Ashes (residues), vanadium-contg.

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

Study period:

03.05.2010-25.05.2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Ashes (residues), vanadium-contg.

EC Number:

282-208-3

EC Name:

Ashes (residues), vanadium-contg.

Cas Number:

84144-87-6

Molecular formula:

Not available

Constituent 2

Reference substance name:

vanadium concentrate

IUPAC Name:

vanadium concentrate

Details on test material:

- Name of test material (as cited in study report): vanadium concentrate
- Lot/batch No.: 14-45810
- Preperation date: 07/2009
- Expiry date: 30. Sept. 2011

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

no data

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A pKM 101

Details on mammalian cell type (if applicable):

no data

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

2-Aminoantracene, Benzo(a)pyrene

Test concentrations with justification for top dose:

Sample was analyzed at these concentrations: 5, 1.6, 0.5, 0.16, 0.05 mg/plate

Vehicle / solvent:

Water: Recently distilled, not demineralised and sterilized in autoclave Water without bacteria toxic or inhibitory substances.

Controls

Untreated negative controls:

yes

Remarks:

100 µL of distilled sterile water

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

no

Positive controls:

yes

Remarks:

100 µL of the positive controls solution, specific for each strain

Positive control substance:

other: Sodium azide (CAS: 26628-22-8), 2-Nitrofluorene (CAS: 607-57-8), 9-Aminoacridine hydrochloride hydrate (CAS: 52417-22-8), N-Nitroquinoline-1-oxide (CAS: 56-57-5), 2-AminoAntracene (CAS: 613-13-8), Benzo(a)pyrene (CAS: 8165 BP)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: none
- Exposure duration: 72 h at 37 °C on a Vogel Bonner plate after adding 100 µL of working solution (and S9 mix for the metabolic activation test)

SELECTION AGENT (mutation assays): UV for uvrA/B mutation; crystal violet for rfa mutation and ampicillin for R factor plasmid

NUMBER OF REPLICATIONS:
without metabolic activation system: test was carried out in triplicates for negative control, positive control and test substance
with metabolic activation system: test was carried out in triplicate for the negative control and in duplicates for the positive control and test substance

Evaluation criteria:

CRITERIA FOR A POSITIVE RESPONSE IN TESTER STRAINS
Tester Strains TA98, TA 100 and WP2uvrA
The test substance is considered positive when, in at least one of these tester strains, it produces at least a 2-fold rise of the increase value over the increase value in the appropriate vehicle control (see tables 2-6). This rise in the increase value must be accompanied by a positive Dunnet’s test (alpha = 0.05 1-sided) and a dose response when the concentrations of the test substance is increased.

Tester Strains TA1535, TA1537
The test substance is considered positive when, in at least one of these tester strains, it produces at least a 3-fold rise of the increase value over the increase value in the appropriate vehicle control (see tables 2-6). This rise in the increase value must be accompanied by a positive Dunnet’s test (alpha = 0.05 1-sided) and a dose response when the concentrations of the test substance is increased.

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:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A pKM 101

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:

not valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

In this study the test substance does not induce significative point mutations.

Executive summary:

In a reverse gene mutation assay in bacteria, four strains of S. typhimurium (TA98, TA100, TA1535, TA1537) and one strain of E. coli (WP2 uvrA pKM101) were exposed to Vanadium concentrate at concentrations of 5, 1.6, 0.5, 0.16, 0.05 mg/plate in the presence and absence of mammalian metabolic activation. 

 

Vanadium concentrate was tested up to the limit concentration (5 mg/plate). The positive controls induced the appropriate responses in the corresponding strains.  There was no evidence or a concentration related positive response of induced mutant colonies over background.

 

This study is classified as acceptable.  This study satisfies the requirement of OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation).