Registration Dossier

Diss Factsheets

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

According to Annex VII,Column 2 of of regulation (EC) 1907/2006,and Chapter R.7B of the ECHA Guidance Document (2008), the requirements for “Ready biodegradability” can be waived if the substance is inorganic (e.g., manganese alumina pink corundum). This pigment is inorganic andtesting is not considered scientifically justifiable. Annex VIII states that "Further degradation testing shall be considered if the chemical safety assessment according to Annex I indicates the need to investigate further the degradation of the substance. The choice of the appropriate test(s) will depend on the results of the chemical safety assessment." Waiving of the need for data for this environmental endpoint may be considered if “The substance is highly insoluble in water) (ECHA 2008, Chapter R.7B – Endpoint Specific Guidance). However, for an inorganic substance for which the chemical assessment is based on the elemental concentration (i.e., pooling all inorganic speciation forms together), biotic degradation in the environment is an irrelevant process: biotic processes may alter the speciation form of an element, but it will not eliminate the element from the environment by degradation or transformation processes. This elemental-based assessment (pooling all speciation forms together) can be considered a worst-case assumption for the chemical assessment.