Propene

Endpoint summary

Description of key information

 Mild rhinitis has only been reported following lifetime exposure to high concentrations of propene gas. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no study available

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Non-human

 

Mild rhinitis (mild nasal inflammation) was reported in rats following lifetime exposure to high concentrations of propene gas, 5000 ppm & 10,000 ppm, (8,600 & 17,200 mg/m3) (NTP, 1985; Harkema 2002). In contrast, no such effects were reported in nasal tissue from 14-day or 14-week studies in rats (NTP, 1985). Mice from the same NTP 2-year chronic toxicity study were reported to have similar effects, albeit with less epithelial alteration than rats (Harkema, 2002). There was no evidence of a clear dose-response relationship in either species, indeed the nasal effects were less pronounced at the higher dose level in male mice (Harkema, 2002). Subsequently, a 4-week investigative study, reporting nasal endpoints, failed to identify any inflammation, irritation or indeed any precursor proliferative event in rats exposed to up to 10,000 ppm (17,200 mg/m3) propene (Pottenger et al., 2007). The authors concluded that any irritant effect of propene must be extremely weak and that other factors may well have contributed. Overall, any irritant properties in rodents were mild in nature, lacking a clear dose-response relationship and reported only when high concentrations of propene gas were maintained throughout lifetime exposure.

 

Human

 

Although propene has been used in humans at concentrations sufficient to induce anaesthesia, there is only one literature report of potential adverse irritation effects associated with repeated induction of anaesthesia in one volunteer “After the first few breaths, there was usually slight reddening of the eyelids with some lacrimation and flushing of the eyes. Sometimes coughing would occur from pharyngeal irritation.” In this study, to efficiently induce anaesthesia, very high concentrations (688,000 – 861,000 mg/m3) of propene were rapidly introduced. This information is not considered useful in assessment of the irritation potential of propene gas, with its lower explosive limit of 34,000 mg/m3.

Justification for classification or non-classification

Any propene-induced rhinitis has been reported as mild in nature, occurring in rodents only after lifetime exposure to high concentrations (5,000ppm & 10,000ppm (8,600 and 17,200 mg/m3) of propene gas). This finding does not warrant classification for skin, eye, or respiratory tract irritation under DSD or CLP.