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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Justification for classification or non-classification

Based on the information given above, no classification of benzaldehyde for carcinogenicity is warranted according to Regulation (EU) 1272/2008 and Directive 67/548/EEC, respectively.

Additional information

Two relevant studies on the carcinogenic potential of benzaldehyde are mentioned in the German MAK report on benzaldehyde (1998).

In a carcinogenicity study, groups of 50 male and 50 female F344 rats and B6C3F1 mice were given gavage doses of benzaldehyde (dissolved in corn oil) on 5 days/week for a period of 103 to 104 weeks. The doses given to the female ntice were 300 and 600 mg/kg body weight and day, and to all other groups 200 and 400 mglkg body weight and day. In all the treated rats and mice, the body weights were comparable with those of the controls; survival was significantly reduced only in the male rats of the 400 mg/kg group after day 373 of the experiment. There were no clinical symptoms of intoxication (Kluwe et al. 1983, NTP 1990).

Some of the rats in the 400 mg/kg group died prematurely (from week 20). The survival of the male animals was significantly decreased from day 373 of the experiment (53 weeks) up to the end ofthe experiment, while survival of the female animals at the end of the experirnent was comparable to that of the control animals. The increase in the incidence of some tumours in the male rats was not regarded as substance-related for the following reasons. The incidence of malignant mesotheliomas was not dose-dependent. The incidences of mesotheliomas and pancreas adenomas were increased relative to the experimental control values, but not relative to the historical control incidences. The overall incidence of monocyte leukaemia was independent of the dose and only slightly increased; the incidences of the relevant stage 2 and stage 3 changes were in the control range. In the female rats, only increased incidences of forestarnach papillomas (c.f. findings in mice) were recorded, which are not relevant for man. The findings in the rat were not regarded by the NTP as evidence of carcinogenic effects. In the mice there was no evidence of toxicity in any dose group; the animals would have tolerated even higher doses. The only pathological change which was not also found in the control group was an increase in the incidence of hyperplasia and squamous cell papillomas of the forestomach. These findings were regarded by the NTP as some evidence of carcinogenicity, but are probably the result of the irritative effects of benzaldehyde and are not of relevance for man because of the species-specific location. Overall, therefore, there was no evidence in either mice or rats of a carcinogenic potential of benzaldehyde, which is in accordance with the, at most, low genotoxic activity of benzaldehyde in vitro.