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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:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.