Registration Dossier

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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Type of assay:
bacterial forward mutation assay

Test material

Reference
Name:
Unnamed
Specific details on test material used for the study:
The test item Ginger, ext. was tested in the Salmonella typhimurium reverse mutation as-say with five strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 and TA1535)

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

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Untreated negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Table8.1‑a   Mean Revertants Experiment 1a

Strain

TA97a

TA98

TA100

TA102

TA1535

Induction

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

Demin. water

Mean

75

85

25

35

77

93

287

376

12

11

sd

4.7

5.3

2.6

6.0

7.2

8.3

28.1

0.0

4.4

3.5

DMSO

Mean

80

78

32

40

74

77

345

403

11

11

sd

4.6

7.4

4.6

11.3

8.1

11.4

22.7

60.6

2.1

0.0

Ethanol

Mean

75

85

30

32

79

84

344

285

15

17

sd

14.1

2.6

5.5

3.1

13.6

20.0

71.1

68.0

3.2

2.5

Positive
Controls*

Mean

603

456

301

103

667

1221

1248

1259

353

216

sd

148.7

136.7

77.4

1.2

43.1

136.1

145.5

24.4

38.9

6.9

f(I)

7.54

5.85

9.41

2.58

8.66

15.86

3.62

3.12

29.42

19.64

5 µL/plate

Mean

80

69

1

3

29

13

287

245

10

13

sd

7.8

7.9

0.0

1.5

4.0

1.0

22.0

25.7

0.0

3.5

f(I)

1.07

0.81

0.03

0.09

0.37

0.15

0.83

0.86

0.67

0.76

1.5 µL/plate

Mean

83

76

7

8

74

85

343

329

22

12

sd

9.2

3.2

1.2

2.1

22.1

10.0

34.5

26.6

4.0

3.8

f(I)

1.11

0.89

0.23

0.25

0.94

1.01

1.00

1.15

1.47

0.71

0.5 µL/plate

Mean

82

82

14

18

68

80

301

254

13

14

sd

13.1

6.7

3.5

4.2

9.5

11.9

26.6

91.0

4.6

3.2

f(I)

1.09

0.96

0.47

0.56

0.86

0.95

0.88

0.89

0.87

0.82

0.15 µL/plate

Mean

72

94

15

12

80

76

264

395

14

13

sd

10.7

8.0

2.3

0.0

15.9

13.5

10.6

37.8

0.0

4.7

f(I)

0.96

1.11

0.50

0.38

1.01

0.90

0.77

1.39

0.93

0.76

0.05 µl/plate

Mean

95

72

32

33

76

72

277

303

15

18

sd

11.4

13.7

11.4

2.9

16.9

8.0

54.3

38.0

4.0

0.6

f(I)

1.27

0.85

1.07

1.03

0.96

0.86

0.81

1.06

1.00

1.06

Table8.2‑a   Mean Revertants Experiment 1b

Strain

TA100

TA1535

Induction

-S9

+S9

-S9

+S9

Demin. water

Mean

94

108

19

20

sd

22.5

12.2

2.0

3.5

DMSO

Mean

83

86

20

15

sd

1.2

7.5

2.5

3.6

Ethanol

Mean

98

93

15

16

sd

12.4

2.5

4.6

4.6

Positive
Controls*

Mean

327

557

219

144

sd

39.3

12.2

68.0

17.8

f(I)

3.48

6.48

11.53

9.60

5 µL/plate

Mean

2

33

2

3

sd

1.2

10.1

1.2

1.2

f(I)

0.02

0.35

0.13

0.19

1.5 µL/plate

Mean

86

82

17

18

sd

3.8

2.1

1.2

4.0

f(I)

0.88

0.88

1.13

1.13

0.5 µL/plate

Mean

73

80

12

17

sd

10.5

9.1

1.5

1.0

f(I)

0.74

0.86

0.80

1.06

0.15 µL/plate

Mean

72

119

17

15

sd

14.0

9.9

3.8

3.8

f(I)

0.73

1.28

1.13

0.94

0.05 µl/plate

Mean

85

95

16

14

sd

7.6

15.0

3.5

2.0

f(I)

0.87

1.02

1.07

0.88

0.015 µl/plate

Mean

94

117

17

19

sd

6.0

26.4

4.9

4.0

f(I)

0.96

1.26

1.13

1.19

Table8.2‑b   Mean Revertants Experiment 1b

Strain

TA98

Induction

-S9

+S9

Demin. water

Mean

35

38

sd

2.0

8.6

DMSO

Mean

35

37

sd

3.2

4.0

Ethanol

Mean

35

43

sd

4.0

9.1

Positive
Controls*

Mean

493

299

sd

69.0

18.5

f(I)

14.09

8.08

0.15 µL/plate

Mean

0

0

sd

0.0

0.0

f(I)

0.00

0.00

0.05 µL/plate

Mean

34

37

sd

2.0

4.0

f(I)

0.97

0.86

0.015 µL/plate

Mean

41

38

sd

4.5

8.1

f(I)

