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Description of key information

Short description of key information on bioaccumulation potential result:
A review was performed of available data and a structural assessment made.

Bioaccumulation of parent molecule and its metabolites is considered to be very low as their metabolism half lives are fast to very fast.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential

Additional information

Evidence for systemic availability of the substance comes from several studies in rats with N-(n-dodecyl) pyrrolidinone or its analogue N-(n-octyl)pyrrolidinone. In an a subacute toxicity study with gavage doses of 0, 10, 100, and 1000 mg/kg/day, clinical chemistry and pathological effects were observed at the 1000 mg/kg/day dose levels (Smith, 1989). In a 28-day oral (gavage) study, rats were dosed with 0, 10, 100, or 1,000 mg/kg/day (once daily) of the substance (Smith, 1989). Changes in general health, bodyweight gain, food consumption, organ weights, macroscopic and microscopic pathology and biochemical parameters were apparent in rats receiving 1,000 mg/kg/day of the substance. Furthermore a 90-day dietary feeding study in rats (ISP, 1991) in which rats were dosed with 0, 60, 600, and 10000 mg/kg/day of the analog substance LP100. Systemic toxicity in males and females was noted in the 10000 mg/kg/day group. Changes in body weight gain and food consumption as well as changes in liver weights and some mild hepatocyte hypertrophy was observed in this relatively high dose group.

Considering the chemical structure of the substance, Cyp 450 linked oxidations of the dodecyl-group and of the heterocyclic ring system as well as the oxidative de-alkylation are possible steps in the phase-I metabolism of the substance. In phase-II metabolism, consequent conjugation reactions can be assumed.

Studies on genotoxicity (Lavelle, 1986; Fowler, 1989, Fowler, 1989) were negative. There were no indications of DNA reactivity of the substance or its metabolites under the test conditions.

Bioaccumulation of parent molecule and its metabolites is considered to be very low as their metabolism half lives are fast to very fast.