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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzyltris(dimethylaminato)phosphorus(1+) tetrafluoroborate(1-)
EC Number:
302-080-5
EC Name:
Benzyltris(dimethylaminato)phosphorus(1+) tetrafluoroborate(1-)
Cas Number:
94088-77-4
Molecular formula:
C13H25BF4N3P
IUPAC Name:
benzyltris(dimethylaminato)phosphorus(1+) tetrafluoroborate(1-)
Test material form:
solid: crystalline

Method

Species / strain
Species / strain / cell type:
other: TA97A, TA98, TA100, TA102, TA1535
Metabolic activation:
with and without
Metabolic activation system:
rat liver S9-mix induced by Aroclor 1254
Test concentrations with justification for top dose:
The following nominal concentrations were prepared for the first experiment:
5000 µg/plate, 1500 µg/plate, 500 µg/plate, 150 µg/plate and 50 µg/plate.
The following nominal concentrations were prepared for the second experiment:
5000 µg/plate, 2500 µg/plate, 1250 µg/plate, 625 µg/plate, 313 µg/plate and 156 µg/plate.
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Remarks:
Solvent
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
benzo(a)pyrene
other: 2-Amino-Anthracene, 4-Nitro-1,2-phenylene diamine

Results and discussion

Test results
Key result
Species / strain:
other: TA97A, TA98, TA100, TA102, TA1535
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

Applicant's summary and conclusion

Conclusions:
Based on the results of this study it is concluded that Tecnoflon BA 104 is not mutagenic in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in this study.
Executive summary:

Two valid experiments were performed.

 

The study procedures described in this report were based on the most recent OECD and EC guidelines. The test itemTecnoflon BA 104was tested in theSalmonella typhimuriumreverse mutation assay with five strains ofSalmonella typhimurium(TA97a, TA98, TA100, TA102 and TA1535). The test was performed in two experiments in the presence and absence of S9-mix (rat liver S9-mix induced by Aroclor 1254).

 

In the first experiment,Tecnoflon BA 104(dissolved in DMSO) was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix (0.74 % final concentration in the treatment)in the strains TA97a, TA98, TA100, TA102 and TA1535 using the plate incorporation method.

Tecnoflon BA 104showed no precipitates on the plates at any of the concentrations.

The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test itemTecnoflon BA 104showed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation.

The results of this experiment showed that none of the tested concentrations showed a significant increase in the number of revertants in all tested strains, in the presence and the absence of metabolic activation.

 

On the base of the first experiment,Tecnoflon BA 104was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix (0.74% final concentration in the treatment)in all bacteria strains using the pre-incubation method.

Tecnoflon BA 104showed no precipitates on the plates at any of the concentrations.

The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test itemTecnoflon BA 104showed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation.

The results of this experiments showed that the test itemTecnoflon BA 104caused no increase in the number of revertants in all bacteria strains compared to the solvent control, in both the absence and presence of metabolic activation. The test itemTecnoflon BA 104did not induce a dose-related increase in the number of revertants colonies in all strains, in the presence and absence of metabolic activation.

 

Based on the results of this study it is concluded thatTecnoflon BA 104is not mutagenic in theSalmonella typhimuriumstrains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in this study.

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