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EC number: 204-822-2 | CAS number: 127-08-2
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on generations indicated in Effect levels (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The analogue Citric Acid which shares the same functional group with Potassium Acetate, also has comparable values for the relevant molecular properties for the toxicity to reproduction endpoint.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- other: read-across
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
- Principles of method if other than guideline:
- Read-across approach from published experimental data on fertility and one-generation study on the analogue Citric acid.
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- Citric acid
- EC Number:
- 201-069-1
- EC Name:
- Citric acid
- Cas Number:
- 77-92-9
- IUPAC Name:
- citric acid
- Details on test material:
- - Name of test material (as cited in study report): Citric acid
- Molecular formula (if other than submission substance): C6H8O7
- Molecular weight (if other than submission substance): 192.1
- Smiles notation (if other than submission substance): OC(=O)CC(O)(CC(O)=O)C(=O)O
- InChl (if other than submission substance): InChI=1/C6H8O7/c7-3(8)1-6(13,5(11)12)2-4(9)10/h13H,1-2H2,(H,7,8)(H,9,10)(H,11,12)
- Structural formula attached as image file (if other than submission substance): see Fig. in attached report
Constituent 1
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
Details on results (P0)
The analogue Citric acid which shares the same functional group with Potassium acetate, also has comparable values for the relevant molecular properties. These properties are:
- a low log Pow value which is -1.72 for Citric acid, and -3.72 for Potassium acetate,
- a high water solubility which is 1330 g/L for Citric acid, and 2.5 g/mL at 20 ºC for Potassium acetate, and
- similar molecular weights which are 192.1 for Citric acid, and 98.14 for Potassium acetate.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 3 831.6 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: (number of pregnancies)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
Details on results (F1)
The analogue Citric acid which shares the same functional group with Potassium acetate, also has comparable values for the relevant molecular properties. These properties are:
- a low log Pow value which is -1.72 for Citric acid, and -3.72 for Potassium acetate,
- a high water solubility which is 1330 g/L for Citric acid, and 2.5 g/mL at 20 ºC for Potassium acetate, and
- similar molecular weights which are 192.1 for Citric acid, and 98.14 for Potassium acetate.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 3 831.6 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: (number of young born, or survival of young animals).
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
The analogue Citric acid which shares the same functional group with Potassium acetate, also has comparable values for the relevant molecular properties. These properties are:
- a low log Pow value, which is -1.72 for Citric acid, and -3.72 for Potassium acetate,
- a high water solubility, which is 1330 g/L for Citric acid, and 2530g/mL at 25 ºC for potassium acetate, and
- similar molecular weights, which are 192.1 for Citric acid, and 98.15 for Potassium acetate.
Both chemicals are grouped together by US EPA category groupCarboxylic Food Acids and Salts Category.
As indicated in the European Chemical Agency Practical Guide 6 “How to report read –across and categories”, the structural grouping was realized using “OECD QSAR APPLICATION TOOL BOX” version 1.1.0.Presented results show that both substances have common (eco)toxicological behavior (attachment).
Table 1: Data Matrix, Analogue Approach
CAS Number
|
Source chemical 77-92-9
|
Target chemical 127-08-2
|
|
CHEMICAL NAME
|
Citric acid |
Potassium acetate |
|
PHYSICO-CHEMICAL DATA
|
|||
Melting Point |
Measured data: 153 ºC |
Measured data: 292 ºC
|
|
Boiling Point |
Decomposes
|
Estimated data: 392.35 °C
|
|
Density |
Measured data: 1.665 g/cm3 at 20 ºC |
Experimental results: 1.8 g/cm3 at 20 ºC
|
|
Vapour Pressure |
Estimated data: 5.6E-09 mm Hg
|
Estimated data: 1.37E-08 mm Hg at 25 ºC |
|
Partition Coefficient (log Kow) |
Measured data: -1.72 |
Estimated data: -3.72
|
|
Water solubility
|
Measured data: 1330 g/L
|
Experimental results: ca. 2530 g/L at 20 ºC (pH = 9.7) |
|
ENVIRONMENTAL FATE and PATHWAY
|
|||
Aerobic Biodegradation
|
Experimental results: Readily biodegradable
|
Read-across from Sodium acetate (category analogue) based on functional group: Readily biodegradable
|
|
ENVIRONMENTAL TOXICITY
|
|||
Acute Toxicity to Fish |
Experimental data: (96 h) LC 50 = 1516 mg/L |
Experimental data: (96 h) LC 50 > 992.7 mg/L (Brachydanio rerio)
|
|
Acute Toxicity to Aquatic Invertebrates |
Experimental data: (48 h) EC 50 = 1535 mg/L |
Experimental data: (48 h) EC 50 > 1000 mg/L (Daphnia magna)
|
|
Toxicity to Aquatic Plants
|
Experimental data: (72 h) EC 50 = 640 mg/L |
Experimental data:
Key study:
(72 h) EC 50 > 500 mg/L (Skeletonema costatum)
(72 h) NOEC = 500mg/L (Skeletonema costatum)
Supporting studies: Read-across from the source chemical to the target chemical, based on molecular weights:
(8 d) Toxicity threshold (TT) = 6542.67 mg/L (Scenedesmus quadricauda)
|
|
MAMMALIAN TOXICITY
|
|||
Acute Toxicity: Oral |
Experimental data: LD 50 = 5790 – 7100 mg/kg bw (mice) LD 50 = 11700 mg/kg bw (rats) |
Experimental data:
LD50 = 3250 (2480 – 4260) mg/kg bw (male rats)
|
|
Acute Toxicity: Inhalation |
No data |
Read-across from Calcium acetate (category analogue) based on molecular weights:
(4h) LC 50 > 6.95 mg/L
|
|
Acute Toxicity: Dermal |
Experimental data:
A 4-hour skin irritation study in rabbits exposed to a solution containing 60% citric acid caused erythema and edema. This study did not assess a lethal dose value. TheLD50 was not provided.
