Registration Dossier
Registration Dossier
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EC number: 213-050-5 | CAS number: 919-31-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In a key bacterial reverse mutation assay (Ames test) conducted according to OECD Test Guideline 471 and in compliance with GLP, 3 -(triethoxysilyl)propiononitrile was concluded to be negative with and without activation in Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and in Escherichia coli WP2 uvrA (BioReliance, 2004a)
In a key mammalian cytogenicity study conducted according to OECD Test Guideline 473 and in compliance with GLP, 3 -(triethoxysilyl)propiononitrile was concluded to be negative with and without activation in Chinese hamster ovary cells (OECD TG 473) (BioReliance, 2004b)
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:
- 2003-10-21 to 2003-12-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1998
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- See table 1
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Sponsors request and compatability with target cells - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- All strains (with activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 (without activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100, TA 1535 (without activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 (without activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2uvrA (without activation)
- 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 to 72 hours
NUMBER OF REPLICATIONS: 3 plates for each test concentration
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; background lawn - Evaluation criteria:
- For the test article to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations. For TA1535 and TA1537 there must be a 3 fold increase. For TA98, TA100 and WP2uvrA, there must be a 2 fold increase.
- Statistics:
- Mean and Standard deviation of the number of revertants per plate were calculated and reported.
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- TA 1535 (-MA) 3333 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Results were within range of historical control data
- Conclusions:
- In a reliable and valid study, conducted in accordance with OECD Test Guideline 471 and in compliance with GLP, 3-(triethoxysilyl)propiononitrile did not induce mutagenic activity in Salmonella and E.coli strains. The test substance was concluded to be negative for mutagenicity to bacteria under the conditions of the test.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-10-16 to 2003-12-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- other: Chinese hamster ovary (CHO-K1) cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- See table 1
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: based on information provided by sponsor and compatibility with target cells - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- (without activation)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- (with activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hours (+/- MA); 20 hours (+ MA)
- Expression time (cells in growth medium): 4 hours (+/- MA); 16 hours (+ MA)
- Fixation time (start of exposure up to fixation or harvest of cells): 4 hours (+/- MA); 20 hours (+ MA)
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
NUMBER OF REPLICATIONS: 2 plates for each test concentration
NUMBER OF CELLS EVALUATED: 100 per test concentration
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- Toxic effects based on cell growth inhibition and mitotic index relative to solvent control. Number and type of aberrations found recorded. The test substance was considered to induce a positive response when the % of cells with aberrations is increased in a dose-responsive manner with one or more concentrations being statistically significant (p=0.05).
- Statistics:
- Cell counts and % viability used to determine cell growth inhibition relative to the solvent control. A minimum of 200 mataphase spreads (100 per duplicate flask) were examined and scored for chromatid-type and chromosome-type aberrations. Statistical analysis of % aberrant cells performed using the Fischer's exact test. In the event of a positive Fischer's exact test at any test substance dose level, the Cochran-Armitage test was used to measure dose-responsiveness.
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: > 2172 ug/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Results were within range of historical control data
- Conclusions:
- In a reliable and valid study conducted in accordance with OECD Test Guideline 473 and in compliance with GLP, 3-(triethoxysilyl)propiononitrile was concluded to be negative for the induction of structural and numerical chromosome aberrations in CHO cells in both the activated and non- activated test systems.
