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EC number: 204-814-9 | CAS number: 126-96-5
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- other: read-across from a chronic study with an analogue
- 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, sodium salt which shares the same functional group with Sodium Diacetate, also has comparable values for the relevant molecular properties for the repeated dose toxicity 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 non-standard study on the analogue Citric acid, sodium salt.
- GLP compliance:
- no
Test material
- Details on test material:
- - Name of test material (as cited in study report): citric acid, sodium salt
- Molecular formula (if other than submission substance): H7NaC6O7
- Molecular weight (if other than submission substance): 214.105
- Smiles notation (if other than submission substance): [Na+].OC(=O)CC([O-])(CC(=O)O)C(=O)O
- InChl (if other than submission substance): InChI=1/C6H7O7.Na/c7-3(8)1-6(13,5(11)12)2-4(9)10;/h1-2H2,(H,7,8)(H,9,10)(H,11,12);/q-1;+1
- Structural formula attached as image file (if other than submission substance): see Fig. in attached report
Constituent 1
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Based on the experimental results obtained with the analogue Citric acid, sodium salt (NOAEL >= 50 mg/kg bw/day, nominal in diet in rats treated daily by feed for ca. 1 year), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium diacetate is calculated to be equal or greater than 50 mg/kg bw/day.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 50 other: mg/kg bw/day (estimated)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The NOAEL with the substance Sodium diacetate is calculated to be equal or greater than 50 mg/kg bw/day.
The analogue Citric acid sodium salt which shares the same functional group with Sodium dicetate, also has comparable values for the relevant molecular properties. These properties are:
- a low log Pow value, which is -0.28 for Citric acid sodium salt and -3.72 for Sodium diacetate,
- a high water solubility, which is 166 g/L for Citric acid sodium salt and 1000 g/L for Sodium dicetate at 25 ºC, and
- similar molecular weights, which are 214.11for Citric acid sodium salt and 142.086 for Sodium dicetate
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
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Source chemical 994-36-5
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Target chemical 126-96-5
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CHEMICAL NAME
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Citric acid, sodium salt |
Sodium diacetate |
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PHYSICO-CHEMICAL DATA
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Melting Point |
No data |
Measured data: Decomposes above 150 ºC
|
|
Boiling Point |
No data |
Measured data: Decomposes above 150°C
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Density |
No data |
Experimental results: 4.405 |
|
Vapour Pressure |
Negligible |
Estimated data: 0.000000716 mm Hg at 25 ºC |
|
Partition Coefficient (log Kow) |
Estimated data: -0.28 |
Estimated data: -3.72
|
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Water solubility
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Estimated data: 1000 g/L
|
Estimated data : 1000 g/L at 25 ºC |
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ENVIRONMENTAL FATE and PATHWAY
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Aerobic Biodegradation
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No data |
Read across: Readily biodegradable
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ENVIRONMENTAL TOXICITY
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Acute Toxicity to Fish |
No data |
Read across: Based on the experimental results obtained with the supporting substance Acetic acid (96-h LC 50 =251 mg/L for gambusia affinis) and the molecular weights, the read-across approach is applied and the LC 50 for the substance Sodium diacetate is calculated to be 297 mg/L under test conditions. Based on the experimental results obtained with the supporting substance Acetic acid (48-h LC 50 =410 mg/L for Leuciscus idus melanotus) and the molecular weights, the read-across approach is applied and the LC 50 for the substance Sodium diacetate is calculated to be 485 mg/L under test conditions. Based on the experimental results obtained with the supporting substance Acetic acid (96-h LC 50 =79 -88 mg/L for Fathead minnow) and the molecular weights, the read-across approach is applied and the LC 50 for the substance Sodium diacetate is calculated to be 93.5 -104 mg/L under test conditions. Based on the experimental results obtained with the supporting substance Acetic acid (96-h LC 50 =272.87 mg/L for Mozambique tilapia) and the molecular weights, the read-across approach is applied and the LC 50 for the substance Sodium diacetate is calculated to be 322.5 mg/L under test conditions. Based on experimental data on the analogue Sodium Acetate (a limit acute toxicity test was performed with Brachydanio rerio in a semi-static system, 96h-LC0 was greater than 100 mg/L) the LC0 calculated for Sodium diacetate is greater than 87 mg/L under test conditions. Based on experimental data on the analogue Sodium Acetate (120h-LC50 was 13.33 g/L) and the molecular weight, the LC50 calculated for Sodium diacetate is 11.54 g/L under test conditions (120h). Based on experimental data on the analogue Sodium Acetate (96h-LC0 was 10.0 g/L) and the molecular weight, the LC50 calculated for Sodium diacetate is 8.664 g/L under test conditions. As it can be observed the LC50 values for fish are much lower when read across are done from data on Acetic Acid. When is done from data on Sodium acetate, the values are even more than 100 times higher. The elevate toxicity of acetic acid is caused bu the low pH of the substance in water. The pH for sodium diacetate is approx 4.5-5.0 and the water solution of the substance is a buffer which keeps the pH constant (the 0.1M acetic acid is 2.9, and 0.1M Sodium acetate is 8.9). To average the LC50 for Sodium diacetate the medium value between the read across of both substances is used: >93.5 and <11540 (average: 5816.8mg/L).
