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EC number: 211-162-9 | CAS number: 631-61-8
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- 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 Ammonium Acetate, also has comparable values for the relevant molecular properties for the skin sensitisation 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 from a skin prick testing on the analogue Citric acid.
- GLP compliance:
- not specified
- Type of study:
- other: read-across from a skin prick testing with an analogue
Test material
- Reference substance name:
- Citric acid
- EC Number:
- 201-069-1
- EC Name:
- Citric acid
- Cas Number:
- 77-92-9
- Molecular formula:
- C6H8O7
- 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
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 0.25
- Group:
- test chemical
- Dose level:
- 2.5 % citric acid
- No. with + reactions:
- 3
- Total no. in group:
- 91
- Clinical observations:
- Weals
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 0.25. Group: test group. Dose level: 2.5 % citric acid. No with. + reactions: 3.0. Total no. in groups: 91.0. Clinical observations: Weals.
- Reading:
- rechallenge
- Hours after challenge:
- 0.25
- Group:
- test chemical
- Dose level:
- 2.5 % citric acid
- No. with + reactions:
- 0
- Total no. in group:
- 11
- Clinical observations:
- No effects
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 0.25. Group: test group. Dose level: 2.5 % citric acid. No with. + reactions: 0.0. Total no. in groups: 11.0. Clinical observations: No effects.
- Reading:
- 1st reading
- Hours after challenge:
- 0.25
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 247
- Clinical observations:
- No effects
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 0.25. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 247.0. Clinical observations: No effects.
Any other information on results incl. tables
Based on the experimental results obtained with the analogue Citric acid (Citric acid, 2.5 % aqueous solution, is not sensitizing for the human skin), the read-across approach was applied and the substance Ammonium acetate is considered to be also not sensitizing for the human skin.
The analogue Citric acid which shares the same functional group with Ammonium 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 -2.79 for Ammonium acetate,
- a high water solubility, which is 1330 g/L for Citric acid, and 1480 g/L at 4 ºC for Ammonium acetate, and
- similar molecular weights, which are 192.1 for Citric acid, and 77.08 for Ammonium acetate.
Both chemicals are grouped together by US EPA category group Carboxylic 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 631-61-8
|
|
CHEMICAL NAME
|
Citric acid |
Ammonium acetate |
|
PHYSICO-CHEMICAL DATA
|
|||
Melting Point |
Measured data: 153 ºC |
Experimental data: 114 ºC
|
|
Boiling Point |
Decomposes
|
Estimated data: 312.76 ºC
|
|
Density |
Measured data: 1.665 g/cm3 at 20 ºC |
Experimental results: 1.07-1.17 g/cm3 at 20 ºC
|
|
Vapour Pressure |
Estimated data: 5.6E-09 mm Hg
|
Estimated data: 0.02 Pa at 25 ºC |
|
Partition Coefficient (log Kow) |
Measured data: -1.72 |
Estimated data: -2.79
|
|
Water solubility
|
Measured data: 1330 g/L
|
Experimental results: 1480 g/L at 4 ºC
|
|
ENVIRONMENTAL FATE and PATHWAY
|
|||
Aerobic Biodegradation
|
Experimental results: Readily biodegradable
|
Experimental results on Ammonium Acetate, read-across from experimental data on Sodium Acetate and read-across from estimated data on Ammonia and Acetic Acid, based on functional group:
Readily biodegradable
|
|
ENVIRONMENTAL TOXICITY
|
|||
Acute Toxicity to Fish |
Experimental data: (96 h) LC 50 = 1516 mg/L |
Experimental data and read-across from Potassium Acetate, based on molecular weights:
LC50 = 392.70 mg/L.
|
|
Acute Toxicity to Aquatic Invertebrates |
Experimental data: (48 h) EC 50 = 1535 mg/L |
Read-across from experimental data on analogues Sodium Acetate, Potassium Acetate and Ammonia, based on molecular weights:
EC50 = 108.81 - 939.66 mg/L
|
|
Toxicity to Aquatic Plants
|
Experimental data: (72 h) EC 50 = 640 mg/L |
Read-across from experimental data on analogues Acetic Acid, Potassium Acetate and Ammonium Sulphate, based on molecular weights: (72 h) EC50 > 392.70 mg/L; (72 h) NOEC = 392.70 mg/L.
|
|
MAMMALIAN TOXICITY
|
|||
Acute Toxicity: Oral |
Experimental data: LD 50 = 5790 – 7100 mg/kg bw (mice) LD 50 = 11700 mg/kg bw (rats) |
Weight of evidence: Read-across from experimental data on Potassium Acetate and Ammonium Sulphate, based on molecular weights: LD50 = 2333.28-3546.59 mg/kg bw
|
|
Acute Toxicity: Inhalation |
No data |
No data |
|
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.
|
Weight of evidence: Read-across from experimental data on Fumaric Acid and Ammonium Sulphate, based on molecular weights: LD50 = 2333.28-26556.42 mg/kg bw
|
|
Skin Irritation/Corrosion |
Experimental data:
Application of 500 mg Citric Acidto rabbit skin produced moderate irritation in 24 hr.
|
Weight of evidence: Read-across approach from experimental data on analogues Potassium Acetate and Ammonium Lactate, and Ammonium Stearate based on functional group: The substance Ammonium Acetate is considered as not irritating for skin. |
|
Eye Irritation/Corrosion |
Experimental data:
Citric Acidtested on rabbit eyes as single drop of 2% to 5% solution in water caused little or no injury. Irrigation for 30 min with 0.5% to 2% solution causes severe injury; the 0.5% solution causes permanent cloudiness of cornea, and the 2% solution causes severe dense opacification.
