Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

Two studies were conducted to investigate the ready biodegradability of the substance. Both were conducted in accordance with standardised guidelines under GLP conditions and awarded a reliability score of 1 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

The key study has been selected on the basis that the OECD 301 B study is historically more sensitive than the OECD 301 C study. In this key study, the substance attained 74 % degradation after 28 days and satisfied the 10-Day window validation criterion. The test material can therefore be considered to be readily biodegradable.

In the supporting study, the biodegradation of the test material was investigated in accordance with the standardised guideline OECD 301 C under GLP conditions. Some of the anionic component of the test material (1,2-cyclohexanedicarboxylic acid ion) was biodegraded by microorganisms and changed into a structure-unknown converted product. The structure-unknown converted product and the rest of the anionic component of the test material were not biodegraded by microorganisms and remained. In this study biodegradation levels were determined to be in the 15-21% range.

Given that the substance was determined in the key screening study to be readily biodegradable, no higher level biodegradation testing has been proposed by the registrant.