Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

There is no measured data available on aquatic/sediment bioaccumulation for the substance. According to REACH Annex XI, alternative approach should be considered before a new vertebrate test is conducted. The following aspects have been taken into account and in conclusion no aquatic/sediment bioaccumulation test is recommended and the substance is expected to be not bioaccumulative.

- The substance is identified as a difficult substance for bioaccumulative assessment regarding REACH guidance R.7c. Preliminary tests for the determination of its water solubility shows, that the substance is insoluble or only poorly soluble in water. A suitable selective and sensitive chromatographical method for the determination of the substance in aqueous solutions could not be established.

- Based on the substance properties regarding log Kow, BCF calculations, and its molecular weight distribution it can be concluded that bioaccumulation is very low.

- Assessing toxicokinetics, metabolism and distribution it can be demonstrated that adsorption via skin or mucosa is assumed to be low and that due to the limited systemic availability accumulation should not be a point of concern for the substance.

 

In conclusion, only a very low bioaccumulation potential in aquatic/sediment organisms of the substance is expected and hence testing in aquatic/sediment bioaccumulation is considered not necessary. More details can be found in attachment.