Registration Dossier
Registration Dossier
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EC number: 209-167-6 | CAS number: 557-28-8
Carcinogenicity
Administrative data
Description of key information
Chronic repeated dose toxicity
LOAEL (local toxicity, rats, life time study): 400 ppm (264 mg/kg bw) Griem et al. 1985
NOAEL (systemic toxicity, rats, life time study): 4000 ppm(2640 mg/kg bw) Griem et al. 1985
Carcinogenicity
Propionic acid is negative for carcinogenicity.
No carcinogenic effect at the highest dose tested : 4000 ppm (2640 mg/kg bw). This concentration is beyond the MTD. Griem et al. 1985
Key value for chemical safety assessment
Justification for classification or non-classification
Classification for carcinogenicity is not warranted according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Additional information
The addition of propionic acid to the diet has produced epithelial changes at the point of contact (forestomach) in rats. Groups of male rats were fed 0, 0.4, or 4% propionic acid in ground rat feed for 20 weeks or their lifetime. Among animals fed 0.4% propionic acid (approximately 264 mg/kg bw/day), there were no gross changes visible in the forestomach, although hyperplasia and hyperkeratosis were observed histologically. No changes were detected in the mucosa of the glandular stomach. Among rats fed a diet containing 4% propionic acid (approximately 2640 mg/kg bw/day), forestomach epithelial changes such as hyperplasia and hyperkeratosis were noted at 20 weeks; hyperplasia with ulceration, dyskeratosis, and papillomatous elevations (one with uncharacterized “carcinomatous changes”) were noted after lifetime exposure (Griem, 1985). Cancer of the forestomach was not observed. The changes observed upon feeding of high dose of propionic acid are the result of chronic irritation and inflammation and the associated hyperplastic proliferative repair response.
The USEPA (2003) concluded that propionic acid and its calcium and sodium salts have a low toxic potential and that there were no concerns for mutagenicity or carcinogenicity by the oral route of exposure.
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