Cinchocaine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

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

1

Reference substance name:

Cinchocaine

EC Number:

201-632-1

EC Name:

Cinchocaine

Cas Number:

85-79-0

Molecular formula:

C20H29N3O2

IUPAC Name:

2-butoxy-N-[2-(diethylamino)ethyl]quinoline-4-carboxamide

Test material form:

solid: particulate/powder

Method

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):

Salmonella typhimurium TA1535, TA1537, TA1538, TA98 and TA100 were obtained from Professor B.N. Ames, University of California.
Their genotypes have been described previously (Ames et al., 1975).

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Details on mammalian cell type (if applicable):

Escherichia coli WP 2 and WP 2 uvrA, described by Professor B.A. Bridges (1972), were obtained from Dr. M.H.L. Green, University of Sussex

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

the
Test item concentrations in the Initial Mutation Test were 5000, 1581, 500, 158.1, 50, 15.81 and 5 μg/plate
In the Confirmatory Mutation Test the test item concentrationswere 5000, 1581, 500, 158.1, 50, 15.81, 5 and 1.581 μg/plate.

Vehicle / solvent:

Dimethyl sulfoxide (DMSO)

Controls

Negative solvent / vehicle controls:

yes

Remarks:

DMSO and distilled water

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

methylmethanesulfonate

other: 2-aminoanthracene and 4-nitro-1,2-phenylenediamine

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

In the Initial Mutation Test and Confirmatory Mutation Test, the number of revertant colonies did not show any biologically relevant increase compared to the solvent

controls. There were no consistent dose-related trends and no indication of any treatment-related effect.

The mean values of revertant colonies of the negative (vehicle/solvent) control plates were within the historical control range, the reference mutagens showed the expected

increase in the number of revertant colonies, the viability of the bacterial cells was checked by a plating experiment in each test. At least five analyzable concentrations

were presented in all strains of the main tests, the examined concentration range was considered to be adequate. The study was considered to be valid.

The reported data of this mutagenicity assay show that under the experimental conditions applied 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:

In conclusion, the test item BUTOXYAMIDE had no mutagenic activity on the applied bacterial strains under the test conditions used in this study.

Executive summary:

The mutagenic potential of Butoxyamide was performed according to OECD471 guideline. The results show that the test item had no mutagenic activity on the applied bacterial strains under the test conditions used in this study.