Tripiperazine dicitrate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Piperazine (CAS No 110-85-0) is the parent molecule from which piperazine citrate has been prepared.

Data source

Reference

Reference Type:

secondary source

Title:

European Union Risk Assessment Report: Piperazine

Author:

European Chemicals Bureau

Year:

2005

Bibliographic source:

European Union Risk Assessment Report – PIPERAZINE, 3rd Priority List Volume: 56;Final Report, 2005; EUR 21642 EN

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Skin irritation test was conducted in white rabbits for test chemical Piperazine according to OECD Test Guideline 404.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Piperazine

EC Number:

203-808-3

EC Name:

Piperazine

Cas Number:

110-85-0

Molecular formula:

C4H10N2

IUPAC Name:

Piperazine

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report): Piperazine- Molecular formula : C4H10N2- Molecular weight : 86.137 g/mole- Substance type:Organic- Physical state: Solid

Test animals

Species:

rabbit

Strain:

other: Weisser Wiener

Details on test animals or test system and environmental conditions:

Sex: Male and female- Housing: kept individually

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

500 mg (50% aqueous solution )

Duration of treatment / exposure:

4 hours

Observation period:

after 30-60 minutes, 24, 48 and 72 hours

Number of animals:

3 (2 males and 1 female)

Details on study design:

- Area of exposure: 6.25 cm2- Type of wrap if used: Gauze patchThe fur was removed by close clipping at least 15 hours pre dosing.

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 48 and 72 hours

Remarks on result:

other: Severe erythema and necrosis was observed in all animals

Irritant / corrosive response data:

Severe erythema and necrosis was observed in all animals.Strongly irritating to the skin

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test chemical Piperazine (CAS No: 110-85-0) was observed to be irritating on skin of rabbits.

Executive summary:

Skin irritation study was carried out in 3 (2 males and 1 female)Weisser Wienerwhite rabbits for test chemical Piperazine (CAS No: 110-85-0) according to OECD Guideline 404 to assess its irritation potential.

 

The rabbits were kept individually and the fur was removed by close clipping at least 15 hours pre dosing. About 500mg of piperazine in a 50% aqueous solution (assumingly piperazine base) was applied to a 6.25 cm2 gauze patch and applied to the skin and covered with a semi-occlusive dressing. After exposure for 4 hours, the test substance was removed, and the skin reaction evaluated after 30-60 minutes, 24, 48 and 72 hours, respectively. Observations at 48 and 72 hours revealedSevere erythema and necrosis in all animals. Hence the test chemical Piperazine (CAS No: 110-85-0) was considered as a strong skin irritant.