|
Read-across from the analogue Fumaric Acid, based on molecular weights: (4 h) LD50 > 33820.97 mg/kg bw (female New Zealand White rabbits)
|
|
Skin sensitisation |
Experimental results:
Citric acid (2.5 % aqueous solution) is not sensitizing for the human skin.
No allergic reactions were seen when 60 patients with hand eczema, all of whom were involved in handling food, were patch tested (covered contact, probably 24 hr) with 2.5% citric acid in petrolatum.
|
Weight of evidence:
Read-across from the analogue substances Citric acid (source chemical), Glycolic acid, Sodium Glycolate, Lactic acid, Ammonium lactate, and Triacetin, based on functional group:
All this substances were not sensitising for human and guinea pigs. Based on these results, Potassium acetate is also considered to be not sensitising.
|
|
Repeated Dose Toxicity |
Repeated dose toxicity: oral: Experimental results:
In a 150-day study with male New Zealand White rabbits daily treated by feed, theNOAEL was 1500 mg/kg bw/day(based on no effects observed at the only dose tested).
In a 6-week study with male Sprague-Dawley rats daily treated by feed, theNOAEL was 4800 mg/kg bw/day(based on no effects observed at the highest dose tested). |
Repeated dose toxicity: oral: Weight of evidence:
Read-across from Sodium Acetate (category analogue) based on molecular weights:
Repeated dose toxicity: oral: 112-day study in male Wistar rats. The NOAEL was equal or greater than 0.012 mg/kg bw/day.
Repeated dose toxicity: oral: 3-month study in male Long-Evans rats. The NOAEL was equal or greater than 25.12 mg/kg bw/day.
Repeated dose toxicity: oral: 4-week study in male Wistar rats. The NOAEL was equal or greater than 4307.01 mg/kg bw/day.
Repeated dose toxicity: oral: 8-month study in male Long-Evans rats. The NOAEL was equal or greater than 0.06 mg/kg bw/day.
Read-across from the analogue Citric acid, sodium salt, based on molecular weights:
Repeated dose toxicity: oral: 1-year study in rats. TheNOAEL was equal or greater than 68.75 mg/kg bw/day.
|
|
Genetic Toxicity in vitro
|
- Gene mutation in bacteria
|
Experimental data:
In a bacterial reverse mutation assays usingS. typhimurium(TA97, TA98, TA100 and TA104) in the presence and absence of metabolic activation and up to 2000μg/plate, citric acid was not mutagenic.
|
Key studies:
Read-across from Sodium Acetate (category analogue) based on functional group:
Reverse mutation assay using S. typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 with metabolic activation. Resultslead to the conclusion that Potassium Acetate did not cause point mutations in the microbial systems.
Read-across from the source chemical to the target chemical, based on functional group:
Potassium Acetate is considered to be not mutagenic on S.typhimurium TA 98, TA 100, TA 1535, TA 97, and/or TA 1537, with and without metabolic activation.
|
- Mammalian gene mutation |
No data |
Read-across: Based on published experimental data on the analogue Phenoxyacetic acid, which is considered to be not mutagenic on mouse lymphoma cells, with and without metabolic activation, and applying the read-across approach, the substance Potasium Acetate is also considered to be not mutagenic under test conditions. Based on published experimental data on the analogue Acetic anhydride which is considered to be ambiguous on mouse lymphoma cells, with and without metabolic activation, and applying the read-across approach, the substance Potasium Acetate is also considered as ambiguous under test conditions.
