1-Propanol, 3-(dimethylamino)-, hydrochloride (1:1)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

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:

May 1983, revised draft March 1996

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

May 1983, revised draft March 1996

GLP compliance:

yes (incl. QA statement)

Remarks:

Department of Toxicology of BASF AG, 67056 Ludwigshafen/Rhein, Germany

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-dimethylaminopropan-1-ol

EC Number:

221-659-2

EC Name:

3-dimethylaminopropan-1-ol

Cas Number:

3179-63-3

IUPAC Name:

3-(dimethylamino)propan-1-ol

Details on test material:

- Name of the test substance used in the study report: 3-Dimethylamino-propanol-1
- Analytical purity: 99.7 w%
- Physical state: colorless liquid
- Storage condition of test material: room temperature (N2 conditions)

Method

Target gene:

his and trp operon

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254

Test concentrations with justification for top dose:

0, 20, 100, 500, 2500 and 5000 µg/plate (standard plate and preincubation test)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: with S9 mix: 2-aminoanthracene for all strains, without S9 mix: N-methyl-N' -nitro-N-nitrosoguanidine for TA 1535, TA 100, 4-nitro-o-phenylendiamine for TA 98, 9-aminoacridine for TA 1537 and N-ethyl-N'-nitro-N-nitrosoguanidine for E. coli

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation) and preincubation

DURATION
- Preincubation period: 20 min (for preincubation assay)
- Exposure duration: 48 - 72 hours

NUMBER OF REPLICATIONS: triplicates

DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of revertants, clearing or diminution of the background lawn, (= reduced his or trp background growth), reduction in the titer

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 metabolising 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

Remarks:

A weakly bacteriotoxic effect was observed in the preincubation assay from about 2500 µg/plate onward and in the standard plate test at 5000µg/plate.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

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

Remarks:

A weakly bacteriotoxic effect was observed in the preincubation assay from about 2500 µg/plate onward and in the standard plate test at 5000µg/plate.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S-9 mix or after the addition of a metabolising system.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.