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Acute Toxicity to Aquatic Invertebrates |
No data |
Read across: Based on experimental data on the analogue Sodium Acetate (the 24 hour LC50 was determined by means of a standardised procedure using 24-h-old animals from a clone of Daphnia magna. The 24-h LC50 was 7170 mg/L) and the molecular weights, the read-across approach is applied and the LC 50 for the substance Sodium diacetate is calculated to be 6209.5 mg/L under test conditions. Based on experimental data on the analogue Sodium Acetate (the 48 hour LC0 was 1000mg/L and the 48-h LC50 was greater than 1000 mg/L) and the molecular weights, the read-across approach is applied and the LC0 for the substance Sodium diacetate is calculated to be 866 mg/L under test conditions and LC50 (48h) is >866mg/L. Based on experimental data on the analogue Acetic acid (the 48 hour EC50 determined for Daphnia magna was 65 mg/L) and the molecular weights, the read-across approach is applied and the EC 50 for the substance Sodium diacetate is calculated to be 77.5 mg/L under test conditions. Based on experimental data on the analogue (EC 50 of acetic acid was 95 mg/L wittout adjustment of pH and EC50 was 6000 mg/L with adjustment of pH to 8 and the molecular weights, the read-across approach is applied and the EC 50 for the substance Sodium diacetate is calculated to be 112 and 7098.5 mg/L respectively under test conditions. Based on experimental data on the analogue Acetate Acetic acid and the molecular weights, the read-across approach is applied and the EC 50 for the substance Sodium diacetate is calculated to be 55.5 mg/L respectively under test conditions. Based on experimental data on the analogue Acetate Acetic acid and the molecular weights, the read-across approach is applied and the 96h LC50 for the substance Sodium diacetate is calculated to be 193.73 mg/L respectively under test conditions. Based on experimental data on the analogue Acetate Acetic acid and the molecular weights, the read-across approach is applied and the 16 h NOEC for the substance Sodium diacetate is calculated to be 177.5 mg/L respectively under test conditions.
As it is observed the LC50 values for Daphnia are much lower when read accross are done from data on Acetic Acid. When is done from data on Sodium acetate, the values are even more than 100 times higher. The pH influence on the toxicity is observed clearly in the study when the EC 50 was measured with and without pH adjustment. The elevate toxicity of acetic acid is caused by the low pH of the substance in water. The pH for sodium diacetate is approx 4.5-5.0 and the water solution of the substance is a buffer which keeps the pH constant (the 0.1M acetic acid is 2.9, and 0.1M Sodium acetate is 8.9).To average the LC50 for Sodium diacetate the medium value between the read across of both substances is used: >55.5 and <866 (average: 460.75 mg/L).
