the substance has a low potential for bioaccumulation (log Kow <3). Nevertheless, QSAR results are available.

Supporting model predictions

Using CATALOGIC BCF base line model the log BCF was calculated to be 0.3816 ± 0.116 (BCF 2.4) taking into account mitigating factors. Without mitigating factors the log BCF was calculated to be 1.025 (BCF 10.58).

The substance fulfils the general properties requirements of the model, the substance is in the interpolation structural space and the substance is in the mechanistic domain of the model. In conclusion the substance is in the applicability domain of the model. Thus, the result of the prediction was regarded as reliable.

 

Based on the results it was concluded that accumulation in organisms is not to be expected.

 

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 2-aminoethyldiethylamine (Q)SAR results were used for bioaccumulation. The criteria listed in Annex XI of Regulation (EC) No 1907/2006 are considered to be adequately fulfilled and therefore the endpoint sufficiently covered and suitable for risk assessment.

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