Registration Dossier

Toxicological information

Carcinogenicity

Currently viewing:

Administrative data

Description of key information

Two studies has been identified as having assessed the carcinogenicity potential of allyl alcohol. 

Key value for chemical safety assessment

Justification for classification or non-classification

Carcinogenicity

Based on the available data allyl alcohol is not classified for carcinogenicity according to the classification criteria of:

- Directive 67/548/EEC

- Regulation 1272/2008 (EU CLP GHS)

- UN GHS

Additional information

No reliable long-term studies were identified as having assessed the carcinogenic potential of allyl alcohol. However a 2-year gavage study conducted with the major metabolite of allyl alcohol, acrolein, is available and deemed reliable. This study was conducted following a method similar to recognised guidelines. Although incidences of mammary neoplasms and neoplastic pancreatic lesions were observed these occurred within historical limits and were not considered to be dose related. No significant increase in the incidence of microscopic lesions (neoplastic or non-neoplastic) was observed in rats treated with acrolein. Toxicokinetic studies confirm that allyl alcohol is converted to acrolein by ADH-mediated hepatic metabolism. Given the available evidence of non-genotoxicity of allyl alcohol in vivo plus this demonstration of non-carcinogenicity of its major metabolite acrolein, it is considered predictable that allyl alcohol will not prove carcinogenic. 

(Although a long-term carcinogenicity study (Lijinsky) with allyl alcohol is available, this is not considered to be reliable: experimental details are limited and the single type of neoplasm claimed to be increased in test animals was found to be a result of incorrect pathology interpretation when stored tissues were later examined by an expert review panel).