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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: similar to guideline study; no data regarding GLP

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:
Environ. Mutagen. 9, Suppl. 9, 1-110, (1987)

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Haworth, S. et al.: Environ. Mutagen. 5, Suppl. 1, 3-142
Principles of method if other than guideline:
Use of S. typhymurium strain TA98, TA100, TA1535, TA1537 and/or TA97, but no E.coli strain.
not toxic chemicals tested up to a maximum dose of 10 mg/plate, poorly soluble chemicals were tested up to the dose defined by solubility, A maximum of 0.05 ml solvent was added to each plate, only 2-Aminoanthracene was used as the indicator of the efficacy of the S9-Mix, not every individual plate count is displayed, no justification that no confirmation of the negative result has been made
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Dimethylamine, no further data

Method

Target gene:
his-
Species / strain
Species / strain / cell type:
other: Salmonella Typhimurium TA98, TA100, TA1535, TA1537, TA97
Metabolic activation:
with and without
Metabolic activation system:
rat and hamster S9 (10% Aroclor 1254-induced)
Test concentrations with justification for top dose:
0.000, 33.000, 100.000, 333.000, 1000.000, 3333.000, 4500.000 µg/plate
Vehicle / solvent:
H2O
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
Remarks:
run with each trial
Positive controls:
yes
Remarks:
without S9: Sodium azide (TA1535, TA100), 9-aminoacridine (TA1537), 4-nitro-o-phenylenediamine (TA98) with S9: 2-aminoanthracene
Evaluation criteria:
An individual trial was judged mutagenic (+) if a dose-related increase over the corresponding solvent control was seen, and it was judged weakly mutagenic C+W) if a low-level dose response was seen. A trial was considered questionable (?) if a dose related
increase was judged insufficiently high to justify a call of " + W," if only a single dose was elevated over the control, or if a non-dose-related increase was seen.
The distinctions between a weak mutagenic response and a mutagenic response, or between a weak mutagenic response and a questionable mutagenic response are highly subjective.
A chemical was judged to be mutagenic (+), or weakly mutagenic (+W), if it produced a reproducible, dose-related increase in his+ revertants over the corresponding solvent controls in replicate trials. A chemical was considered to be questionable (?) if a reproducible increase of hist revertants did not meet the criteria for either a " + " or " + W," or if only single doses produced an increase in his+ revertants in repeat trials
Statistics:
no data

Results and discussion

Test results
Species / strain:
other: all strains tested
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: > 1000 µg/plate
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

Table 82.1 DIMETHYLAMINE (LAB: EGG   SOLVENT: H2O)

DOSE

TA100

TA1535

TA1537

TA98

NA

10% HLI

10% RLI

NA

10% HLI

10% RLI

NA

10% HLI

10% RLI

NA

10% HLI

10% RLI

ug/PLATE

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

0.000

93

8.0

89

9.1

76

2.5

24

1.9

8

1.7

13

1.2

4

1.5

4

0.9

8

1.5

18

5.2

20

0.6

24

3.2

33.000

92

5.4

 

 

 

 

21

1.5

 

 

 

 

8

1.0

 

 

 

 

20

2.7

 

 

 

 

100.000

91

8.7

90

3.1

77

2.0

19

2.5

7

1.5

11

0.9

8

0.6

6

0.9

8

2.6

15

2.8

24

2.2

17

1.0

333.000

92

6.4

80

4.5

91

0.6

20

4.0

10

0.6

10

2.7

5

1.3

6

2.3

6

2.2

17

4.8

20

2.0

17

2.7

1000.000

88

6.3

92

7.0

88

5.2

16

2.3

7

1.2

8

1.7

5

1.5

8

0.3

5

1.7

17

1.2

20

3.9

24

3.0

3333.000

t

 

88

5.2

89

11.0

11s

1.5

8

1.2

9

1.3

6s

0.7

7

1.5

10

0.3

t

 

19

5.0

22

1.5

4500.000

 

 

82

6.7

86

2.5

 

 

9s

1.8

8

2.4

 

 

6

1.3

6

3.3

 

 

19

1.2

20

1.5

POS

2003

16.5

887

78.0

580

31.2

1176

36.1

80

1.9

51

2.7

573

199.4

94

4.2

58

8.7

840

81.5

1011

82.4

639

64.7

 

Table 82.2 DIMETHYLAMINE (LAB: EGG   SOLVENT: H2O)

DOSE

TA100

TA1535

TA1537

TA98

NA

10% HLI

10% RLI

NA

10% HLI

10% RLI

NA

10% HLI

10% RLI

NA

10% HLI

10% RLI

ug/PLATE

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

MEAN

SEM

0.000

117

10.1

107

6.2

132

16.2

21

3.5

13

1.5

10

0.7

7

2.0

8

0.9

8

0.6

22

4.4

34

2.9

28

3.2

100.000

126

4.8

124

3.2

106

7.0

14

1.2

10

1.2

15

4.2

8

1.9

8

0.3

9

1.5

25

2.7

25

2.9

28

1.5

333.000

112

9.5

116

5.0

120

0.9

15

3.9

15

1.8

10

0.0

8

1.3

7

1.2

10

2.2

21

1.7

28

1.7

26

1.2

1000.000

126

4.4

136

4.4

127

4.3

18

3.2

10

2.0

10

1.7

5

0.3

5

0.9

9

0.6

22

0.7

29

6.2

31

1.9

2000.000

108

7.6

115

5.1

113

16.4

15s

3.0

12s

1.9

14

1.5

9s

2.8

9

0.3

11

1.7

24s

1.8

26

1.2

27

1.2

3333.000

97s

11.5

129s

4.7

117

14.7

t

 

11s

1.2

11

1.2

t

 

7

0.6

8

0.6

20s

1.5

29

2.4

27

1.8

4000.000

 

 

 

 

 

 

 

 

16s

2.3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

POS

2012

55.2

1503

72.7

1255

49.0

1205

65.2

116

7.2

60

1.7

535

18.1

184

21.0

133

2.1

2002

38.4

1270

40.2

1022

55.2

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Dimethylamine was considered not mutagenic in the tests performed.
Executive summary:

This test was performed according to Haworth, S. et al.: Environ. Mutagen. 5, Suppl. 1, 3-142 with Salmonella typhimurium TA1535, TA1537, TA98, TA100, and TA 97. The concentrations of the test substance ranged from 0.000, 33.000, 100.000, 333.000, 1000.000, 3333.000 and 4000.000 or 4500.000 µg/plate using the pre-incubation method in either the presence or absence of 10% rat or hamster liver metabolic activation. The highest in some strains nontoxic dose tested was 1000.000 mg/plate and the test result was negative according to all strains, with and without metabolic activation. (Zeiger et al., 1987).