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EC number: 203-930-7 | CAS number: 112-04-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro gene mutation:
Bacterial reverse mutation assay (Ames test / OECD 471): negative (RA
from CAS 5157-75-5, CAS 5894-60-0 and CAS 18643-08-8)
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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
- 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, other: TA 1535, TA 1537, TA 98 and 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 S9-mix)
- 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 S9-mix)
- 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. - Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2002-05-13 to 2002-09-23
- 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
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his/trp 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:
- 31.6, 100, 316, 1000 and 3160 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, other: TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 3160 µg/plate for all tester strains
- 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
- 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. - Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2002-05-07 to 2002-08-26
- 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
- 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
- Additional strain / cell type characteristics:
- other: uvr B-, rfa- (TA 98 & TA 100: pKM 101)
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: wild-type, rfa-, pKM 101
- 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:
- 10, 31.6, 100, 316 and 1000 μg/plate (with and without metabolic activation)
Experiment II:
- 10, 31.6, 100, 316 and 1000 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 per concentration in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: other: reduced background lawn and/or a reduction in the number of revertant colonies by more than 50% compared with the solvent control
- Evaluation criteria:
- The test chemical 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 random samples on
histidine free agar plates.
Cytotoxicity is defined as a reduction in the number of colonies by more than 50% compared with the solvent control and/or a scarce background
lawn. - Statistics:
- MANN and WHITNEY and Spearman's rank
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA 100, TA 1535 and TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1000 µg/plate for tester strains TA 100, TA 1535, TA 1537 (experiment I without S9-mix) and TA 1537 (experiment I with S9-mix); ≥316 µg/plate for all tester strains (experiment II without S9-mix)
- 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:
- ≥316 µg/plate (experiment II without S9-mix)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Data were within range of historical control data
- Conclusions:
- Interpretation of results:
negative
Trichloro(hexadecyl)silane has been tested in compliance with OECD 471, under GLP conditions. No increase in the number of revertant colonies compared with the solvent control was observed for the test substance in any of the Salmonella typhimurium strains TA98, TA 100, TA102, TA 1535 and TA 1537 when tested with and without metabolic activation in either the initial plate incorporation or the repeat pre-incubation assay. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test. - Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to the attached justification below and the overall justification for grouping of substances attached in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA 100, TA 1535 and TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 1000 µg/plate for tester strains TA 100, TA 1535, TA 1537 (experiment I without S9-mix) and TA 1537 (experiment I with S9-mix); ≥316 µg/plate for all tester strains (experiment II without S9-mix)
- 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:
- ≥316 µg/plate (experiment II without S9-mix)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 1535, 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 S9-mix)
- 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 S9-mix)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 3160 µg/plate for all tester strains
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: CAS 5894-60-0
- Remarks:
- LPT, 2002
- Conclusions:
- Interpretation of results:
