Registration Dossier
Registration Dossier
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EC number: 200-580-7 | CAS number: 64-19-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP. Near-guideline study. Published in peer reviewed literature. Minor restrictions in design and/or reporting but otherwise adequate for assessment
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:
- not specified
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 30 min, 24, 48 and 72 h after removal of the patches using the Draize scale.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.5
- Reversibility:
- not specified
- Remarks on result:
- other: score for 3.3 % acetic acid
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.1
- Reversibility:
- not specified
- Remarks on result:
- other: score for 10 % acetic acid
- Irritation parameter:
- erythema score
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: Not reported
- Irritation parameter:
- edema score
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- other: Not reported
- 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 after removal of the patches. PII was calculated by adding the average erythema and average oedema 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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