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EC number: 242-472-2 | CAS number: 18643-08-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Bacterial mutagenicity (OECD 471): negative
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-05-10 to 2002-09-9
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Freie und Hansestadt Hamburg Behörde für Arbeit, Gesundheit und Soziales, Germany
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- His operon
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9-mix
- Test concentrations with justification for top dose:
- Preliminary toxicity test:
- 0.316, 1, 3.16, 10, 31.6, 100, 316, 1000, 3160 and 5000 μg/plate (without metabolic activation)
Experiment I:
- 100, 316, 1000, 3160 and 5000 μg/plate (with and without metabolic activation)
Experiment II:
- 31.6, 100, 316, 1000 and 3160 μg/plate (with and without metabolic activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Ethylene glycol dimethylether
- Justification for choice of solvent/vehicle: Solubility properties and relative non-toxicity to bacteria - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9-mix: sodium azide, 10 µg/plate (TA 100, TA 1535); 2-nitro-fluorene, 10 µg/plate (TA 98); 9-AA, 100 µg/plate (TA 1537); MMS, 1300 µg/plate (TA 102); +S9-mix: 2-AA, 2 µg/plate (TA 98, TA 102, TA 1537); CPA, 1500 µg/plate (TA 100, TA 1535)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 minutes
- Expression time (cells in growth medium): 48 hours
NUMBER OF REPLICATIONS: 3 plates for each test concentration
DETERMINATION OF CYTOTOXICITY
- Method: Background lawn assessment, revertant colony counts - Evaluation criteria:
- A result is positive if the number of revertants is significantly increased compared with the solvent control to at least 2-fold of the solvent control for TA 98, TA 100 and TA 102 and 3-fold of the solvent control for TA 1535 and TA 1537 in both experiments.
Positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking on histidine-free agar plates.
Cytotoxicity is defined as a reduction in the number of colonies by > 50 % compared with the solvent control and/or a sparse background lawn. - Statistics:
- MANN and WHITNEY and Spearman’s rank.
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 3160 μg/plate for all tester strains (experiment II with and without metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 3160 μg/plate for all tester strains (experiment II with and without metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 3160 μg/plate for all tester strains (experiment II with and without metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 3160 μg/plate for all tester strains (experiment II with and without metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 3160 μg/plate (experiment II with and without metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Results were within range of historical control data
- Conclusions:
- Interpretation of results: negative
In a highly reliable test, conducted under OECD 471, with GLP, no mutagenic effect was observed for the test substance tested up to cytotoxic concentration in any of the test strains in two independent experiments without and with metabolic activation. The test substance is non-mutagenic in test strains used.
Reference
Table 2: Dose range-finding study Number of revertants per plate (2 plates)
|
TA 100 |
||
Conc. |
Plate 1 |
Plate 2 |
Cytotoxic |
0* |
123 |
131 |
No |
0.316 |
113 |
118 |
No |
1 |
117 |
106 |
No |
3.16 |
108 |
179 |
No |
10 |
108 |
116 |
No |
31.6 |
105 |
129 |
No |
100 |
139 |
149 |
No |
316 |
140 |
149 |
No |
1000 |
130 |
124 |
No |
3160 |
159 |
145 |
No |
5000 |
192 |
189 |
No |
*solvent control with Ethylene glycol dimethylether
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA 98 |
TA 100 |
TA 102 |
||||||
Conc. |
-S9 mix |
+S9 mix |
Cytotoxic |
-S9 mix |
+S9 mix |
Cytotoxic |
-S9 mix |
