16,17-dimethoxyviolanthrene-5,10-dione

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

only four strains used

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

16,17-dimethoxyviolanthrene-5,10-dione

EC Number:

204-896-6

EC Name:

16,17-dimethoxyviolanthrene-5,10-dione

Cas Number:

128-58-5

Molecular formula:

C36H20O4

IUPAC Name:

16,17-dimethoxyviolanthrene-5,10-dione

Test material form:

solid: particulate/powder

Details on test material:

Name of test substance: Vat Green 1, purified (ETAD T 2015-38)

Method

Target gene:

Salmonella typhimurium histidine (his) reversion system

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix (Rat liver enzymes)

Test concentrations with justification for top dose:

0, 20, 100, 500, 2500, 5000 and 10000 µg/plate

Vehicle / solvent:

DMSO

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

other: N-methyl-N'-nitro-N-nitroso-guanidine (MNNG) - TA 100 And TA 1535; 4-nitro-o-phenylenediamine - TA 98

Remarks:

without S9-mix

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

with S9-mix

Details on test system and experimental conditions:

The test substance was tested in the standard plate test with and without S-9 mix in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at

I. 0, 20, 100, 500, 2500, 5000 and 10000 µg/plate
II. 0, 100, 500, 2500, 5000 and 10000 µg/plate


The test substance was dissolved in DMSO and every concentration was tested in triplicate.

Evaluation criteria:

- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Incomplete solubility of the test substance in DMSO from 500 µg/plate onwards

Applicant's summary and conclusion

Conclusions:

The test item was not mutagenic in the bacteria reverse mutation assay

Executive summary:

The test item was tested in the standard plate incorporation test in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at concentrations from 20 to 10000 µg/plate both in the presence and absence of metabolic activation. An increase in the number of revertant colonies could not be observed up to the highest dose of 10000 µg/plate. Vat Green 1, purified is thus not mutagenic in the Ames test under the experimental conditions chosen.