Reaction mass of 2-Piperazin-1-ylethanol and Piperazine-1,4-diethanol and Piperazine

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data taken from EU risk assessment of piperazine. Piperazine is one constituent (ca. 15%) of the test substance.

Data source

Reference

Reference Type:

publication

Title:

Study to evaluate the potential to induce micronuclei in the bone marrow of treated mice

Author:

Marshall, R.R.

Year:

1987

Bibliographic source:

Cited in the EC Risk Assessment Report for Piperazine, vol. 56, 2005

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

In accordance with Salamone, Heddle Stuart, Katz, Mutat. Res., 74, 347 - 356, 1980

GLP compliance:

yes

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

Piperazinium dihydrogen phosphate

EC Number:

238-572-0

EC Name:

Piperazinium dihydrogen phosphate

Cas Number:

14538-56-8

IUPAC Name:

piperazin-1-ium dihydrogen phosphate

Details on test material:

- Name of test material (as cited in study report): piperazine phosphate
- The piperazine content ist 42%.

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male/female

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

Carboxymethylcellulose in distilled water

Duration of treatment / exposure:

single dose

Frequency of treatment:

single dose

Post exposure period:

24, 48 and 72 h

Doses / concentrations

Remarks:

Doses / Concentrations:
5000 mg/kg bw
Basis:
actual ingested

No. of animals per sex per dose:

2 mice /sex

Control animals:

yes, concurrent vehicle

Positive control(s):

Cyclophosphamide oral administration at 80 mg/kg bw to 5 male and 5 female mice.

Examinations

Tissues and cell types examined:

erythrocytes from bone marrow

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

yes

Vehicle controls validity:

valid

Negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

Mice treated with piperazine phosphate exhibited ratios of polychromatic erythrocytes (PCE) to normochromatic erythrocyte (NCE), and frequencies of micronucleated PCE and NCE which were similar to negative controls.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
Piperazine phosphate did not induce micronuclei in the polychromatic or normochromatic erythrocytes of the bone marrow of mice administered at 5000 mg/kg bw.

Executive summary:

In a micronucleus assay CD-1 mice were dosed orally with 5000 mg piperazine phosphate per kg bodyweight. No significant increase in the level of micronuclei of polychromatic or normochromatic erythrocytes of the bone marrow could be detected.