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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted in a manner similar to the current O.E.C.D. 471 Testing Guideline without GLP compliance.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Conducted without either strain TA 102 or E. coli tester strains.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
As per IUCLID5 Sections 1.1. - 1.4.

Method

Target gene:
Histidine operon
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:
Arochlor induced rat liver S9 fraction.
Test concentrations with justification for top dose:
0. 25, 75, 225, 675 and 2025 ug/0.1 mL.
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
cyclophosphamide
Remarks:
Other positive controls were tester strain specific.

Migrated to IUCLID6: with S9 metabolic activation.
Details on test system and experimental conditions:
The tester strains were grown up overnight in nutrient broth. The pour-plate method was used. Platings for mutant selection were made in triplicate for controls and all dose levels of the test substance. To test tubes containing 2 mL of molten minimal top agar was added 0.1 ml of test solution, 0.1 mL of tester strain culture and either 0.5 ml of phosphate buffer or 0.5 ml of rat liver S9 fraction mix. The test tubes were rapidly mixed and poured over Vogel-Bonner Medium E minimal glucose bottom plates. The plates were incubated at 37 C for approximately 48 hr before being scored.
Evaluation criteria:
In order to be consider a positive mutational response, an increase of at least 2-fold over the solvent control background value must be observed.
Statistics:
No data

Results and discussion

Test results
Species / strain:
other: Strains TA 1535 and TA 100.
Metabolic activation:
with and without
Genotoxicity:
ambiguous
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
Treatment with Bisphenol F Diglycidylether induced dose-related mutational responses in tester strains TA 1535 and TA 100 with and without rat liver derived S9 metabolic activation preparation. For tester strain TA 1535 the increase of mutant frequency over the control background values was 10.4-fold without S9 metabolic activation and was 46.6-fold with S9 metabolic activation at the high dose level of 2025 ug/0.1 mL.
Remarks on result:
other: strain/cell type:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive

Bisphenol F Diglycidylether inducted a positive dose-related gene-mutation response in tester strains TA 1535 and TA 100 in the presence and absence of a rat liver derived S9 metabolic activation preparation. The mutational response appeared to be enhanced by S9 metabolic activation.
Executive summary:

Bisphenol F Diglycidylether was tested for induction of gene-mutation in a manner similar to O.E.C.D. Testing Guideline 471 with Ames/Salmonella tester strains TA 1535, TA 1537, TA 98 and TA 100. Bisphenol F Diglycidylether inducted a positive dose-related gene-mutation response in tester strains TA 1535 and TA 100 in the presence and absence of a rat liver derived S9 metabolic activation preparation. The mutational response appeared to be enhanced by S9 metabolic activation.