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Toxicity to Aquatic Plants
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No data |
Read across: Based on published experimental data on the analogue Acetic acid (8d-Toxicity threshold (TT) Microcystis aeruginosa was 90 mg/L) and the molecular weights, the read-across approach is applied and the Toxicity Threshold for Sodium dicetate is calculated to be 106 mg/L. Based on published experimental on the analogue Acetic acid (24h-EC 50 was 156 mg/L) and the molecular weights, the read-across approach is applied and the 24h EC50 for Sodim dicetate is calculated to be 184 mg/L in Green algae. Based on published experimental data on the analogue Acetic acid (8d-Toxicity threshold (TT) for Scenedesmus quadricauda was 4000 mg/L) and the molecular weights, the read-across approach is applied and the Toxicity Threshold for Sodium dicetate is calculated to be 4732.5 mg/L. Based on published experimental data on the analogue Sodium acetate (60h-Growth inhibition for Anacystis nidulans was 2460 mg/L) and the molecular weights, the read-across approach is applied and the Toxicity Threshold for Sodim dicetate is calculated to be 2130.5 mg/L.
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MAMMALIAN TOXICITY
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Acute Toxicity: Oral |
Experimental data: LD 50 = 7100 mg/kg bw (mice) |
The oral LD50 of Sodium diacetate for rats is 5600 mg/kg bw. .
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Acute Toxicity: Inhalation |
No data |
Read across: Based on the experimental results obtained with the analogue Calcium Acetate (LC 50 for female rats > 5.6 mg/L air) and the molecular weights, the read-across approach is applied and the LC50 for substance Sodium Acetate is calculated to be higher than 5.03 mg/L air under test conditions. Based on the experimental results (reported under the endpoint record 07.02.02_03) obtained with the analogue Acetic Acid (LCLo for rats = 16000 mg/L air) and the molecular weights, the read-across approach is applied and the LCLo for substance Sodium Diacetate is calculated to be than 18929 mg/L air under test conditions. |
|
Acute Toxicity: Dermal |
No data |
The dermal LD50 of Sodium diacetate for rats is greater than 2000 mg/kg bw |
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Skin Sensitization
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No data |
Weight of evidence:
Read-across from the analogue substances 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, Sodium diacetate is also considered to be not sensitising.
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Repeated Dose Toxicity |
Repeated dose toxicity: oral: Experimental results:
In a 1 year study with rats daily treated by feed, theNOAEL was ca. 50 mg/kg bw/day(based on no effects observed at the only dose tested). |
Read across: Based on the experimental results obtained with the analogue Citric acid, sodium salt (NOAEL >= 50 mg/kg bw/day, nominal in diet in rats treated daily by feed for ca. 1 year), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium acetate is calculated to be equal or greater than 50 mg/kg bw/day. Based on the experimental results obtained with the analogue Sodium acetate (NOAEL >= 0.05 mg/kg bw/day in male Long-Evans rats treated daily by drinking water for 8 months), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium diacetate is calculated to be equal or higher than 0.043 mg/kg bw/day. Based on the experimental results obtained with the analogue Sodium acetate (NOAEL >= 3600 mg/kg bw/day in male Wistar rats treated daily by feed for 4 weeks), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium diacetate is calculated to be equal or greater than 3117mg/kg bw/day. Based on the experimental results obtained with the analogue Sodium acetate (NOAEL >= 21 mg/kg bw/day in male Long-Evans rats treated daily by feed for 3 months), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium diacetate is calculated to be equal or greater than 18 mg/kg bw/day. Based on the experimental results obtained with the analogue Sodium acetate (NOAEL >= 0.01 mg/kg bw/day in male Wistar rats treated daily by drinking water for 112 days), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium diacetate is calculated to be equal or greater than 0.0085 mg/kg bw/day
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Genetic Toxicity in vitro
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Gene mutation in bacteria Mammalian gene mutation Chromosomal aberration |
Experimental data:
Citric acid, sodium salt was tested in an assay usingSaccharomyces cerevisiaecells in the presence and absence of metabolic activation; however, insufficient information was provided in the robust summary of this study to adequately evaluate the results. |
