Methanone, 1,1'-(1,4-phenylene)bis[1-(4-fluorophenyl)-

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

OECD 471 full cGLP compliant study on test material.

Link to relevant study records

Reference

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:

6 Days

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Completed to cGLP standard following OECD Guidleines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation Test", Method B13/14 of Regulation (EC)No 440/2008 of 230 May 2008.

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

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

Metabolic activation:

with and without

Test concentrations with justification for top dose:

50, 150, 500, 1500 and 5000 μg/plate

Vehicle / solvent:

dimethytl sulphoxide

Untreated negative controls:

yes

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

N-ethyl-N-nitro-N-nitrosoguanidine

benzo(a)pyrene

Details on test system and experimental conditions:

Expt 1:
Measured aliquots (0.1 ml) of one of the bacterial cultures were dispensed into sets of
test tubes followed by 2 ml of molten, trace histidine or tryptophan supplemented, top
agar, 0.1 ml of the test item formulation, vehicle or positive control and either 0.5 ml of
S9-mix or phosphate buffer. The contents of each test tube were mixed and equally
distributed onto the surface of Vogel-Bonner Minimal agar plates (one tube per plate).
This procedure was repeated, in triplicate, for each bacterial strain and for each
concentration of test item both with and without S9-mix.
All of the plates were incubated at 37°C for approximately 48 hours and the frequency of
revertant colonies assessed using a Domino colony counter
Expt 2:
As it is good scientific practice to alter one condition in the replicate assay, the exposure
condition was changed from plate incorporation to pre-incubation.

Evaluation criteria:

There are several criteria for determining a positive result. Any, one, or all of the
following can be used to determine the overall result of the study:
1. A dose-related increase in mutant frequency over the dose range tested (De
Serres and Shelby (1979)).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al (1989)).
5. Fold increase greater than two times the concurrent solvent control for any tester
strain (especially if accompanied by an out-of-historical range response).
A test item will be considered non-mutagenic (negative) in the test system if the above
criteria are not met.

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:

valid

Positive controls validity:

valid

Additional information on results:

All of the positive control chemicals used in the test induced marked increases in the
frequency of revertant colonies thus confirming the activity of the S9-mix and the
sensitivity of the bacterial strains.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Conclusions:

Interpretation of results (migrated information):
negative

The test item, 1,4'-bis(4-fluorobenzoyl)benzene, was considered to be non-mutagenic
under the conditions of this test.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Justification for selection of genetic toxicity endpoint
Study is fully GLP compliant and in line with present study guidelines.

Justification for classification or non-classification

The test item, 1,4'-bis(4-fluorobenzoyl)benzene, was considered to be non-mutagenic under the conditions of this test.