Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

The in vitro rate of metabolism was determined for [1,3(or 1,4)- Phenylenebis(1 -methylethylidene)] bis[tert-butyl] peroxide using thein vitrometabolism trout liver S9 assay (OECD Test Guideline 319B, adopted in June 2018).

This organic peroxide metabolized rapidly under biologically active conditions with a metabolic half- life of 67 minutes or 1.13 hours. This data was used to extrapolatein vivorate constants of metabolism or kMETof 0.184 day-1or 0.475 day-1using hepatic portal blood flow or hepatic portal and arterial blood flow, respectively. The use of these kMET values in conjunction with the Gobas model dropped the calculated BCF from 45,294 kg day-1(assuming no metabolism) to 536 or 209 kg day-1. The impact of metabolism on [1,3(or 1,4)- Phenylenebis(1-methylethylidene)] bis[tert-butyl] peroxide drops the BCF to less than the action level of 2000 (Reach Criteria) and should not be considered to have significant bioaccumulation potential.

A bioacucmulation in fish study according to the OECD 305 Test Guideline using aqueous exposure will be performed on analog 25155 -25 -3 and submitted later if required based on ECHA decision number SEV-D-2114369067-43-01/F.

Additional information