N,N-bis(3-aminopropyl)methylamine

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:

key study

Study period:

1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

March 1996

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Version / remarks:

92/69/EEC (December 1992)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N,N-bis(3-aminopropyl)methylamine

EC Number:

203-336-8

EC Name:

N,N-bis(3-aminopropyl)methylamine

Cas Number:

105-83-9

Molecular formula:

C7H19N3

IUPAC Name:

bis(3-aminopropyl)(methyl)amine

Method

Target gene:

Histidine operon.

Species / strain

Species / strain / cell type:

other: TA 1535, TA 100, TA 1537, TA 98 and E . coli WP2 uvrA

Additional strain / cell type characteristics:

other: All Salmonella typhimurium strains have a defective excision repair system (uvrB) and a a considerably reduced hydrophilic polysaccharide layer (rfa). Strains TA 98 and TA 100 are resistant to antibiotics and modified postreplication DNA repair system.

Metabolic activation:

with and without

Metabolic activation system:

Aroclor-induced rat liver S-9 mix

Test concentrations with justification for top dose:

0, 100, 500, 2500, 5000, 7500 µg/plate (SPT)
0, 4, 20, 100, 500, 2500 µg/plate (PIT )

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: Due to the good solubility of the test substance in water, water was selected as the vehicle .

Controls

Untreated negative controls:

other: sterility control

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: without S9 mix: N-methyl-N'-nitro-N-nitrosoguanidine (TA100, TA1535), 4-nitro-o-phenylendiamine (TA98), 9-aminoacridine (TA1537), N-ethyl-N'-nitro-N-nitrosoguanidin (WP2 uvrA); with S9 mix: 2-aminoanthracene (all strains)

Details on test system and experimental conditions:

1) METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48-72 h at 37°C in the dark
NUMBER OF REPLICATIONS: 3

2) METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min at 37°C
- Exposure duration: 48-72 h at 37°C in the dark
NUMBER OF REPLICATIONS: 3

Evaluation criteria:

The test chemical is considered positive in this assay if the following criteria are met :
• A dose-related and reproducible increase in the number of revertant colonies, i .e . about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system .

A test substance is generally considered nonmutagenic in this test if :
• The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other

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

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS

- Precipitation: No precipitation of the test substance was found .

ADDITIONAL INFORMATION ON CYTOTOXICITY: A bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants, reduction in the titer) was observed in the standard plate test depending on the strain and test conditions from about 2,500 - 5,000 μg/plate onward. In the preincubation assay bacteriotoxicity was observed depending on the strain and test conditions from about 4 μg/plate (TA 100), 20 μg/plate (E . coli), 100 μg/plate (TA 1535) or 500 μg/plate(TA 1537, TA 98) onward.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.