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EC number: 902-537-4 | CAS number: -
Genetic toxicity: in vitro
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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Salmonella mutagenicity test results for 250 chemicals
- Author:
- Haworth S, Lawlor T, Mortelmans K, Speck W & Zeiger E
- Year:
- 1 983
- Bibliographic source:
- Environ. Mutagen. Suppl. 1, 3-142
- Reference Type:
- publication
- Title:
- Mutagenicity of carcinogenic azo dyes and their derivatives.
- Author:
- Yahagi, T, Degawa M, Seino Y, Matsushima T, Sugimura T & Hashimoto Y.
- Year:
- 1 975
- Bibliographic source:
- Cancer Lett. 1, 91-96.
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Ames test plus preincubation as in Yahagi et al., 1975
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only four S. typhimurium strains tested (TA1535, TA1537, TA98, TA100)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Choline chloride
- EC Number:
- 200-655-4
- EC Name:
- Choline chloride
- Cas Number:
- 67-48-1
- Molecular formula:
- C5H14NO.Cl
- IUPAC Name:
- 2-hydroxy-N,N,N-trimethylethanaminium chloride
Constituent 1
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S-9 fractions from male Sprague-Dawley rats and male Syrian hamsters, injected, ip, with Aroclor 1254 (200 mg/ml in corn oil) at 500 mg/kg
- Test concentrations with justification for top dose:
- Tests were performed in three laboratories with varying doses:
CWR: 0, 333, 1000, 3333, 10000, 20830 µg/plate
EGG & SRI: 0, 100, 333, 1000, 3333, 10000 µg/plate - Vehicle / solvent:
- water
Controls
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- no
- Remarks:
- not needed
- True negative controls:
- yes
- Remarks:
- glycerol, glycine, mannitol, and sodium phosphate
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 2-Aminoanthracene (2-AA) and 4-Nitro-o-phenylenediamine (NOPD)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation;
DURATION
- Preincubation period: 20 min
- Exposure duration: 48h
- Expression time (cells in growth medium): 1-2 × 10 exp8 cells
- Selection time (if incubation with a selection agent): 48 h
- Fixation time (start of exposure up to fixation or harvest of cells): 48 h
SELECTION AGENT (mutation assays): histidine
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: other: One or more parameters were used as an indication of toxicity: viability on complete medium (EGG) and reduced numbers of revertant colonies per plate and/or thinning or absence of the bacterial lawn (CWR, EGG, SRI)
CWR: Case Western Reserve University. Dr. William Speck
EGG: Microbiological Associates (formerly EG&G Mason Research Institute), Dr. Steve Haworth
SRI: SRI International, Dr. Kristien Mortelmans - Evaluation criteria:
