Stearoyl chloride

Skin irritation / corrosion

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

Test material information

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

Results

Results 1

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

Results 2

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

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

20 h occlusive exposure

Time point:

other: 24

Score:

ca. 0

Max. score:

4

Results 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.