Registration Dossier

Administrative data

Description of key information

No data are available for carcinogenicity after oral and dermal exposure and inhalation, respectively.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No carcinogenicity study is available for octanoic acid.

Studies on mutagenicity/genotoxicity that were either performed with octanoic acid (NTP, 1985) and/or reference substances within the fatty acids category were negative (refer to endpoint genetic toxicity). Moreover, the available long-term studies did not reveal any systemic effects and thus also preneoplastic lesions were not observed.

QSAR calculation (OECD Toolbox) for octanoic acid did not reveal an alert for mutagenicity/carcinogenicity.A review of the SIDS “Aliphatic Acids Category” updated in October 2014 (SIDS Aliphatic Acids Category, 2014) and of further publicly available data including reviews do not provide any hint that octanoic acid or other aliphatic acids are suspected to be carcinogens. Octanoic acid is not listed by ACGIH, IARC, NIOSH, NTP or OSHA. Octanoic acid is affirmed as generally recognized as safe (GRAS) for use as direct (CFR 184.1025) and indirect (21 CFR 186.1025) food substance.

Fatty acids are found in all living organism fulfilling three fundamental roles. Besides their function as part of molecules like phospholipids and glycolipids important for the cell-structure, they are often precursors of signaling molecules such as prostanoids. The third and best understood role of fatty acid is their role as nutritional energy source. Thus based on the nature of octanoic acid, the knowledge about the toxicokinetics of aliphatic acids, octanoic acid indicates no potential for carcinogenicity.

In conclusion, all available data on octanoic acid as well as data on further fatty acids within the fatty acids category indicate that octanoic acid is neither a mutagen nor a suspected or even proven carcinogen.

 

References:

SIDS Aliphatic Acids Category Oct 2014

http://webnet.oecd.org/Hpv/UI/handler.axd?id=47068cc3-9878-41d3-b6a1-86c06e3939f6

Justification for classification or non-classification