Read-across from experimental results with Sodium acetate: In the first study, reported by Ishidate et al., 1984, a reverse mutation assay using S. typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 was carried out with Sodium Acetate according to the method of Ames et al. (1975), but only with metabolic activation. No significant increases in the numbers of revertant colonies were detected in any S. typhimurium strains at the maximum dose tested. Based on these results, the read-across approach is applied and Sodium Diacetate is also considered as not mutagenic under test conditions. In the same report, Ishidate et al. reported chromosomal aberrations tests with Sodium Acetate using a Chinese hamster fibroblast cell line, CHL. The cells were exposed to each sample at three different doses for 24 and 48 hours. No metabolic activation systems were applied. The maximum dose of each sample was selected by a preliminary test in which the dose needed for 50% cell-growth inhibition was estimated using a cell densiometer. The incidence of cells with aberrations (including gaps) was 0%. Based on these results, the read-across approach is applied and Sodium Diacetate is also considered as not mutagenic under test conditions. Read-across from experimental results obtained with Acetic Acid: A test within the National Toxicology Program’s mutagenicity testing program and according to GLP was reported by Zeiger et al., 1992. This test was carried out with Acetic acid using Salmonella typhimurium strains TA 98, TA 100, TA 1535, and TA 97, with and without matabolic activation. Acetic acid did not show any mutagenic effect under test conditions. Based on these results, the read-across approach is applied and Sodium Diacetate is also considered as not mutagenic under test conditions. In the next report (by Morita et al., 1990) a cytogenetic assay was carried out with Acetic acid using Chinese hamster ovary K1 cells, with and without metabolic activation. In the absence of S9 mix, cells were exposed for 24 h to test substance at doses of 8, 10, 12, 14, and 16 mM. In the presence of S9 mix, cells were exposed for 6 h to test substance at doses of 4, 8, 10, and 12 mM, and recultured in fresh medium for 18 h. The medium used was Ham’s F12 supplemented with 17 mM NaHCO3 and 10% fetal calf serum. Cytotoxicity was evaluated by counting surviving cells. The relationship between the pH of the medium and the clastogenic activity was examined. In order to study the effects of neutralization of the treatment medium, two kinds of treatment media were examined. One was adjusted to pH 5.8 or pH 6.0 and the other was so adjusted and then immediately neutralized to pH 6.4 and pH 7.2 with 1 M NaOH. Acetic acid was not clastogenic at concentrations close to those showing cytotoxicity. Low pH did induce some artificial chromosome aberrations, but these were eliminated by neutralization of the test medium. The read-across approach is applied and Sodium Diacetate is also considered to be not clastogenic under test conditions. Read-across from experimental results obtained with Acetic Anhydride: In the paper reported by Seifreid et al. (2006), a L5178Y Mouse Lymphoma Cell Mutation Assay was performed with Acetic anhidride to test its mutagenic potencial. The chemical was tested with and without metabolic activation. The range of concentartions was 0.04 - 0.3 g/mL. The toxicity of test substance was also determined both with and without liver S9. The mutagenicity assay was performed according to the procedure described by Clive and Spector. Resistance to trifluorothymidine (TFT) was determined by adding TFT (final concentration, 3 µg/mL) to the cloning medium for mutant selection. Results have been evaluated under the traditional criteria (old evaluation) as well as the current international “harmonization” recommendations (new evaluation). With old evaluation: Test substance was not mutagenic with metabolic activation, and was positive without metabolic activation (this positive result is not reliable, because full requeriments for a valid test were not met). With new evaluation: Test substance was ambiguous with and without metabolic activation. Based on these results, the read-across approach is applied and Sodium Diacetate is considered to be ambiguous on mouse lymphoma cells, with and without metabolic activation. Read-across from experimental results obtained with Phenoxyacetic acid: A L5178Y Mouse Lymphoma Cell Mutation Assay was performed with Phenoxyacetic acid (National Toxicology Program Database). The chemical was tested with and without metabolic activation and, in general, tested concentrations were: 62.5, 125, 250, 500, 750, 1000, 1500, and 2000 µg/mL. Phenoxyacetic acid resulted to be not mutagenic with and without metabolic activation. It was toxic to cells, but at higher concentrations than precipitating concentrations. The read-across approach is applied and Sodium diacetate is considered to be not mutagenic on mouse lymphoma cells. Estimated results with Sodium Diacetate from Danish (Q)SAR Database: A Danish (Q)SAR prediction with the Multicase model was realized to estimate the mutagenic potencial of sodium diacetate on mammalian cells (mouse lymphoma and HGRT (CHO): Chinese hamster ovary cell HGPRT forward mutation assay). The substance sodium diacetate was predicted to be not mutagenic in mammalian cells. This prediction should be used for classification and risk assessment.
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Genetic Toxicity in vivo
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No data |
.Read-across from experimental results with Sodium Acetate: The Testicular DNA-synthesis inhibition test (DSI test) was performed on male mice with Sodium Acetate. This is not a standard genotoxicity test system, but it provides evidence that acetic acid, sodium salt is not genotoxic in animals. The basis of the method is to measure 3H-thymidine incorporation. Animals receive a single oral dose by gavage at concentrations of 200, 500, and 1000 mg/kg bw of test substance. No inhibitory effect on DNA-replication was detectable in animals treated with Sodium Acetate. Based on these results, the read-across approach is applied and Sodium Diacetate is also considered as not mutagenic under test conditions.
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Carcinogenicity
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No data |
No data |
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Reproductive Toxicity |
TOXICITY TO REPRODUCTION: Experimental data: In a 1 year study with rats daily treated by feed, theNOAEL was ca. 50 mg/kg bw/day(based on no effects observed at the only dose tested).
DEVELPMENTAL TOXICITY / TERATOGENICITY: No data |
TOXICITY TO REPRODUCTION: Read across: Based on the experimental results obtained with the analogue Citric acid on rats daily treated by feed for several months (NOAEL for reproductive effects = 600 mg/kg bw/day; LOAEL > 600 mg/kg bw/day for the same effects), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium diacetate is calculated to be 665.5 mg/kg bw/day, and LOAEL higher than 665.5 mg/kg bw/day for reproductive effects. Based on the experimental results 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 Sodium diacetate is calculated to be equal or greater than 2274 mg/kg bw/day for studied effects. Based on the experimental results obtained with the analogue Citric acid, sodium salt, on rats daily treated by feed for several months (NOAEL for reproductive effects = 50 mg/kg bw/day; LOAEL > 50 mg/kg bw/day for the same effects), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium diacetate is calculated to be 50 mg/kg bw/day, and LOAEL greater than 50 mg/kg bw/day for reproductive effects.
DEVELOPMENTAL TOXICITY / TERATOGENICITY: Read across: Based on the experimental resultsobtained with the analogue Sodium Acetate (NOAEL >= 1000 mg/kg bw/day in Pregnant CD-1 mice treated by oral gavage on days 8-12 of gestation, based on maternal toxicity: mortality, pregnancy and resorption; and on neonatal effects: mortality and body weight), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium diacetate is calculated to be equal or greater than 866 mg/kg bw/day. Based on the experimental results (reported under the endpoint record 07.08.02_02) obtained with the analogue Acetic acid (NOAEL >= 1600 mg/kg bw/day in female mices, rats and rabbits treated for 10 days for maternal toxicity, mortality and body weight gain, and for developmental toxicity, numbers of live and dead fetuses, external and internal examinations), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium acetate is calculated to be equal or greater than 1893 mg/kg bw/day for maternal and developmental toxicity. Based on the experimental results obtained with the analogue Citric acid (NOAEL >= 2500 mg/kg bw/day in mice and 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 Sodium diacetate is calculated to be equal or higher than 2774 mg/kg bw/day for studied effects. Based on the experimental results obtained with the analogue Calcium formate (NOAEL >= 200 mg/kg bw/day in Wistar rats for maternal and developmental toxicity), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium diacetate is calculated to be equal or higher than 218.5 mg/kg bw/day for maternal and developmental toxicity.
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Applicant's summary and conclusion
- Conclusions:
- The NOAEL with the substance Sodium acetate is calculated to be equal or greater than 50 mg/kg bw/day.
- Executive summary:
Based on the experimental results (reported under the endpoint record 07.05.01_07) obtained with the analogue Citric acid, sodium salt (NOAEL >= 50 mg/kg bw/day, nominal in diet in rats treated daily by feed for ca. 1 year), and the molecular weights, the read-across approach was applied and the NOAEL with the substance Sodium acetate is calculated to be equal or greater than 50 mg/kg bw/day.
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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