3-methoxypropylamine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 January 1982 - 21 January 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Very abnormal lawn and pindat colonies observed at the highest test concentration (10000 µg/mL).

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-methoxypropylamine

EC Number:

226-241-3

EC Name:

3-methoxypropylamine

Cas Number:

5332-73-0

Molecular formula:

C4H11NO

IUPAC Name:

3-methoxypropan-1-amine

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): 4236-45-35, Order J-89
- Substance type: clear colorless liquid
- Physical state: liquid
- Analytical purity: responsibility of the Sponsor
- Lot/batch No.: # J-89
- Other: miscible in distilled water
- Stability: there was no apparent change in the physical state of the test or control articles during the assay.

Method

Target gene:

Histidine gene

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 applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Details on mammalian cell type (if applicable):

not applicable

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Arcolor 1254-treated Sprague Dawley rat S9 liver homogenate

Test concentrations with justification for top dose:

10.000, 3333, 1000, 333 and 100 µg/plate

Vehicle / solvent:

solvent(s) used: distilled water

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

without metabolic activation: 1 µg/plate for strains TA 1535 and TA100

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

without metabolic activation: 150 µg/plate for TA1537

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

without metabolic activation: 5 µg/plate for strains TA1538 and TA98

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene: 5 µg/plate for all strains

Remarks:

with metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48-72h

NUMBER OF REPLICATIONS:
negative and positive controls: in triplicate
compound-treated plates: in duplicate

DETERMINATION OF CYTOTOXICITY
- Method: growth inhibition is tested at following concentration: 33.3, 10, 3.3 and 1 mg/mL with strains TA1538 and TA100 ( in duplicate)

Evaluation criteria:

- positive result is defined as a reproducible, dose-related increase in the number of histidine-independent colonies.
- negative result is defined as the absence of a reproducible increase in the number of histidine-independent colonies

Statistics:

not applicable

Results and discussion

Test results

Test results 1

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 10000 µg/mL

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 10000 µg/mL

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES: screening study showed cytotoxicity at 10000 ug/plate: abnormal lawn was observed with sparse growth.

COMPARISON WITH HISTORICAL CONTROL DATA: all solvent and positive controls used in the evaluation of the test article were within the acceptable range of mean historical data.

Remarks on result:

other: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:

Interpretation of results:
negative

The substance showed no mutagenic effects in S. typhimurium tester strains both with and without metabolic activation.