Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
no data available
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented guideline study.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
NTP technical report on the toxicology and carcinogenesis - studies of vanadium pentoxide (CAS NO. 1314-62-1) in F344/N rats and B6C3F1 mice (inhalation studies)
Author:
Anonymous
Year:
2002
Bibliographic source:
NTP TR 507, NIH Publication No. 03-4441

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): vanadium pentoxide
- Physical state: solid, orange, crystalline
- Analytical purity: ~99%
- Impurities (identity and concentrations): Spark source mass spectrometry indicated vanadium as the major component; the principal impurities were barium (170 ppm), iron (110 ppm), calcium (440 ppm), potassium (550 ppm), sulfur (270 ppm), silicon and sodium (approximately 1,100 ppm each), aluminum (260 ppm), and magnesium (340 ppm). The total concentration of all other impurities was 565 ppm.
- Composition of test material, percentage of components:
- Lot/batch No.: 1210490 and 1210140
No further details are given.

Method

Target gene:
not applicable
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 97
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 98
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 100
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 102
Additional strain / cell type characteristics:
not specified
Species / strain / cell type:
S. typhimurium TA 1535
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
TA102, TA1535 and TA 97: 0, 0.03, 0.1, 0.3, 1.0, 3.0, 6.0, 10.0 and 33.0 µg/plate
TA100 and TA 98: 0, 0.1, 0.3, 1.0, 3.0, 6.0, 10.0, 33.0, 100.0 and 333.0 µg/plate
Vehicle / solvent:
No vehicle is reported, but in the results (summary table) of the reference an evidence is given that a vehicle was used: "0 μg/plate was the solvent control."
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
without metabolic activation; strains TA100 and TA1535
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
without metabolic activation; strain TA97
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylenediamine
Remarks:
without metabolic activation; strain TA98
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
mitomycin C
Remarks:
without metabolic activation; strain TA102
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
with metabolic activation; all strains
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar; preincubation

DURATION
- Preincubation period: 20 minutes at 37°C
- Exposure duration: 48 hours at 37°C

NUMBER OF REPLICATIONS: Each trial consisted of triplicate plates.

DETERMINATION OF CYTOTOXICITY
- Method: no data, but the high dose concentration was limited by toxicity.

OTHER EXAMINATIONS:
no other examinations performed
Evaluation criteria:
In this assay, a positive response is defined as a reproducible, dose-related increase in histidine-independent (revertant) colonies in any one strain/activation combination.
An equivocal response is defined as an increase in revertants that is not dose related, is not reproducible, or is not of sufficient magnitude to support a determination of mutagenicity.
A negative response is obtained when no increase in revertant colonies is observed following chemical treatment.
There is no minimum percentage or fold increase required for a chemical to be judged positive or weakly positive.
Statistics:
not mandatory for this test system

Results and discussion

Test results
Species / strain:
other: TA97, TA98, TA100, TA102 and TA1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Vehicle controls validity:
not specified
Untreated negative controls validity:
not examined
Positive controls validity:
not specified
Additional information on results:
No details are reported.
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

Under the test conditions reported the test substance was determined to be negative mutagenic in strains TA97, TA98, TA100, TA102 and TA1535 with and without S9.
Executive summary:

The genetic toxicity of vanadium pentoxide was assessed by testing the ability of the chemical to induce mutations in various strains of Salmonella typhimurium. Vanadium pentoxide was not mutagenic in Salmonella typhimurium strain TA97, TA98, TA100, TA102, or TA1535, with or without induced rat or hamster liver S9 enzymes.