Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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: Comparable to guideline study with acceptable restrictions (non-GLP; only 4 strains tested; E. coli WP2 or S. typhimurium TA102 strain missing)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
E. coli WP2 or S. typhimurium TA102 strain missing
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Tridecylamine (mixture as present in CAS 86089-17-0)
- Substance no. 88/1023
- Degree of purity >98%
- Storage: Room temperature

Method

Species / strain
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver S-9 mix
Test concentrations with justification for top dose:
Standard plate test: 6 - 5000 µg/plate; Preincubation test: 1.25 - 50 µg/plate
Vehicle:
- Vehicle used: DMSO
- Justification for choice of solvent/vehicle: Copmplete solubility of test substance in DMSO
Controls
Negative controls:
not specified
Solvent controls:
yes
Remarks:
DMSO
True negative controls:
no
Positive controls:
yes
Remarks:
without S-9: 5 µg N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) for strains TA 100 and TA 1535, 10 µg 4-nitro-o-phenylendiamine for the strain TA 98 and 100 µg 9-aminoacridine chloride monohydrate for the strain TA 1537; with S-9: 10 µg 2-aminoanthracene fo
Details on test system and conditions:
METHOD OF APPLICATION: standard plate test (in agar, plate incorporation) and preincubation test


DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours


NUMBER OF REPLICATIONS:
- Standard plate test: 2 individual experiments in triplicates
- Preincubation test: one experiment in triplicates


DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (his- background growths)
Evaluation criteria:
A substance is regarded as positive if the following is fulfilled:
- doubling of the spontaneous mutation rate
- dose-response relationship
- reproducibility of results

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:
yes
Remarks:
from 25-50 µg/plate (standard test); from 20 µg/plate (preincubation test)
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
other: positive control substances caused increases in the number of revertants as expected, indicating proper test conditions
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.
Additional information on results:
ADDITIONAL INFORMATION ON CYTOTOXICITY:
A bacteriotoxic effect was observed in the standard plate test from about 25 µg - 50 µg/plate onward (without S-9 mix) or from about 50 µg - 100 µg onward (with S-9 mix). In the preincubation test bacteriotoxicity was found using all tester strains at 20 µg/plate (without S-9 mix) or using TA 1535 at 50 µg/plate (with S-9 mix).

Any other information on results incl. tables

Standard plate test:

Dose/plate

(µg)

Without S9 mix

With S9 mix

Mean

SD

Mean

SD

Salmonella typhimurium TA 1535

0 (DMSO)

18

8

18

3

6

18

6

18

2

12

21

4

27

4

20

17

1

25

3

25

18

3

24

10

50

14 B

3

24

2

100

6 B

4

21

2

500

0

0

3 B

1

2500

0

0

0

0

5000

0

0

0

0

MNNG

5.0 µg

1130

140

2-AA

2.5 µg

221

20

Salmonella typhimurium TA 100

0 (DMSO)

100

15

102

13

6

112

9

117

5

12

111

9

117

10

20

88

8

111

9

25

93

6

116

11

50

20 B

8

105

16

100

1

2

82 B

29

500

0

0

2

0

2500

0

0

0

1

5000

0

0

0

0

MNNG

5.0 µg

1123

148

2-AA

2.5 µg

1480

197

Salmonella typhimurium TA 1537

0 (DMSO)

15

2

13

2

6

13

1

12

1

12

11

1

13

7

20

16

4

16

2

25

13 B

7

17

3

50

4 B

1

13

3

100

2 B

2

9 B

3

500

0

0

6

1

2500

0

0

0

0

5000

0

0

0

0

AAC

100.0 µg

327

29

2-AA

2.5 µg

108

15

Salmonella typhimurium TA 98

0 (DMSO)

25

5

43

8

6

23

7

46

7

12

29

6

48

8

20

29

3

40

3

25

30 B

3

36

4

50

B

43

8

100

3 B

4

35 B

10

500

0

0

0

0

2500

0

0

0

0

5000

0

0

0

0

NOPD

10.0 µg

782

76

2-AA

2.5 µg

834

61

B = reduced his- background

.

Preincubation Test:

Dose/plate

(µg)

Without S9 mix

With S9 mix

Mean

SD

Mean

SD

Salmonella typhimurium TA 1535

0 (DMSO)

18

3

17

2

1.25

21

1

2.5

24

2

3

11

1

5

18

6

6

12

1

10

14

3

12

15

4

20

8 B

2

25

15

3

50

8 B

2

MNNG 5.0 µg

1383

90

2-AA 2.5 µg

134

15

Salmonella typhimurium TA 100

0 (DMSO)

100

10

105

5

1.25

134

21

2.5

123

5

3

122

7

5

119

14

6

118

5

10

115

23

12

138

18

20

78 B

8

25

110

9

50

98

22

MNNG 5.0 µg

1140

53

2-AA 2.5 µg

513

86

Salmonella typhimurium TA 1537

0 (DMSO)

9

1

7

2

1.25

12

3

2.5

10

1

3

6

1

5

7

3

6

8

2

10

9

1

12

13

5

20

B

25

8

2

50

5

1

AAC 100.0 µg

416

49

2-AA 2.5 µg

95

5

Salmonella typhimurium TA 98

0 (DMSO)

20

2

29

1

1.25

20

3

2.5

19

1

3

32

3

5

19

4

6

29

2

10

16

1

12

33

6

20

6 B

3

25

28

8

50

33

6

NOPD 10.0 µg

796

105

2-AA 2.5 µg

1093

155

B = reduced his- background

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without metabolic activation

No mutagenicity was seen with bacterial test strains
specific for base substitution and frame shift mutation in
the Ames test both with and without metabolic activation.