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)

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records

Reference

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)

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

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

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

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

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'.

Conclusions:

Interpretation of results (migrated information):
negative

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Justification for selection of genetic toxicity endpoint
As only one study can be indicated as key study and as both key study and supporting studies reveal the same result, the first received report was indicated as key study and the second and third ones as supporting studies.