Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

The substance's potential oxidising properties were investigated in a study conducted under conditions of GLP to EU method A21. The test item is a solid at room temperature and therefore the oxidising properties should ideally be tested using Method A17 Oxidising Properties (Solids) of Commission Regulation (EC) No 440/2008 of 30 May 2008. However on handling, it became apparent that the A17 test was not appropriate due to the physical nature of the test item. The test item was initially determined to have oxidising properties as the mean pressure rise time for the test item/cellulose mixtures was faster than the mean pressure rise time for the nitric acid /cellulose mixtures. However, this conclusion was proved to be false in subsequent testing using kieselguhr, as the mean pressure rise time for the test item/kieselguhr mixtures was also faster than the mean pressure rise time for the nitric acid /cellulose mixtures. Since kieselguhr is an inert material and so cannot be oxidised, the fast pressure rise in the pressure vessel is concluded to be due to reactions other than oxidising. The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability & repeatability).

Key value for chemical safety assessment

Oxidising properties:
no

Additional information

A reliability rating of 1 was assigned to the key study, according to the criteria of Klimisch, 1997 as the study was conducted in accordance with recognised guidelines and GLP.

Justification for classification or non-classification

The test item was initially determined to have oxidising properties as the mean pressure rise time for the test item/cellulose mixtures was faster than the mean pressure rise time for the nitric acid /cellulose mixtures. However, this conclusion was proved to be false in subsequent testing using kieselguhr, as the mean pressure rise time for the test item/kieselguhr mixtures was also faster than the mean pressure rise time for the nitric acid /cellulose mixtures. Since kieselguhr is an inert material and so cannot be oxidised, the fast pressure rise in the pressure vessel is concluded to be due to reactions other than oxidising. The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability & repeatability).

As such the substance has not been classified for this endpoint and is not considered as having oxidisng properties.