Registration Dossier
Registration Dossier
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EC number: 609-736-2 | CAS number: 39672-75-8
Carcinogenicity
Administrative data
Description of key information
Read-across from supporting substance Budesonide (CAS 51333-22-3)
Key value for chemical safety assessment
Justification for classification or non-classification
Based on avaliable data on the supporting substance Budesonide, the substance "Pregna-1,4-diene-3,20-dione, 9,11-epoxy-21-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (9β,11β,16α)- (9CI)" was not classified as carcinogen.
Additional information
Carcinogenicity studies with budesonide were conducted in rats and mice. In a 2-year study in Sprague-Dawley rats, budesonide caused a statistically significant increase in the incidence of gliomas in male rats at an oral dose of 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis). In addition, there were increased incidences of primary hepatocellular tumors in male rats at 25 mcg/kg (approximately 0.023 times the maximum recommended human dose on a body surface area basis) and above. No tumorigenicity was seen in female rats at oral doses up to 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis). In an additional 2-year study in male Sprague-Dawley rats, budesonide caused no gliomas at an oral dose of 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis). However, it caused a statistically significant increase in the incidence of hepatocellular tumors at an oral dose of 50 mcg/kg (approximately 0.05 times the maximum recommended human dose on a body surface area basis). The concurrent reference corticosteroids (prednisolone and triamcinolone acetonide) showed similar findings. In a 91-week study in mice, budesonide caused no treatment-related carcinogenicity at oral doses up to 200 mcg/kg (approximately 0.1 times the maximum recommended human dose on a body surface area basis).
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