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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:
guideline study with acceptable restrictions
Remarks:
pre-GLP, pre-OECD guideline, occlusive exposure for 1, 5, 15 min and 20 h, observation period 8 days.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

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:
Method: BASF-Test: Animals were treated for 1, 5, 15 min and 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time (1, 5, 15 min and 20 hours) the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 h and 72 h from the raw data were taken into account.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Substance name: 1-Methylimidazol (flüssig)
Substance number: XVI/41

Test animals

Species:
rabbit
Strain:
Vienna White

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
1, 5 , 15 min and 20 h
Observation period:
8 d
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm (patch test)

REMOVAL OF TEST SUBSTANCE
- After the application time the skin was washed with Lutrol (50%).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
1 min of exposure
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: scaling (scoring after 8 days not possible)
Irritation parameter:
erythema score
Remarks:
5 min of exposure
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: necrosis (scoring after 8 days not possible), hardening of the skin
Irritation parameter:
erythema score
Remarks:
15 min of exposure
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: severe necrosis (scoring after 8 days not possible)
Irritation parameter:
erythema score
Remarks:
20 h of exposure
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: severe necrosis (scoring after 8 days not possible), scarring of the skin
Irritation parameter:
edema score
Remarks:
1 min of exposure
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
4
Remarks on result:
other: scaling (scoring after 8 days not possible)
Irritation parameter:
edema score
Remarks:
5 min of exposure
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: necrosis (scoring after 8 days not possible), hardening of the skin
Irritation parameter:
edema score
Remarks:
15 min of exposure
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: severe necrosis (scoring after 8 days not possible)
Irritation parameter:
edema score
Remarks:
20 h of exposure
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: severe necrosis (scoring after 8 days not possible), scarring of the skin

Applicant's summary and conclusion

Interpretation of results:
corrosive