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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
Study period:
06. Oct 1965 - 14. Oct 1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Principles of method if other than guideline:
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 and 15 min) 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 animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: male: 2.76 kg (mean), female: 3.01 kg (mean)

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 days
Number of animals:
1 min: 4
5 and 15 min: 6
20 h: 2
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 1x Lutrol and 1x 50% Lutrol
- Time after start of exposure: Immediately after 1, 5 and 15 min exposure.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
1 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Remarks:
5 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1.1
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: bleeding in 3/6 animals
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1.4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: bleeding in 4/6 animals, anemic necrosis at the end of the observation period in 1/6 animal
Irritation parameter:
erythema score
Remarks:
20 h exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: grey-blackish, relocatable necrosis beyond the application area
Irritation parameter:
edema score
Remarks:
1 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
5 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.7
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: bleeding in 3/6 animals
Irritation parameter:
edema score
Remarks:
15 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0.6
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: bleeding in 4/6 animals, anemic necrosis at the end of the observation period in 1/6 animal
Irritation parameter:
edema score
Remarks:
20 h exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: grey-blackish, relocatable necrosis beyond the application area
Irritant / corrosive response data:
At the end of the observation period of 8 days scale and crust formation was noted and in one animal of the 15 min application group anemic necrosis was observed.

Any other information on results incl. tables

Mean erythema score after 24, 48 and 72 h (animal 1/2/3/4/5/6):

Exposure time  24 h  48 h  72 h  mean        
 1 min  2/0/0/0  2/0/0/0  2/0/-/- 2/0/0/0        
 5 min  2/2/1/1/1/0 2/2/1/1/1/0 -/2/1/1/0/-  2/2/1/1/0.6/0        
 15 min  2/2/1/2/2/0  2/2/1/2/2/0  -/2/1/2/0/- 2/2/1/2/1.3/0        
 20 h  3/0  3/0  3/0  3/0        

Mean edema score after 24, 48 and 72 h (animal 1/2/3/4/5/6):

 Exposure time  24 h  48 h  72 h  mean        
 1 min  0/0/0/0  0/0/0/0  0/0/0/0  0/0/0/0        
 5 min  2/0/0/0/2/0  2/0/0/0/2/0  2/0/0/0/2/0  2/0/0/0/2/0        
 15 min  2/2/0/0/0/0  2/2/0/0/0/0  2/0/0/0/0/0  2/1.3/0/0/0/0        
 20 h  3/3  3/3  0/3  2/3        

The test substance caused bleeding after a 5 minute (3/6) or 15 min (4/6) application. At the end of the observation period of 8 days scale and crust formation was noted and in one animal of the 15 min application group anemic necrosis was observed.

The 20 h application led to severe edema and erythema and caused grey-blackish, relocatable necrosis beyond the application area.

The original BASF grading was converted into the numerical grading according the OECD Draize system (according to Grundler, 1983).

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
During the application of the test substance, a 5 minute application period resulted into severe edema and erythema and caused grey-blackish, relocatable necrosis beyond the application. Besides bleeding was observed for 3/6 animals.