N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)

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

Study period:

1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed by an experienced laboratory using an accepted methodology that included the typical Salmonella strains plus E. coli, both with and without metabolic activation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Japanese Industrial Safety and Health Law, 1979,

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)

EC Number:

251-118-6

EC Name:

N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)

Cas Number:

32588-76-4

Molecular formula:

C18H4Br8N2O4

IUPAC Name:

N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)

Test material form:

other: Pale yellow powder

Method

Target gene:

Typical for the bacterial strains tested.

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

other: tryptophan-deficient E.coli WP2 uvrA

Metabolic activation:

with and without

Metabolic activation system:

Rat liver S9

Test concentrations with justification for top dose:

10, 50, 100, 500, 1000, 5000 ug/plate; duplicate plates/dose, bacterial strain, and activation

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Remarks:

2 -(2 -furyl)-3 -(5 -nitro-2 -furyl)acrylamide, N-ethyl-N'nitro-N-nitrosoguanidine, 9 -Aminoacridine, 2 -nitrofluorene, 2 -aminoanthracene

Results and discussion

Test results

Test results 1

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

See attached document for table of results.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

EBTBP was not mutagenic to 5 strains of Salmonella typhimurium and E. coli WP2 uvrA when tested with and without S9 metabolic activation.

Executive summary:

In the Ames assay, the tester strains used wereSalmonellaTA98, TA100, TA1535, TA1537, and TA1538 andE. coli, WP2 uvrA. Each strain was tested with and without a source of exogenous metabolic activation of Arochlor-induced rat liver microsomes. EBTBP dose levels were 0, 1, 10, 100, 500, 1,000 and 5,000 ug/plate. Positive and negative controls were included, and performed as expected. No increase in revertant colonies was found at any EBTBP dose level either in the presence or absence of microsomal enzymes. EBTBP was not genetically active in this assay.