Registration Dossier

Administrative data

Description of key information

No conclusions can be drawn from the available information on carcinogenicity.

Key value for chemical safety assessment

Additional information

Non-human data:

In one study 30 male Sprague-Dawley rats were treated for up to 117 weeks with phenazone (270 mg/kg bw/day) in the diet (Johansson; 1981). In this study effects in the urinary tract and renal pelvic and vesical tumours were reported.

In a lifetime study in rats with 300 mg phenazone per day no increased incidence of tumours and thus no carcinogen impact was observed (Greenberg; 1950).

Human data:

No data available.

Justification for classification or non-classification

Based on results of available carcinogenicity studies, phenazone was not classified and labelled as carcinogenic according to Directive 67/548/EEC (DSD) and to Regulation 1272/2008/EC (CLP).