Quinoline, 1,2,3,4-tetrahydro-1-(1-methylpropyl)-

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:

2012

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

8-(butan-2-yl)-5,6,7,8-tetrahydroquinoline

EC Number:

938-871-2

Cas Number:

6613-31-6

Molecular formula:

C13H19N

IUPAC Name:

8-(butan-2-yl)-5,6,7,8-tetrahydroquinoline

Results and discussion

Any other information on results incl. tables

The test item GR-50-0572 was assessed for its potential to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA. The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration and the controls were tested in triplicate. The test item was tested at the following concentrations: Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 Mg/plate Experiment II without S9 mix Salmonella typhimurium: 0.3; 1; 3; 10; 33; 100; 333; and 1000 Mg/plate Escherichia coli: 1; 3; 10; 33; 100; 333; 1000; and 2500 Mg/plate Experiment II with S9 mix: 1; 3; 10; 33; 100; 333; 1000; and 2500 Mg/plate Reduced background growth was observed at the following concentrations (Mg/plate): Strain Experiment I Experiment II without S9 mix with S9 mix without S9 mix with S9 mix TA 1535 100 - 5000 333 - 5000 33 - 1000 333 - 2500 TA 1537 100 - 5000 333 - 5000 33 - 1000 100 - 2500 TA 98 100 - 5000 333 - 5000 33 - 1000 333 - 2500 TA 100 100 - 5000 333 - 5000 33 - 1000 100 - 2500 WP2 uvrA 333 - 5000 1000 - 5000 100 - 2500 333 - 2500 Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups at the following concentrations (Mg/plate): Strain Experiment I Experiment II without S9 mix with S9 mix without S9 mix with S9 mix TA 1535 333 - 5000 333 - 5000 333, 1000 333 - 2500 TA 1537 333 - 5000 1000 - 5000 333, 1000 333 - 2500 TA 98 333 - 5000 1000 - 5000 333, 1000 333 - 2500 TA 100 333 - 5000 1000 - 5000 333, 1000 333 - 2500 WP2 uvrA 1000 - 5000 1000 - 5000 1000, 2500 333 - 2500 No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with GR-50-0572 at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Appropriate reference mutagens were used as positive controls. They showed a distinct increase of induced revertant colonies. In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

In conclusion, it can be stated that during the described mutagenicity test and under the
experimental conditions reported, the test item did not induce gene mutations by base pair
changes or frameshifts in the genome of the strains used.
Therefore, GR-50-0572 is considered to be non-mutagenic in this Salmonella typhimurium
and Escherichia coli reverse mutation assay.

Executive summary:

This study was performed to investigate the potential of GR-50-0572 to induce gene mutations in the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, and TA 100, and the Escherichia coli strain WP2 uvrA. The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations: Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 Mg/plate Experiment II without S9 mix Salmonella typhimurium: 0.3; 1; 3; 10; 33; 100; 333; and 1000 Mg/plate Escherichia coli: 1; 3; 10; 33; 100; 333; 1000; and 2500 Mg/plate Experiment II with S9 mix: 1; 3; 10; 33; 100; 333; 1000; and 2500 Mg/plate The plates incubated with the test item showed reduced background growth with and without metabolic activation in both independent experiments. Distinct toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups with and without metabolic activation in both independent experiments. No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with GR-50-0572 at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.