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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:
other: Conducted at GLP-accredited facility to current guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2016

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
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Test concentrations with justification for top dose:
The test item concentrations to be applied in the main experiments were chosen according to the results of the pre-experiment. 5000 µg/plate was selected as the emaximum concentration. The concentration range covered two logarrithmic decades.

Results and discussion

Test resultsopen allclose all
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
detected by a clearing or rather diminuation of the background lawn (indicated as "N" or "B" in the result tables) or a reduction in the number of revertants down to a mutation factor of. appr.
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
detected by a clearing or rather diminuation of the background lawn (indicated as "N" or "B" in the result tables) or a reduction in the number of revertants down to a mutation factor of. appr.
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
detected by a clearing or rather diminuation of the background lawn (indicated as "N" or "B" in the result tables) or a reduction in the number of revertants down to a mutation factor of. appr.
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
detected by a clearing or rather diminuation of the background lawn (indicated as "N" or "B" in the result tables) or a reduction in the number of revertants down to a mutation factor of. appr.
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
detected by a clearing or rather diminuation of the background lawn (indicated as "N" or "B" in the result tables) or a reduction in the number of revertants down to a mutation factor of. appr.
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
True negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
It can be stated that during the described mutagenicity test and under the experimental conditions reported VSV16 did not cause gen mutations by base pair changes or frameshifts in the genome of the tester strains used.
Therefore VSV16 is considered to be non-mutagenic in this bacterail reverse mutation assay.
Executive summary:

In order to investigate the potential of VSV16 for its ability to induce gene mutations the plate incorporation test (experiment I) and the pre-incubation test (experiment II) were performed with the Salmonella typhimuriam strains TA 98, TA 100, TA 1535, TA 1537 and TA 102.

In two independent experiments several concentrations of VSV16 were used. Each assay was conducted with and without metabolic activation. The concentrations, including the control, were tested in triplicate..

No precipation of VSV16 was observed in any tester strain used in experiment I and II (with and without metabolc activation).

Toxic effects of VSV16 were noted in all tester strains used in both experiments.

No biological relevant increases in revertant colony numbers of any of the tester strains were observed following the treatment with VSV16 at any concentration level, neither in presence nor absence of metabolic acivation in experiment I and II.