Tripiperazine dicitrate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journal

Data source

Reference

Reference Type:

publication

Title:

Occupational asthma due to piperazine citrate (Case Report)

Author:

S. Quirce, R. Pelta, J. Sastre

Year:

2006

Bibliographic source:

J Investig Allergol Clin Immunol 2006; Vol. 16(2): 138-139

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

Skin sensitization study of Piperazine citrate was conducted by using Skin prick test on a 42-year-old woman.

GLP compliance:

not specified

Type of study:

other: Skin prick test

Justification for non-LLNA method:

Skin sensitization study of Piperazine citrate was conducted by using Skin prick test on a 42-year-old woman following the observed occupational effects.

Test material

Test material information

Constituent 1

Reference substance name:

Tripiperazine dicitrate

EC Number:

205-622-8

EC Name:

Tripiperazine dicitrate

Cas Number:

144-29-6

Molecular formula:

C6H8O7.3/2C4H10N2

IUPAC Name:

piperazine 2-hydroxypropane-1,2,3-tricarboxylate (3:2) (salt)

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Piperazine citrate - Molecular formula: C12H30N6•Cl2H16O14 - Molecular weight: 642.76 g/mole - Substance type: Organic - Physical state: Solid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Piperazine citrate - Molecular formula: C12H30N6•Cl2H16O14 - Molecular weight: 642.76 g/mole - Substance type: Organic - Physical state: Solid

In vivo test system

Test animals

Species:

human

Strain:

other: not applicable

Sex:

female

Details on test animals and environmental conditions:

- Age at study initiation: 42-year-old

Study design: in vivo (non-LLNA)

Induction

Route:

other: inhalation

Vehicle:

other: air

Concentration / amount:

0 mg/ml, 10 mg/ml

Adequacy of induction:

not specified

Challenge

Adequacy of challenge:

not specified

No. of animals per dose:

0 mg/ml: 5 10 mg/ml : 1 female woman

Details on study design:

No data available

Challenge controls:

No data available

Positive control substance(s):

not specified

Results and discussion

Positive control results:

No data available

In vivo (non-LLNA)

Results

Key result

Reading:

1st reading

Group:

test chemical

Dose level:

10 mg/ml

No. with + reactions:

1

Total no. in group:

1

Clinical observations:

5 mm wheal

Remarks on result:

other: Reading: 1st reading. Group: test group. Dose level: 10 mg/ml . No with. + reactions: 1.0. Total no. in groups: 1.0. Clinical observations: 5 mm wheal.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Conclusions:

Piperazine citrate when exposed at a concentration of 10 mg/ml to the skin of 42-yr-old woman showed 5 mm wheal and is positive for skin sensitization. Thus Piperazine citrate can be classified as skin sensitising under category 1 as per CLP classification criteria.

Executive summary:

Skin sensitization test of Piperazine citrate was conducted on a 42-year-old woman by using Skin prick test following the observed occupational effects.. A 42-yr-old woman was exposed with the test compound Piperazine citrate at a concentration of 10 mg/ml produced which produce 5 mm wheal in the patient. Since the women showed positive skin senitization reaction for Piperazine citrate, it is considered to be classified as skin sensitising under category 1 as per CLP classification criteria.