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EC number: 215-892-9 | CAS number: 1445-45-0
- 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:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP, non-guideline, animal experimental study. Minor restrictions in design and/or reporting but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Effect of Vitamin B12 on the Metabolism in the Rat of volatile Fatty Acids
- Author:
- Dryden LP and Hartman AM
- Year:
- 1 971
- Bibliographic source:
- Journal of Nutrition, Vol. 101, pp 589-592
Materials and methods
- Principles of method if other than guideline:
- Feeding study designed to determine whether vitamin B12 is required for the metabolism of odd-carbon fatty acids higher than propionate and of certain branched-chain fatty acids that lead to propionate.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Sodium acetate
- EC Number:
- 204-823-8
- EC Name:
- Sodium acetate
- Cas Number:
- 127-09-3
- Molecular formula:
- C2H4O2.Na
- IUPAC Name:
- sodium acetate
- Details on test material:
- - Name of test material (as cited in study report): Sodium acetate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- From mothers who were transferred from a stock ration to a vitamin B12 deficient ration at parturition and continued on the deficient ration during lactation.
- Age at study initiation: Approximately 28 days
- Housing: Individually in cages with raised screen floors
- Diet: 25% protein, vitamin B12 deficient diet ad libitum, with or without the addition of fatty acids
- Fatty acids, when fed, replaced an equal quantity of dextrin in the diet. 1.58% acetate moiety (fed as sodium acetate, 3.58% of ration)
- Vitamin B12, when given, was included in the ration at a level of 5 µg/10 g diet
- Water: ad libitum
- Acclimation period: At least 3 days
ENVIRONMENTAL CONDITIONS: no data
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- Continuous
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
3.58% sodium acetate
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
equivalent to 1.58% as the acetate moiety
Basis:
nominal in diet
- No. of animals per sex per dose:
- 6 males (without vitamin B12), 7 males (with vitamin B12)
- Control animals:
- yes, plain diet
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):
- no effects observed
- Food efficiency:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1.58 other: % based on the acetate moiety
- Sex:
- male
- Basis for effect level:
- other: The effect on growth of rats fed diet containing 3.58% sodium acetate, with or without vitamin B12, was not significantly changed when compared to rats fed basal diet only.
- Remarks on result:
- other: see "Overall remarks, attachments"
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Acetate and higher even-carbon fatty acids had no effect on such growth. While the 5-, 7- and 9-carbon straight-chain fatty acids depressed growth on the control ration, as did propionate itself, the extent of depression decreased as the carbon chain lengthened, reflecting perhaps a tendency for the higher acids to be partially metabolized by an alternate pathway. The branched-chain acids (isobutyric, 2-methyl butyric and 4-methyl valeric), depressed growth on the control ration but isovaleric acid did not.
Effect of vitamin B12 on growth of rats fed acetic acid
|
|
|
Average weight gain g (weeks 2-4) |
||
Amount in diet % |
# rats per group |
Vitamin B12 |
Basal diet |
Basal diet + fatty acid |
% change |
1.58 |
6 |
No |
39 |
45 |
+15 |
1.58 |
7 |
Yes |
125 |
124 |
-1 |
Applicant's summary and conclusion
- Conclusions:
- The effect on growth of rats fed diet containing 3.58% sodium acetate (1.58% acetate moiety) in basal diet, with or without vitamin B12, was not significantly changed when compared to rats fed basal diet only. Accordingly, the NOAEL was determined to be 3.58% sodium acetate or 1.58% based on the acetate moiety. These doses correspond to concentrations of 5370 mg/kg bw/day for sodium acetate and 2370 mg/kg bw/day for the acetate moiety (see "Overall remarks, attachments").
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