+S9 mix |
Cytotoxic |
0* |
29.7 |
28 |
No |
128.3 |
122.7 |
No |
297.3 |
297.3 |
No |
100 |
26.7 |
24.7 |
No |
130.7 |
144.7 |
No |
308 |
274.7 |
No |
316 |
32 |
37.3 |
No |
131.7 |
129.3 |
No |
302 |
264.7 |
No |
1000 |
39.3 |
31.7 |
No |
130.3 |
142 |
No |
298.7 |
299 |
No |
3160 |
34.3 |
33.7 |
No |
123.3 |
128 |
No |
290.3 |
276 |
No |
5000 |
40 |
30 |
No |
126 |
125.7 |
No |
294 |
273.7 |
No |
Positive control |
916 |
944.3 |
No |
1022.3 |
1007 |
No |
1051 |
1027.7 |
No |
*solvent control with Ethylene glycol dimethylether
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA 1535 |
TA 1537 |
||||
Conc. |
-S9 mix |
+S9 mix |
Cytotoxic |
-S9 mix |
+S9 mix |
Cytotoxic |
0* |
14.3 |
21.3 |
No |
7 |
4.7 |
No |
100 |
14 |
15.7 |
No |
5 |
3.3 |
No |
316 |
15.3 |
14.7 |
No |
5.7 |
5.7 |
No |
1000 |
18.7 |
14 |
No |
4.3 |
3.7 |
No |
3160 |
15.7 |
14 |
No |
5 |
7.7 |
No |
5000 |
18.3 |
12.7 |
No |
3.7 |
5.3 |
No |
Positive control |
404.7 |
410.7 |
No |
407.3 |
414.3 |
No |
*solvent control with Ethylene glycol dimethylether
Table 4: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA 98 |
TA 100 |
TA 102 |
||||||
Conc. |
-S9 mix |
+S9 mix |
Cytotoxic |
-S9 mix |
+S9 mix |
Cytotoxic |
-S9 mix |
+S9 mix |
Cytotoxic |
0* |
34 |
36.3 |
No |
126.7 |
147 |
No |
277 |
280.7 |
No |
31.6 |
31 |
38.7 |
No |
138.3 |
109 |
No |
284 |
275 |
No |
100 |
28 |
29.7 |
No |
126 |
121.7 |
No |
287.3 |
269 |
No |
316 |
31.7 |
36.3 |
No |
140.7 |
133.3 |
No |
266 |
279 |
No |
1000 |
33.3 |
32.7 |
No |
132.7 |
134.7 |
No |
271.3 |
272.3 |
No |
3160 |
0 |
0 |
Yes |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
538.7 |
557.7 |
No |
1122 |
1195.3 |
No |
1335.3 |
1240.7 |
No |
*solvent control with Ethylene glycol dimethylether
Table 4: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA 1535 |
TA 1537 |
||||
Conc. |
-S9 mix |
+S9 mix |
Cytotoxic |
-S9 mix |
+S9 mix |
Cytotoxic |
0* |
12.7 |
14 |
No |
5.7 |
4.3 |
No |
31.6 |
13.3 |
14 |
No |
4 |
4.3 |
No |
100 |
14 |
12.3 |
No |
4 |
5 |
No |
316 |
11.7 |
14 |
No |
5 |
5 |
No |
1000 |
13.7 |
12 |
No |
5.7 |
6.7 |
No |
3160 |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
337 |
333 |
No |
336.3 |
339 |
No |
*solvent control with Ethylene glycol dimethylether
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A reliable bacterial gene mutation study (Ames test) performed according to OECD TG 471 and in compliance with GLP with chloro(dimethyl)octadecylsilane (CAS 18643-08-8) is available (LPT, 2002). The strains Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 were tested according to the plate incorporation (experiment I) and pre-incubation (experiment II) procedure in the absence and presence of a metabolic activation system (Aroclor-induced rat liver S9-mix). Two independent experiments were conducted in three repetitions at each concentration from 100 to 5000 µg/plate (experiment I) and 31.6 to 3160 µg/plate (experiment II). Cytotoxicity was observed in all tester strains in the second experiment carried out with and without metabolic activation at the highest concentration of 3160 µg/plate. Appropriate solvent (ethylene glycol dimethylether) and positive controls were included and gave the expected results. No significant increase in the number of revertants was observed in any of the tester strains with and without metabolic activation. Based on the results the test material was considered to be not mutagenic to bacteria under the conditions of the tests.
Justification for classification or non-classification
Based on the available data on genetic toxicity, there is no indication that the substance induces genetic toxicity in bacteria. However, no final decision on classification for genetic toxicity according to Regulation (EC) 1272/2008 can be made, as no information on mutagenicity and clastogenicity in mammalian cells/in vivo is available.
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