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Carcinogenicity

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Description of key information

There was not a treatment related increase in stomach tumor incidence (papilloma and carcinoma) in rats orally exposed to 1000 mg/kg/day of 
gaiacol when compared to controls in a study described by Hirose et al. (1989). Therefore no NOAEL can be identified for carcinogenic effect.

Key value for chemical safety assessment

Additional information

Two studies were available, but only one, with reliability 2 was selected as a key study. The other one has the reliability 3 and was not taken into account. In this carcinogenicity study (Hirose et al., 1989) according to the OECD guideline 451, 1.5% (corresponding to 1000 mg/kg/day) of gaiacol in diet was administered to 16 male rats (Fisher 344) for 51 weeks. Mild and moderate forestomach hyperplasia was found in 93.8 % of the rats received guaiacol but papilloma and carcinoma were not detected. Forestomach lesions were focal and characterized by down ward basal cell growth.The LOAEL for non-carcinogenic effects is 1000 mg/kg bw/day, based on calculation, regarding forestomach lesions and hyperplasia.

At the dose tested, there was not a treatment related increase in stomach tumor incidence (papilloma and carcinoma) when compared to controls.

Justification for classification or non-classification