Registration Dossier

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: Test comparable to guideline test.

Data source

Reference
Reference Type:
publication
Title:
Salmonella mutagenicity tests: III. Results from the testing of 255 chemicals
Author:
Zeiger, E., Anderson, B., Haworth, S., Lawlor, T., Mortelmans, K., and Speck, W. et al.
Year:
1987
Bibliographic source:
Environ. Mol. Mutagen. 9: 1-110

Materials and methods

Principles of method if other than guideline:
Salmonella/microsome preincubation assay using a standard protocol approved by the National Toxicology Program
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
CAS 75-64-9 (tert-butylamine), purity not indicated

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
deficiency: histidine
Metabolic activation:
with and without
Metabolic activation system:
rat and hamster S9 (10% Aroclor 1254-induced)
Test concentrations with justification for top dose:
0, 33, 100, 333, 1000, 1666 and 3333 ug/plate
Vehicle / solvent:
water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Remarks:
- Positive control groups and treatment: without S9: Sodium azide (TA1535, TA100), 9-aminoacridine (TA1537), 4-nitro-o-phenylenediamine (TA98). With S9: 2-aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

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

NUMBER OF REPLICATIONS: 3
Evaluation criteria:
Positive if a reproducible dose related response over the solvent control was obtained.

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: 1000 ug/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Precipitation concentration: not indicated
Cytotoxic concentration: 1000 ug/plate

Mutagenicity:
- With metabolic activation: negative
- Without metabolic activation: negative
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

TA1535

Dose

No Activation
(Negative)

No Activation
(Negative)

10% HLI
(Negative)

10% HLI
(Negative)

10% RLI
(Negative)

10% RLI
(Negative)

Protocol

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

ug/Plate

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0     

4

1.2

7

2.1

5

1.2

22

2

5

0.9

15

2.2

33     

 

 

 

 

5

0.9

20

3.2

5

1

15

0.7

100     

3

0.6

4

1.2

4

2.1

14

2.9

5

1.9

12

2.1

333     

1

1

4

0.6

5

0.7

21

6.1

6

1.2

12

0.7

1000     

4

0.9

6

0.9

5

1.2

8

0.7

5

0.7

10

2.1

3333     

4

0.7

5

1.2

9

0.9

t

 

4

1.5

t

 

10000     

4

1.2

0t

0

 

 

 

 

 

 

 

 

Positive Control

1280

127.7

742

30.7

93

4.3

290

19.1

96

4.7

188

17.8

 

TA100

Dose

No Activation
(Negative)

No Activation
(Negative)

10% HLI
(Negative)

10% HLI
(Negative)

10% RLI
(Negative)

10% RLI
(Negative)

Protocol

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

ug/Plate

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0     

160

6.8

97

3.6

146

3

179

1.3

111

4.8

159

5.7

33     

 

 

 

 

105

3.1

188

14.2

93

10

171

5.3

100     

155

5.2

86

4.3

114

13.3

181

12.9

86

5.5

184

9.6

333     

161

8.2

96

10.5

100

7

170

10.9

96

3.8

182

11.4

1000     

147

0

101

8.5

84

6.2

186

5

83

4.1

173

10

3333     

165

11.9

94

7

77t

6.5

134

5.2

80

3.6

138

10.9

10000     

11

10.7

t

 

 

 

 

 

 

 

 

 

Positive Control

1032

16.4

1616

45.9

2049

77.5

1971

201.8

1621

142.2

2183

283.7

 

TA98

Dose

No Activation
(Negative)

No Activation
(Negative)

10% HLI
(Negative)

10% HLI
(Negative)

10% RLI
(Negative)

10% RLI
(Negative)

Protocol

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

ug/Plate

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0     

13

0.9

10

0.3

23

4.4

44

2.6

25

1

18

3.5

33     

 

 

 

 

23

3.8

40

1.5

24

2.6

19

3.8

100     

11

0.9

10

0.9

16

3

37

2.2

23

0.9

23

1.8

333     

12

1

12

1.3

22

4.7

34

1.7

29

0.9

23

4

1000     

11

2.2

9

0.7

18

2.4

33

1.2

19

1.5

20

1.7

3333     

14

1

12

2.3

t

 

17

1.9

15

1.5

17

1.2

10000     

13

1.8

3

2.5

 

 

 

 

 

 

 

 

Positive Control

155

17.2

171

9

838

36.6

1176

67

425

46.3

696

31.1

 

TA1537

Dose

No Activation
(Negative)

No Activation
(Negative)

10% HLI
(Negative)

10% HLI
(Negative)

10% RLI
(Negative)

10% RLI
(Negative)

Protocol

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

Preincubation

ug/Plate

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

Mean

± SEM

0     

6

1.9

3

0.9

4

0.6

11

1.8

4

0.7

7

0.7

33     

 

 

 

 

4

1.2

13

1.2

5

1

5

1.5

100     

7

1.7

6

0.9

4

1.2

12

2.5

8

1.9

8

1.5

333     

5

1.5

4

1.2

8

3.5

9

2.5

7

1

7

0.7

1000     

4

0.7

3

0.9

5

1.9

13

5.5

3

0.7

6

1.5

3333     

6

0.7

4

0.7

5

0.7

4

1.5

5

1.2

5

1

10000     

4

1

1t

0.5

 

 

 

 

 

 

 

 

Positive Control

82

5.2

129c

33.5

162

25.4

212

26

262

29.7

337

12.8

 

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

 

 

Applicant's summary and conclusion