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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable well documented publication which meets basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
Salmonella Mutagenicity Tests: III. Results From the Testing of 255 Chemicals
Author:
Zeiger E. et al
Year:
1987
Bibliographic source:
Environmental Mutagenesis Vol. 9, Suppl. 9, 1-110

Materials and methods

Principles of method if other than guideline:
according to Haworth, S. et al.: Environ. Mutagen. 5, Suppl. 1, 3-142
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Dipropylamine
EC Number:
205-565-9
EC Name:
Dipropylamine
Cas Number:
142-84-7
Molecular formula:
C6H15N
IUPAC Name:
N-propylpropan-1-amine
Details on test material:
- Name of test material (as cited in study report): Di-n-propylamine

Method

Target gene:
Histidine operon
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
induced male Sprague Dawley rat liver S9, induced male Syrian hamster liver S9
Test concentrations with justification for top dose:
33, 100, 333, 1000 und 3333 µg/Platte
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
water
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: For strains tested in the absence of S9: TA98, 2-nitrofluorene, TA100 and TA1535, sodium azide, TA1537, 9-aminoacridine. For strains tested with S9: All strains, 2-aminoanthracene.
Details on test system and experimental conditions:
IUCLID4 Type: Ames test
METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h

NUMBER OF REPLICATIONS: 3

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:
cytotoxicity
Remarks:
TA 100 at 3333 µg
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
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

Strain 1535

Dose

No Activation
(Negative)

No Activation
(Negative)

10% HLI
(Negative)

10% HLI
(Negative)

10% RLI
(Negative)

10% RLI
(Negative)

µg/Plate

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0     

18

1.2

8

1.5

17

3

9

0.6

20

1.5

8

0.7

33     

20

3.2

7

1.5

19

2

8

1.7

20

0.3

7

2.6

100     

19

1.7

5

0.7

19

1

8

0.7

17

1.9

6

2.6

333     

16

1.2

7

0.6

20

1.2

6

0.9

25

1.2

5

1.2

1000     

17

2.3

6

1.7

16

2.3

7

1.2

20

2.4

7

1.7

3333     

13

2.7

3

1.2

23

3.3

9

1.2

27

0.6

9

0.7

Positive Control

1224

75.1

522

28.9

298

12.2

213

11.7

260

9.3

170

20.8

Strain: TA100

Dose

No Activation
(Negative)

No Activation
(Negative)

10% HLI
(Negative)

10% HLI
(Negative)

10% RLI
(Negative)

10% RLI
(Negative)

ug/Plate

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0     

160

3.5

133

9.8

164

12.1

178

15.9

195

8.8

162

9.8

33     

150

3.5

133

2.2

176

12.9

157

5.8

186

3.6

156

4.2

100     

155

6.9

120

9.4

176

13.4

160

11.7

196

4.6

175

13.1

333     

144

2.1

131

4.7

187

2.6

174

6.7

200

5.1

124

8.1

1000     

151

9.2

125

4.3

174

20.2

125

5.6

157

20.5

108

6.7

3333     

t

 

123

2.6

t

 

80

7.3

t

 

92

1.2

Positive Control

1707

21.1

1393

35.5

2583

115.7

1536

96.6

1946

104.3

1563

85.9

 

  

Strain TA 98

Dose

No Activation
(Negative)

No Activation
(Negative)

10% HLI
(Negative)

10% HLI
(Negative)

10% RLI
(Negative)

10% RLI
(Negative)

ug/Plate

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0     

19

4.6

11

0.6

26

2.7

16

3.5

28

4.3

18

0.9

33     

16

3.1

7

1.8

14

1.9

12

0.7

18

3.4

13

1.3

100     

20

1.3

10

0.9

12

1.9

11

0.7

18

1.5

13

0.9

333     

12

0.7

12

2.5

19

0.3

9

3

19

1.5

12

2.2

1000     

18

1.9

6

1

16

1.5

11

1

17

3.5

10

1

3333     

18

3.1

11

0.6

19

2.3

8

0

16

2.3

10

0.9

Positive Control

259

10

156

2.5

1322

66.6

1297

59.5

984

19.7

916

203.8

Strain: TA1537

Dose

No Activation
(Negative)

No Activation
(Negative)

10% HLI
(Negative)

10% HLI
(Negative)

10% RLI
(Negative)

10% RLI
(Negative)

ug/Plate

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0     

9

0.9

9

1.2

12

2.7

8

2.2

13

1

11

0.6

33     

6

1.5

5

1.3

17

0.9

10

2.3

10

1.8

7

2.2

100     

11

2.1

4

0.9

18

2.3

8

0.9

11

1.2

5

0.9

333     

7

1.2

5

1.7

16

2.7

6

2

10

0.9

7

0.7

1000     

6

1.2

7

2.3

12

2.1

7

1.2

14

3.3

5

0.6

3333     

7

1

7

2.3

11

1.9

4

2

9

2.9

6

0.7

Positive Control

888

239.7

141

22.5

184

42.5

165

2.7

500

11.3

218

5

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Abbreviations:
RLI = induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9
s = Slight Toxicity; p = Precipitate; x = Slight Toxicity and Precipitate; T = Toxic; c = Contamination

Under the conditions tested the test substance was non mutagenic in the bacterial AMES-Test. The positive control gave the expected values.

Applicant's summary and conclusion

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