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EC number: 939-125-9 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- 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:
- 09 Jan - 23 Feb 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- 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
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Behörde für Soziales, Familie, Gesundheit und Verbraucherschutz, Hamburg, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- hydrolysis products of 3-(triethoxysilyl)propan-1-amine
- EC Number:
- 939-125-9
- Molecular formula:
- not applicable for UVCB substance
- IUPAC Name:
- hydrolysis products of 3-(triethoxysilyl)propan-1-amine
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- co-factor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Arochlor 1254
- Test concentrations with justification for top dose:
- Preliminary cytotoxicity test: 0.316, 1.0, 3.16, 10.0, 31.6, 100, 316, 1000, 3160 and 5000 µg/plate with and without metabolic activation
Experiment I and II: 10, 31.6, 100, 316, 1000 and 3160 μg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- -S9: 10 µg/plate SA (TA 1535, TA 100), 10 µg/plate 2-NF (TA 98), 100 μg/plate 9-AA (TA 1537), 1300 μg/plate MMS (TA 102); + S9: 2 μg/plate 2-AA (TA 98, TA 102, TA 1537), 1500 μg/plate CA (TA 100, TA 1535)
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- cyclophosphamide
- methylmethanesulfonate
- other: 2-amino-anthracene
- Remarks:
- SA: sodium azide; 2-NF: 2-nitro-fluorene; 9-AA: 9-amino-acridine; MMS: methylmethanesulfonate; 2-AA: 2-amino-anthracene; CA: cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION 1: preliminary cytotoxicity test and experiment I: in agar (plate incorporation)
DURATION
- Exposure duration: 48 to 72 h
METHOD OF APPLICATION 2: experiment II: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 to 72 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments for the main assay
DETERMINATION OF CYTOTOXICITY
- Method: inspection of background lawn and reduction on the number of revertants - Evaluation criteria:
- The test item was considered to show a positive response if:
- the number of revertants was significantly increased (p ≤ 0.05, U-test according to MANN and WHITNEY) 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 independent experiments;
- in addition, a significant (p ≤ 0.05) concentration (log value)-related effect (Spearman’s rank correlation coefficient) was observed;
- positive results were reproducible and the histidine independence of the revertants was confirmed by streaking random samples on histidine-free agar plates. - Statistics:
- Mean values and standard deviations of revertant colonies were calculated. Statistical analysis between treated and solvent control samples was performed using the U-test according to MANN and WHITNEY and statistical significance was indicated at p ≤ 0.05. Concentration (log value)-related effects were analysed using the Spearman’s rank correlation coefficient (statistical significance indicated at p ≤ 0.05).
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 3160 µg/plate (±S9)
- Vehicle controls validity:
- not valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: in two preliminary cytotoxicity tests, the Salmonella typhimurium strain TA 100 was tested at concentrations ranging from 0.316 to 5000 µg/plate with and without metabolic activation. Cytotoxicity (scarce background lawn and reduction of the number of revertants) was noted at concentrations ≥ 3160 µg/plate in both experiments. Hence, 3160 µg/plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test, respectively.
