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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:
14. Nov 1967 - 23. Nov 1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Principles of method if other than guideline:
Method: BASF-Test.
Two animals were treated for 1, 5, 15 min 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) the skin was washed with Lutrol (conc.) and Lutrol/water (1:1). 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 and 72 hours from the raw data were taken into account.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Monomethylpiperazin
- Analytical purity: 99 %

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.43 and 3.93 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Duration of treatment / exposure:
1, 5 and 15 min and 20 h.
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol (conc.) and Lutrol/water (1:1).
- Time after start of exposure: 1, 5 and 15 min post application

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
1 min exposure
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
I min exposure
Basis:
mean
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
> 4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
probability of severe irritation
Remarks:
Necrosis
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
> 4
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
probability of severe irritation
Remarks:
Necrosis
Irritant / corrosive response data:
1 min exposure: heavy redness
5 min exposure: heavy redness and moderate necrosis.
15 min exposure: heavy redness and necrosis.
20 h exposure: heavy necrosis and necrosis.

Any other information on results incl. tables

Mean erythema/necrosis score after 24, 48 and 72 h (animal1/2)

 Exposure time  24 h  48 h  72 h  
 1 min 3/3 3/3 3/3  
 5 min 3/N+ N+/N+ N+/N+  
 15 min N+/N++ N+/N++ N+/N++
 20 h N++/N++ N++/N++ N++/N++

The original BASF grading was converted into the numerical grading according the OECD Draize system.

N+: parchment-like necrosis.

N++: hart, leathery necrosis.

The application of the test substance caused necrosis to the exposed skin.

Applicant's summary and conclusion