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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Acceptable, well documented publication/ study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
To determine the irritation potential of the test substance, rabbits were exposed dermally to the test substance for 24 hours under occlusive conditions.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Breeder: W. Ostrop / Meerbusch
The animals were caged single and had "mümmel z" (ssniff / Soest) for diet and water ad libitum.
Temperature 16 - 18 °C, Humidity 40 %
12 h light/12 h dark cycle
Acclimatization period 7 - 14 d.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
500 mg in water
Duration of treatment / exposure:
24 h
Observation period:
8 d
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-72 h
Score:
2.8
Max. score:
4
Reversibility:
other: animals died
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
2.3
Max. score:
3
Reversibility:
other: animals died
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24-72 h
Score:
5.8
Irritant / corrosive response data:
The test substance caused strong erythema and edema after a 24 h treatment. The irritation index of 5.8 gives indication that the substance is strongly irritating to the skin.
Other effects:
72 h after application all animals were dead because of hematuria, splenic congestion, bloody intestine lymph nodes, petechia at the thymus, soaked liver - alltogether, a strong substance-related toxicity was found.

Any other information on results incl. tables

Readings

Animal

Erythema

Edema

Additional findings

24 h

1

4

3

2

2

3

3

2

2

72 h

1

4

3

2

2

2

3

3

1

8 d

1

dead

dead

2

dead

dead

3

dead

dead

Mean

24, 48, 72 h

1

4

3

2

2

2.5

3

2.5

1.5

Mean 24, 48, 72 h

1-3

2.8

2.3

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test substacne caused strong erythema and edema after a 24 h treatment. The irritation index was 5.8.
Executive summary:

To determine the irritation potential of the test substance, rabbits were exposed dermally to the test substance for 24 hours under occlusive conditions. The test substance caused strong erythema and edema after a 24 h treatment. The irritation index of 5.8 gives indication that the substance is strongly irritating to the skin.