Registration Dossier
Registration Dossier
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EC number: 204-699-5 | CAS number: 124-41-4
Carcinogenicity
Administrative data
Description of key information
Based on the available data on the hydrolysis products sodium hydroxide (CAS 1310-73-2) and methanol (CAS 67-56-1), there is no concern for carcinogenicity of sodium methanolate.
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
Based on data from the hydrolysis products methanol and sodium hydroxide, there is no indication or evidence leading to concern for a carcinogenic potential of sodium methanolate.
Additional information
No data are available on carcinogenicity of sodium methanolate. The abiotic hydrolysis of sodium methanolate with tissue water results in the formation of methanol and sodium hydroxide. The latter dissociate into the corresponding cations (Na+) and anions (OH-). Therefore, data of the hydrolysis products were taken into account for hazard assessment of sodium methanolate.
According to the EU RAR of sodium hydroxide (EC, 2007), no data on the carcinogenicity of sodium hydroxide are available (European Commission, 2007). However, it is not expected that NaOH will induce tumors. First of all, NaOH did not induce mutagenicity in in vitro and in vivo studies. Secondly, systemic carcinogenicity is not expected to occur because NaOH is not expected to be systemically available in the body under normal handling and use conditions.
For the hydrolysis product methanol, there are studies available, which showed carcinogenicity in mice and rats via the oral or inhalation route (please refer to the endpoint summary of methanol for details). However, the studies have been challenged and it was concluded that methanol is not likely to be carcinogenic in humans.
In conclusion, based on the available data there is no concern for carcinogenicity of sodium methanolate. In addition, the available data on genotoxicity indicate that sodium methanolate and its hydrolysis products are not genotoxic.
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