Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

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: Data sheet with overview of serveral studies, no full test report available. However, all relevant information is given. Therefore, the study can be regarded as valid for assessment.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
0.5 ml undiluted liquid was applied to intact and abraded skin of 6 albino rabbits. Erythema and edema were investigated after 24 and 72 h.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Albino

Test system

Type of coverage:
not specified
Preparation of test site:
other: abraded, no further information
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
No data
Observation period:
72 h
Number of animals:
6

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(intact and abraded skin after 24 and 72 h)
Time point:
other: 24 and 72 h
Score:
1.84
Max. score:
8
Reversibility:
no data
Remarks on result:
other: Draize Score

Any other information on results incl. tables

Response

Time of observation

Rabbit No.

1

2

3

4

5

6

Erythema

Intact skin

24 h

2

2

2

2

2

2

Intact skin

72 h

2

1

2

2

2

1

Abraded skin

24 h

2

2

2

2

2

2

Abraded skin

72 h

2

1

2

2

2

1

Edema

Intact skin

24 h

0

0

0

0

0

0

Intact skin

72 h

0

0

0

0

0

0

Abraded skin

24 h

0

0

0

0

0

0

Abraded skin

72 h

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A mean score of. 1.84 (maximum score 8) was observed after 24 and 72 h. Therefore, the substance is not classified as irritating to skin according to EU criteria.
Executive summary:

05. ml of undiluted liquid was applied to intact and abraded skin of 6 albino rabbits. Erythema and edema were investigated after 24 and 72 h. No edema were observed after 24 and 72 h (grade 0). After 24h a grade of 2 (maximum score 8) was assed for erythema both for intact and abraded skin. After 72 h the score was 1.67.