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Toxicological information

Carcinogenicity

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Description of key information

A published chronic feeding study with the disodium salt of the C10 analog dicarboxylic acid sebacic acid in both rats and rabbits at dose levels of up to 1000 mg/kg bw/day (4.06 mmol/kg bw/d corresponding to 935 mg dodecanedioic acid/kg bw/d) gave no signs of carcinogenic activity.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Dose descriptor:
NOAEL
935 mg/kg bw/day

Justification for classification or non-classification

No carcinogenicity was observed in chronic feeding studies with sebacic acid, both in rats and rabbits. Sebacic acid is the the C-10 analog dicarboxylic acid. Sebasic acid is the C10 analog of dodecanedioic acid, and both are present in Corfree® M1. Based on the read-across Corfree® M1 is considered to be non-carcinogenic and a classification is not required.

Additional information

No signs of carcinogenic activity was noted in chronic feeding studies with the disodium salt of sebacic acid, the C10 analog of dodecanedioic acid and an ingredient in Corfree® M1, at dose levels of up to 1000 mg/kg bw/day (4.06 mmol/kg bw/d corresponding to 935 mg dodecanedioic acid/kg bw/d) albeit the duration of exposure was only 180 days.

Based on read across to sebacic acid,and considering the lack of alert structural features for carcinogenicity and the lack of genotoxic activity as demonstrated in an array of short term tests and the fact that dodecanedioic acid is a natural intermediate in long-chain fatty acid catabolism in the organism, there is no indication for a carcinogenic activity of dodecanedioic acid.