4-chloro-N-methylpiperidine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from J check

Data source

Reference

Reference Type:

other: Authoritative database

Title:

Gene toxicity in vitro study for 1-Methylpiperazine

Author:

Ministry of Health, Labour and Welfare", "Ministry of the Environment" and "National Institute of Technology and Evaluation

Year:

2016

Bibliographic source:

Japan chemicals collborative knowledge database (J-check)

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: As mention below

Principles of method if other than guideline:

Gene mutation toxicity study was performed to evaluate the mutagenic nature of the test compound 1-Methylpiperazine

GLP compliance:

not specified

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-methylpiperazine

EC Number:

203-639-5

EC Name:

1-methylpiperazine

Cas Number:

109-01-3

Molecular formula:

C5H12N2

IUPAC Name:

1-methylpiperazine

Details on test material:

- Name of test material: 1-Methylpiperazine
- Molecular formula: C5H12N2
- Molecular weight: 100.16 g/mol
- Substance type: Organic
- Physical state: No data available
- Purity: No data available
- Impurities (identity and concentrations): No data available

Specific details on test material used for the study:

- Name of test material: 1-Methylpiperazine
- Molecular formula: C5H12N2
- Molecular weight: 100.16 g/mol
- Substance type: Organic

Method

Target gene:

Histidine for S. typhimurium and Tryptophan for E. coli

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A pKM 101

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 metabolic activation system

Test concentrations with justification for top dose:

0,2.29- 5000 µg/plate

Vehicle / solvent:

Water

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

not specified

Positive control substance:

not specified

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: No data
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data

NUMBER OF REPLICATIONS: No data

NUMBER OF CELLS EVALUATED: No data

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data

OTHER: No data

Evaluation criteria:

Increase in the number of revertants was noted

Statistics:

No data available

Results and discussion

Test results

Test results 1

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 98 and E. coli WP2 uvr A pKM 101

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

Test results 2

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

positive

Remarks:

Maximum specific activity: 139 rev/mg (S9mix, TA100, 1667 microg/plate)

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

No data

Remarks on result:

other: No mutagenic effect were observed.

Applicant's summary and conclusion

Conclusions:

The test compound failed to induce mutation in the S. typhimurium TA 1535, TA 1537, TA 98 and E. coli WP2 uvr A pKM 101 and mutagenic activity could be noted in the S. typhimurium TA 100 both in the presence and absence of S9 metabolic activation system.

Executive summary:

Gene mutation toxicity study was performed to evaluate the mutagenic nature of the test compound 1-Methylpiperazine. The study was performed using dose levels of 2.29- 5000µg/plate in S. typhimurium TA 1535, TA 1537, TA 98, TA100 and E. coli WP2 uvr A pKM 101 both in the presence and absence of S9 metabolic activation system.

 

The test compound failed to induce mutation in the S. typhimurium TA 1535, TA 1537, TA 98 and E. coli WP2 uvr A pKM 101 and mutagenic activity could be noted in the S. typhimurium TA 100 both in the presence and absence of S9 metabolic activation system. Hence the substance can not be classified as gene mutant in vitro.