ADDITIONAL INFORMATION ON CYTOTOXICITY: in the plate incorporation test and in the preincubation test, cytotoxicity (scarce background lawn and reduction of the number of revertants) was noted at the top concentration of 3160 µg/plate in all test strains both in the presence and absence of metabolic activation. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Test results of experiment I
Bacterial Reverse Mutation Assay, mean revertant colonies/plate (n=3 ± SD) |
|||||
EXPERIMENT I (plate incorporation) |
|||||
S9-Mix |
Without |
||||
Concentration (per plate) |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
SC (DMSO) |
30 ± 6 |
142 ± 10 |
278 ± 12 |
15 ± 5 |
6 ± 3 |
Test item |
|
|
|
|
|
10 µg |
34 ± 4 |
119 ± 20 |
260 ± 10 |
14 ± 4 |
6 ± 3 |
31.6 µg |
31 ± 3 |
123 ± 14 |
274 ± 12 |
16 ± 2 |
7 ± 2 |
100 µg |
29 ± 2 |
115 ± 16 |
265 ± 3 |
16 ± 6 |
5 ± 4 |
316 µg |
34 ± 6 |
122 ± 7 |
259 ± 7 |
12 ± 2 |
4 ± 2 |
1000 µg |
30 ± 5 |
110 ± 6 |
262 ± 13 |
12 ± 3 |
6 ± 1 |
3160 µg |
13 ± 2# |
67 ± 10# |
230 ± 3# |
7 ± 1# |
1 ± 1# |
PC |
|
|
|
|
|
SA (10 µg) |
- |
1045 ± 45 |
- |
145 ± 27 |
- |
2-NF (10 µg) |
204 ± 15 |
- |
- |
- |
- |
9-AA (100 µg) |
- |
- |
- |
- |
151 ± 12 |
MMS (1300 µg) |
- |
- |
1019 ± 14 |
- |
- |
S9-Mix |
With |
||||
Concentration (per plate) |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
SC (DMSO) |
26 ± 6 |
125 ± 11 |
262 ± 2 |
13 ± 2 |
7 ± 3 |
Test item |
|
|
|
|
|
10 µg |
36 ± 2 |
126 ± 6 |
268 ± 11 |
13 ± 2 |
7 ± 1 |
31.6 µg |
28 ± 8 |
134 ± 31 |
272 ± 2 |
13 ± 2 |
8 ± 2 |
100 µg |
26 ± 4 |
134 ± 5 |
280 ± 11 |
20 ± 6 |
9 ± 1 |
316 µg |
23 ± 2 |
123 ± 4 |
274 ± 11 |
16 ± 8 |
5 ± 2 |
1000 µg |
24 ± 3 |
102 ± 2 |
265 ± 9 |
21 ± 8 |
5 ± 1 |
3160 µg |
17 ± 3# |
87 ± 10# |
221 ± 3# |
5 ± 2# |
1 ± 0 |
PC |
|
|
|
|
|
2-AA (2 µg) |
248 ± 13 |
- |
1023 ± 34 |
- |
152 ± 4 |
CA (1500 µg) |
- |
1000 ± 21 |
- |
161 ± 7 |
- |
SC = solvent control; PC = positive control substances; SD = standard deviation; SA: sodium azide; 2-NF: 2-nitro-fluorene; 9-AA: 9-amino-acridine; MMS: methylmethanesulfonate; 2-AA: 2-amino-anthracene; CA: cyclophosphamide # scarce background lawn |
Table 2. Test results of experiment II
Bacterial Reverse Mutation Assay, mean revertant colonies/plate (n=3 ± SD) |
|||||
EXPERIMENT I (preincubation) |
|||||
S9-Mix |
Without |
||||
Concentration (per plate) |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
SC (DMSO) |
30 ± 7 |
138 ± 19 |
292 ± 1 |
19 ± 4 |
5 ± 1 |
Test item |
|
|
|
|
|
10 µg |
22 ± 2 |
190 ± 3 |
275 ± 8 |
22 ± 2 |
6 ± 2 |
31.6 µg |
29 ± 7 |
174 ± 4 |
280 ± 12 |
13 ± 4 |
5 ± 3 |
100 µg |
39 ± 5 |
178 ± 19 |
276 ± 6 |
14 ± 7 |
4 ± 1 |
316 µg |
42 ± 3 |
168 ± 7 |
280 ± 9 |
14 ± 4 |
5 ± 1 |
1000 µg |
25 ± 2 |
165 ± 11 |
280 ± 6 |
19 ± 5 |
6 ± 1 |
3160 µg |
16 ± 1# |
81 ± 7# |
144 ± 3# |
6 ± 2# |
1 ± 1# |
PC |
|
|
|
|
|
SA (10 µg) |
- |
1082 ± 28 |
- |
216 ± 6 |
- |
2-NF (10 µg) |
120 ± 5 |
- |
- |
- |
- |
9-AA (100 µg) |
- |
- |
- |
- |
268 ± 5 |
MMS (1300 µg) |
- |
- |
1055 ± 48 |
- |
- |
S9-Mix |
With |
||||
Concentration (per plate) |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
SC (DMSO) |
30 ± 8 |
132 ± 18 |
285 ± 4 |
18 ± 10 |
4 ± 3 |
Test item |
|
|
|
|
|
10 µg |
27 ± 2 |
113 ± 11 |
288 ± 9 |
15 ± 6 |
4 ± 2 |
31.6 µg |
30 ± 9 |
128 ± 17 |
269 ± 25 |
12 ± 2 |
6 ± 3 |
100 µg |
31 ± 10 |
127 ± 24 |
253 ± 6 |
13 ± 3 |
4 ± 2 |
316 µg |
25 ± 5 |
123 ± 11 |
257 ± 11 |
15 ± 8 |
3 ± 2 |
1000 µg |
25 ± 3 |
114 ± 5 |
259 ± 2 |
13 ± 2 |
4 ± 4 |
3160 µg |
14 ± 2# |
84 ± 10# |
155 ± 12# |
4 ± 1# |
2 ± 1# |
PC |
|
|
|
|
|
2-AA (2 µg) |
126 ± 3 |
- |
1030 ± 7 |
- |
222 ± 4 |
CA (1500 µg) |
- |
1065 ± 17 |
- |
172 ± 9 |
- |
SC = solvent control; PC = positive control substances; SD = standard deviation; SA: sodium azide; 2-NF: 2-nitro-fluorene; 9-AA: 9-amino-acridine; MMS: methylmethanesulfonate; 2-AA: 2-amino-anthracene; CA: cyclophosphamide # scarce background lawn |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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