negative
As explained in the analogue justification, the differences in molecular structure between the target and the source are unlikely to lead to differences in genetic toxicity.
Referenceopen allclose all
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. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
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. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
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. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
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. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
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
Table 2: Dose range-finding study Number of revertants per plate (2 plates)
|
TA100 |
||
Conc. |
Plate 1 |
Plate 2 |
Cytotoxic |
0* |
123 |
160 |
No |
0.316 |
142 |
128 |
No |
1 |
121 |
121 |
No |
3.16 |
129 |
152 |
No |
10 |
134 |
134 |
No |
31.6 |
168 |
154 |
No |
100 |
170 |
152 |
No |
316 |
157 |
155 |
No |
1000 |
104 |
156 |
No |
3160 |
0 |
0 |
Yes |
5000 |
0 |
0 |
Yes |
*solvent control with Ethylene glycol dimethylether
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA102 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
36 |
39.7 |
No |
145.3 |
155 |
No |
257 |
312 |
No |
31.6 |
26 |
31 |
No |
152.7 |
145 |
No |
287 |
263.7 |
No |
100 |
37.7 |
31 |
No |
151 |
139.7 |
No |
275.3 |
265 |
No |
316 |
35.7 |
28.7 |
No |
143 |
156.7 |
No |
299.3 |
281.3 |
No |
1000 |
25.3 |
27.7 |
No |
151.3 |
165.3 |
No |
291 |
274 |
No |
3160 |
0 |
0 |
Yes |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
1063 |
1078 |
No |
1312.7 |
1313.3 |
No |
1309 |
1251.3 |
No |
*solvent control with ethylene glycol dimethyl ether
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
11.7 |
12 |
No |
4 |
4.3 |
No |
31.6 |
13 |
12.7 |
No |
4.3 |
3 |
No |
100 |
11.7 |
14 |
No |
3.3 |
4 |
No |
316 |
12.3 |
12 |
No |
3 |
4 |
No |
1000 |
12.7 |
12 |
No |
3 |
4 |
No |
3160 |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
473 |
475.3 |
No |
470.7 |
467.3 |
No |
*solvent control with ethylene glycol dimethyl ether
Table 4: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA102 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
35.3 |
32.7 |
No |
166.3 |
135.3 |
No |
275 |
301 |
No |
31.6 |
30.3 |
35 |
No |
141.3 |
155.3 |
No |
265 |
273 |
No |
100 |
32.3 |
35.7 |
No |
140.3 |
151.3 |
No |
261 |
256.3 |
No |
316 |
25 |
35.3 |
No |
134.3 |
150.7 |
No |
258.3 |
277.7 |
No |
1000 |
40 |
33.7 |
No |
178 |
161.3 |
No |
256.7 |
279.7 |
No |
3160 |
0 |
0 |
Yes |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
446.7 |
448 |
No |
1268.7 |
1283 |
No |
1278 |
1260.7 |
No |
*solvent control with ethylene glycol dimethyl ether
Table 4: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
14 |
14.3 |
No |
5 |
3.3 |
No |
31.6 |
12.7 |
14.3 |
No |
2.7 |
3 |
No |
100 |
13 |
11.7 |
No |
4.7 |
4 |
No |
316 |
12.3 |
12.7 |
No |
3 |
4 |
No |
1000 |
14 |
13 |
No |
4.3 |
4 |
No |
3160 |
0 |
0 |
Yes |
0 |
0 |
Yes |
Positive control |
357.3 |
358 |
No |
360 |
359 |
No |
*solvent control with ethylene glycol dimethyl ether
Table 2: Dose range-finding study Number of revertants per plate (2 plates)
|
TA100 |
||
Conc. |
Plate 1 |
Plate 2 |
Cytotoxic |
0* |
137 |
137 |
No |
0.316 |
140 |
145 |
No |
1 |
144 |
143 |
No |
3.16 |
132 |
106 |
No |
10 |
127 |
116 |
No |
31.6 |
121 |
126 |
No |
100 |
109 |
107 |
No |
316 |
142 |
122 |
No |
1000 |
175 |
170 |
Yes |
3160 |
0 |
0 |
Yes |
5000 |
0 |
0 |
Yes |
*solvent control with DMSO
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA102 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
38 |
36 |
No |
123.3 |
131.3 |
No |
271.7 |
278.3 |
No |
10 |
44.7 |
34 |
No |
150.7 |
133.7 |
No |
259.3 |
279.7 |
No |
31.6 |
43 |
37 |
No |
136.0 |
138 |
No |
269.7 |
284 |
No |
100 |
41.7 |
30 |
No |
131.7 |
148.7 |
No |
275 |
280.7 |
No |
316 |
46 |
28.7 |
No |
156.0 |
143 |
No |
253.7 |
266.3 |
No |
1000 |
47 |
31 |
No |
147.7 |
132.7 |
Yes |
291.3 |
258 |
No |
Positive control |
1041.7 |
987.3 |
No |
1271.3 |
1267 |
No |
1223 |
1219 |
No |
*solvent control with DMSO
Table 3: Experiment 1 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
13.7 |
13 |
No |
5 |
4 |
No |
10 |
13.7 |
12.3 |
No |
3.7 |
4.7 |
No |
31.6 |
13 |
13 |
No |
4.7 |
3 |
No |
100 |
11.3 |
12 |
No |
3 |
3.3 |
No |
316 |
13.7 |
12.3 |
No |
4 |
3.3 |
No |
1000 |
12 |
11.7 |
Yes |
4.7 |
5 |
