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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (non-GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
6 animals used, no analytical purity of test substance reported, only readings at 24 and 72 hours
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped/abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test substance was applied to each test site.

Duration of treatment / exposure:
4 h
Observation period:
observation after 4, 24, and 72 h
Number of animals:
6 rabbits
Details on study design:
TEST SITE
- Area of exposure: Two test sides located lateral to the midline of the back (approx. 10 cm apart) were selected. One of the two sites was abraded, while the other test site remained intact.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean of readings at
Time point:
other: 24, 48 and 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: intact skin, 48 h-value extrapolated from 24 h-value
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
mean of readings at
Time point:
other: 24,48 and 72 h
Score:
1
Max. score:
4
Reversibility:
other: no data
Remarks on result:
other: intact skin, 48 h-value extrapolated from 24 h-value
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of the remaining 4 animals and mean of readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin, 48 h-value extrapolated from 24 h-value
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals and mean of readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: intact skin, 48 h-value extrapolated from 24 h-value

Any other information on results incl. tables

Table 1: Irritation Scores, abraded skin

Animal #

4 h

24 h

48 h*

72 h

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

1

1

0

1

0

1

0

0

0

2

2

0

0

0

0

0

0

0

3

2

0

0

0

0

0

0

0

4

2

0

0

0

0

0

0

0

5

1

0

1

0

1

0

1

0

6

2

0

0

0

0

0

0

0

*No 48 h values were obtained in the study. The 48 h-values are extrapolated from the 24 h-value (worst case) for the calculation of the mean values relevant for classification.

 

 

 

Table 2: Irritation Scores, intact skin 

Animal #

4 h

24 h

48 h*

72 h

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

1

1

0

1

0

1

0

0

0

2

1

0

0

0

0

0

0

0

3

1

0

0

0

0

0

0

0

4

1

0

0

0

0

0

0

0

5

0

0

0

0

0

0

0

0

6

1

0

0

0

0

0

0

0

*No 48 h values were obtained in the study. The 48 h-values are extrapolated from the 24 h-value (worst case) for the calculation of the mean values relevant for classification.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU