[No public or meaningful name is available]

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

[4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene]diethylammonium chloride

EC Number:

219-231-5

EC Name:

[4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene]diethylammonium chloride

Cas Number:

2390-59-2

Molecular formula:

C31H42N3.Cl

Method

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:

Aroclor-induced rat liver S-9 mix

Test concentrations with justification for top dose:

SPT: 5-1000 µg/plate; PIT: 5-80 µg/plate

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Remarks:

with S-9 mix: 2.5 µg 2-AA for all strains; without S-9 mix: 5 µg MNNG for strains TA 100 and TA 1535; 10 µg NPD for strain TA 98; 100 µg AAC for strain TA 1537

Details on test system and experimental conditions:

The test substance was tested for its mutagenic potential based on the ability to induce back mutations in selected loci in several strains of Salmonella typhimurium in the Ames test. Both standard plate test (SPT) and preincubation test (PIT) were performed with and without metabolic activation (Aroclor induced-rat liver S-9 mix).

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:

other: SPT: >= 80 µg/plate; PIT: >= 5 µg-10 µg/plate

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:

other: SPT: >= 80 µg/plate; PIT: >= 5 µg-10 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

other: not tested

Cytotoxicity / choice of top concentrations:

other: not tested

Test results 4

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: SPT: >= 80 µg/plate; PIT: >= 5 µg-10 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 5

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: SPT: >= 80 µg/plate; PIT: >= 5 µg-10 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Toxicity: a bacteriotoxic effect (reduced his- background growth, decrease in the number of his+ revertants) was observed in the standard plate test at doses >= 80 µg/plate. In the preincubation assay bacteriotoxicity was observed depending on the strain and test conditions from about 5 µg – 10 µg/plate onward.

Mutagenicity: an increase in the number of his+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolizing system. According to the results of this study, the test substance is not mutagenic in the Ames test under the test conditions chosen.

Applicant's summary and conclusion

Conclusions:

Under the experimental conditions the substance does not show mutagenic effect.

Executive summary:

The substance was tested following OECD 471 for its mutagenic potential based on the ability to induce back mutations in selected loci in several strains of Salmonella typhimurium (TA 1535, TA 1537, TA 98 and TA 100). Both a standard plate test (SPT, 5-1000 µg/plate) and preincubation test (PIT, 5-80 µg/plate) were performed with and without metabolic activation (Aroclor induced-rat liver S-9 mix).

Toxicity: a bacteriotoxic effect (reduced his- background growth, decrease in the number of his+ revertants) was observed in the standard plate test at doses >= 80 µg/plate. In the preincubation assay bacteriotoxicity was observed depending on the strain and test conditions from about 5-10 µg/plate onward.

Mutagenicity: an increase in the number of his+ revertants was not observed both in the standard plate test and in the preincubation test either without S-9 mix or after the addition of a metabolising system.

According to the results of this study, the test substance is not mutagenic in the Ames test under the test conditions chosen.