Registration Dossier
Registration Dossier
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EC number: 212-736-1 | CAS number: 865-33-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Potassium 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 potassium methanolate via any route as indicated by the available information on the hydrolysis / dissociation products methanol and KOH.
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 potassium methanolate. Potassium methanolate is classified as corrosive to the skin according to Annex VI of the CLP regulation (EC 1272/2008).
The abiotic hydrolysis of potassium methanolate under aqueous conditions results in the formation of methanol and potassium hydroxide. The latter dissociates into the corresponding cations (K+) and anions (OH-). For hazard assessment of potassium 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 potassium hydroxide (CAS No. 1310-58-3) is local irritation and/or corrosion. Potassium 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 a skin and eye irritant. Potassium hydroxide is not expected to be systemically available in the body under normal handling and use conditions and for this reason it can be stated that the substance will neither reach the foetus nor male and female reproductive organs in effective toxic concentrations (OECD, 2002; OECD 2006). In addition, no effects on reproduction have been observed with other potassium salts (KCl, K2CO3) according to the OECD SIDS for sodium and potassium methanolate (OECD, 2006). 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:
Potassium 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 potassium methanolate via any route as indicated by the available information on the hydrolysis / dissociation products methanol or KOH.
References not included as study summaries in IUCLID:
OECD SIDS Initial Assessment Report for SIAM 13 (2002): Potassium Hydroxide (CAS No: 1310-58-3).
OECD SIDS Initial Assessment Report for SIAM 22 (2006): Category of Methanolates: Sodium Methanolate, Potassium Methanolate (CAS No: Sodium Methanolate: 124-41-4; Potassium Methanolate: 865-33-8).
Effects on developmental toxicity
Description of key information
Potassium 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 potassium methanolate via any route as indicated by the available information on the hydrolysis / dissociation products methanol and KOH. It is unlikely that exposure to potassium 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 potassium methanolate. Potassium methanolate is classified as corrosive to the skin according to Annex VI of the CLP regulation (EC 1272/2008).
The abiotic hydrolysis of potassium methanolate under aqueous conditions results in the formation of methanol and potassium hydroxide. The latter dissociates into the corresponding cations (K+) and anions (OH-). For hazard assessment of potassium 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 potassium hydroxide (CAS No. 1310-58-3) is local irritation and/or corrosion. Potassium 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 a skin and eye irritant. Potassium hydroxide is not expected to be systemically available in the body under normal handling and use conditions and for this reason it can be stated that the substance will neither reach the foetus nor male and female reproductive organs in effective toxic concentrations (OECD, 2002; OECD 2006). In addition, no effects on the developing embryo or fetus have been observed with other potassium salts (KCl, K2CO3) according to the OECD SIDS for sodium and potassium methanolate (OECD, 2006). 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 potassium 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 potassium methanolate.
References not included as study summaries in IUCLID:
OECD SIDS Initial Assessment Report for SIAM 13 (2002): Potassium Hydroxide (CAS No: 1310-58-3).
OECD SIDS Initial Assessment Report for SIAM 22 (2006): Category of Methanolates: Sodium Methanolate, Potassium Methanolate (CAS No: Sodium Methanolate: 124-41-4; Potassium Methanolate: 865-33-8).
Toxicity to reproduction: other studies
Description of key information
Potassium 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 potassium methanolate via any route as indicated by the available information on the hydrolysis / dissociation products methanol and KOH. It is unlikely that exposure to potassium 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 potassium methanolate with tissue water results in the formation of methanol and potassium hydroxide. The latter dissociate into the corresponding cations (K+) and anions (OH-). For hazard assessment of potassium 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 potassium methanolate is dominated by its corrosive properties. The abiotic hydrolysis of potassium methanolate with tissue water results in the formation of methanol and potassium hydroxide. At non-irritant concentrations, exposure to potassium 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 potassium methanolate is conclusive but not sufficient for classification according to CLP (1272/2008/EC) / UN-GHS.
Additional information
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