Registration Dossier
Registration Dossier
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EC number: 204-062-1 | CAS number: 115-07-1
Carcinogenicity
Administrative data
Description of key information
There is no evidence of carcinogenicity of propene following evaluation in 2 rat and 2 mouse strains.
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 adverse effect observed
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Propene was not carcinogenic in near-guideline tests (NTP, 1985), no classification is warranted under DSD or CLP.
Additional information
Propene did not produce cancer in lifetime tests in 2 strains of each rat and mouse (F344 rat & B6C3F1 mouse by NTP, 1985), (Sprague-Dawley rat & Swiss mouse by Ciliberti et al.,1988). Of the two groups of studies reported, those conducted by NTP are more fully reported and therefore have been selected as the key studies of carcinogenicity.
Key 2-year Toxicity Studies, NTP
Based on the risk of explosion that can occur at high propene concentrations, the highest dose level considered safe for use in these studies was 10,000 ppm (17,200 mg/m3). Groups of 50 F344/N rats of each sex were exposed to propene in air (98.6% - 99.7% pure) by inhalation at concentrations of 5,000 or 10,000 ppm, (8,600 or 17,200 mg/m3) 6 hours per day, 5 days per week, for 103 weeks. Other groups of 50 rats of each sex received air only on the same schedule and served as chamber controls. The survival of exposed and control rats was comparable.
B6C3F1 mice (50 males and 49-50 females/group) were also exposed to propene in air (98.6% - 99.7% pure) by inhalation at concentrations of 5,000 or 10,000 ppm, (8,600 or 17,200 mg/m3) 6 hours per day, 5 days per week, for 103 weeks. Other groups of 50 mice of each sex received air only on the same schedule and served as chamber controls. The survival of exposed and control mice was comparable.
Complete necropsy and histopathology examination was performed on all animals.
There was no evidence of carcinogenicity in male and female F344/N rats or in male and female B6C3F1 mice exposed to propene by inhalation at concentrations of 5000 or 10000 ppm (8,600 or 17,200 mg/m3), for 103 weeks (NTP, 1985), or in the supporting study in male and female Swiss mice at concentrations up to 5000 ppm (8,600 mg/m3), following exposure for 78 weeks, or in male and female Sprague-Dawley rats at concentrations up to 5000 ppm (8,600 mg/m3), following exposure for 104 weeks (Ciliberti et al, 1988).
Oral and dermal routes of exposure are not relevant for a gas.
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