Referenceopen allclose all
Table 2 : Experiment 1 Preliminary toxicity assay Number of revertants per plate
Strain |
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
12 |
18 |
No |
136 |
186 |
No |
15 |
12 |
No |
6.7 |
13 |
18 |
No |
117 |
138 |
No |
13 |
11 |
No |
10 |
14 |
16 |
No |
134 |
126 |
No |
10 |
9 |
No |
33 |
13 |
13 |
No |
121 |
105 |
No |
12 |
12 |
No |
67 |
11 |
13 |
No |
107 |
128 |
No |
8 |
10 |
No |
100 |
12 |
15 |
No |
124 |
112 |
No |
11 |
13 |
No |
333 |
15 |
17 |
No |
114 |
101 |
No |
13 |
14 |
No |
667 |
11 |
11 |
No |
115 |
109 |
No |
13 |
9 |
No |
1000 |
10 |
15 |
No |
122 |
121 |
No |
14 |
10 |
No |
3333 |
10 |
17 |
No |
119 |
168 |
No |
9 |
10 |
No |
5000 |
16 |
19 |
No |
134 |
117 |
No |
6 |
11 |
Yes |
*solvent control with DMSO
Table 3 : Experiment 1 Preliminary toxicity assay Number of revertants per plate
Strain |
TA1537 |
WP2uvrA |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
7 |
6 |
No |
10 |
12 |
No |
6.7 |
6 |
5 |
No |
13 |
11 |
No |
10 |
10 |
3 |
No |
14 |
10 |
No |
33 |
6 |
8 |
No |
11 |
14 |
No |
67 |
5 |
6 |
No |
12 |
10 |
No |
100 |
7 |
8 |
No |
10 |
11 |
No |
333 |
8 |
3 |
No |
14 |
12 |
No |
667 |
4 |
4 |
No |
13 |
13 |
No |
1000 |
6 |
7 |
No |
10 |
8 |
No |
3333 |
6 |
5 |
No |
10 |
13 |
No |
5000 |
4 |
5 |
No |
12 |
15 |
No |
*solvent control with DMSO
Table 4: Experiment 2 Plate incorporation assay, Number of revertants per plate (mean of 3 plates)
Strain |
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
17 |
22 |
No |
184 |
196 |
No |
8 |
11 |
No |
100 |
13 |
21 |
No |
147 |
226 |
No |
10 |
10 |
No |
333 |
18 |
18 |
No |
193 |
206 |
No |
10 |
12 |
No |
1000 |
19 |
23 |
No |
158 |
196 |
No |
9 |
10 |
No |
3333 |
24 |
21 |
No |
172 |
179 |
No |
7 |
8 |
No |
5000 |
16 |
25 |
No |
186 |
208 |
No |
9 |
6 |
No |
Positive control |
157 |
873 |
No |
645 |
1002 |
No |
194 |
264 |
No |
*solvent control with DMSO
Table 5: Experiment 2 Plate incorporation assay, Number of revertants per plate (mean of 3 plates)
Strain |
TA1537 |
WP2uvrA |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
8 |
6 |
No |
11 |
11 |
No |
100 |
9 |
8 |
No |
12 |
11 |
No |
333 |
9 |
4 |
No |
12 |
11 |
No |
1000 |
8 |
5 |
No |
13 |
12 |
No |
3333 |
6 |
6 |
No |
13 |
12 |
No |
5000 |
8 |
6 |
No |
12 |
12 |
No |
Positive control |
400 |
72 |
No |
230 |
82 |
No |
*solvent control with DMSO
Table 6: Experiment 3 Preincubation assay, Number of revertants per plate (mean of 3 plates)
Starin |
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
14 |
18 |
No |
152 |
180 |
No |
21 |
12 |
No |
100 |
13 |
21 |
No |
157 |
242 |
No |
15 |
11 |
No |
333 |
14 |
15 |
No |
165 |
180 |
No |
21 |
10 |
No |
1000 |
15 |
18 |
No |
170 |
208 |
No |
11 |
11 |
No |
3333 |
10 |
14 |
No |
166 |
190 |
No |
11** |
12 |
Yes |
5000 |
9 |
12 |
No |
168 |
208 |
No |
8** |
11 |
Yes |
Positive control |
394 |
904 |
No |
486 |
1105 |
No |
270 |
70 |
No |
*solvent control with DMSO
**Moderate reduction in background lawn
Table 7: Experiment 3 Preincubation assay, Number of revertants per plate (mean of 3 plates)
Starin |
TA1537 |
WP2uvrA |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
4 |
4 |
No |
11 |
12 |
No |
100 |
5 |
5 |
No |
11 |
10 |
No |
333 |
5 |
4 |
No |
14 |
9 |
No |
1000 |
4 |
5 |
No |
12 |
13 |
No |
3333 |
3 |
6 |
No |
11 |
8 |
No |
5000 |
2 |
4 |
Yes |
12 |
8 |
No |
Positive control |
220 |
126 |
No |
205 |
614 |
No |
*solvent control with DMSO
Table 2:
Results of chromosome analysis Experiment 1, 4h treatment without activation (total count from 2 cultures)
|
Solvent* Control*** |
Positive Control** |
543 µg/ml |
1086 µg/ml |