|
|
Chromosomal aberration |
No data |
Key studies: Read-across from Sodium Acetate (category analogue) based on functional group:
In an in vitro chromosomal aberration assay with a Chinese hamster fibroblast cell line, CHL, without metabolic activation systems, it is concluded that Potassium acetate did not induce chromosomal aberrations(including gaps). Read-across from the source chemical to the target chemical, based on functional group:
Potassium Acetate is considered as not clastogenic on Chinese hamster Ovary (CHO) cells, without metabolic activation. |
|
Genetic Toxicity in vivo
|
Experimental data:
In a Dominant Lethal assay using male/female rats dosed at 3 g/kg for 5 days, citric acid did not induced germ cell genotoxicity.
|
Key studies: Read-across from Sodium Acetate (category analogue) based on functional group:
The Testicular DNA-synthesis inhibition test (DSI test) on male mice provides evidence that Potassium acetate is not genotoxic in animals (basis of the method: measuring 3H-thymidine incorporation). Test substance did not inhibit DNA replication in this assay.
|
|
Carcinogenicity
|
No data |
Data waiving (the substance is not classified as mutagen)
|
|
Reproductive Toxicity |
TOXICITY TO REPRODUCTION: Experimental data: In a one-generation oral reproductive toxicity study, female rats and mice were daily treated with citric acid before, during, and after mating. The NOAEL was equal or greater than 2500 mg/kg bw/day (basis for effect: number of pregnancies, number of young born, or survival of young). In a fertility study, female rats were exposed to citric acid in their daily diet for several months. TheNOAEL (reproductive toxicity) was 600 mg/kg bw/day(based on no effects observed at the only dose tested).
DEVELOPMENTAL TOXICITY / TERATOGENICITY:
Experimental data:
In a one-generation oral reproductive toxicity study, female rats and mice were daily treated with citric acid before, during, and after mating. The NOAEL was equal or greater than 2500 mg/kg bw/day (basis for effect: number of pregnancies, number of young born, or survival of young).
|
TOXICITY TO REPRODUCTION: Weight of evidence: Read-across from the analogue Citric Acid, based on molecular weights: A study on rats daily treated by feed before, during, and after mating. For Potassium Acetate, the NOAEL is calculated to be equal or greater than 3831.60 mg/kg bw/day (basis for effect: number of pregnancies, number of young born, or survival of young). A study on mice daily treated by feed before, during, and after mating. For Potassium Acetate, the NOAEL is calculated to be equal or greater than 3831.60 mg/kg bw/day (basis for effect: number of pregnancies, number of young born, or survival of young). A fertility test on female rats daily treated by feed for several months. For Potassium Acetate, the NOAEL is calculated to be 919.58 mg/kg bw/day, and LOAEL greater than 919.58 mg/kg bw/day for reproductive effects. Read-across from the analogue Citric Acid, sodium salt, based on molecular weights: A fertility study on female rats daily treated by feed for several months. For Potassium Acetate, the NOAEL is calculated to be 68.76 mg/kg bw/day, and LOAEL greater than 68.76 mg/kg bw/day for reproductive effects.
DEVELOPMENTAL TOXICITY / TERATOGENICITY: Weight of evidence: Read-across from Sodium Acetate (category analogue) based on molecular weights: Pregnant CD-1 mice were treated by oral gavage on days 8-12 of gestation. For Potassium Acetate, the NOAEL was equal or greater than 1196.39 mg/kg bw/day for maternal toxicity and neonatal effects (mortality and body weight).
Read-across from the analogue Citric Acid, based on molecular weights: A study on rats daily treated by feed before, during, and after mating. For Potassium Acetate, the NOAEL is calculated to be equal or greater than 3831.60 mg/kg bw/day (basis for effect: number of pregnancies, number of young born, or survival of young). A study on mice daily treated by feed before, during, and after mating. For Potassium Acetate, the NOAEL is calculated to be equal or greater than 3831.60 mg/kg bw/day (basis for effect: number of pregnancies, number of young born, or survival of young).
|
Applicant's summary and conclusion
- Conclusions:
- The NOAEL with the substance Potassium acetate is calculated to be equal or greater than 3831.60 mg/kg bw/day (basis for effect: number of pregnancies, number of young born, or survival of young animals).
- Executive summary:
Based on the experimental results (reported under the endpoint record 07.08.01_01 Citric acid) obtained with the analogue Citric acid (NOAEL >= 2500 mg/kg bw/day in rats (basis for effect: number of pregnancies, number of young born, or survival of young animals)), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Potassium acetate is calculated to be equal or greater than 3831.60 mg/kg bw/day for studied effects.
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