Salicylaldehyde

Skin irritation / corrosion

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

Test material information

Constituent 1

Reference substance name:

Salicylaldehyde

EC Number:

201-961-0

EC Name:

Salicylaldehyde

Cas Number:

90-02-8

Molecular formula:

C7H6O2

IUPAC Name:

2-hydroxybenzaldehyde

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24,48,72h

Score:

2

Max. score:

2

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24,48,72h

Score:

1.67

Max. score:

2

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24,48,72h

Score:

0.83

Max. score:

1

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: 24,48,72h

Score:

1.67

Max. score:

2

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24,48,72h

Score:

1.5

Max. score:

2.5

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24,48,72h

Score:

1.17

Max. score:

1.5

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24,48,72h

Score:

0.17

Max. score:

0.5

Results 8

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