Registration Dossier

Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Review by authorities (EU RAR, 2005)

Data source

Reference
Reference Type:
publication
Title:
European Union Risk Assessment report - Piperazine
Author:
EU RAR
Year:
2005
Bibliographic source:
Institute for Health and Consumer Protection, European Chemicals Bureau, Existing Substances

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Case studies of patients with allergic dermatitis
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Piperazine
EC Number:
203-808-3
EC Name:
Piperazine
Cas Number:
110-85-0
Molecular formula:
C4H10N2
IUPAC Name:
piperazine

Method

Type of population:
other: Both general public after medical treatment and occupational exposure.
Ethical approval:
not applicable
Subjects:
Patients treated with piperazine containing antihelmintics, and people with occupational dermal exposure to piperazine

Results and discussion

Results of examinations:
Several cases of allergic dermatitis after contact with, or treatment with piperazine containing substances have been reported.

Applicant's summary and conclusion

Conclusions:
Piperazine is a dermal sensitiser in humans.
Executive summary:

In the EU Risk Assessment Report for piperazine several case reports of allergic dermatitis havee been documented. The reports concern patients treated with piperazine, or workers exposed to piperazine. It can be concluded that piperazine is a dermal sensitiser in humans.