Registration Dossier
Registration Dossier
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EC number: 204-699-5 | CAS number: 124-41-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Sodium methanolate is classified as corrosive to the skin according to Annex VI of the CLP regulation (EC 1272/2008). At non-irritant concentrations / dose levels, no effects on fertility are expected after exposure to sodium methanolate via any route as indicated by the available information on the hydrolysis / dissociation products methanol and NaOH.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No data are available on the toxicity to reproduction of sodium methanolate. Sodium methanolate is classified as corrosive to the skin according to Annex VI of the CLP regulation (EC 1272/2008).
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-). For hazard assessment of sodium methanolate at potentially non-irritating concentrations / dose levels, information on the hydrolysis / dissociation products was taken into account.
The major health hazard (and the mode of action) of sodium hydroxide (CAS No. 1310-73-2) is local irritation and/or corrosion. Sodium hydroxide is classified as corrosive to the skin according to Annex VI of the CLP regulation (EC 1272/2008). At concentrations between 0.5 and 2%, it is classified as skin and eye irritant. Repeated exposure to Na+ions and OH-ions at non-irritant concentrations is unlikely to produce systemic toxic effects by any route and under normal handling and use conditions (European Commission, 2007; OECD, 2002). Moreover, sodium hydroxide is not expected to be systemically available under normal handling and use conditions. Therefore, it can be stated that the substance will not reach the foetus nor reach male and female reproductive organs. It can be concluded that a specific study to determine the toxicity to reproduction is not necessary (European Commission, 2007). Therefore, hazard assessment is mainly focused on data of methanol (CAS No. 67-56-1). For methanol, no relevant adverse effects on fertility were observed (for details please refer to the endpoint summary of methanol).
In conclusion:
Sodium methanolate is classified as corrosive to the skin according to Annex VI of the CLP regulation (EC 1272/2008). At non-irritant concentrations / dose levels, no effects on fertility are expected after exposure to sodium methanolate via any route as indicated by the available information on the hydrolysis / dissociation products methanol or NaOH.
References not included as study summaries in IUCLID:
OECD SIDS Initial Assessment Report for SIAM 14 (2002): Sodium Hydroxide (CAS No: 1310-73-2).
European Union Risk Assessment Report (2007): Sodium Hydroxide (CAS No: 1310-73-2).
Effects on developmental toxicity
Description of key information
Sodium methanolate is classified as corrosive to the skin according to Annex VI of the CLP regulation (EC 1272/2008). At non-irritant concentrations / dose levels, no developmental toxicicty / teratogenicity effects are expected after exposure to sodium methanolate via any route as indicated by the available information on the hydrolysis / dissociation products methanol and NaOH. It is unlikely that exposure to sodium methanolate at non-irritant concentrations / dose levels would result in exposure to toxic doses of the hydrolysis / dissociation products, in particular methanol.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No data are available on the toxicity to development of sodium methanolate. Sodium methanolate is classified as corrosive to the skin according to Annex VI of the CLP regulation (EC 1272/2008). 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-). For hazard assessment of sodium methanolate at potentially non-irritating concentrations / dose levels, information on the hydrolysis / dissociation products was taken into account.
The major health hazard (and the mode of action) of sodium hydroxides (CAS No. 1310-73-2) is local irritation and/or corrosion. Sodium hydroxide is classified as corrosive to the skin according to Annex VI of the CLP regulation (EC 1272/2008). At concentrations between 0.5 and 2%, it is classified as skin and eye irritant. Repeated exposure to Na+ions and OH-ions at non-irritant concentrations is unlikely to produce systemic toxic effects by any route and under normal handling and use conditions (European Commission, 2007; OECD, 2002). Moreover, sodium hydroxide is not expected to be systemically available under normal handling and use conditions. Therefore, it can be stated that the substance will not reach the foetus nor reach male and female reproductive organs. It can be concluded that a specific study to determine the developmental toxicity is not necessary (European Commission, 2007). Therefore, hazard assessment is mainly focused on data of methanol (CAS No. 67-56-1). For methanol, developmental effects were observed in several studies with rodents (please refer to the endpoint summary of methanol for details). However, the weight of evidence of all available data does not indicate that a classification of methanol for developmental toxicity is required.
In addition, it is unlikely that concentrations associated with serious developmental effects in rodents could be reached by administration of sodium methanolate to experimental animals, as those dose levels would be in the acute toxic dose range and associated with massive local irritation at the site of first contact. The maximum tolerated dose in such studies is therefore likely to be below the dose that would result in methanol-mediated developmental effects. Therefore, for animal welfare reasons it is not recommended to perform further animal studies with sodium methanolate.
References not included as study summaries in IUCLID:
OECD SIDS Initial Assessment Report for SIAM 14 (2002): Sodium Hydroxide (CAS No: 1310-73-2).
European Union Risk Assessment Report (2007): Sodium Hydroxide (CAS No: 1310-73-2).
Toxicity to reproduction: other studies
Description of key information
Sodium methanolate is classified as corrosive to the skin according to VI of the CLP regulation (EC 1272/2008). At non-irritant concentrations / dose levels, no effects on reproduction or developmental toxicicty / teratogenicity effects are expected after exposure to sodium methanolate via any route as indicated by the available information on the hydrolysis / dissociation products methanol and NaOH. It is unlikely that exposure to sodium methanolate at non-irritant concentrations / dose levels would result in exposure to toxic doses of the hydrolysis / dissociation products, in particular methanol.
Additional information
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-). For hazard assessment of sodium methanolate at potentially non-irritating concentrations / dose levels, information on the hydrolysis / dissociation products was taken into account (please refer to the endpoint summary of methanol for details).
Justification for classification or non-classification
The health hazard of sodium methanolate is dominated by its corrosive properties. The abiotic hydrolysis of sodium methanolate with tissue water results in the formation of methanol and sodium hydroxide. At non-irritant concentrations, exposure to sodium methanolate via any route will not result in exposure to toxic doses of any of its hydrolysis / dissociation products, in particular methanol. Therefore, the available information on reproductive / developmental toxicicty of sodium methanolate is conclusive but not sufficient for classification according to CLP (1272/2008/EC) / UN-GHS.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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