Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

Corfree® M1 is expected to be rapidly absorbed, metabolized via normal beta-oxidation processes to shorter diacids, and the metabolites excreted almost exclusively in urine with no significant potential for accumulation.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Corfree® M1 is comprised of linear dicarboxylic acids (primarily C10-12), including the C12 chemical, dodecanedioic acid (DDDA).  In an in vivo toxicokinetics study in rats, DDDA was rapidly and completely absorbed from the gastrointestinal tract, was rapidly distributed, was extensively metabolized to shorter diacids, and excretion was almost exclusively via urine (Passi, et al, 1983).  Additionally, extensive beta-oxidation of DDDA has been demonstrated in a rat liver microsome assay (Mortensen, et. al., 1982).  Therefore, because it is comprised of DDDA and other shorter diacids, Corfree® M1 can likewise be expected to be metabolized via normal beta-oxidation processes to shorter diacids and excreted in urine with no significant potential for accumulation.