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EC number: 204-699-5 | CAS number: 124-41-4
- Life Cycle description
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- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
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- Stability: thermal, sunlight, metals
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- Additional physico-chemical properties of nanomaterials
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Endpoint summary
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- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Skin Irritation: corrosive
Eye irritation: corrosive
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Well documented report, details missing
- Principles of method if other than guideline:
- The test substance (ca. 0.5 g of the 80% suspension in water) was applied to a 2.5 x 2.5 cm application site of white Vienna rabbits for 3 min under occlusive conditions. The skin was left intact. Animals were observed for 8 days and skin changes were observed on working days. Findings were recorded after 24, 48 hours and at the end of the observation period. Findings were graded as described in OECD test guideline 404.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.91 and 3.0 kg - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: untreated skin of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 g
- Concentration (if solution): 80% - Duration of treatment / exposure:
- 3 minutes
- Observation period:
- 8 days
- Number of animals:
- 2
- Details on study design:
- no information given
- Irritation parameter:
- erythema score
- Basis:
- other: 1 animal of 2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- extended patchy necrosis (not specified if animal 1 or 2), which led to full thickness necrosis of the skin (day 8)
- Irritation parameter:
- erythema score
- Basis:
- other: 1 animal of 2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- patchy necrosis (not specified if animal 1 or 2), which led to full thickness necrosis of the skin (day 8)
- Irritation parameter:
- edema score
- Basis:
- other: 1 animal of 2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other:
- Remarks:
- extended in 1 animal (not specified if animal 1 or 2)
- Irritation parameter:
- edema score
- Basis:
- other: 1 animal of 2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 day
- Remarks on result:
- other:
- Remarks:
- extended in 1 animal (not specified if animal 1 or 2)
- Irritation parameter:
- erythema score
- Basis:
- other: 1 animal of 2
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: extended patchy necrosis (not specified if animal 1 or 2), which led to full thickness necrosis of the skin (day 8)
- Irritation parameter:
- erythema score
- Basis:
- other: 1 animal of 2
- Time point:
- 48 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: very severe necrosis (parchement-like; not specified if animal 1 or 2), which led to full thickness necrosis of the skin (day 8).
- Irritation parameter:
- edema score
- Basis:
- animal: 1 animal of 2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: extended in 1 animal (not specified if animal 1 or 2)
- Irritation parameter:
- edema score
- Basis:
- other: 1 animal of 2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: extended in 1 animal (not specified if animal 1 or 2)
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not determinable
- Remarks:
- score not provided due to sever necrosis
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not determinable
- Remarks:
- score not provided due to severe necrosis
- Irritant / corrosive response data:
- - 3 min: Erythema: 2 (2/2 animals), Edema 0 (2/2 animals)
- 8 days: Erythema: 4 (Necrosis, leather-like, 2/2 animals), Edema: 1 (2/2 animals) - Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- The test material was found to be corrosive to rabbit skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- study design not suitable for categorization of corrosion
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: twelve to sixteen weeks
- Weight at study initiation: 2.4 - 2.9 kg
- Housing: individually in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-18
- Humidity (%): 60-75
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- A quantity of 0.5 g of the test material, moistened with 0.5 mL of distilled water, was introduced under a 2.5 cm X 2.5 cm gauze patch and placed in position on the shorn skin.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Due to severe adverse dermal reactions and for animal welfare reasons the study was terminated after the one-hour observation.
- Number of animals:
- 6
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: Due to severe adverse dermal reactions and for animal welfare reasons the study was terminated after the one-hour observation.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 1 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- Due to severe adverse dermal reactions and for animal welfare reasons the study was terminated after the one-hour observation.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- Due to severe adverse dermal reactions and for animal welfare reasons the study was terminated after the one-hour observation.
- Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- The test material was found to be corrosive to rabbit skin.
The observation schedule was not suitable to determine the corrosivity category, however the early study termination for ethical reasons indicates a high corrosivity of the substance. For precautionary reasons, the study result is assessed with Cat 1A.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Well documented report, details missing
- Principles of method if other than guideline:
- according to BASF-internal standards
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- Amount applied: 50 µL
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 2
- Irritation parameter:
- other: Signs of necrosis
- Basis:
- animal #1
- Time point:
- other: 1 h
- Reversibility:
- not reversible
- Remarks on result:
- other: Grey discoloration of the nictating membrane. Severe corneal opacity. Severe pain reaction after application of the test substance.
- Irritation parameter:
- other: Signs of necrosis
- Basis:
- animal #2
- Time point:
- other: 1 h
- Reversibility:
- not reversible
- Remarks on result:
- other: Grey discoloration of the nictating membrane. Severe corneal opacity. Severe pain reaction after application of the test substance.
- Irritation parameter:
- other: Signs of necrosis
- Basis:
- animal #1
- Time point:
- 24 h
- Reversibility:
- not reversible
- Remarks on result:
- other: Grey discoloration of the nictating membrane and the conjunctiva (partly). Moderate conjuctival redness, slight oedema, severe corneal opacity. Necrosis of the edges of the eye lids.
