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EC number: 205-488-0 | CAS number: 141-53-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- 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
Carcinogenicity
Administrative data
Description of key information
Studies of carcinogenicity in the rat and mouse are available for the read-across substance, potassium formate (secondary sources).
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Species:
- mouse
- Sex:
- male/female
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 80 weeks
- Frequency of treatment:
- 7/week
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- Remarks:
- Based on diet
- Control animals:
- yes
- Histopathological findings: neoplastic:
- no effects observed
- Relevance of carcinogenic effects / potential:
- Potassium diformate did not show potential for carcinogenicity in a mouse long-term rodent feed study.
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Conclusions:
- Potassium diformate did not show potential for carcinogenicity in a mouse long-term rodent feed study. This can be extrapolated to sodium formate.
- Executive summary:
In oral feed studies comparable to OECD TG 453, potassium diformate did not show potential for carcinogenicity in mice in an 80-week test using doses up to 2000 mg/kg bw/d. It is unlikely that the sodium formate would have the potential to exhibit carcinogenicity (OECD, 2008).
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Species:
- rat
- Sex:
- male/female
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 104 weeks
- Frequency of treatment:
- 7/week
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- Remarks:
- Based on diet
- Control animals:
- yes
- Histopathological findings: neoplastic:
- no effects observed
- Relevance of carcinogenic effects / potential:
- Potassium diformate did not show potential for carcinogenicity in a rat long-term rodent feed study.
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Conclusions:
- Potassium diformate did not show potential for carcinogenicity in a rat long-term rodent feed study. The results of this study can be extrapolated to sodium formate.
- Executive summary:
In oral feed studies comparable to OECD TG 453, potassium diformate did not show potential for carcinogenicity in rats in a 104-week test using doses up to 2000 mg/kg bw/d. It is unlikely, therefore, that sodium formate would have the potential to exhibit carcinogenicity (OECD, 2008).
- Endpoint:
- carcinogenicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Species:
- mouse
- Sex:
- male/female
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 80 weeks
- Frequency of treatment:
- 7/week
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- Remarks:
- Based on diet
- Control animals:
- yes
- Histopathological findings: neoplastic:
- no effects observed
- Relevance of carcinogenic effects / potential:
- Potassium diformate did not show potential for carcinogenicity in a mouse long-term rodent feed study.
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Conclusions:
- Potassium diformate did not show potential for carcinogenicity in a mouse long-term rodent feed study. This can be extrapolated to sodium formate.
- Executive summary:
In oral feed studies comparable to OECD TG 453, potassium diformate did not show potential for carcinogenicity in mice in an 80-week test using doses up to 2000 mg/kg bw/d. It is unlikely that the sodium formate would have the potential to exhibit carcinogenicity (OECD, 2008).
- Endpoint:
- carcinogenicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Species:
- rat
- Sex:
- male/female
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 104 weeks
- Frequency of treatment:
- 7/week
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- Remarks:
- Based on diet
- Control animals:
- yes
- Histopathological findings: neoplastic:
- no effects observed
- Relevance of carcinogenic effects / potential:
- Potassium diformate did not show potential for carcinogenicity in a rat long-term rodent feed study.
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Conclusions:
- Potassium diformate did not show potential for carcinogenicity in a rat long-term rodent feed study. This can be extrapolated to sodium formate.
- Executive summary:
In oral feed studies comparable to OECD TG 453, potassium diformate did not show potential for carcinogenicity in rats in a 104-week test using doses up to 2000 mg/kg bw/d. It is unlikely, therefore, that sodium formate would have the potential to exhibit carcinogenicity (OECD, 2008).
Referenceopen allclose all
SIAP attached, cf. section 13
SIAP attached, cf. section 13
SIAP attached, cf. section 13
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 2 092 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Studies of carcinogenicity in the rat and mouse are available for the read-across substance, potassium formate.
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
There is no indication of carcinogenicity in studies performed with potassium diformate in the rat and mouse. It can therefore be concluded that sodium formate is not carcinogenic and does not require classification according to CLP criteria.
Additional information
Potassium diformate, tested at dose levels of up to 2000 mg/kg bw/d; did not show a potential for carcinogenicity in two valid long-term rodent feed studies using rats and mice, respectively. This can be extrapolated to formic acid and other formate salts. The highest tested dose is equivalent to 2120 mg sodium formate/kg bw/d.
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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