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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
Endpoint summary
Administrative data
Description of key information
Studies of skin and eye irritation in the rabbit are available for sodium formate
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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): natriumformiat
- Substance type: salt
- Physical state: white powder
- Analytical purity: 97% - Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.9 kg
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 20-40
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg - Duration of treatment / exposure:
- Single treatment
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to table contained in OECD TG 404 - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There were no skin reactions noted except from a slight (grade 1) edema seen in one of 3 animals at 24 hours after application of the test substance. This reaction was fully reversible within one day.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Sodium formate was not a skin irritant.
- Executive summary:
In an OECD guideline 404 study, sodium formate was tested for its skin irritating properties under GLP conditions in three rabbits. Skin reactions were scored at 24, 48, and 72 hours after treatment according to the table contained in the guideline. There were no skin reactions noted except from a slight (Grade 1) Oedema in one of 3 animals at 24 hours after application. This reaction was fully reversible within one day.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- OECD TG 404 requires skin reactions immediately after patch removal and after 24, 48, and 72 hours thereafter. Study report contains only 72 hour readings. The report is either incomplete, or there are methodological defienciencies, e.g. 24 hour skin contact.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- either no readings at 24 and 48 hours, or the study report is incomplete
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): C-1261, sodium formate
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- Concentration: 100 %
- Duration of treatment / exposure:
- 24 hour(s)
- Number of animals:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0
- Max. score:
- 4
- Interpretation of results:
- study cannot be used for classification
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Remarks:
- Secondary source (ECB IUCLID 2000). The full report was not available for review.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Specific details on test material used for the study:
- Sodium Formate.
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Irritation parameter:
- erythema score
- Time point:
- other: Not specified
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Time point:
- other: Not specified
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- No evidence of skin irritation was seen under the conditions of this study.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Referenceopen allclose all
There was no skin reaction (score = 0) at any treated site in any of the four animals tested.
Score: 0/8, no edemas or erythemas occurred.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- The nature and purity of the test material is unclear
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): C-1261, sodium formate.
- Physical state: solid - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Summit View Farm,Hazleton, Pennsylvania, USA
- Age at study initiation: at least 8 weeks at study initiation.
- Housing: individually, in stainless steel cages
- Diet: standard rabbit diet ad libitum
- Water: tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-21
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Single dose
- Observation period (in vivo):
- Group I: 7 days (data not shown, because no readings made at 24 and 48 hours)
Group II: 17 days - Number of animals or in vitro replicates:
- Group I: 4 animals
Group II: 6 animals - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: according to EPA test guideline [similar to the table contained in OECD guideline No. 405 (1987)].
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.89
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- All six animals showed moderate to severe conjunctival irritation (redness, chemosis, and reversible changes) that was fully reversible. The mean redness score was 1.89 across all animals and readings at 24, 48, and 72 hours.
There were no effects on cornea or iris. - Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Instillation of sodium formate powder caused reversible moderate to severe conjunctival reactions without affecting cornea or iris.
Four of the six animals have mean values for conjunctival redness of at least 2 (24/48/72 hours following installation of the test material) which was fully reversible within 7 days. - Executive summary:
In a study of eye irritating properties, 0.1 mL sodium formate was instilled into one eye of six rabbits. The study is equivalent to a guideline study (an OECD 405) and was conducted under GLP conditions. Eye reactions were evaluated according to the provisions of the OECD guideline No. 405. The observation period of up to 17 days allowed effects to subside. Following treatment, all six animals showed moderate to severe conjunctival irritation (redness, chemosis, and reversible changes) that was fully reversible. Chemosis was absent after 3 and redness after 7 days. The mean redness score was 1.89 across all animals and readings at 24, 48, and 72 hours, although four animals showed a mean score of grading at 24, 48 and 72 hours of at least 2.0. Changes of the nictitating membrane and conjunctivae subsided within 7 days in five and were absent in all animals on day 17 after treatment. There were no effects on cornea or iris noted at any time after dosing (Biodynamics, 1990).
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 30th - November 3rd 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SAFEWAY SE; >97% Sodium formate; >98% purity. White crystalline powder
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: EA Prinzhorn, Germany
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Housing: Individual
- Diet: Not reported
- Water: Not reported
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 30th October 1995 To: 3rd November 1995 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- Not applicable; single exposure
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three rabbits
- Details on study design:
- 0.1 g of the unchanged test material was instilled into one (left) eye of three male NZW rabbits. The untreated (right) eye of each animal acted as a control. Ocular reactions were scored at up to 72 hours using the Draize scale.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- erythema
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- probability of mild irritation
- Other effects:
- Slight ocular secretion was also noted in all animals at the 1-hour observation.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results of this study indicate that sodium formate causes moderate transient eye irritation and is not classified for eye irritation according to the CLP criteria.
