Piperazine, compound with phosphoric acid

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In mouse lymphoma test using test solutions containing 200, 250, 300, 350, and 400  µ/L of Piperazine, compound with phosphoric acid, negative results were reported both with and without metabolic activation.

Based on the in-vitro bacterial reverse mutation assay test on Salmonella typhimurium strain TA 1535, TA 1537, TA 98, and TA 100 tested at the concentrations 33, 100, 333, 1,000, or 2,167 μg/plate with and without S9 metabolic activation it was found that Piperazine does not exhibit positive gene mutation effect.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

Mouse lymphoma assay (test)

GLP compliance:

not specified

Type of assay:

mammalian cell gene mutation assay

Species / strain / cell type:

other: mouse lymphoma

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

no data

Test concentrations with justification for top dose:

200, 250, 300, 350, and 400 µ/L

Species / strain:

other: mouse lymphoma

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Conclusions:

Interpretation of results (migrated information):
negative

In mouse lymphoma test using test solutions containing 200, 250, 300, 350, and 400 µ/L of Piperazine, compound with phosphoric acid, negative results were reported both with and without metabolic activation

Executive summary:

In mouse lymphoma test using test solutions containing 200, 250, 300, 350, and 400 µ/L of Piperazine, compound with phosphoric acid, negative results were reported for both with and without metabolic activation Thus the substance was found to be non genotoxic.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

The chemical Piperazine, compound with phosphoric acid, was not found to have genetic toxicity effect. The summary of the various studies used in weight of evidence that supports this fact is presented below

S. No	Experimental system	Effect	Chemical	Source
1	mouse lymphoma	Negative	Piperazine phosphate	Mutation Research/Fundamental and Molecular Mechanisms of Mutagenesis
2	Chinese hamster Ovary (CHO)	Negative	Piperazine phosphate	USEPA High volume program (HPV) report
3	Chinese hamster Ovary (CHO)	Negative	Piperazine phosphate	Danish EPA
4	S. typhimurium TA 1535, TA 1537, TA 98 and TA 1	Negative	Piperazine	Environ. Mut. suppl. 1, 3-142.
5	Chinese hamster Ovary (CHO)	Negative	Piperazine	Report Reckitt and Colman from Huntingdon Research Centre Lt

Justification for classification or non-classification

Based on the data available from various data sources for the target chemical piperazine, compound with phosphoric acid, as well as the read across chemical piperazine, it can be concluded that the chemical piperazine phosphate is not a genetic toxicant.