1H-Benz[e]indolium, 2-[2-[2-chloro-3-[2-(1,3-dihydro-1,1,3-trimethyl-2H-benz[e]indol-2-ylidene)ethylidene]-1-cyclohexen-1-yl]ethenyl]-1,1,3-trimethyl-, 4-methylbenzenesulfonate (1:1)

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

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

420-680-6

EC Name:

-

Cas Number:

134127-48-3

Molecular formula:

C47 H47 Cl N2 O3 S

IUPAC Name:

2-{2-[2-chloro-3-(2-{1,3,3-trimethyl-1H,2H,3H-benzo[g]indol-2-ylidene}ethylidene)cyclohex-1-en-1-yl]ethenyl}-1,1,3-trimethyl-1H-benzo[e]indol-3-ium 4-methylbenzene-1-sulfonate

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Additional strain / cell type characteristics:

other: histidine mutations: hisC3076, hisD3052/plasmid pKM101, hisG46, hisG46/plasmid pKM101, Trp

Metabolic activation:

with and without

Metabolic activation system:

S9-fraction

Test concentrations with justification for top dose:

Dose range finding: tested up to concentrations of 5000µg/plate in the absence and presence of S9-mix, resulted in precipitations at 333µg/plate and toxicity in TA100
Main study (first and second mutation assay): 3, 10, 33, 100 and 333µg/plate in the absence and presence of S9-mix

Vehicle / solvent:

dimethyl sulfoxide

Controls

Untreated negative controls:

yes

Remarks:

dimethyl sulfoxide

Negative solvent / vehicle controls:

yes

Remarks:

dimethyl sulfoxide

Positive controls:

yes

Remarks:

see positive control substances below

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

sodium azide

methylmethanesulfonate

other: daunomycine; 2-aminoanthracene

Remarks:

The chemical used for positive control depends on the strain and the absence/presence of S9

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

all strains, both in the presence and absence of the S9-metabolic activation

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

precipitation at 333µg/plate; cytotoxicity only in TA1537, TA98 and TA100

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