Registration Dossier
Registration Dossier
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EC number: 201-185-2 | CAS number: 79-20-9
Carcinogenicity
Administrative data
Description of key information
For methyl acetate no experimental study on cancerogenocity is available.
Methyl acetate is rapidly hydrolysed after uptake to methanol and acetic acid.
Methanol was reported not to be carcinogenic in inhalation studies of rats and mice. No animal data are known on carcinogenic potential of acetic acid. However based on long time of human experience there are no concerns about a relevant carcinogenic potential of acetic acid. As discussed in section 5.7, methyl acetate as well as methanol and acetic acid did not show a genotoxic potential that is indicative for carcinogenicity by a genotoxic mode of action.
Therefore, in accordance with Annex X 8.9.1 column 2 and because of reasons of animal welfare, no study on carcinogenicity is necesary.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Experimental data on the carcinogenic potential of methyl acetate are not available. Methyl acetate did not show genotoxic action in vitro and in vivo. Methyl acetate is rapidly hydrolysed after intake. Cleavage products are methanol and acetic acid. Neither of them is classified as carcinogenic. Thus methyl acetate does not require classification as carcinogen.
Additional information
Methyl acetate
No animal data is available on methyl acetate.Methyl acetate did not show mutagenic or genotoxic properties.Methyl acetate is rapidly hydrolysed after uptake. Data on the hydrolysis product can be used for carcinogenicity discussion.
Methanol
No significant increase of tumor rate was observed in mice of an 18-month inhalation study exposed to 0, 10, 100, and 1,000 ppm methanol. A 24-month inhalation study on rats exposed to the same concentrations of methanol resulted in a dose-dependent increase of papillary lung adenoma or adenomatosis in males which gained significance at the 1,000 ppm-dose group. (Data are only reported as summary from Takeda and Katoh, 1988). Another summary report (NEDO, 1987) possibly presents the same data presented in the Japanese study reported by Takeda and Katoh (1988) as the rat (F344/DuCrj) and mice (Crj:B6C3F1) strains, dosages and treatment durations are identical. In the NEDO publication (1987) on the whole body exposure inhalation study, a higher incidence of lung adenomas was reported to be not related to methanol concentrations (1/52, 5/52, 2/52 and 6/52 in control, 10, 100 and 1,000 ppm males only). The occurrence of the adenomas was reported to be within the range of historical data. The numbers of animals having either adenoma or adenomatoid lesions was dose dependently increased but not significant different from control group (5/52, 6/52, 7/52 and 10/52). A higher, but not significantly increased incidence of phaechromocytomas was seen in the 1,000 ppm females (2/50, 3/51, 2/49 and 7/51 in control, 10, 100 and 1,000 ppm groups). In summary, methanol was reported not to be carcinogenic in inhalation studies of rats and mice.
Acetic acid
No animal data are known on carcinogenic potential of acetic acid.
Conclusion
Methyl acetate is not regarded as carcinogen. However based on long time of human experience there are no concerns about a relevant carcinogenic potential of acetic acid. As discussed in section 5.7, methyl acetate as well as methanol and acetic acid did not show a genotoxic potential that is indicative for carcinogenicity by a genotoxic mode of action.
Literature:
NEDO (1987). Toxicological Research of methanol as a fuel for Power Station, Summary Report on Tests with Monkeys, Rats and Mice. New Energy Development Organization. Tokyo, Japan. Takeda K, Katoh M (1988). Long-term Effects of Methanol Vapor at Low Concentration. Proc. of the 8th Int. Symp. Alcohol Fuels, Tokyo, Japan.
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