Yes |
Positive control |
789 |
788.7 |
No |
779.7 |
789.3 |
No |
*solvent control with DMSO
Table 4: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA102 |
||||||
Conc. |
— M |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
37.3 |
38.3 |
No |
114.7 |
134.7 |
No |
277 |
259.3 |
No |
10 |
41.3 |
28 |
No |
108.3 |
104.7 |
No |
252.3 |
281.3 |
No |
31.6 |
36.3 |
37 |
No |
134.3 |
114.7 |
No |
256 |
268.7 |
No |
100 |
33.3 |
37 |
No |
120.3 |
134.3 |
No |
248 |
278.7 |
No |
316 |
46.7 |
30.7 |
Yes |
132 |
151.3 |
Yes |
260.3 |
272 |
Yes |
1000 |
53.3 |
40.7 |
Yes |
117.7 |
123.7 |
Yes |
296.3 |
276 |
Yes |
Positive control |
637.7 |
654.7 |
No |
997.3 |
976 |
No |
1222 |
1226.3 |
No |
*solvent control with DMSO
Table 4: Experiment 2 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA1535 |
TA1537 |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
14 |
17.3 |
No |
5 |
6 |
No |
10 |
14.3 |
13.3 |
No |
4.7 |
6 |
No |
31.6 |
13.7 |
13.7 |
No |
4.7 |
5 |
No |
100 |
13 |
13 |
No |
5 |
5.3 |
No |
316 |
12 |
13.7 |
Yes |
5.3 |
5.3 |
Yes |
1000 |
14 |
14 |
Yes |
4.3 |
5 |
Yes |
Positive control |
902.3 |
900 |
No |
377.3 |
381.3 |
No |
*solvent control with DMSO
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No data on genetic toxicity (mutagenicity) in bacteria cells is available for trichloro(octadecyl)silane (CAS 112-04-9).Therefore, the risk assessment was performed based on the available data from the source substancetrichloro(hexadecyl)silane (CAS 5894-60-0), dichloromethyloctadecylsilane (CAS 5157-75-5) and chlorodimethyloctadecylsilane (CAS 18643-08-8).In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and in accordance with the Read across assessment framework (RAAF, ECHA 2017) read across from analogue substances has been applied to support the human health hazard assessment oftrichloro(octadecyl)silane(CAS 112-04-9).
Genetic toxicity (mutagenicity) in bacteria in vitro
CAS 5894-60-0
A reliable bacterial gene mutation study (Ames test) performed according to OECD TG 471 and in compliance with GLP with Trichloro(hexadecyl)silane (CAS 5894-60-0) is available (LPT, 2002a). 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 10 to 1000 µg/plate (experiment I and II). Cytotoxicity was recorded in the tester strains TA 100, TA 1535 and TA 1537 at the highest concentration of 1000 µg/plate (experiment I without metabolic activation) and for the tester strain TA 1537 at 1000 µg/plate (experiment I with metabolic activation). Moreover, cytotoxic effects were recorded at concentrations ≥316 µg/plate for all tester strains in the second experiment without metabolic activation. No precipitation was recorded in both experiments carried out with and without metabolic activation. 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.
CAS 5157-75-5
Another reliable bacterial gene mutation study (Ames test) performed according to OECD TG 471 and in compliance with GLP with Dichloromethyloctadecylsilane (CAS 5157-75-5) is available (LPT, 2002b). 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 31.6 to 3160 µg/plate (experiment I and II). Cytotoxicity was observed in all tester strains in both experiments carried out with and without metabolic activation at the highest concentration of 3160 µg/plate. Precipitation was recorded at the highest concentration of 3160 µg/plate in both experiments with and without metabolic activation. 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.
CAS 18643-08-8
Another reliable bacterial gene mutation study (Ames test) performed according to OECD TG 471 and in compliance with GLP with Chlorodimethyloctadecylsilane (CAS 18643-08-8) is available (LPT, 2002c). 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. No precipitation was recorded in both experiments carried out with and without metabolic activation. 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.
Taking into consideration the above results generated from the structurally analogue substances the target substance Trichloro(octadecyl)silane (CAS 112-04-9) is not expected to be mutagenic to bacteria.
Justification for classification or non-classification
The available data on genetic toxicity of the registered substance do not meet the criteria for classification according to Regulation (EC) No 1272/2008 and are therefore conclusive but not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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