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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information
Triethylammonium bromide is considered as “not mutagenic under the conditions of the ”bacterial reverse mutation assay".
Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 2013 - November 2013
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
Principles of method if other than guideline:
None as known.
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
other: Salmonella typhimurium (TA 97a, TA 98, TA 100, TA 102 and TA 1535)
Metabolic activation:
with and without
Metabolic activation system:
S9 (produced from the livers of male Sprague-Dawley rats which were treated with 500 mg Aroclor 1254/kg body weight intraperitoneally)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Deionised water
- Justification for choice of solvent/vehicle: because the test item was sufficiently soluble, and this solvent doesn’t have any effects on the viability of the bacteria or the number of spontaneous revertants.
Untreated negative controls:
yes
Remarks:
Deionised water
Negative solvent / vehicle controls:
yes
Remarks:
Deionised water
True negative controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
sodium azide
benzo(a)pyrene
other: 4-Nitro-1,2-phenylene diamine; 2-Amino-anthracene
Species / strain:
other: Salmonella typhimurium (TA 97a, TA 98, TA 100, TA 102 and TA 1535)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

First Experiment

Confirmation of the Criteria and Validity

The treatments for the sterility control and the determination of the titre didn’t show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory. All positive controls (diagnostic mutagenes) showed mutagenic effects with and without metabolic activation.

Solubility and Toxicity

The test item was dissolved in deionised water. A stock solution containing 50.0±0.5 g/L was prepared.

No signs of toxicity towards the tested strains could be observed. The background lawn was visible and the number of revertant colonies was not reduced.


Main Revertants First Experiment

Strain

TA97a

TA98

TA100

TA102

TA1535

Induction

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

H2O

Mean

99

106

15

17

151

135

186

220

21

21

sd

13.7

16.1

2.2

4.5

3.3

21.6

9.4

9.9

3.3

5.4

DMSO

Mean

128

105

17

18

152

122

186

217

19

17

sd

22.9

10.4

2.2

2.2

7.4

10.1

9.8

17.4

4.3

7.8

Positive
Controls*

Mean

590

652

118

95

689

630

540

449

108

125

sd

97

39

10

10

31

89

111

20

14

12

f(I)

4.61

6.21

6.94

5.28

4.56

5.16

2.90

2.07

5.14

7.35

5007 µg/pl.

Mean

121

119

20

18

135

114

181

203

22

21

sd

7

8

2

3

14

24

14

23

3

2

f(I)

1.22

1.12

1.33

1.06

0.89

0.84

0.97

0.92

1.05

1.00

1502 µg/pl.

Mean

118

103

17

18

151

132

194

216

22

20

sd

21

6

2

6

25

10

37

14

5

4

f(I)

1.19

0.97

1.13

1.06

1.00

0.98

1.04

0.98

1.05

0.95

501 µg/pl.

Mean

114

111

15

19

126

132

192

198

25

18

sd

9

27

3

2

10

7

7

22

6

2

f(I)

1.15

1.05

1.00

1.12

0.83

0.98

1.03

0.90

1.19

0.86

150 µg/pl.

Mean

105

113

19

17

141

122

194

227

22

20

sd

15

19

3

1

3

26

15

19

6

2

f(I)

1.06

1.07

1.27

1.00

0.93

0.90

1.04

1.03

1.05

0.95

50 µg/pl.

Mean

122

119

18

21

154

133

208

234

24

20

sd

9

3

2

4

11

39

14

7

2

3

f(I)

1.23

1.12

1.20

1.24

1.02

0.99

1.12

1.06

1.14

0.95

f(I) = increase factor

* Different positive controls were used

Mutagenicity

No significant increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed.No concentration-related increase over the tested range was found.

 

Therefore, the test item is stated as not mutagenic under the test conditions.

To verify this result, a second experiment was performed using the pre-incubation method.


