γ-methylaziridine-1-propylamine

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:

supporting study

Study period:

1978

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Study was not conducted under GLP conditions. The study was a screening assay and not meant for classification purposes.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

no guideline followed

Guideline:

other: Internal lab protocol: Huntingdon Research Centre Protocol MCB/101

Principles of method if other than guideline:

The study was a bacterial reverse mutation screening assay utilizing S. thyphimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

C4A

IUPAC Name:

C4A

Test material form:

other: Liquid

Details on test material:

- Name of test material (as cited in study report): C4A
- Substance type: Mono-constituent
- Physical state: Not reported
- Analytical purity: Not reported
- Purity test date: Not reported
- Lot/batch No.: Not reported

Method

Target gene:

Hisitidine operon.

Species / strain

Species / strain / cell type:

other: TA 98, TA 100, TA 1535, TA 1537, TA 1538

Metabolic activation:

with and without

Metabolic activation system:

Rat liver S9 mix

Test concentrations with justification for top dose:

0.1, 1, 10, and 100 ug/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: None

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: TA 1535 and 100: beta-naphthylamine, TA 98 and 1538: 2-acetylaminofluorene, TA 1537: Neutral red

Details on test system and experimental conditions:

METHOD OF APPLICATION: Not reported

DURATION
- Preincubation period: Not reported
- Exposure duration: Not reported
- Expression time (cells in growth medium): Not reported
- Selection time (if incubation with a selection agent): Not reported
- Fixation time (start of exposure up to fixation or harvest of cells): Not reported

SELECTION AGENT (mutation assays): Not reported

NUMBER OF CELLS EVALUATED: Not reported

DETERMINATION OF CYTOTOXICITY
- Method: Not reported

Evaluation criteria:

Not reported

Results and discussion

Test results

Species / strain:

other: TA 98, TA 100, TA 1535, TA 1537, TA 1538

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not examined

Positive controls validity:

not specified

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
positive

Based on the results of the study, the test article was mutagenic in the Bacterial Reverse Mutation Assay in the presence and absence of metabolic activation.

Executive summary:

The mutagenic potential of the test article (CASRN 74993-03-6, Appearance, purity and batch not reported) was evaluated in the Bacterial Reverse Mutation Assay with S. thyphimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 in the presence and absence of a metabolic activation system (S9 mix).  The study was not GLP compliant. The test method was based on Huntingdon Research Centre Protocol MCB/101.  The test article (solvent not listed) was dosed at 0.1, 1, 10, and 100 ug/plate. Separate experiments were performed in the presence and absence of metabolic activation. Strain specific positive controls and vehicle controls were tested in parallel. The test article produced a 1 0 -270 -fold, dose related increase of control values in the number of revertant colonies in tester strains TA 1535, TA 98, and TA 100 in the presence and absence of metabolic activation. There was no increase in revertant colonies in treated TA 1537 and TA 1538 strains in the presence and absence of metabolic activation.  Based on the results of the study, the test article was mutagenic in the Bacterial Reverse Mutation Assay in the presence and absence of metabolic activation.