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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Bismuth vanadium tetraoxide
EC Number:
237-898-0
EC Name:
Bismuth vanadium tetraoxide
Cas Number:
14059-33-7
Molecular formula:
Bi O4 V
IUPAC Name:
vanadium(5+) bismuth(3+) tetraoxidandiide
Details on test material:
- Name of test material (as cited in study report): Bismuth Vanadate
- Molecular formula (if other than submission substance): BiVO4
- Molecular weight (if other than submission substance): 323.92
- Physical state: yellow powder
- Analytical purity: >99.5% w/w
- Impurities (identity and concentrations): water and others, <0.5% w/w
- Lot/batch No.: BVB-1018
- Stability under test conditions: stable
- Other: melting point>800°C

Method

Target gene:
bacterial reverse mutation assay
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9-mix from treated SD rats
Test concentrations with justification for top dose:
50, 100, 200, 500, 1000, 2000 and 5000 µg/plate in the first experiment (dose selection) and 313, 625, 1250, 2500 and 5000 µg/plate in the econdt experiment
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2AA for all strains with S9-mix; AF-2for TA100, WP2 uvrA and TA98, NaN3 for TA1535 and ICR-191 for TA1537 without S9-mix
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min
- Incubation: 48 hours

DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency
Evaluation criteria:
not reported
Statistics:
not reported

Results and discussion

Test results
Species / strain:
other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
Because there was no increase in the colony number of reverse mutation for every strain, comparing with negative control, we concluded that the mutagenicity of this test substance is negative (see Table 1&2)
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
the test substance was tested up to 5000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
- Solubility of the test substance was less than 5 w/v % in water and DMSO and less than 10 w/v % in acetone (measured at this test institute)
- We selected DMSO as the solvent, because it made more stable suspension than water and acetone.
- We observed yellow precipitation of the test substance above 625 µg/plate without S9-mix and 313 µg/plate with S9-mix. But there was no obstacle to count the colony number of reverse mutation.

Any other information on results incl. tables

Table 1; first experiment: Dose selection result

 

With(+) or without (-) S9-mix

Test substance concentration (mg/plate

Mean number of revertants (number of colonies/plate; triplicate)

Based-pair substitution type

Frameshift type

TA100

TA1535

WP2 uvrA

TA98

TA1537

 

Solvent control

102

9

24

25

10

50

120

11

32

19

10

100

113

10

22

20

12

200

120

10

23

23

13

500

112

14

22

20

10

1000

103

10

23

20

8

2000

109

10

19

20

11

5000

99

11

19

22

10

 

Solvent control

109

12

29

32

22

50

115

8

35

43

18

100

107

13

35

33

14

200

102

10

36

31

20

500

109

12

26

37

15

1000

117

10

29

32

21

2000

101

13

30

25

18

5000

114

13

28

40

18

 

 

 

Pos. Ctrl

Without S9-mix

Name

AF-2

NaN3

AF-2

AF-2

ICR-191

Concentration (µg/plate

0.01

0.5

0.01

0.1

0.1

Mean number of colonies/plate

446

283

203

507

2178

With S9-mix

Name

2AA

2AA

2AA

2AA

2AA

Concentration (µg/plate

1

2

10

0.5

2

Mean number of colonies/plate

520

160

580

163

135

Table 2; second experiment: Dose selection result

 

With(+) or without (-) S9-mix

Test substance concentration (mg/plate

Mean number of revertants (number of colonies/plate; triplicate)

Based-pair substitution type

Frameshift type

TA100

TA1535

WP2 uvrA

TA98

TA1537

 

 

 

S9-mix (-)

Solvent control

114

10

27

24

14

313

117

12

32

22

13

625

123

9

23

24

15

1250

134

11

22

27

13

2500

116

10

27

20

13

5000

129

9

22

24

14

 

 

 

S9-mix (+)

 

Solvent control

111

10

30

30

21

313

126

11

38

37

26

625

133

10

38

35

28

1250

128

11

39

36

27

2500

127

9

33

37

20

5000

117

10

31

34

25

 

 

 

Pos. Ctrl

Without S9-mix

Name

AF-2

NaN3

AF-2

AF-2

ICR-191

Concentration (µg/plate

0.01

0.5

0.01

0.1

0.1

Mean number of colonies/plate

515

282

532

2572

2178

With S9-mix

Name

2AA

2AA

2AA

2AA

2AA

Concentration (µg/plate

1

2

10

0.5

2

Mean number of colonies/plate

545

129

601

190

130

 

Applicant's summary and conclusion