Heptylamine

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:

1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Heptylamine

EC Number:

203-895-8

EC Name:

Heptylamine

Cas Number:

111-68-2

Molecular formula:

C7H17N

IUPAC Name:

heptan-1-amine

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): N-heptylamine
- Physical state: colorless liquid
- Analytical purity: 99.04%
- Purity test date: 1989-09-07
- Lot/batch No.: 8905P0172

Method

Target gene:

Histidine operon

Species / strain

Species / strain / cell type:

S. typhimurium, other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver S9

Test concentrations with justification for top dose:

50, 100, 500, 1000, 2500, 5000 and 10000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: no data

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO, solvent

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

other: 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours

DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of colonies per plate/control groups

Evaluation criteria:

Evaluation criteria:
- Number of the revertant His+ colonies per plate increased at least two fold compared to the negative/vehicle control
- Dose-response relationhip
- Reproductibility

Statistics:

No data

Results and discussion

Test results

Species / strain:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Cytotoxicity from 1000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

RANGE-FINDING/SCREENING STUDIES:
-Two strains studied: 1000, 5000 and 10000 µg/plate for TA98; 100, 500, 1000 and 5000 µg/plate for TA100.
-Triplicate assays

COMPARISON WITH HISTORICAL CONTROL DATA: no

ADDITIONAL INFORMATION ON CYTOTOXICITY: Without metabolic activation, concentrations up to 1000 µg/plate caused an important cytotoxicity on TA98 and TA100 strains. With metabolic activation, only concentrations of 5000 and 10000 µg/plate were toxic on TA98 and concentration of 5000µg/plate on TA100.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Results of the two studies confirm the absence of genotoxicity for the test item N-heptylamine at the higher concentration of 2500 µg/plate and at the lesser concentrations, with and without metabolic activation.

Executive summary:

The potential of the test item N-heptylamine to induce reverse mutation in Salmonella typhimurium (strains: TA 1535, TA 1537, TA 1538, TA 98 and TA 100) was evaluated in accordance with the international guidelines (OECD 471, Commission Directive No. B13/14) in compliance with the Principles of Good Laboratory Practice.

The test item was tested in two independent experiments, with and without a metabolic activation system, both performed according to preincubation method. Bacterias were exposed to the test item at five dose-levels (three plates/dose-level) selected from a preliminary toxicity test: 50, 100, 500, 1000 and 5000µg/plate. After 48 of incubation at 37°C, the revertant colonies were scored.

 

The test item did not induce any noteworthy increase in the number of revertants, both with and without S9 mix, in any of the five strains.

Under our experimental conditions, N-heptylamine did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.