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Diss Factsheets
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EC number: 953-863-9 | CAS number: -
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute 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, restrictions in design and or reporting but otherwise adequate for assessment
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Acetic acid is one of the main components of the target substance (1.9-9.9%). The majority of the target substance consists of water, which is non-toxic and thus would not contribute to the oral toxicity of the target substance.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
The source substance is pure acetic acid. The target substance is a UVCB which consists mostly of water (66.7-95.3%), and contains 1.9-9.9% acetic acid.
3. ANALOGUE APPROACH JUSTIFICATION
Use of data on acetic acid is justified for determining the toxic properties of the target substance due to it being one of the main components of the target substance (1.9-9.9%). As the majority of the target substance is water, which is non-toxic, any potential toxic properties would be due to the organic components of the substance.
Data source
Reference
- Reference Type:
- publication
- Title:
- The acute oral toxicity of acetic, chloroacetic, dichloroacetic and trichloroacetic acids
- Author:
- Woodard G, Lange SW, Nelson KW and Calvery HO
- Year:
- 1 941
- Bibliographic source:
- J Ind Hyg Toxicol, Vol 23, PP 78-82
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The sodium salt of acetic acid was administered by oral gavage to groups of rats (at a dose rate of approx. 0.1 mL/g bodyweight). The rats were fasted for 18 hours prior to dosing. The animals were observed for 6 days following dosing.
- 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): acetic acid
- Ionisation constant: 1.86 x 10 E-5
- Acetic acid was adjusted with sodium hydroxide, before dosing, to pH between 6 and 7
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): acetic acid
- Ionisation constant: 1.86 x 10 E-5
- Acetic acid was adjusted with sodium hydroxide, before dosing, to pH between 6 and 7
Test animals
- Species:
- rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sex: predominantly males
- Age: 70-100 days
- Weight: 150-250 g
- No further details
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- Dose concentration: 0.01 cc/g bw
- Doses:
- 2239, 2512, 2859, 3100, 3500, 4000, 4467 mg/kg
- No. of animals per sex per dose:
- 10, except for 2859 mg/kg group when only 5 were dosed
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 6 days
- Statistics:
- Dose-mortality curves prepared according to the methods of Bliss (Bliss CI. An. Appl. Biol. 22, 134 (1935)) and according to the example described by Laug et al (Laug EP, Calvery HO, Morris HJ and Woodard G, J. Ind. Hyg. Toxicol. 21, 173 (1939)).
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 310 mg/kg bw
- Remarks on result:
- other: sodium salt of acetic acid
- Mortality:
- 1/10, 0/10, 3/5, 5/10, 6/10, 7/10, 8/10 for 2239, 2512, 2859, 3100, 3500, 4000, 4467 mg/kg respectively.
- Clinical signs:
- other: No data
- Gross pathology:
- No data
Any other information on results incl. tables
Dose Level (mg/kg bw) | Mortality (number) | Number in Group |
2.239 | 1 | 10 |
2.512 | 0 | 10 |
2.859 | 3 | 5 |
3.1 | 5 | 10 |
3.5 | 6 | 10 |
4.0 | 7 | 10 |
4.467 | 8 | 10 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The acute oral LD50 of the sodium salt of acetic acid was 3310 mg/kg bw for rats.
- Executive summary:
The acute oral toxicity of acetic acid was determined in by exposing rats by oral gavage to sodium acetate. The dosage levels tested were 2239, 2512, 2859, 3100, 3500, 4000, 4467 and mg/kg. 10 rats per group were exposed, except for the 2859 dose level where only 5 rats were exposed. The acute oral LD50 of the sodium salt of acetic acid was 3310 mg/kg bw for rats.
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