Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

The substance contains an amide group which is generally susceptible for hydrolysis. However, hydrolysis is extremely slow.

Since the substance is readily biodegradable, the very slow calculated hydrolysis is not expected to be a major fate pathway.

Key value for chemical safety assessment

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 ofReaction product of Maleic anhydride, 2-Ethylhexylamine and Triethanolamine(Q)SAR results were used for Hydrolysis.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, further experimental studies onHydrolosisare not provided.

The test substance is readily biodegradable. In Annex VIII of Regulation (EC) No 1907/2006, it is laid down that the study on hydrolysis does not need to be conducted if the substance is readily biodegradable. Though the substance has the potential to hydrolyse due to its amide group, the reaction with water a neutral pH values is expected to be extremely slow and does not contribute to the environmental fate of the substance.