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EC number: 200-659-6 | CAS number: 67-56-1
Several studies showed carcinogenicity for mouse and rat via oral or inhalation route. The studies have been callenged and can therefore not be transferred to humans.
Exposure per day was 19 h, which implies that prolonged steady-state blood levels were reached which even may have been higher than in studies using the same exposure concentration, but shorter exposure times.
The result gave no evidence of a cancerogenic potential of methanol in mice.
Incidences (number of tumor-bearing animals/total animals):
A + B
-- = not examined
A) Papillary adenomas (males)
B) Adematoids = hyperplastic changes (pre-neoplastic, lung) (males)
C) Adrenal chromaffinoma (males)
D) Testis hyperplastic changes (males)
A) Papillary adenomas (females)
B) Adematoids = hyperplastic changes (pre-neoplastic) (females)
C) Adrenal chromaffinoma (females)
The results gave no evidence of a clearly cancerogenic potential of methanol in rats. The biological significance of the increase in the incidence of the phaeochromocytomas in the aged female high-dose rats is considered to be low.
Methanol was investigated for chronic toxicity and carcinogenicity in two long-term whole-body inhalation studies (24 months in rats and 18 months in mice for 20 and 19 hours per day, respectively). There was no evidence of a carcinogenic potential in rats and mice exposed to air concentrations of up to 1.3 mg/L.
Overall tumour frequencies showed no statistically significant differences between treatment groups and controls in either rats or mice. There was a non-statistically significant increase in phaeochromocytoma incidence among aged female high-dose rats; the biological significance of this observation was considered to be low. On balance, these results did not suggest that methanol is carcinogenic in rodents from this exposure route.
In studies with oral administration in rats (drinking water; Soffritti et al., 2002) and mice (gavage; Apaja, 1980) the number of tumor-bearing animals in the rat study showed a clear dose-related trend. Target organs were less pronounced (some indication of ear duct tumors, osteosarcomas and lymphoid tumors); the authors postulate a multi-site potential for carcinogenicity. The validity of the study has been challenged (Cruzan, 2009; http://www.epa.gov/iris/ramazzini.htm; EFSA DRAFT Scientific Opinion on the re-evaluation of aspartame (E 951) as a food additive, 2013) due to early mortality and it was concluded that methanol is not likely to be carcinogenic in humans. Furthermore, the effective doses were above 500 mg/kg/day which is about 35 g/person and day. An acute oral dose level of this magnitude would saturate the folate-dependent metabolism of formic acid to CO2 and be close to a lethal level. Upon inhalation over several hours such a dose, equivalent to an air concentration of 3500 mg/m3, would have to be associated with eye irritation, blurred vision and nausea (Greim, H., 2001).The EU OEL and proposed DNEL is 13-fold lower.
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008 The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. In mouse and rat effects were shown, but can not be transfered to humans. As a result the substance is not considered to be classified for carcinogenicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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