2172 µg/ml |
|
Cytotoxicity |
no |
no |
no |
no |
no |
|
|
Mean |
|||||
Chromatid aberrations |
gaps |
0 |
0 |
0 |
0 |
0 |
breaks |
1 |
19 |
1 |
1 |
1 |
|
exchanges |
0 |
4 |
0 |
0 |
1 |
|
Chromosome aberrations |
breaks |
0 |
0 |
0 |
0 |
0 |
Dic |
1 |
1 |
1 |
0 |
4 |
|
Ring |
0 |
0 |
0 |
0 |
0 |
|
Mitotic index |
NR |
NR |
NR |
NR |
NR |
|
Polyploidy |
NR |
NR |
NR |
NR |
NR |
|
Endo reduplication |
NR |
NR |
NR |
NR |
NR |
|
*Solvent control with DMSO
** Per 50 cells
*** Per 100 cells
NR not reported
Table 3: Results of chromosome analysis Experiment 1, 4h treatment with activation (total count from 2 cultures)
|
Solvent* Control*** |
Positive Control** |
543 µg/ml |
1086 µg/ml |
2172 µg/ml |
|
Cytotoxicity |
no |
no |
no |
no |
no |
|
|
Mean |
|||||
Chromatid aberrations |
gaps |
0 |
0 |
0 |
0 |
0 |
breaks |
0 |
4 |
0 |
1 |
1 |
|
exchanges |
0 |
20 |
0 |
0 |
1 |
|
Chromosome aberrations |
breaks |
0 |
2 |
0 |
0 |
0 |
Dic |
0 |
0 |
0 |
0 |
0 |
|
Ring |
0 |
0 |
0 |
0 |
0 |
|
Mitotic index |
NR |
NR |
NR |
NR |
NR |
|
Polyploidy |
NR |
NR |
NR |
NR |
NR |
|
Endo reduplication |
NR |
NR |
NR |
NR |
NR |
|
*Solvent control with DMSO
** Per 50 cells
*** Per 100 cells
NR not reported
Table 4: Results of chromosome analysis Experiment 1, 20h treatment without activation (total count from 2 cultures)
|
Solvent* Control*** |
Positive Control** |
543 µg/ml |
1086 µg/ml |
2172 µg/ml |
|
Cytotoxicity |
no |
no |
no |
no |
no |
|
|
Mean |
|||||
Chromatidaberrations |
gaps |
0 |
0 |
0 |
0 |
0 |
breaks |
0 |
4 |
0 |
0 |
3 |
|
exchanges |
0 |
10 |
0 |
0 |
1 |
|
Chromosome aberrations |
breaks |
0 |
3 |
0 |
0 |
1 |
Dic |
0 |
1 |
0 |
0 |
2 |
|
Ring |
0 |
0 |
1 |
0 |
2 |
|
Mitotic index |
NR |
NR |
NR |
NR |
NR |
|
Polyploidy |
NR |
NR |
NR |
NR |
NR |
|
Endo reduplication |
NR |
NR |
NR |
NR |
NR |
|
*Solvent control with DMSO
** Per 50 cells
*** Per 100 cells
NR not reported
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Data are available from reliable in vitro studies on mutagenicity to bacterial cells and on cytogenicity to mammalian cells.
3-(Triethoxysilyl)propiononitrile has been tested for mutagenicity to bacteria in a key study conducted according to OECD Test Guideline 471 and in compliance with GLP (BioReliance, 2004a).
No evidence of a substance related increase in the number of revertants was observed with or without activation in TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA in the initial and confirmatory assays, using the plate incorporation and preincubation methods, respectively. No toxicity to bacteria was observed up to limit concentrations. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
3-(Triethoxysilyl)propiononitrile has been tested for cytogenicity in mammalian cells in a key study conducted according to OECD Test Guideline 473 and in compliance with GLP (BioReliance, 2004b). The substance was concluded to be negative for the induction of structural and numerical chromosome aberrations in CHO cells in both the activated and non-activated test systems.
Further in vitro testing is not considered necessary as the substance is used as a transported isolated intermediate.
Justification for classification or non-classification
The available information for the substance indicates that 3-(triethoxysilyl)propiononitrile does not induce mutations in bacterial cells nor structural chromatid- or chromosomes-type aberrations in Chinese hamster ovary cells. Therefore, it is considered that classification for mutagenicity is not required according to Regulation (EC) No. 1272/2008
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