- A positive response was indicated by a reproducible, dose-related increase of revertant colonies, whether it be twofold over background or not.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Mutagenic responses on Choline chloride on four S. typhimurium strains, Case Western Reserve University
Dose µg/plate |
TA 100 |
TA 1535 |
TA 1537 |
TA 98 |
||||||||
NA |
RLI |
HLI |
NA |
RLI |
HLI |
NA |
RLI |
HLI |
NA |
RLI |
HLI |
|
0 |
132 ± 12.1 |
183 ± 12.8 |
182 ± 25.6 |
6 ± 1.5 |
10 ± 1.8 |
11 ± 2.9 |
7 ± 1.2 |
9 ± 2.3 |
7 ± 0.3 |
10 ± 3.2 |
23 ± 1.5 |
25 ± 2.4 |
333 |
170 ± 14.6 |
203 ± 5.8 |
195 ±4.1 |
9 ± 1.7 |
7 ± 0.6 |
12 ± 2.4 |
7 ± 1.2 |
7 ± 2.0 |
8 ± 0.6 |
17 ± 3.2 |
24 ± 2.2 |
17 ± 2.1 |
1000 |
160 ± 10.7 |
199 ± 16.2 |
192 ± 11.5 |
10 ± 2.1 |
8 ± 0.9 |
12 ± 3.5 |
3 ± 0.3 |
10 ± 1.5 |
8 ± 2.7 |
14 ± 3.5 |
24 ± 4.0 |
31 ± 1.7 |
3333 |
174 ± 6.4 |
204 ± 17.1 |
208 ± 7.9 |
5 ± 0.9 |
5 ± 1.5 |
11 ± 3.5 |
3 ± 1.2 |
10 ± 1.2 |
7 ± 1.0 |
15 ± 2.6 |
22 ± 0.6 |
22 ± 4.0 |
10000 |
175 ± 11.0 |
193 ± 14.6 |
208 ± 20.6 |
9 ± 2.8 |
8 ± 1.9 |
9 ± 3.2 |
4 ± 0.3 |
11 ± 1.9 |
9 ± 1.5 |
14 ± 1.5 |
25 ± 4.4 |
20 ± 3.4 |
20830 |
185 ± 9.5 |
203 ± 6.7 |
201 ± 11.8 |
9 ± 0.6 |
9 ± 0.9 |
12 ± 2.6 |
5 ± 1.9 |
12 ± 1.5 |
6 ± 1.8 |
17 ± 3.2 |
25 ± 2.7 |
24 ± 2.7 |
POS |
471 ± 7.8 |
2551 ± 47.3 |
2132 ± 23.0 |
450 ± 7.6 |
111 ± 6.0 |
121 ± 6.8 |
1315 ± 109.8 |
122 ± 9.9 |
178 ± 19.0 |
479 ± 22.8 |
2089 ± 207.8 |
2269 ± 106.2 |
Table 2: Mutagenic responses on Choline chloride on four S. typhimurium strains, Microbiological Associates (formerly EG&G Mason Research Institute)
Dose µg/plate |
TA 100 |
TA 1535 |
TA 1537 |
TA 98 |
||||||||
NA |
RLI |
HLI |
NA |
RLI |
HLI |
NA |
RLI |
HLI |
NA |
RLI |
HLI |
|
0 |
192 ± 3.5 |
160 ± 14.1 |
141 ± 2.5 |
20 ± 4.1 |
14 ± 1.8 |
13 ± 1.3 |
8 ± 1.8 |
10 ± 1.2 |
8 ± 0.6 |
20 ± 2.8 |
31 ± 1.5 |
31 ± 1.8 |
100 |
172 ± 2.3 |
173 ± 10.0 |
135 ± 4.3 |
18 ± 3.0 |
16 ± 1.7 |
13 ± 2.0 |
8 ± 2.1 |
11 ± 2.3 |
11 ± 1.7 |
18 ± 2.4 |
36 ± 5.4 |
32 ± 3.5 |
333 |
170 ± 7.3 |
158 ± 10.1 |
128 ± 6.7 |
21 ± 2.2 |
15 ± 2.3 |
12 ± 0.6 |
10 ± 2.9 |
8 ± 0.3 |
13 ± 1.5 |
18 ± 2.3 |
21 ± 1.5 |
31 ± 3.2 |
1000 |
174 ± 2.4 |
170 ± 4.9 |
147 ± 6.4 |
18 ± 2.3 |
15 ± 0.3 |
13 ± 3.8 |
9 ± 1.9 |
12 ± 4.0 |
10 ± 4.2 |
20 ± 3.5 |
36 ± 3.3 |
37 ± 2.4 |
3333 |
167 ± 13.1 |
169 ± 12.2 |
137 ± 6.2 |
20 ± 3.1 |
12 ± 2.5 |
8 ± 0.7 |
9 ± 1.7 |
9 ± 2.6 |
9 ± 3.1 |
21 ± 1.5 |
26 ± 3.5 |
31 ± 4.1 |
10000 |
171 ± 8.3 |
163 ± 7.8 |
142 ± 2.0 |
14 ± 0.9 |
17 ± 3.8 |
13 ± 1.2 |
9 ± 1.8 |
9 ± 2.6 |
12 ± 1.5 |
23 ± 2.0 |
37 ± 3.5 |
36 ± 1.3 |
POS |
1123 ± 10.7 |
1155 ± 34.2 |
1204 ± 38.1 |
378 ± 25.9 |
74 ± 4.9 |
85 ± 2.7 |
469 ± 36.7 |
87 ± 2.5 |
110 ± 11.2 |
1459 ± 8.6 |
960 ± 28.6 |
1115 ± 16.0 |
Table 3: Mutagenic responses on Choline chloride on four S. typhimurium strains, SRI International