1.17

0.88

0.005 µL/plate

Mean

38

38

sd

3.1

7.0

f(I)

1.09

0.88

0.0015 µl/plate

Mean

36

35

sd

7.6

2.6

f(I)

1.03

0.81

0.0005 µl/plate

Mean

38

41

sd

3.2

3.0

f(I)

1.09

0.95

Table8.3‑a  Mean Revertants Experiment 2

Strain

TA97a

TA102

Induction

-S9

+S9

-S9

+S9

Demin. water

Mean

90

79

307

356

sd

9.0

7.6

10.1

10.6

DMSO

Mean

88

83

291

329

sd

4.0

10.4

11.5

39.3

Ethanol

Mean

80

81

260

363

sd

9.8

8.7

65.5

41.1

Positive
Controls*

Mean

365

915

1235

1235

sd

14.7

28.1

119.8

180.0

f(I)

4.15

11.02

4.24

3.75

5 µL/plate

Mean

1

4

188

252

sd

0.0

3.2

42.1

21.2

f(I)

0.01

0.05

0.72

0.69

2.5 µL/plate

Mean

7

2

203

284

sd

4.7

1.0

17.0

45.1

f(I)

0.09

0.02

0.78

0.78

1.25 µL/plate

Mean

82

91

249

291

sd

9.6

9.5

75.1

25.7

f(I)

1.03

1.12

0.96

0.80

0.63 µL/plate

Mean

81

94

260

260

sd

5.9

5.8

46.1

30.2

f(I)

1.01

1.16

1.00

0.72

0.31 µL/plate

Mean

71

92

283

377

sd

4.6

7.0

67.0

115.5

f(I)

0.89

1.14

1.09

1.04

0.16 µL/plate

Mean

80

97

339

280

sd

9.1

19.6

78.9

36.0

f(I)

1.00

1.20

1.30

0.77

0.08 µL/plate

Mean

84

72

252

352

sd

9.6

5.2

36.7

174.4

f(I)

1.05

0.89

0.97

0.97

Table8.3b Mean Revertants Experiment 2

Strain

TA100

TA1535

Induction

-S9

+S9

-S9

+S9

Demin. water

Mean

114

100

22

23

sd

18.7

16.4

3.5

2.9

DMSO

Mean

114

109

20

21

sd

3.5

8.1

0.6

1.2

Ethanol

Mean

109

96

15

17

sd

5.0

15.9

5.0

4.0

Positive
Controls*

Mean

341

816

346

153

sd

20.1

83.1

50.3

12.9

f(I)

2.99

7.49

15.73

7.29

1.5 µL/plate

Mean

9

31

2

4

sd

1.5

5.9

1.2

2.1

f(I)

0.08

0.32

0.13

0.24

0.75 µL/plate

Mean

15

44

3

4

sd

3.1

2.1

1.5

2.9

f(I)

0.14

0.46

0.20

0.24

0.38 µL/plate

Mean

77

87

17

13

sd

14.7

18.7

2.5

4.2

f(I)

0.71

0.91

1.13

0.76

0.19 µL/plate

Mean

76

80

14

14

sd

10.1

13.9

4.4

3.6

f(I)

0.70

0.83

0.93

0.82

0.09 µL/plate

Mean

85

115

17

18

sd

10.0

5.3

6.0

6.2

f(I)

0.78

1.20

1.13

1.06

0.05 µL/plate

Mean

79

120

14

15

sd

5.9

4.6

2.6

3.8

f(I)

0.72

1.25

0.93

0.88

0.02 µL/plate

Mean

90

128

17

18

sd

5.6

13.5

5.9

3.1

f(I)

0.83

1.33

1.13

1.06

Table8.3‑c  Mean Revertants Experiment 2

Strain

TA98

Induction

-S9

+S9

Demin. water

Mean

35

37

sd

6.9

5.3

DMSO

Mean

40

39

sd

11.8

4.0

Ethanol

Mean

38

38

sd

9.9

3.0

Positive
Controls*

Mean

685

188

sd

92.4

38.0

f(I)

17.13

4.82

0.05 µL/plate

Mean

29

30

sd

4.9

11.8

f(I)

0.76

0.79

0.025 µL/plate

Mean

37

40

sd

2.5

4.6

f(I)

0.97

1.05

0.0125 µL/plate

Mean

32

35

sd

2.1

3.8

f(I)

0.84

0.92

0.0063 µL/plate

Mean

35

37

sd

1.0

5.0

f(I)

0.92

0.97

0.0031 µL/plate

Mean

29

36

sd

1.2

2.6

f(I)

0.76

0.95

0.0016 µL/plate

Mean

37

36

sd

3.5

4.6

f(I)

0.97

0.95

0.0008 µL/plate

Mean

35

33

sd

6.1

2.1

f(I)

0.92

0.87

Applicant's summary and conclusion

Conclusions:
Based on the results of this study it is concluded that Ginger, ext. is not mutagenic in the Salmonella typhimurium test strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in the present study.