Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

The Nicotinic acid toxicokinetic assessment is based on a weight of evidence approach. The toxicokinetic behavior of Nicotinic acid was previously reviewed by the European Commission Scientific Committee on Food, the EFSA Panel on Additives and Products or Substances used in Animal Feed, the US FDA and the UK Food Standards Agency Expert Group on Vitamins and Minerals. An OECD SIDS review concluded that nicotinic acid is essential for human and animal health and that based on the available information the substance does not present a hazard to human health.
Nicotinic acid is mainly taken up via the oral route, even though dermal and inhalation exposure may also lead to substance bioavailability. Once absorbed Nicotinic acid circulates in the plasma in the unbound form as both the acid and the amide. Animal studies have shown that Nicotinic acid rapidly disappears from the blood, with plasma half-life of ca. 1 hour. Main metabolites in humans are N-methylnicotinamide, N-methyl-2-pyridone-5-carboxamide and N-methyl-4-pyridone-5-carboxamide. Excretion is mainly via urine. The pattern of nicotinic acid products excreted after ingestion of the vitamin depends largely on the amount and form of Nicotinic acid ingested and on the Nicotinic acid status of the individual.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

The Nicotinic acid toxicokinetic assessment is based on a weight of evidence approach. Following references were included: EC Scientific Committee on Food (2002) Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Levels of Nicotinic Acid and Nicotinamide (Niacin) EFSA Panel on Additives and Products or Substances used in Animal Feed (2012) Scientific Opinion on the safety and efficacy of Niacin (nicotinic acid and nicotinamide) as a feed additive for all animal species. EFSA Journal 10(7): 2781. FDA 21CFR184.1530 (2012) UK Food Standards Agency Expert Group on Vitamins and Minerals (2003) Safe Upper Levels for Vitamins and Minerals