1-methylpiperazine

Skin irritation / corrosion

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

Test guideline

Qualifier:

no guideline available

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

Test material information

Constituent 1

Reference substance name:

1-methylpiperazine

EC Number:

203-639-5

EC Name:

1-methylpiperazine

Cas Number:

109-01-3

Molecular formula:

C5H12N2

IUPAC Name:

1-methylpiperazine

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 or test system 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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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.

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

Interpretation of results:

study cannot be used for classification

Conclusions:

After 1 min exposure: heavy redness, after 5 min exposure: heavy redness and moderate necrosis, after 15 min exposure: heavy redness and necrosis, and after 20 h exposure: heavy necrosis.