Registration Dossier

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: Study meets scientific standards with acceptable restrictions (limited documentation, e.g. no details about test substance or applied amount of test substance)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Principles of method if other than guideline:
White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5 and 15 minutes and 2 other animals for 20 hours using occlusive conditions.
An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened test substance. In addition, skin tissue from the ear was
tested by wrapping the ear. These results from the ear, however, would not be taken into account for evaluation as they do not represent testing of the dorsal/lateral flank of the back. After the application time, the skin was washed with water which sometimes contained a mild detergent.
The animals were observed 7 to 8 days and skin changes were recorded on working days. Tests used occlusive dressing, in contrast to the semiocclusive dressing specified by the guidelines.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
stearic acid chloride
IUPAC Name:
stearic acid chloride
Details on test material:
- Name of test material (as cited in study report): Stearinsäurechlorid
- Physical state: liquid
- Analytical purity: 98 %
- pH: acidic
- melting point: 7,3

Test animals

Species:
rabbit
Strain:
Vienna White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no volume or weight reported. an application site of 2,5 x 2,5 cm was coverd with liquid
Duration of treatment / exposure:
Experiment 1: 1, 5, or 15 minutes
Experiment 2: 20 h
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: An aerea of 2,5 x 2.5 cm of the flank was exposed
- Type of wrap if used: occlusive dressing


REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the exposure time, the skin was washed with 50% Lutrol in water.
- Time after start of exposure: 20 h

SCORING
- see table below

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
20 h occlusive exposure
Time point:
other: 24 h
Score:
ca. 2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
occlusive exposure 20 h
Time point:
other: 24 h
Score:
ca. 2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
20 h occlusive exposure
Time point:
other: 24
Score:
ca. 0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
20 h occlusive exposure
Time point:
other: 24 h
Score:
ca. 1
Max. score:
4
Reversibility:
fully reversible within: 6 days

Any other information on results incl. tables

Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h and the 15 min exposition will serve as approximation.

Descriptive scores of the raw data have been converted to Draize numerical scores.Erythema scoring was at the border of the necrotic aerea.

Exposition:

20 h

Animal

Reading

Erythema

Edema

Comment

1

24 h

2

1

 

2

24 h

2

0

necrosis

1

48 h

2

1

 

2

48 h

2

0

necrosis

1

72 h

2

1

 

2

72 h

1

0

necrosis

1

8 d

0

0

superficial necrosis squamation

2

8 d

0

0

necrosis squamation

mean

24 - 48 h

2.0

0.5

 

 

 

 

 

 

Exposition:

15 min

Animal

Reading

Erythema

Edema

Comment

1

24 h

2

1

 

2

24 h

2

0

 

1

48 h

2

1

 

2

48 h

2

0

 

1

72 h

2

1

 

2

72 h

1

0

 

1

8 d

0

0

squamation

2

8 d

0

0

squamation

mean

24 - 72 h

2.5

3.25

 

Applicant's summary and conclusion

Executive summary:

Study meets scientific standards with acceptable restrictions (limited documentation, e.g. no details about test substance or applied amount of test substance). 2 rabbits were treated for 1, 5 and 15 minutes and 2 other animals for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened test substance. After the application time, the skin was washed with water which sometimes contained a mild detergent. The animals were observed 8 days and skin changes were recorded on working days. Marked erythema, slight edema and minimal necrotic effects were obseved afte 20 h occlusive exposure. Marked erythema, slight edema but not any necrotic effects were see after 15 min exposure.

Conclusion

The test substance was graded irritating. Minor necrotic effects after 20 h occlusive exposure were judge to be due to the more stringent test procedure in comparisson to a OECD Guideline study.