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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:
2002-06-21 - 2002-08-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to current guideline and GLP; only standard plate test performed

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
(1997)
GLP compliance:
yes (incl. QA statement)
Remarks:
Freiburger Labor für Mutagenitätsprüfung der King & Harnasch GmbH
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
(R*,R*)-α,4-dimethyl-α-(4-methyl-3-pentenyl)cyclohex-3-ene-1-methanol
EC Number:
208-205-9
EC Name:
(R*,R*)-α,4-dimethyl-α-(4-methyl-3-pentenyl)cyclohex-3-ene-1-methanol
Cas Number:
515-69-5
Molecular formula:
C15H26O
IUPAC Name:
6-methyl-2-(4-methylcyclohex-3-en-1-yl)hept-5-en-2-ol
Test material form:
other: liquid
Details on test material:
Bisabolol alpha nat.

Method

Target gene:
His
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver S9 mix
Test concentrations with justification for top dose:
1.5 - 1500 µg/plate in the presence of S9-mix.
0.5 - 500 µg/plate in the absence of S9-mix.
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: without S9-mix: 9-Aminoacridine, mitomycin C, sodium azide, 2-nitrofluorene; with S9-mix: 2-aminoanthracene
Details on test system and experimental conditions:
Standard Plate Test

DURATION
- Exposure duration: 48h-72h

NUMBER OF REPLICATIONS: 2 independent experiments performed in triplicates

DETERMINATION OF CYTOTOXICITY
- Method: number of revertant colonies and/or a diminution of the background lawn
Statistics:
The estimation of the statistical significance of the difference between the mean number of revertants in the negative controls and the plates at each dosage level was tested using a X²-test (Mohn and Ellenberger, 1977).

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
bacteriotoxic towards the strains TA1535, TA1537, TA98, and TA100 at 150 µg/plate and towards the strain TA102 at 500 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
bacteriotoxic towards the strains TA1535, TA1537, and TA100 at 500 µg/plate and towards the strains TA98 and TA102 at 1500 μg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: was not observed
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Table: Induction of revertants in S. typhimurium by the test subtance in the absence of a metabolizing system (1st Experiment)

Substance

Concentration [µg/plate]

TA 98

TA100

TA 102

TA 1535

TA 1537

Control

0

28

147

268

14

14

Solvent control

0

25

131

267

17

13

Test item

1.5

30

129

 

16

13

5

19

137

281

18

9

15

26

132

250

18

14

50

12

120

244

16

10

150

3 T

6 T

206

7 T

0 T

500

 

 

174 T

 

 

NaN3

0.7

 

361

 

313

 

2-NF

2.5

448

 

 

 

 

9-AA

50

 

 

 

 

153

Mitomycin C

0.15

 

 

884

 

 

Table: Induction of revertants in S. typhimurium by the test subtance in the presence of a metabolizing system (1st Experiment)

Substance

Concentration [µg/plate]

TA 98

TA100

TA 102

TA 1535

TA 1537

Control

0

40

120

266

19

16

Solvent control

0

40

123

283

16

12

Test item

1.5

 

129

 

 

14

5

37

126

262

13

12

15

41

114

272

14

14

50

39

134

259

14

9

150

46

127

300

13

11

500

26

 

300

9 T

 

2-AA

0.8

630

636

 

 

 

2-AA

0.9

 

 

423

155

 

2-AA

1.7

 

 

 

 

86

Table: Induction of revertants in S. typhimurium by the test subtance in the absence of a metabolizing system (2rd Experiment)

Substance

Concentration [µg/plate]

TA 98

TA100

TA 102

TA 1535

TA 1537

Control

0

32

116

263

23

14

Solvent control

0

31

132

260

18

15

Test item

0.5

30

 

 

 

11

1.5

27

130

264

17

12

5

33

123

253

21

11

15

20

132

246

18

9

50

31

130

249

16

9

150

 

7 T

207

1 T

 

NaN3

0.7

 

358

 

326

 

2-NF

2.5

556

 

 

 

 

9-AA

50

 

 

 

 

274

Mitomycin C

0.15

 

 

817

 

 

Table: Induction of revertants in S. typhimurium by the test subtance in the presence of metabolizing system (2rd Experiment)

Substance

Concentration [µg/plate]

TA 98

TA100

TA 102

TA 1535

TA 1537

Control

0

39

116

311

17

14

Solvent control

0

40

114

312

16

19

Test item

5

 

113

 

20

17

15

40

121

309

20

17

50

35

101

333

12

17

150

38

92

367

14

15

500

21

1 T

292

6 T

0 T

1500

0 T

 

151

 

 

2-AA

0.8

455

349

 

 

 

2-AA

0.9

 

 

535

175

 

2-AA

1.7

 

 

 

 

260

T: bacteriotoxic

2-AA: 2-aminoanthracene

2-NF: 2-nitrofluorene

9-AA: 9-aminoacridin

Applicant's summary and conclusion

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