Piperazine, compound with phosphoric acid

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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.

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

Species:

human

Sex:

not specified

Route:

other: no data

Vehicle:

no data

Concentration / amount:

1% piperazine solution

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.

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.

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

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

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

Migrated from Short description of key information:

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. Thus, it is concluded that the chemical piperazine phosphate shall also exhibit positive sensitization property which is supported by the harmonized classification of the CLP regulation

Justification for selection of skin sensitisation endpoint:

Experimental results conducted on humans.

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.

Respiratory sensitisation

Link to relevant study records

Reference

Endpoint:

respiratory sensitisation: in vivo

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Respiratory allergy. Multicase model

GLP compliance:

no

Species:

other: no data

Strain:

not specified

Sex:

not specified

Route of induction exposure:

other: no data

Route of challenge exposure:

other: no data

Vehicle:

not specified

Results:

The substance piperazine compound with phosphoric acid gave positive result for respiratory sensitisation.

Interpretation of results:

sensitising

Conclusions:

The substance piperazine compound with phosphoric acid gave positive result for respiratory sensitisation.

Executive summary:

The substance piperazine compound with phosphoric acid gave positive result for respiratory sensitisation.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

The available data indicates that the chemical piperazine compound with phosphoric acid has skin sensitizing properties as well as respiratory sensitizing properties.

Migrated from Short description of key information:

The substance piperazine compound with phosphoric acid gave positive result for respiratory sensitisation.

Justification for selection of respiratory sensitisation endpoint:

Data is from an authoritative database

Justification for classification or non-classification

The available data indicates that the chemical piperazine compound with phosphoric acid has skin sensitizing properties as well as respiratory sensitizing properties. Thus, the chemical is classified as a Skin sensitizer 1 as well as Respiratory sensitizer 1 to match the harmonized calssifiation within the CLP regulation.