4-chloro-1-methylpiperidinium chloride

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

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, 2017

Data source

Reference

Reference Type:

other: J-check

Title:

Gene mutation in vitro toxicity study for 1-methyl-diethylenediamine

Author:

National Institute of Technology and Evaluation

Year:

2017

Bibliographic source:

Japan Chemicals Collaborative Knowledge Database, 2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Bacterial reverse mutation test was performed to determine the mutagenic nature of 1-Methylpiperazine

GLP compliance:

not specified

Type of assay:

bacterial reverse 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: Colorless transparent liquid
- Purity: No data
- Impurities (identity and concentrations): No data

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
- Physical state: Colorless transparent liquid
- Purity: No data
- Impurities (identity and concentrations): No data

Method

Target gene:

Histidine for Salmonella 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

Cytokinesis block (if used):

No data

Metabolic activation:

with

Metabolic activation system:

S9 metabolic activation system

Test concentrations with justification for top dose:

2.29 - 5000 microg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Water was used as vehicle but its role as vehicle control is not mentioned in the reference mentioned
- Justification for choice of solvent/vehicle: The test chemical was soluble in 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

Rationale for test conditions:

No data

Evaluation criteria:

The plates were observed for reversion of mutation

Statistics:

No data

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 potential

Applicant's summary and conclusion

Conclusions:

1-Methylpiperazine did not induce gene mutation in S. typhimurium TA 1535, TA 1537, TA 98 and E. coli WP2 uvr A pKM 101 in the presence and absence of S9 metabolic activation system. It however induced gene mutation in Salmonella typhimurium strain TA100 in the presence and absence of S9 activation system. The details necessary to justify the positive nature is not available and hence the test chemical is not likely to classify as a gene mutant in vitro

Executive summary:

Bacterial reverse mutation test was performed to determine the mutagenic nature of 1-Methylpiperazine. The study was performed as per the preincubation protocol using S. typhimurium TA 1535, TA 1537, TA 98, TA100 and E. coli WP2 uvr A pKM 101 in the presence and absence of S9 metabolic activation system. The test chemical was dissolved in water and used at dose levels of 2.29 - 5000 microg/plate with and without S9. 1-Methylpiperazine did not induce gene mutation in S. typhimurium TA 1535, TA 1537, TA 98 and E. coli WP2 uvr A pKM 101 in the presence and absence of S9 metabolic activation system. It however induced gene mutation in Salmonella typhimurium strain TA100 in the presence and absence of S9 activation system. The details necessary to justify the positive nature is not available and hence the test chemical is not likely to classify as a gene mutant in vitro.