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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted under GLP compliance

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Salicylaldehyde
EC Number:
201-961-0
EC Name:
Salicylaldehyde
Cas Number:
90-02-8
Molecular formula:
C7H6O2
IUPAC Name:
salicylaldehyde
Details on test material:
- Name of test material (as cited in study report): Salicylaldehyde - Purity: > 98 % -Source: Firmenich 

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: intact skin
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
- Amount(s) applied: 0.5 mL- Concentration: undiluted 
Duration of treatment / exposure:
4 hours
Observation period:
1 hour and 1, 2, 3 and 7 days after application
Number of animals:
4
Details on study design:
SCORING SYSTEM The grading scale for irritant effects on rabbit skin, originally proposed by Draze and adopted by OECD Test Guideline 404 and the US and EC regulatory agencies, is shown below. - Erythema and eschar formation: No erythema: 0, Very slight erythema (barely perceptible): 1, Well-defined erythema: 2, Moderate to severe erythema: 3, Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4 - Oedema formation: No oedema: 0, Very slight oedema (barely perceptible): 1, Slight oedema (edges of area well defined by definite raising): 2, Moderate oedema (raised approximately millimeter): 3, Severe oedema (raised more than 1 millimetre and extending beyond area of exposure): 4 The skin irritation potential was shown as Primary Irritation index (PII), which was calculated according to the following forumula: PII = [Sum Erythema 24/48/72 hr + Sum Oedema 24/48/72 hr] / [3 x no of animals]

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24,48,72h
Score:
2
Max. score:
2
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24,48,72h
Score:
1.67
Max. score:
2
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24,48,72h
Score:
0.83
Max. score:
1
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24,48,72h
Score:
1.67
Max. score:
2
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24,48,72h
Score:
1.5
Max. score:
2.5
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24,48,72h
Score:
1.17
Max. score:
1.5
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24,48,72h
Score:
0.17
Max. score:
0.5
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24,48,72h
Score:
1.17
Max. score:
1.5
Irritant / corrosive response data:
Yellow staining was observed in all animals

Any other information on results incl. tables

Observation interval (days)

1h

1d

2d

3d

7d

Animal No. 1

Erythema

2

2

2

2

2.5

Oedema

4

2.5

1

1

1.5

Animal No. 2

Erythema

2

2

1.5

1.5

2

Oedema

3

1.5

1

1

0.5

De

Animal No. 3

Erythema

1

1

1

0.5

0

Oedema

0.5

0.5

0

0

0

Animal No. 4

Erythema

2

2

1.5

1.5

1.5

Oedema

2

1.5

1

1

0.5

De

De: Desquamation from te skin

Yellow staining was observed in all animals

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU

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