[1,1':3',1''-Terphenyl]-2'-ol, 5',5''''-(2,2,2-trifluoro-1-methylethylidene)bis-

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)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-phenyl-5-(1,1,1-trifluoro-2-{6-hydroxy-5-phenyl-[1,1'-biphenyl]-3-yl}propan-2-yl)-[1,1'-biphenyl]-2-ol

EC Number:

610-104-3

Cas Number:

43100-47-6

Molecular formula:

C39 H29 F3 O2

IUPAC Name:

3-phenyl-5-(1,1,1-trifluoro-2-{6-hydroxy-5-phenyl-[1,1'-biphenyl]-3-yl}propan-2-yl)-[1,1'-biphenyl]-2-ol

Details on test material:

- Name of the test substance used in the study report: Ligand TFME-DPP
- Purity: 94.8 g/100 g
- Physical state: white solid
- Test substance No.: 08/0260-1
- Date of production: Feb 2008
- Homogeneity: mixing before preparation of thest substance solutions
- Stability under test conditions: The stability of the test substance under storage conditions throughout the study period was guaranteed as indicated by the manufacturer.
- Storage condition of test material: room temperature

Method

Target gene:

histidine operon (S. typhimurium) and tryptophan operon (E. coli)

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

induced rat liver S9 mix

Test concentrations with justification for top dose:

Experiment 1:
0 µg - 5000 µg/plate (standard plate test; all tester strains)

Experiment 2:
0 µg - 2500 µg/plate (preincubation test; TA 1535, TA 100, TA 1537, TA 98, E. coli)
0 µg - 5000 µg/plate (preincubation test; E. coli)

Experiment 3:
0 µg - 5000 µg/plate (preincubation test; TA 1535, TA 100)

Experiment 4:
0 µg - 5500 μg/plate (preincubation test; E. coli)

Vehicle / solvent:

Due to the insolubility of the test substance in water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: with metabolic activation: 2-aminoanthracene; without metabolic activation: N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylenediamine, 9-aminoacridine and 4-nitroquinoline-N-oxide

Details on test system and experimental conditions:

standard plate test and preincubation test

Evaluation criteria:

The test chemical is considered positive in this assay if:
• a dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system, is observed.

A test substance is generally considered non-mutagenic in this test if:
• the number of revertants for all tester strains were within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other.

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:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

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:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY:
A weak bacteriotoxic effect (slight decrease in the number of his+ or trp+ revertants, slight reduction in the titer) was observed in the standard plate test from about 2500 μg/plate onward.
In the preincubation assay bacteriotoxicity (slight decrease in the number of his+ or trp+ revertants, slight reduction in the titer) was occasionally observed depending on the strain and test conditions from about 1250 μg/plate onward.

An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S9 mix or after the addition of a metabolizing system.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.