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Description of key information

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

No toxicokinetic studies are available for tripropenyl succinic anhydride.

Based on the physicochemical properties (MW< 500; estimated log Kow for anhydride < 5; log Kow for hydrolysis degradation products < 3), the registered substance is considered to be bioavailable via oral and dermal routes. Tripropenyl succinic anhydride undergoes hydrolysis in abiotic medium (see IUCLID 5.2.1) with half-lives in the range of 1 -2 hours. Prior to the performance of the 28 -day toxicity study the hydrolysis stability in corn oil and PEG was investigated (see IUCLID 7.5.1). Thripropenyl succinic anhydride was stable up to 4 hours at 37°C in corn oil and in PEG. Resorption and distribution of anhydride itself are possibly performed via lymphatic system.

Based on the results of the 28 -day repeated dose toxicity study in rats including a 14 -day recovery period, no bioaccumulation potential is expected. Histopathological findings clearly attributable to the test item were seen in the kidney. Kidney changes were more prominent in the females and corroborated the renal weight changes noted in this study. They are indicative of degeneration and repair of renal tubular cells and were found to be completely resolved at the end of the recovery period. Therefore, an efficient elimination can be assumed.

The cytotoxicity of the test item was investigated in in-vitro genotoxic studies with and without metabolic activation. With the presence of metabolic activation S9 mix, the test item was less cytotoxic. It is indicated that the metabolism was also mediated by the enzymes in S9 mix and lead to detoxification of the test item. The cytochrome P450 mediated metabolism with the presence of S9 mix is presumed to occur at the branched aliphatic moiety, based on the structure.