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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:
other: Acceptable, well documented study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1961
Report Date:
1961

Materials and methods

Principles of method if other than guideline:
Internal BASF method was used
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.43, 2.37 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 1 ml
- Concentration (if solution): 80%
Duration of treatment / exposure:
1, 5, 15 min, 20 h
Observation period:
3 d
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: back of animal; 2.5 x 2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 20 h


SCORING SYSTEM:
Gradings for erythema and edema scoring could be converted to numerical grading system acc. to Draize:
0 = no symptom - questionable
1 = slight
2 = marked
>= 3 = severe

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: for 1min to 20 h applictions
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: for 1min to 20 h applictions

Any other information on results incl. tables

Results:

Exposure period: 1 min Exposure period: 5 min Exposure period: 15 min Exposure period: 20 h
Readings Animal Erythema Edema Additional findings Erythema Edema Additional findings Erythema Edema Additional findings Erythema Edema Additional findings
1h 1 0 0   0 0   0 0   0 0  
2 0 0   0 0   0 0   0 0
24 h 1 0 0   0 0   0 0   0 0  
2 0 0   0 0   0 0   0 0  
48 h 1 0 0   0 0   0 0   0 0  
2 0 0   0 0   0 0   0 0  
72 h 1 0 0   0 0   0 0   0 0  
2 0 0   0 0   0 0   0 0  
8 d 1 0 0   0 0   0 0   0 0  
2 0 0   0 0   0 0   0 0  
Mean 24 - 72 h 1 0 0   0 0   0 0   0 0  
2 0 0   0 0   0 0   0 0  
Mean   0 0   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