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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Valid without restriction. Well documented GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: flakes
Details on test material:
Purity: 100% active matter
Remarks: White, solid.
Solubility: Poorly soluble (=< 2 mg/L in test medium).
Carbon chain length distribution: C16 2,98%, C18 92,9%, C18:1 1,04%

Method

Metabolic activation:
with and without
Metabolic activation system:
500 μl
Test concentrations with justification for top dose:
33, 100, 333, 1000, 2500, 5000 μg/plate
Controls
Untreated negative controls:
yes
Positive controls:
yes
Remarks:
without metabolic activation, treated with sodium azide, 4-nitro-o-phenylene-diamine and methyl methane sulfonate with metabolic activation, treated with 2-aminoanthracene
Remarks:
Sodium azide (10 ug/plate): TA 1535 & 1004-nitro-o-phenylene-diamine: TA 1537 (50 ug/plate), TA 98 (10 ug/plate) Methyl-methane-sulfonate (5 ul/plate): TA 102 2-aminoanthracene: TA 1535, 1537, 98 & 100 (2.5 ug/plate), TA 102 (10 ug/plate)

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: Without metabolic activation: 5000 μg/plateWith metabolic activation: 2500-5000 μg/plate

Any other information on results incl. tables

Toxicity effects

Strain

Experiment I

(¼g/plate)

Experiment II

(¼g/plate)

 

Without S-9 Mix

With S-9 Mix

Without S-9 Mix

With S-9 Mix

TA 1535

5000

--

--

--

TA 1537

5000

2500 - 5000

--

5000

TA 98

--

5000

--

--

TA 100

--

--

--

--

TA 102

--

5000

--

--

Summary of Results without S-9 Mix

Concentration

(¼g/plate)

Revertants/plate

(mean from three plates)

TA 98

TA 100

TA 102

TA 1535

TA 1537

I

II

I

II

I

II

I

II

I

II

Negative Control

23

25

142

158

270

280

13

20

5

11

Solvent Control

20

20

157

164

247

240

13

20

5

9

Positive Control[1]

198

198

656

997

1063

1005

907

710

56

60

33

19

19

152

124

239

239

13

16

4

8

100

20

20

147

125

256

256

13

18

6

9

333

21

21

163

105

316

293

17

18

5

6

1000

20

20

175

133

250

292

14

19

5

8

2500

19

19

146

122

304

296

11

18

4

7

5000

10

10

136

123

172

193

5

12

0

6

 

Summary of Results with S-9 Mix

Concentration

(¼g/plate)

Revertants/plate

(mean from three plates)

TA 98

TA 100

TA 102

TA 1535

TA 1537

I

II

I

II

I

II

I

II

I

II

Negative Control

21

38

169

157

366

255

10

19

4

18

Solvent Control

26

40

220

158

431

221

14

18

9

14

Positive Control[2]

509

346

907

486

979

748

110

123

95

52

33

27

32

190

149

313

272

14

19

5

13

100

22

39

208

133

200

266

13

19

6

12

333

27

33

219

140

366

274

15

14

4

12

1000

26

37

225

150

299

288

12

16

6

9

2500

16

29

215

183

229

298

23

16

1

9

5000

6

28

177

128

191

185

9

11

0

6


[1]Sodium azide (10 ug/plate): TA 1535 & 100

4-nitro-o-phenylene-diamine: TA 1537 (50 ug/plate), TA 98 (10 ug/plate)

Methyl-methane-sulfonate (5 ul/plate): TA 102

[2]2-aminoanthracene: TA 1535, 1537, 98 & 100 (2.5 ug/plate), TA 102 (10 ug/plate)

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Not mutagenic