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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
GLP status unknown

Data source

Reference
Reference Type:
publication
Title:
The results of microbial mutation test for 43 industrial chemicals
Author:
Shimizu H., Suzuki Y., Tekemura N., Goto S., Matsushita H.
Year:
1985
Bibliographic source:
Jpn. J. Ind. Health, 27, 400-419,

Materials and methods

Principles of method if other than guideline:
According to Ames et al., Mut. Res., 31, 1975
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Sebacic acid
EC Number:
203-845-5
EC Name:
Sebacic acid
Cas Number:
111-20-6
Molecular formula:
C10H18O4
IUPAC Name:
sebacic acid
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source of test material: Tokyo Kasei Kogyo Co. LTD. Tokyo, Japan

Method

Target gene:
S. typhimurium: his-
E. coli: trp-
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Details on mammalian cell type (if applicable):
CELLS USED
- Type and source of cells:
S. typhimurium provided by B.N. Ames (USA)
E.coli provided by M. Ishizawa (Japan)
Species / strain / cell type:
S. typhimurium TA 1538
Details on mammalian cell type (if applicable):
CELLS USED
- Type and source of cells:
S. typhimurium provided by B.N. Ames (USA)
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
1; 5; 10; 50; 100; 500; 1,000; 5,000 ug/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
9-aminoacridine
N-ethyl-N-nitro-N-nitrosoguanidine
benzo(a)pyrene
other: without S9-mix: 2-(2 furyl)-3-(5-nitro-2-furyl) acrylamide, with S9-mix: 2-Aminoanthracene

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA98, TA100, TA1535, TA1537, TA1538 and E.coli WP2uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
True negative controls validity:
not applicable
Positive controls validity:
valid

Any other information on results incl. tables

Table 1: Mutagenic acitivities of the test substances and the positive control

Compound

Dose

µg/plate

Revertant colonies/plate

 

TA100

TA1535

WP3 uvrA

TA98

TA1537

TA1538

 

 

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

Decanedioic acid

1

130

130

29

9

17

26

43

49

17

23

23

38

 

5

119

138

34

11

24

22

52

50

13

25

26

38

 

10

131

130

26

15

23

27

39

46

14

24

31

33

 

50

125

123

34

13

18

24

47

56

11

24

27

33

 

100

136

119

36

16

26

29

50

47

13

27

36

39

 

500

140

122

28

13

24

32

42

56

11

18

20

36

 

1,000

127

132

26

12

27

23

34

45

18

12

28

33

 

5,000

112

134

36

14

24

27

45

47

12

20

30

32

Control

 

 

 

 

 

 

 

 

 

 

 

 

 

AF-2

0.01

501 ± 84.7

- b

-

-

-

-

-

-

-

-

-

-

 

0.05

-

-

-

-

1,082± 293.7

-

278± 64.8

-

-

-

-

-

ENNG

5.0

-

-

1,101± 683.1

-

-

-

-

-

-

-

-

-

9-AC

80.0

-

-

-

-

-

-

-

-

889 ± 275.7

-

-

-

4-NQO

0.25

-

-

-

-

-

-

-

-

-

-

270 ± 66.2

-

B(a)P

5.0

-

1,084± 236.3

-

-

-

-

-

809± 108.4

-

313± 41.6

-

354± 89.4

2-AA

5.0

-

-

-

440± 198.6

-

359± 127.0

-

-

-

-

-

-

b: not tested

AF-2: 2-(2 furyl)-3-(5-nitro-2-furyl) acrylamide, ENNG: N-Ethyl-N'-nitro-N-nitrosoguanidine, 9 -AC: 9-Aminoacridine, 4 -NQO: 4-Nitroquinoline-l-oxide, B(a)P: Benzo(a)pyrene, 2-AA: 2-Aminoanthracene

Applicant's summary and conclusion

Conclusions:
The test substance was not found mutagenic in the strains specified.