3-phenyl-7-[4-(tetrahydrofurfuryloxy)phenyl]-1,5-dioxa-s-indacen-2,6-dione

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:

1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EEC B.14 (Ames test)

Principles of method if other than guideline:

None

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-phenyl-7-[4-(tetrahydrofurfuryloxy)phenyl]-1,5-dioxa-s-indacen-2,6-dione

EC Number:

413-330-9

EC Name:

3-phenyl-7-[4-(tetrahydrofurfuryloxy)phenyl]-1,5-dioxa-s-indacen-2,6-dione

Cas Number:

134724-55-3

Molecular formula:

C27H20O6

IUPAC Name:

6-{4-[(oxolan-2-yl)methoxy]phenyl}-12-phenyl-4,10-dioxatricyclo[7.3.0.0^{3,7}]dodeca-1(12),2,6,8-tetraene-5,11-dione

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Specific details on test material used for the study:

None

Method

Target gene:

None

Species / strain

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

E. coli WP2uvrA

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

Rat-liver post mitochondrial supernatant (S9 fraction)

Test concentrations with justification for top dose:

0.05, 0.5, 5, 50, 500, 5000 μg/plate for pretest0.015, 0.05, 0.15, 0.5, 1.5, 5 μg/plate for TA100 without S9 activation on main test I & II0.5, 1.5, 5, 15, 50, 150 μg/plate for TA100 with S9 activation on main test I & II156, 313 ,625, 1250, 2500, 5000 μg/plate for TA 1535, TA 1537, TA 98 and WP2uvrA on main test I & II

Vehicle / solvent:

Solvent:DMSO

Controls

Untreated negative controls:

yes

Remarks:

DMSO

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

benzo(a)pyrene

Details on test system and experimental conditions:

None

Rationale for test conditions:

None

Evaluation criteria:

Does not use statistical approach for data analysis. A number of revertant colonies treated with test sample solution shows twice or more as many as a number of revertant colonies treated with solvent. And it increase concentration-dependent.Th result is judged as "Positive" for mutagenicity

Statistics:

Does not use statistical approach for data analysis.

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

None

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

FAT 40554 is considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.

Executive summary:

With or without S9 mix, the number of revertant colonies treated with test sample solution for TA100 shows more than twice as many as the one treated with solvent. And it increased concentration-dependent.

Pretest organized with 0.05, 0.5, 5, 50, 500, 5000 μg/plate.

With or without S9 mix, fatal effect was not observed. Without S9 mix, precipitation was observed on the concentration of 50μg/plate and more. With S9 mix, precipitation was observed on the concentration of 500μg/plate and more. With or without S9 mix, the number of revertant colonies treated with test sample solution for TA100 shows more than twice as many as the one treated with solvent.

Based on pretest result, TA100 without S9mix takes 0.015, 0.05, 0.15, 0.5, 1.5, 5 μg/plate and TA100 with S9mix takes 0.5, 1.5, 5, 15, 50, 150 μg/plate for main test I and II. (Table 2 and 4) Other species with or without S9 mix takes 156, 313 ,625, 1250, 2500, 5000 μg/plate. (Table 3 and 5) Based on main test result, with or without S9 mix, the number of revertant colonies treated with test sample solution for TA100 shows more than twice as many as the one treated with solvent. And it increased concentration-dependent. And without S9 mix, the number of revertant colonies treated with test sample solution for TA98 shows almost twice as many as the one treated with solvent. Based on above result, the test substance is judged as "Positive" for mutagenicity.

In conclusion, FAT 40554 is considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.