Application of 750 mg caused severe irritation in the rabbit eye.
|
Weight of evidence: Read-across approach from experimental data on analogues Potassium Acetate, Ammonium Sulphate, and Ammonium Stearate, based on functional group: The substance Ammonium Acetate is considered as not irritating for eyes. |
|
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 approach from experimental results on Citric Acid, 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, Ammonium acetate is considered to be not sensitizing.
|
|
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: Experimental results:
Repeated dose toxicity: oral: 90 days withfemale Wistar rats. The NOAEL was 3150.4 mg/kg bw/day . Repeated dose toxicity: oral: 15 days study with female Wistar rats. The NOAEL was 3102.2 mg/kg bw/day . Read-across from the analogue Sodium Acetate, based on molecular weights:
The NOAEL >= 0.047 mg/kg bw/day, in male rats chronically treated for 8 months via drinking water. The NOAEL >= 3382.76 mg/kg bw/day, in male Wistar rats daily treated for 4 weeks by feed. The NOAEL >= 19.73 mg/kg bw/day, in male Long-Evans rats treated for 3 months in the diet. The NOAEL >= 0.0094 mg/kg bw/day, in male Wistar rats treated by drinking water for 112 days.
Read-across from the analogue Citric acid, sodium salt, based on molecular weights:
The NOAEL >= 54 mg/kg bw/day, in albino rats treated for ca. 1 year.
|
|
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.
|
Weight of evidence:
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 Ammonium Acetate did not cause point mutations in the microbial systems. Read-across from Acetic Acid, based on functional group:
Ammonium 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. Read-across from experimental data on Ammonia, anhydrous, based on functional group: Ammonium acetate is considered to be not mutagenic on Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, and TA 1538, and Escherichia coli WP2uvrA, with and without metabolic activation.
Read-across from experimental data on Ammonia, aqueous solution, based on functional group: Ammonium acetate is considered not mutagenic on E. coli Sd-4-73, without metabolic activation.
|
- Mammalian gene mutation |
No data |
Weight of evidence: Read-across from the analogue Acetic anhydride, based on functional group: Ammonium acetate is considered to be not mutagenic on mouse lymphoma L5178Y cells, with and without metabolic activation. Read-across from the analogue Phenoxy acetic acid, based on functional group: Ammonium acetate is considered to be not mutagenic on Chinese hamster ovary cells, with and without metabolic activation.
Estimated data from Danish (Q)SAR Database: Ammonium acetate was not mutagenic in mammalian cell gene mutation assays on mouse lymphoma L5178Y cells nor on Chinese hamster ovary cells.
|
|
Chromosomal aberration |
No data |
Weight of evidence: 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 Ammonium acetate did not induce chromosomal aberrations(including gaps). Read-across from Acetic Acid, based on functional group:
Ammonium Acetate is considered as not clastogenic on Chinese hamster Ovary (CHO) cells, without metabolic activation. Read-across from Ammonium Sulfate, based on functional group: Ammonium Acetate is not considered mutagenic on Chinese Hamster Ovary cells, in the absence of a metabolic activation system.
|
|
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 Ammonium 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 |
No data |
|
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 and mice daily treated by feed before, during, and after mating. For Ammonium Acetate, the NOAEL is calculated to be equal or greater than 3009.37 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 Ammonium Acetate, the NOAEL is calculated to be 722.25 mg/kg bw/day, and LOAEL greater than 722.25 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 Ammonium Acetate, the NOAEL is calculated to be 54.0 mg/kg bw/day, and LOAEL greater than 54.0 mg/kg bw/day for reproductive effects. Read-across from the analogue Ammonium sulfate, based on molecular weights: A study on male and female rats exposed for 13 weeks to diets with Ammonium Sulfate. For Ammonium Acetate, the NOAEL is calculated to be 1033.64 mg/kg bw/day for males, and 2304.12 mg/kg bw/day for females.
DEVELOPMENTAL TOXICITY / TERATOGENICITY: Weight of evidence: Experimental results: A study on female rats fed an ammonium-containing diet starting on day 1 of pregnancy until weaning (at posnatal day on 21). After weaning, pups were either fed a normal diet, with no ammonium acetate added, or continued on ammonium until sacrifice. The NOAEL for developmental toxicity was 4293 mg/kg bw/day . Read-across from the analogue Sodium Acetate, based on molecular weights: Pregnant CD-1 mice were treated by oral gavage with Sodium Acetate on days 8-12 of gestation. For Ammonium Acetate, theNOAEL is calculated to be939.66 mg/kg bw/day (based on maternal toxicity: mortality, pregnancy and resorption; and on neonatal effects: mortality and body weight). Read-across from the analogue Citric Acid, based on molecular weights: A study on rats and mice daily treated by feed before, during, and after mating. For Ammonium Acetate, the NOAEL is calculated to be equal or greater than 3009.37 mg/kg bw/day (basis for effect: number of pregnancies, number of young born, or survival of young). Read-across from the analogue substance Calcium Formate, based on molecular weights: A three-generation drinking water study was performed. For Ammonium Acetate, the NOAEL is calculated to be equal or higher than 236.96 mg/kg bw/day. Read-across from Acetic Acid, based on molecular weights: A one-generation study was performed on female mice, rats and rabbits with Acetic Acid. The read-across approach was applied and the NOAEL with the substance Ammonium acetate is calculated to be equal or greater than 2055.47 mg/kg bw/day for maternal and developmental toxicity in mice, rats, and rabbits.
|
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Ammonium acetate is considered to be not sensitizing for the human skin.
- Executive summary:
Based on the experimental results (reported under the endpoint record 07.04.01_01 Citric acid) obtained with the analogue Citric acid (Citric acid, 2.5 % aqueous solution, is not sensitizing for the human skin), the read-across approach was applied and the substance Ammonium acetate is considered to be also not sensitizing for the human skin.
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