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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
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- chronic toxicity: dermal
- 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, non- guideline study, published in peer reviewed literature. No restrictions, fully 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:
- Acetic acid, a potent stimulator of mouse epidermal macromolecular synthesis and hyperplasia but with weak tumour-promoting ability
- Author:
- Slaga T, Bowden G & Boutwell R
- Year:
- 1 975
- Bibliographic source:
- Nat. Cancer Inst., Vol 55, pp 983-987
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Acetic acid was used as a promotor for tumour development in mice initiated with DMBA or β-PL and was applied dermally 1-3 times per week (at doses of 1-40 mg/animal) for 32 weeks. Control animals received acetic acid dermally once per week. The incidence of papillomas and carcinomas was recorded and they were removed at random for histological verification.
- GLP compliance:
- no
- Limit test:
- 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
- Analytical purity: Not reported
- No details reported
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Mouse Farms, North Wilmington, Massachusetts, USA
- Age at study initiation: 7-12 weeks old
- Weight at study initiation: not reported
- Housing: not reported
- Diet (e.g. ad libitum): not reported
- Water (e.g. ad libitum): not reported
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- acetone
- Details on exposure:
- TEST SITE
- Area of exposure: No details reported
- % coverage: No details reported
- Type of wrap if used: No details reported
- Time intervals for shavings or clippings: shaved 2 days before exposure
REMOVAL OF TEST SUBSTANCE
- no details reported
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 mL in acetone
- Concentration (if solution): 33, 167, 333, 500, 667, 833 or 1000 μmoles/animal
- Constant volume or concentration used: yes
VEHICLE
- Justification for use and choice of vehicle (if other than water): No details reported
- Amount(s) applied (volume or weight with unit): 0.2 mL
USE OF RESTRAINERS FOR PREVENTING INGESTION: no details - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 32 weeks
- Frequency of treatment:
- 1-3 times per week.
Controls dosed once per week.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 17, 33, 167, 333, 667 μmoles
Basis:
- Remarks:
- Doses / Concentrations:
0, 1. 2, 10, 20, 40 mg/animal
Basis:
- No. of animals per sex per dose:
- 20-30
- Control animals:
- yes, sham-exposed
- Positive control:
- 0.25% croton oil
Examinations
- Observations and examinations performed and frequency:
- The animals were observed and the incidence of papillomas and carcinomas was recorded weekly
- Sacrifice and pathology:
- GROSS PATHOLOGY: No data
HISTOPATHOLOGY: Yes - during the 32 week study, papillomas and carcinomas were removed for histological verification at random
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Details on results:
- Mortality:
- A single dermal application of acetic acid at doses of up to 40 mg/animal, in mice initiated with ß-PL or DMBA did not induce excessive mortality. However, more than one weekly application of 10-40 mg acetic acid caused excessive mortality. 33% of mice died when 10 mg acetic acid/animal was applied dermally 3 times per week and approximately 50% of mice died when 20 mg was applied twice a week.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- toxicity
- Effect level:
- 30 other: mg/animal
- Sex:
- female
- Basis for effect level:
- other: No deaths when applied dermally once per week for 32 weeks
- Dose descriptor:
- LOAEL
- Remarks:
- toxicity
- Effect level:
- 10 other: mg/animal
- Sex:
- female
- Basis for effect level:
- other: Mortality (33%) when applied dermally 3 times per week.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
Acetic acid was used as a promotor for tumour development in mice initiated with DMBA orβ-PL and was applied dermally 1-3 times per week (at doses of 1-40 mg/animal) for 32 weeks. Control animals received acetic acid dermally once per week.
A single dermal application of acetic acid at doses of up to 40 mg/animal, in mice initiated with ß-PL or DMBA did not induce excessive mortality. However, more than one weekly application of 10 -40 mg acetic acid caused excessive mortality. 33% of mice died when 10 mg acetic acid/animal was applied dermally 3 times per week and approximately 50% of mice died when 20 mg was applied twice a week.
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