[No public or meaningful name is available]

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:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

adopted July 21, 1997

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:

benzene, 1,4-bis[2-[3,5-dimethoxy-4-(1- methylpropoxy)phenyl]ethenyl]-

Cas Number:

586410-55-1

Molecular formula:

C34 H42 O6

IUPAC Name:

benzene, 1,4-bis[2-[3,5-dimethoxy-4-(1- methylpropoxy)phenyl]ethenyl]-

Details on test material:

Read-across from CASRN586410-55-1 to the substance defined in section 1 allowed by belgian authority.

Method

Target gene:

histidine-requiring Salmonella typhimurium TA98, TA100, TA1535 and TA1537
tryptophan-requiring Escherichia coli WP2uvrA

Species / strain

Species / strain 1

Species / strain / cell type:

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

Additional strain / cell type characteristics:

other: histidine-requiring

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Additional strain / cell type characteristics:

other: tryptophan-requiring

Metabolic activation:

with and without

Metabolic activation system:

S9 liver homogenate from rat treated with Aroclor 1254.

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 3 ... 333 µg/plate
Concentration range in the main test (without metabolic activation): 3 ... 333 µg/plate

Vehicle / solvent:

Dimethyl sulfoxide (test substance suspended in dimethyl sulfoxide at 33mg/ml and higher, or dissolved at 10mg/ml and lower)

Controls

Controls 1

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

positive control for strain TA1535 without metabolic activation

Migrated to IUCLID6: dissolved in saline

Controls 2

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

positive control for strain TA1537 without metabolic activation

Migrated to IUCLID6: dissolved in water

Controls 3

Positive controls:

yes

Positive control substance:

other: daunomycin dissolved in saline

Remarks:

positive control for strain TA98 without metabolic activation

Controls 4

Positive controls:

yes

Positive control substance:

methylmethanesulfonate

Remarks:

positive control for strain TA100 without metabolic activation

Migrated to IUCLID6: dissolved in dimethyl sulfoxide

Controls 5

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

Remarks:

positive control for strain WP2uvrA without metabolic activation

Migrated to IUCLID6: dissolved in dimethyl sulfoxide

Controls 6

Positive control substance:

other: 2-aminoanthracene dissovled in dimethyl sulfoxide

Remarks:

for all strains with metabolic activation

Controls 7

Untreated negative controls:

yes

Remarks:

dimethyl sulfoxide

Remarks:

for all strains, with and without metabolic activation

Details on test system and experimental conditions:

Concentration of the test substance resulting in precipitation: 333 µg/plate

Evaluation criteria:

No formal hypothesis testing was done.
A test substance is considered negative (not mutagenic) in the test if:
1. the total number of revertants in any tester strain is not greater than two times the solvent control value, with or without metabolic activation
2. the negative response should be reproducible in at least one independently repeated experiment
A test substance is considered positive (mutagenic) in the test if:
1. it induces at least a 2-fold , dose-related increase in the number of revertants with respect to the number induced by the solvent control lin any of the tester strains, either with or without metabolic activation. However, any mean plate count of less than 20 is considered to be not significant.
2. the positive response should be reproducible in at least one independently repeated experiment.
These criteria are not absolute and other modifying factors might enter into the final evaluation decision.

Results and discussion

Test results

Test results 1

Species / strain:

bacteria, other: Salmonella typhimurium TA100 and Escherichia coli WP2uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

tested up to 5000 µg/plate; precipitated >=333µg/plate

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

bacteria, other: Salmonella typhimurium TA1535, TA1537, TA98, TA100 and Escherichia coli WP2uvrA

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Remarks:

<333 µg/plate

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: other: preliminary test

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

not mutagenic in the Salmonella typimurium reverse mutation assay and in the Escherichia coli reverse mutation assay