- Irritation parameter:
- other: Signs of necrosis
- Basis:
- animal #2
- Time point:
- 24 h
- Reversibility:
- not reversible
- Remarks on result:
- other: Grey discoloration of the nictating membrane and the conjunctiva (partly). Moderate conjuctival redness, slight oedema, severe corneal opacity. Necrosis of the edges of the eye lids.
- Irritation parameter:
- other: Signs of necrosis
- Basis:
- animal #1
- Time point:
- other: 8 days
- Reversibility:
- not reversible
- Remarks on result:
- other: Severe necrosis, severe suppuration, eyelids shrunken.
- Irritation parameter:
- other: Signs of necrosis
- Basis:
- animal #2
- Time point:
- other: 8 days
- Reversibility:
- not reversible
- Remarks on result:
- other: Severe necrosis, severe suppuration, eyelids shrunken.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- due to signs of necrosis
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- due to signs of necrosis
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- due to signs of necrosis
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- due to signs of necrosis
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test material was found to be corrosive to rabbit eye.
Reference
After 1 h: Grey discoloration of the nictating membrane. Severe corneal opacity. Severe pain reaction after application of the test substance.
After 24 h: Grey discoloration of the nictating membrane and the conjunctiva (partly). Moderate conjuctival redness, slight oedema, severe corneal opacity. Necrosis of the edges of the eye lids.
After 8 days: Severe necrosis, severe suppuration, eyelids shrunken.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In a standard skin irritation/corrosion test according to EPA OPP 81-5 and GLP, solid sodium methanolate moistened with water was applied to the skin of 6 rabbits for 4 hours under semiocclusive conditions. Due to severe necrosis at all application sites, the study was terminated one hour after removal of the patches for human reasons. The observation schedule was not suitable to determine the corrosivity category, however the early study termination indicates a high corrosivity of the substance. (Evonik, 1988).
In another study on 2 rabbits, an 80% solution of sodium methanolate in water was highly corrosive after 3 minutes of exposure to the skin and resulted in necrosis that was irreversible after the 8-day post exposure observation period (BASF SE, 1979).
In addition, a 30% sodium methanolate solution in methanol was highly corrosive to the skin of rabbits when exposed for 1 to 15 minutes. Necrosis was already observed after an exposure time of 1 minute. A severe pain reaction was observed shortly after the application of the test substance (BASF SE, 1978). As a 30% sodium methanolate solution in methanol was used for testing, the results are not reliable as this kind of exposure does neither reflect a possible exposure situation nor is in line with current guidelines. Therefore, the study was disregarded for hazard assessment.
Eye irritation
In a preliminary non-GLP study with two rabbits, 50 mL [note: presumably 50 µL] of a sodium methanolate solution (30% in methanol) were administered to the eyes. Already after 1 h, grey discolouration of the nictating membrane and severe corneal opacity were observed. After 24 h, observations included grey discolouration of the nictating membrane and the conjunctiva (partly), moderate conjunctival redness, slight edema, severe corneal opacity and necrosis of the edges of the eye lids. The effects were irreversible within the 8-day observation period. At this time point, severe necrosis, severe suppuration and shrunken eyelids were observed. The substance was corrosive to rabbit eye (BASF SE, 1978).
Conclusion
Sodium methanolate was highly corrosive to rabbit skin and eyes. Based on the skin and eye irritation data, it can be assumed that sodium methanolate will also cause irritation/corrosion to the mucous membranes of the upper respiratory tract in case of an exposure via the inhalation route. As the corrosivity is mediated by the exothermic liberation of sodium hydroxide, the data for the hydroxide may be important for the evaluation of this endpoint as well. For sodium hydroxide (CAS No. 1310-73-2), OECD (2002) concluded that based on the animal data a NaOH solution of 8% can be considered corrosive. Based on human data, concentrations of 0.5 to 4% were irritating to the skin and concentrations slightly lower than 0.5% were considered non-irritating.
References not included in IUCLID:
OECD SIDS Initial Assessment Report for SIAM 14 (2002): Sodium Hydroxide (CAS No: 1310-73-2).
Justification for classification or non-classification
According to Annex VI of the CLP regulation (EC 1272/2008), potassium methanolate is classified as corrosive (Skin Corr. 1B - H314). This classification was also confirmed in an in vitro skin corrosion test according to OECD guideline 435 with potassium methanolate. However, taken also into account the harmonised classification for the hydrolysis product potassiumhydroxide (Skin Corr. 1Aat≥2%)according to CLP Regulation No 1272/2008, Annex VI Table 3.1 a worst-case approach was undertaken for potassium hydroxide and therefore, potassium methanolate fulfils the criteria for classification as corrosive causing severe burns:
CLP / UN-GHS: Skin Corr. 1A - H314
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