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Toxicological information

Carcinogenicity

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Description of key information

No carcinogenicity study on experimental animals is available for EUF. The compound is assumed to hydrolyse rapidly within the body. Effects for hydrolysis products in adequate dilutions are supposed. 
As the database for formaldehyde is comprehensive, no test for carcinogenicity is required. Assuming that the discussed in-vitro mutagenic effects of EUF are based on formaldehyde, no tumour formation is expected at non-irritant concentrations. No carcinogenic effects were reported for ethylene glycol or urea respectively.

Key value for chemical safety assessment

Additional information

Data on experimental animals: Data on long-term drinking water studies in rats revealed neither systemic carcinogenic effects nor sufficient evidence for local carcinogenic effects in the gastrointestinal tract. However, repeated oral studies consistently show that exposure to drinking water dose levels >50 mg/kg/day can damage epithelial tissue of the gastrointestinal tract, especially at dose levels >100-200 mg/kg/day.

Data on this endpoint showed local irritation but no carcinogenic effects. However, in initiation/promotion experiments formaldehyde significantly reduced the latency time for the development of tumours.

The available data on dermal exposure revealed local irritation but no carcinogenic effects.

In summary, the weight of evidence that formaldehyde induces systemic or local carcinogenic effects after oral or dermal exposure is insufficient.

There is clear evidence from chronic inhalation studies in rats that formaldehyde causes tumours in the nasal cavity. Even after subchronic exposure periods nasal tumours were induced. Limited data are available in mice; no tumours were detected in hamsters.

 

Data on carcinogenicity in humans: Numerous epidemiological studies are available in humans occupationally exposed via inhalation. The data suggested an increased risk of cancer at two tumour sites: the upper respiratory tract and the haematopoietic system. Some evidence for an association between nasopharyngeal tumours and formaldehyde exposure was reported in former cohort studies. Some epidemiological evidence for an association between formaldehyde exposure and leukaemia has been reported. However, in contrast to nasopharyngeal tumours, no plausible mechanism for the induction of leukaemia in humans is found.

Justification for classification or non-classification

The new legal harmonised classification of formaldehyde (Index No 605-001-00-5) is Carc. 1B and Muta. 2.