Dose µg/plate |
TA 100 |
TA 1535 |
TA 1537 |
TA 98 |
||||||||
NA |
RLI |
HLI |
NA |
RLI |
HLI |
NA |
RLI |
HLI |
NA |
RLI |
HLI |
|
0 |
102 ± 5.3 |
111 ± 8.1 |
141 ± 2.5 |
25 ± 3.1 |
9 ± 0.3 |
10 ± 0.7 |
16 ± 1.5 |
24 ± 4.3 |
41 ± 1.2 |
46 ± 2.4 |
60 ± 5.0 |
53 ± 3.4 |
100 |
105 ± 6.5 |
89 ± 6.1 |
135 ± 4.3 |
24 ± v2.3 |
7 ± 0.9 |
9 ± 1.5 |
19 ± 1.2 |
17 ± 2.1 |
37 ± 2.6 |
47 ± 3.6 |
53 ± 0.3 |
33 ± 3.6 |
333 |
118 ± 7.2 |
90 ± 10.7 |
124 ± 10.2 |
23 ± 2.8 |
9 ± 2.0 |
12 ± 3.4 |
25 ± 3.2 |
11 ± 1.0 |
41 ± 6.1 |
46 ± 4.5 |
59 ± 4.7 |
34 ± 2.8 |
1000 |
110 ± 2.6 |
86 ± 3.2 |
113 ± 5.2 |
26 ± 3.5 |
6 ± 1.3 |
11 ± 2.7 |
26 ± 0.6 |
15 ± 1.2 |
34 ± 1.9 |
49 ± 4.3 |
54 ± 6.2 |
36 ± 4.0 |
3333 |
111 ± 4.3 |
85 ± 2.9 |
120 ± 8.9 |
20 ± 2.5 |
12 ± 3.6 |
11 ± 2.3 |
24 ± 2.6 |
12 ± 1.7 |
40 ± 2.0 |
44 ± 5.4 |
58 ± 5.0 |
24 ± 2.7 |
10000 |
113 ± 8.2 |
85 ± 5.4 |
120 ± 5.4 |
23 ± 4.1 |
4 ± 1.0 |
12 ± 1.3 |
18 ± 1.8 |
6 ± 1.5 |
31 ± 1.0 |
47 ± 3.5 |
47 ± 2.8 |
28 ± 0.3 |
POS |
526 ± 12.0 |
627 ± 18.2 |
1278 ± 34.7 |
444 ± 17.0 |
374 ± 12.8 |
300 ± 6.3 |
166 ± 5.6 |
238 ± 45.9 |
358 ± 6.0 |
850 ± 18.0 |
509 ± 20.5 |
1170 ± 9.5 |
Table 4: Concentrations of Positive Control Chemicals (µg/plate)
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
||||
-S9 NOPD |
+S9 2-AA |
-S9 SA |
+S9 2-AA |
-S9 SA |
+S9 2-AA |
-S9 9AAD |
+S9 2-AA |
|
CWR |
3.3 |
1.0 |
3.2 |
1.0 |
3.3 |
2.0 |
33.0 |
2.0 |
EGG |
12.0 |
RLI 1.5b HLI 0.75 |
2.5 |
RLI 1.5 HLI 0.75 |
2.5 |
RLI 1.5 HLI 0.75 |
80.0 |
RLI 1.5 HLI 0.75 |
SRL |
5.0 |
1.0 |
1.0 |
1.0 |
1.0 |
2.5 |
50.0 |
2.5 |
NA, not activated
RLI, rat liver S-9, Aroclor 1254 induced
HLI, hamster liver S-9, Aroclor 1254 induced
POS, positive control, see Table 4
NOPD, 4-nitro+-phenylenediamine
2-AA, 2-aminoanthracene
SA, sodium azide
9AAD, 9-aminoacridine.
bDifferent concentrations for each S-9 source.
CWR: Case Western Reserve University. Dr. William Speck
EGG: Microbiological Associates (formerly EG&G Mason Research Institute), Dr. Steve Haworth
SRI: SRI International, Dr. Kristien Mortelmans
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:Negative with and without metabolic activation.
Bacterial reverse mutation studies with choline chloride in 3 different laboratories revealed consistent negative results with and without metabolic activation. Consequently, choline chloride does not need to be classified as mutagenic.
Apart from choline chloride, Si and Ca are naturally occuring in the body in low concentrations and do not show indications for mutagenic, clastogenic or DNA damaging potential when tested in vitro. Therefore the results for choline chloride are also applicable for "Reaction mass of tetrahydroxysilane and choline chloride and calcium chloride and water".
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