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Toxicological information

Genetic toxicity: in vitro

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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:
2009-12-07 - 2010-03-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-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 (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Mullite
EC Number:
215-113-2
EC Name:
Mullite
Cas Number:
1302-93-8
Molecular formula:
Al6O13Si2
IUPAC Name:
Mullite

Method

Target gene:
TA97a: hisD6610, uvrB, pKM 101, rfa
TA 98: hisD3052, uvrB, pKM 101, rfa
TA 100 : hisG46, uvrB, pKM 101, rfa
TA102: hisG428, pKM 101, rfa
TA1535 : hisG46, uvrB, rfa.
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 97
Additional strain / cell type characteristics:
other: hisD6610, uvrB, pKM 101, rfa
Species / strain / cell type:
S. typhimurium TA 98
Additional strain / cell type characteristics:
other: hisD3052, uvrB, pKM 101, rfa
Species / strain / cell type:
S. typhimurium TA 100
Additional strain / cell type characteristics:
other: hisG46, uvrB, pKM 101, rfa
Species / strain / cell type:
S. typhimurium TA 102
Additional strain / cell type characteristics:
other: hisG428, pKM 101, rfa
Species / strain / cell type:
S. typhimurium TA 1535
Additional strain / cell type characteristics:
other: hisG46, uvrB, rfa.
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
Plate incorporation test: 5010 / 1523 / 567 / 152 / 57 µg/plate
Pre-incubation method: 4993 / 2543 / 1229 / 632 / 338 µg/plate
Vehicle / solvent:
deionised water
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: 4-Nitro-1,2-phenylene diamine
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-Amino-anthracene

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 97
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
Species / strain:
S. typhimurium TA 98
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
Species / strain:
S. typhimurium 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
Species / strain:
S. typhimurium TA 102
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
Species / strain:
S. typhimurium TA 1535
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
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

 Mean Revertants First Experiment

Strain

TA97a

TA98

TA100

TA102

TA1535

Induction

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

H2O

Mean

104

114

9

7

101

122

155

210

7

7

sd

16.1

16.1

1.4

1.3

15.4

17.1

32.2

11.8

1.8

3.3

DMSO

Mean

110

116

10

9

101

101

177

194

9

7

sd

8.2

10.1

0.6

1.3

7.4

5.3

18.0

25.1

0.5

3.7

Pos.Contr.

Mean

362

441

274

208

493

628

819

830

217

188

sd

27

43

48

34

231

49

58

74

50

19

f(I)

3.29

3.80

27.40

23.11

4.88

6.22

4.63

4.28

31.00

26.86

5010 µg/pl.

Mean

105

118

9

8

111

145

192

233

5

10

sd

10

9

2

2

14

6

8

26

1

1

f(I)

1.01

1.04

1.00

1.14

1.10

1.19

1.24

1.11

0.71

1.43

1523 µg/pl.

Mean

103

111

10

8

123

123

197

198

4

5

sd

11

10

2

3

26

18

8

13

1

2

f(I)

0.99

0.97

1.11

1.14

1.22

1.01

1.27

0.94

0.57

0.71

567 µg/pl.

Mean

114

117

10

9

101

133

215

182

10

9

sd

10

8

2

1

7

23

8

18

1

2

f(I)

1.10

1.03

1.11

1.29

1.00

1.09

1.39

0.87

1.43

1.29

152 µg/pl.

Mean

116

103

11

9

113

95

153

185

4

11

sd

4

17

1

2

10

13

28

4

0

2

f(I)

1.12

0.90

1.22

1.29

1.12

0.78

0.99

0.88

0.57

1.57

57 µg/pl.

Mean

120

98

6

8

109

108

234

203

8

9

sd

5

8

1

2

15

24

42

21

2

1

f(I)

1.15

0.86

0.67

1.14

1.08

0.89

1.51

0.97

1.14

1.29

Mean Revertants Second Experiment

Strain

TA97a

TA98

TA100

TA102

TA1535

Induction

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

H2O

Mean

155

143

12

14

120

121

170

165

7

10

sd

7.0

6.0

1.9

4.8

28.2

18.4

29.9

4.9

2.4

2.1

DMSO

Mean

158

153

12

13

115

128

170

155

10

10

sd

22.3

15.2

2.5

3.6

12.1

16.0

23.8

20.0

3.3

3.1

Pos.Contr.

Mean

475

439

249

225

532

767

868

789

194

192

sd

56

61

44

34

137

241

90

142

62

47

f(I)

3.01

2.87

20.75

17.31

4.43

5.99

5.11

5.09

27.71

19.20

4993 µg/pl.

Mean

108

106

9

8

123

116

191

178

4

7

sd

17

8

1

1

22

20

13

10

1

3

f(I)

0.70

0.74

0.75

0.57

1.03

0.96

1.12

1.08

0.57

0.70

2543 µg/pl.

Mean

110

116

9

9

123

106

197

188

8

7

sd

13

5

1

2

32

11

26

8

4

3

f(I)

0.71

0.81

0.75

0.64

1.03

0.88

1.16

1.14

1.14

0.70

1229 µg/pl.

Mean

119

116

5

8

126

112

210

232

7

5

sd

4

7

2

2

18

21

40

30

3

2

f(I)

0.77

0.81

0.42

0.57

1.05

0.93

1.24

1.41

1.00

0.50

632 µg/pl.

Mean

118

115

9

8

119

111

259

238

7

6

sd

3

4

1

3

23

7

40

8

2

2

f(I)

0.76

0.80

0.75

0.57

0.99

0.92

1.52

1.44

1.00

0.60

338 µg/pl.

Mean

107

107

9

9

122

106

239

253

6

8

sd

14

10

1

1

25

8

41

23

3

3

f(I)

0.69

0.75

0.75

0.64

1.02

0.88

1.41

1.53

0.86

0.80

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test item did not show mutagenic effects in both experiments. The number of revertant colonies was not increased in comparison with the spontaneous revertants (solvent only).
Cytotoxicity of the test item was not detected. The background lawn was visible and the number of revertants was not significantly decreased.
Therefore it can be stated, that under the test conditions, the test item White Fused Mullite is not mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium, strains TA 97a, TA 98, TA 100, TA 102 and TA 1535.
Executive summary:

The test item did not show mutagenic effects in both experiments. The number of revertant colonies was not increased in comparison with the spontaneous revertants (solvent only).

Cytotoxicity of the test item was not detected. The background lawn was visible and the number of revertants was not significantly decreased.

Therefore it can be stated, that under the test conditions, the test itemWhite Fused Mulliteis not mutagenic in the Bacterial Reverse Mutation Test usingSalmonella typhimurium,strainsTA 97a, TA 98, TA 100, TA 102 and TA 1535.

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