[2-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxoallyl]oxy]ethyl][3-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxoallyl]oxy]propyl]dimethylammonium chloride

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (non-GLP, E. coli or S.typhimurium strain TA 102 missing).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

non-GLP, E.Coli or S.typhimurium strain TA 102 missing

GLP compliance:

no

Remarks:

pre-GLP

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

preparation containing CAS 78181-99-4

IUPAC Name:

preparation containing CAS 78181-99-4

Details on test material:

Please refer to confidential details on test material

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 1535, TA 100, TA 1537, TA 1538, TA 98

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S-9 mix

Test concentrations with justification for top dose:

20, 100, 500, 1000, 2500, 5000 µg/plate

Vehicle / solvent:

- Vehicle/solvent used: acetone

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Remarks:

W/o S-9: 5 µg N-methyl-N'-nitro-N-nitroso-guanidine (strains TA 100, TA 98, TA 1535), 10 µg 4-nitro-o-phenylenediamine (strain TA 1538), 100 µg 9-aminoacridine chloride monohydrate (strain TA 1537); W/ S-9: 10 µg 2-aminoanthracene (all strains)

Details on test system and experimental conditions:

METHOD: standard plate test

DURATION
- Exposure duration: 48 hours

NUMBER OF REPLICATIONS:
3 experiments, 4 plates per dose or per control

DETERMINATION OF CYTOTOXICITY
- Method: his- background growth, reduction in number of bacterial colonies

Evaluation criteria:

In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results

Results and discussion

Test results

Species / strain:

S. typhimurium, other:

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

≥ 2500 µg/plate with and without metabolic activation

Vehicle 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