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Toxicological information

Genetic toxicity: in vitro

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 / strainopen allclose all
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 / 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 resultsopen allclose all
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
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.