Second Experiment

Confirmation of the Criteria and Validity

The treatments for the sterility control and the determination of the titre didn’t show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory. All positive controls showed mutagenic effects with and without metabolic activation.

Solubility and Toxicity

The test item was dissolved in deionised water. A stock solution containing 50.0±0.5 g/L was prepared.

No signs of toxicity towards the tested strains could be observed. The background lawn was visible and the number of revertant colonies was not significantly reduced.

Survey of the Findings

The mean revertant values of the four replicates are presented in the following table.

Mean Revertants Second Experiment

Strain

TA97a

TA98

TA100

TA102

TA1535

Induction

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

H2O

Mean

100

114

14

10

115

121

207

196

19

19

sd

6.2

16.6

3.0

0.0

9.5

16.9

17.5

24.1

2.9

1.3

DMSO

Mean

105

113

15

13

118

117

198

205

20

21

sd

3.6

11.0

1.3

0.0

13.4

12.8

20.8

28.3

4.3

3.0

Positive
Controls*

Mean

581

767

109

146

569

957

676

804

155

140

sd

151

165

4

49

116

253

56

161

23

36

f(I)

5.53

6.79

7.27

11.23

4.95

8.18

3.41

3.92

8.16

6.67

5023 µg/pl.

Mean

116

131

15

16

123

119

237

198

21

21

sd

15

27

2

2

17

22

7

14

3

4

f(I)

1.16

1.15

1.07

1.60

1.07

0.98

1.14

1.01

1.11

1.11

2512 µg/pl.

Mean

103

118

14

15

127

107

226

178

19

17

sd

7

13

3

2

14

6

31

16

2

2

f(I)

1.03

1.04

1.00

1.50

1.10

0.88

1.09

0.91

1.00

0.89

1256 µg/pl.

Mean

105

118

16

12

139

129

211

188

24

21

sd

4

13

2

2

13

20

22

29

2

2

f(I)

1.05

1.04

1.14

1.20

1.21

1.07

1.02

0.96

1.26

1.11

628 µg/pl.

Mean

106

119

17

13

114

119

222

174

19

21

sd

11

28

4

1

21

17

25

15

3

2

f(I)

1.06

1.04

1.21

1.30

0.99

0.98

1.07

0.89

1.00

1.11

314 µg/pl.

Mean

98

107

16

12

129

117

194

207

22

22

sd

3

13

3

1

8

8

28

22

2

2

f(I)

0.98

0.94

1.14

1.20

1.12

0.97

0.94

1.06

1.16

1.16

f(I) = increase factor

* Different positive controls were used

Mutagenicity

No significant increase of the number of revertant colonies in the treatments with and without metabolic activation was observed.

No concentration-related increase over the tested range was found.

Therefore, the test item is stated as not mutagenic under the test conditions.

 

Conclusions:
Interpretation of results (migrated information):
negative

The test item triethylammonium bromide is considered as “not mutagenic under the conditions of the test”.
Executive summary:

The test item is considered not mutagenic for the reasons given above. The test item did not show any cytotoxicity towards the bacteria.

The confirmation tests of the genotype didn’t show any irregularities. The control of the titre was above the demanded value.

The numbers of revertant colonies of the positive controls were within the range of the historical data (all batch numbers of bacteria) of the laboratory and were definitely increased in comparison with the negative controls, as well as showing mutagenic potential of the diagnostic mutagenes.

Spontaneous revertants were within the normal range in comparison with the historical data (all batch numbers of bacteria) of the LAUS GmbH. For these reasons, the result of the test is considered valid.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

The test item did not show any cytotoxicity towards the bacteria. The confirmation tests of the genotype didn’t show any irregularities. The control of the titre was above the demanded value. The numbers of revertant colonies of the positive controls were within the range of the historical data (all batch numbers of bacteria) of the laboratory and were definitely increased in comparison with the negative controls, as well as showing mutagenic potential of the diagnostic mutagenes.

Justification for classification or non-classification