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EC number: 217-775-8 | CAS number: 1951-97-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Piperazine (CAS No 110-85-0) is the parent molecule from which piperazine, compound with phosphoric acid or piperazine phosphate (CAS No 1951-97-9) is synthesized. In medicine piperazine is used in the form of the hexahydrate or as the citrate, tartrate, phosphate (1951-97-9) or adipate. Thus, piperazine and piperazine phosphate can be considered as belonging to the same category.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Results of patch testing with a special series of rubber allergens.
- Author:
- Holness and Nethercott
- Year:
- 1 997
- Bibliographic source:
- Contact Dermatitis 36, 207-211.
- Reference Type:
- other: study report
- Title:
- European Union Risk Assessment Report : Piperazine
- Author:
- European Chemicals Bureau
- Year:
- 2 005
- Bibliographic source:
- 3rd Priority List Volume: 56;Final Report, 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Version / remarks:
- Patch-Test
- Principles of method if other than guideline:
- Patch-Test
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Piperazine
- EC Number:
- 203-808-3
- EC Name:
- Piperazine
- Cas Number:
- 110-85-0
- IUPAC Name:
- piperazine
Constituent 1
In vivo test system
Test animals
- Species:
- human
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: no data
- Vehicle:
- no data
- Concentration / amount:
- 1% piperazine solution
Challengeopen allclose all
- Route:
- other: no data
- Vehicle:
- no data
- Concentration / amount:
- 1% piperazine solution
- No. of animals per dose:
- 93 humans
- Details on study design:
- Patch testing of a 1% piperazine solution on 93 patients on a clinic revealed 3.2% positive allergic reactions. The test strip was applied on the subject’s back and left in place for 2 or 3 days. Readings of reactions took place immediately after removing and 2-3 days later.
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 3
- Total no. in group:
- 93
- Clinical observations:
- positive allergic reactions was observed
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 1%. No with. + reactions: 3.0. Total no. in groups: 93.0. Clinical observations: positive allergic reactions was observed.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Patch testing of a 1% piperazine solution on 93 patients on a clinic revealed 3.2% positive allergic reactions.Thus piperazine was found to be sensitising on human skin.
- Executive summary:
Patch testing of a 1% piperazine solution on 93 patients on a clinic revealed 3.2% positive allergic reactions.Thus piperazine was found to be sensitising on human skin. Since the experimental results for the parent compound indicate skin sensitization and the prediction result is negative, it is concluded that piperazine phosphate shall also be sensitizing. The harmonized classification of piperazine phosphate also supports the below weight of evidence.
The summary of the skin sensitization study is presented below:
S. No
Result
Species
Source of data
1
positive allergic reactions observed
Humans
Contact Dermatitis 36, 207-211, 1997
2
positive sensitization reactions observed
Mouse
European Union Risk Assessment Report : Piperazine
3
Not sensitizing
Human
QSAR predictions by Danish Environmental Protection Agency (EPA)model
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