2-(4-bromo-3-hydroxy-2-quinolyl)-1H-indene-1,3(2H)-dione

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

other: read across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study under GLP condition

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according 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:

3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one

EC Number:

241-753-7

EC Name:

3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one

Cas Number:

17772-51-9

Molecular formula:

C18H11NO3

IUPAC Name:

3-hydroxy-2-(3-hydroxyquinolin-2-yl)-1H-inden-1-one

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Additional strain / cell type characteristics:

other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

S9-mix was prepared from livers of at ieast six adult male Sprague Dawley rats induced with Aroclor 1254 five days prior to sacrifice

Test concentrations with justification for top dose:

0, 5000, 1581, 500, 158, 50, 16µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

sodium azide

cumene hydroperoxide

other: nitrofurantoin, 4-nitro-1,2-phenylene diamine, 2-aminoanthracene

Details on test system and experimental conditions:

plate incorporation methodology and pre-incubation methodology were used

Evaluation criteria:

A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result. For TA1535, TA100, and TA98this increase should be about twice that of the negative contros. whereas for TA1537 at least a threefold increase should be reached. For Ta103 an increase avout 250 mutants should be reached . Otherwise the result is evaluated as negative.

Statistics:

no data

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: Mo inhibition of growth was noted; at 1581 µg/plate the substance started to precipitate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Executive summary:

Similar substance 1 was examined for point mutations in bacteria using the Ames test according to OECD TG 471 under GLP conditions. Incubation metholology and the plate incorporation metholology were used each with 5 strains ( S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102) and concentrations up to 5000 µg/plate in the presence and absence of a metabolic activation system. No inhibition of growth was observed, the substance precipitation occurred at the dose of 1581 µg/plate and above. Evidence of mutagenic activity was not seen. No biologically relevant increase in the mutant count in comparison with the negative controls was observed.

Therefore, under the conditions of this assay, the tested substance was considered to be non-mutagenic without and with S9 mix in the plate incorpration as well as in the preincubation modification of the Salmonella/microsone test.