Registration Dossier
Registration Dossier
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EC number: 203-868-0 | CAS number: 111-42-2
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
Description of key information
Significant accumulation in organisms is not to be expected.
Key value for chemical safety assessment
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 diethanolamine (Q)SAR results were used for aquatic bioaccumulation.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 aquatic bioaccumulation are not provided.
Assessment
In accordance with Regulation (EC) 1907/2006, Annex IX, Section 9.3.2, Column 2, the study does not need to be conducted if the substance has a log Kow ≤ 3. The target substance diethanolamine (CAS 111-42-2) has a log Kow of ‑2.46 (measured; SASOL, 2009; report no.: 06480900035).
However, in order to assess the bioaccumulation potential of the test substance, the BCF was calculated using the BCF baseline model v.04.11 (OASIS Catalogic v5.14.1.5) (BASF SE, 2021). The BCF was 2.7 L/kg considering all mitigating factors (9.2 L/kg not considering any mitigating factors). The substance was completely within the applicability domain of the model.
Conclusion:
Based on the available information on the log Kow (log Kow = -2.46) and the estimated BCF of diethanolamine, it can be concluded that accumulation in organisms is not to be expected.
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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