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Toxicological information

Skin irritation / corrosion

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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:
1990
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

Constituent 1
Chemical structure
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

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%.