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Diss Factsheets
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EC number: 943-366-5 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: 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: see 'Remark'
- Remarks:
- Non GLP. Near-guideline study. Published in peer reviewed literature. Minor restrictions in design and/or reporting but otherwise adequate for assessment. Read-across justification: The available toxicological data for the target and source substances is outlined in the data matrix (Annex I). The toxicological properties of the target substance are related mainly to acetic acid/acetate since the anhydride components of the substance are hydrolytically unstable. When the target substance comes in contact with water or moisture a complete hydrolysis will take place to form no other hydrolysis products than acetic acid/acetate and adipic acid. Thus, the use of data from acetic acid and adipic acid is justified to evaluate toxicological properties of the target substance. Furthermore, data from acetic anhydride is used in the assessment. Experimental data obtained with the source substances indicate that the substances has low oral (LD50 > 1780 – 3310 mg/kg bw) and inhalation (LC50 1680 - 7700 mg/m3) acute toxicity. Furthermore, the acetic acid and acetic anhydride are irritating to skin at concentration < 25% and corrosive to skin at ≥ 25%. Acetic anhydride and acetic acid are not tested for sensitisation due corrosive properties; adipic acid did not show any evidence of sensitising in an animal study. The source substances did not show positive response in genetic toxicity studies available. Repeated toxicity studies via oral route conducted for acetic acid showed NOAEL values ≥ 210 mg kg bw/day and via inhalation route for acetic anhydride 4.2 mg/m3.. Reproduction toxicity studies conducted for acetic acid did not show any adverse effects on reproduction at the highest concentration tested (1600 mg/kg bw/day).
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of modified methods for determining skin irritation
- Author:
- Nixon GA, Bannan EA, Gaynor TW, Johnston DH & Griffith JF
- Year:
- 1 990
- Bibliographic source:
- Regul. Toxicol. Pharmacol. Vol 12, pp 127-136
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Acetic acid
- EC Number:
- 200-580-7
- EC Name:
- Acetic acid
- Cas Number:
- 64-19-7
- Molecular formula:
- C2H4O2
- IUPAC Name:
- acetic acid
- Details on test material:
- - Name of test material (as cited in study report): Acetic acid
- Substance type: 3.3% and 10% aqueous solutions
- Physical state: liquid
- Analytical purity: not reported
- Stability under test conditions: not reported
- Storage condition of test material: not reported
- No further details
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - no further details reported
ENVIRONMENTAL CONDITIONS - no details reported
IN-LIFE DATES: Not reported
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 3.3% and 10% - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: not reported
- % coverage: not reported
- Type of wrap if used: gauze patches
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h
SCORING SYSTEM:
Sites were graded for erythema and oedema at 4, 24, 48 and 72 h using the Draize scale.
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.5 - 1.1
- Remarks on result:
- other: scores for 3.3 % and 10%, acetic acid, respectively
- Other effects:
- No other effects reported
Any other information on results incl. tables
Table 1 Primary Irritation Indices (PII) in rabbits
Acetic acid % |
3.3 |
10 |
PII |
0.5 |
1.1 |
Sites were graded for erythema and oedema at 4, 14, 48 and 72 h. PII was calculated by averaging the scores for all test sites.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information
- Conclusions:
- Acetic acid, as a 3.3% or a 10% aqueous solution, was slightly irritating to rabbit skin.
- Executive summary:
In a study with rabbits, acetic acid was applied to shaved, intact skin using gauze pads for 4 h and the sites graded for erythema and oedema at 4, 24, 48 and 72 h. Primary Irritation Indices (PII) were calculated by averaging the scores for all test sites. The PII for a 3.3% aqueous solution of acetic acid was 0.5 and for a 10% aqueous solution was 1.1. Thus acetic acid was considered to be slightly irritating to rabbit skin at concentrations of 3.3 and 10%.
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