- Executive summary:
The eye irritation potential of sodium formate was investigated in a GLP- and guideline (OECD 405)-compliant rabbit study. 0.1 g of the unchanged test material was instilled into one (left) eye of three male New Zealand White rabbits. The untreated (right) eye of each animal acted as a control. Ocular reactions were scored at up to 72 hours using the Draize scale.There were no corneal or iridic effects in any rabbit. There were no corneal or iridic effects in any rabbit. Initial conjunctival erythema (Grade 2 or 3) was seen in all animals but had resolved or decreased in severity to Grade 1 by 24 hours. Findings had resolved in all animals by 72 hours. Initial conjunctival chemosis (Grade 1 or 2) was seen in all animals but had resolved or decreased in severity to Grade 1 by 24 hours. Findings had resolved in all animals by 48 hours. Slight ocular secretion was also noted in all animals at the 1-hour observation. The results of this study indicate that sodium formate causes moderate transient eye irritation and is not classified for eye irritation according to the CLP criteria.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Remarks:
- Secondary source (ECB IUCLID 2000). The full report was not available for review.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Specific details on test material used for the study:
- Sodium Formate.
- Species:
- rabbit
- Strain:
- not specified
- Interpretation of results:
- not irritating
Referenceopen allclose all
Eye reactions after instillation of 0.1 mL of sodium formate powder:
- cornea: not affected
- Iris: not affected
- conjunctivae: all six animals exhibited moderate to severe conjunctival irritation, necrosis was seen in 4 of 6 animals. Necrosis was not further specified, but irritation and “necrosis” were reversible and absent in 5 animals on day 7 and in all animals on day 17.
Detail results are tabulated below.
Effect |
Time (hours) |
Animal No. |
||||||
1 |
2 |
3 |
4 |
5 |
6 |
|||
Cornea |
opacity |
24 |
0 |
0 |
0 |
0 |
+ |
+ |
|
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
area |
24 |
0 |
0 |
0 |
0 |
1 |
1 |
|
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Ulceration |
24 |
0F |
0F |
0F |
0F |
0F |
0F |
|
|
48 |
0F |
0F |
0F |
0F |
0F |
0F |
|
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
|
24 |
0 |
0 |
0 |
0 |
+ |
0 |
|
|
48 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctivae |
redness |
24 |
2 |
2 |
2 |
2 |
2 |
2 |
|
|
48 |
2 |
2 |
2 |
2 |
2 |
2 |
|
|
72 |
1 |
2 |
2 |
2 |
2 |
1 |
Means (24-72 h) |
1.67 |
2.0 |
2.0 |
2.0 |
2.0 |
1.67 |
||
|
chemosis |
24 |
0 |
1 |
1 |
1 |
1 |
1 |
|
|
48 |
0 |
1 |
1 |
0 |
1 |
0 |
|
|
72 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|||||||
|
Ulceration / necrosis |
24 |
0 |
0 |
N |
N |
N |
0 |
|
|
48 |
0 |
0 |
N |
N |
N |
N |
|
|
72 |
0 |
0 |
N |
N |
N |
N |
|
|
Day 7 or 17 |
0 |
0 |
0 |
0 |
0 |
0 |
N = necrosis
F = confirmed with fluorescein
+ = slight reaction
Summary of ocular findings
Finding |
1h |
24h |
48h |
72h |
Mean (24-72h) |
|
Cornea |
Opacity |
0,0,0 |
0,0,0 |
0,0,0 |
0,0,0 |
0.00 |
Iris |
0,0,0 |
0,0,0 |
0,0,0 |
0,0,0 |
0.00 |
|
Conjunctivae |
Erythema |
2,2,3 |
1,0,1 |
1,0,0 |
0,0,0 |
0.33 |
Chemosis |
1,1,2 |
0,0,1 |
0,0,0 |
0,0,0 |
0.11 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
In an OECD guideline 404 study, sodium formate was tested for its skin irritating properties under GLP conditions in three rabbits. Skin reactions were scored at 24, 48, and 72 hours after treatment according to the table contained in the guideline. There were no skin reactions noted except for slight (Grade 1) oedema in one of 3 animals at 24 hours after application of the test substance. This reaction was fully reversible within one day. Thus, sodium formate lacks skin irritating properties (Försvarets Forskningsanstalt, 1988).
Eye irritation
In one study on the eye irritating properties, 0.1 mL sodium formate was instilled into one eye of six rabbits. The study is equivalent to a guideline study (OECD 405) and was conducted under GLP conditions. Eye reactions were evaluated according to the provisions of the guideline. The observation period of up to 17 days allowed effects to subside. Following treatment, all six animals showed moderate to severe conjunctival irritation (redness, chemosis, and reversible changes) that was fully reversible. Chemosis was absent after 3 and redness after 7 days. The mean redness score was 1.89 across all animals and readings at 24, 48, and 72 hours. Changes of the nictitating membrane and conjunctivae subsided within 7 days in five and were absent in all animals on day 17 after treatment. There were no effects on cornea or iris noted at any time after dosing (Biodynamics, 1990). Although this study is guideline-compliant, the nature and purity of the test material is unclear and not reported. The study is not therefore considered to be adequately reliable for the purposes of hazard identification and classification. In an additional eye irritation study performed to GLP and OECD 405 and with characterised test material (Medcon, 1995), moderate transient eye irritation was seen but reactions are not sufficient to trigger classification according to the CLP criteria. Based on the results of reliable studies, sodium formate is not classified as a skin or eye irritant.
Justification for classification or non-classification
Based on the results of reliable studies, sodium formate is not classified as a skin or eye irritant according to the CLP criteria.
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