Registration Dossier

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: Acceptable, well documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Fed. Reg. 38 No. 187, § 1500.41
Deviations:
yes
Remarks:
(occlusive treatment, duration of test substance application)
Principles of method if other than guideline:
Fed. Reg. 38 No. 187, § 1500.41
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Anisaldehyd
- Physical state: liquid
- Analytical purity: > 99 % (data from order sheet)

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 3.05 kg (male), 2.76 (male), 2.32 kg (female)
- Diet: Ssniff, Intermast

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
- Area of test site: 2.5 cm x 2.5 cm
- Amount applied: 0.5 mL
Duration of treatment / exposure:
24 h
Observation period:
8 d
Number of animals:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data

SCORING SYSTEM: according to the Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: scaling at day 8
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0.67
Max. score:
4
Reversibility:
not fully reversible within: 48 hours
Remarks on result:
other: scaling at day 8
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: scaling at 72 hours and day 8
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

Exposition: 

24 h, intact skin

Animal 

Reading 

Erythema

Edema

Symptoms

1

24 h

2

2

 

2

24 h

2

0

 

3

24 h

2

2

 

1

48 h

0

0

 

2

48 h

0

0

 

3

48 h

2

0

 

1

72 h

1

0

 

2

72 h

0

0

 

3

72 h

2

0

scaling

1

8 d

0

0

scaling

2

8 d

0

0

scaling

3

8 d

1

0

scaling

1

24 - 72 h

1.00

0.67

 

2

24 - 72 h

0.67

0.00

 

3

24 - 72 h

2.00

0.67

 

Applicant's summary and conclusion