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EC number: 245-904-8 | CAS number: 23843-64-3
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 Feb - 04 Apr 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- 2-aminoanthracene was used as the only positive control in the presence of S9-mix, at least a second positive control substance must be included for the efficacy testing of S9-mix.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [3-(trimethoxysilyl)propyl]urea
- EC Number:
- 245-904-8
- EC Name:
- [3-(trimethoxysilyl)propyl]urea
- Cas Number:
- 23843-64-3
- Molecular formula:
- C7H18N2O4Si
- IUPAC Name:
- [3-(trimethoxysilyl)propyl]urea
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium strains) and trp operon (for E. coli strain)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- Preliminary toxicity test:
- 6.7, 10, 33, 67, 100, 333, 667, 1000, 333 and 5000 µg/plate (with and without metabolic activation, TA 100 and E. coli WP2 uvrA)
Experiment I+II:
- 100, 333, 1000, 3333 and 5000 µg/plate (with and without metabolic activation)
Experiment III:
- 100, 333, 1000, 3333 and 5000 µg/plate (TA 100 without metabolic activation)
5000 µg/plate is the highest recommended dose level based on the current OECD guideline - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Acetone
- Justification for choice of solvent/vehicle: Solubility properties and relative non-toxicity to bacteria
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: +S9-mix: 2-aminoanthracene (2-AA); -S9-mix: 2-nitrofluorene (2-NF), sodium azide (NaN), 9-aminoacridine (9-AA), methyl methanesulfonate (MMS)
- Remarks:
- 2-AA: 1 µg/plate (all TA strains), 10 µg/plate (E. coli WP2 uvrA), 2-NF: 1 µg/plate (TA 98), NaN: 1 µg/plate (TA 100, TA 1535), 9-AA: 75 µg/plate (TA 1537), MMS: 1000 µg/plate (E. coli Wp2 uvrA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar ; preincubation
DURATION
- Preincubation period: 60 min
- Expression time (cells in growth medium): 48 h
NUMBER OF REPLICATIONS: 3 plates for each test concentration in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: A dose level is considered toxic if one or both of the following criteria are met: a >50 % reduction in the mean number of revertants per plate as compared to the mean vehicle control - this reduction must be accompanied by an abrupt dose-dependent drop in the revertant count and/or a reduction in the background lawn. - Evaluation criteria:
- The mean of each positive control must exhibit at least a three-fold increase in the number of revertants over the mean value of the respective vehicle control. A minimum of three non-toxic dose levels are required to evaluate assay data. For the test material to be evaluated positive, it must cause a dose-related increase in the mean revertants per plate of at least one tester strain with a minimum of two increasing concentrations of test material. Data sets for strains TA 1535 and TA 1537 were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than three times the mean vehicle control value. Data sets for strains TA 98, TA 100 and E. coli WP2 uvrA were judged positive if the increase in mean revertants at the peak of the dose is equal to or greater than two times the mean vehicle control value.
- Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test resultsopen allclose all
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- 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:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: All results of the vehicle and positive controls as well as the test groups were within range of historical control data.
Any other information on results incl. tables
Table 2: Dose range-finding study Number of revertants per plate (2 plates per strain)
TA 100 |
WP2 uvrA |
|||||
Concentration (µg/Plate) |
Plate 1 + MA |
Plate 2 - MA |
Cytotoxic (Yes/No) |
Plate 1 + MA |
Plate 2 - MA |
Cytotoxic (Yes/No) |
0 |
142 |
112 |
No |
13 |
16 |
No |
6.7 |
138 |
119 |
No |
16 |
20 |
No |
10 |
126 |
101 |
No |
9 |
18 |
No |
33 |
146 |
128 |
No |
15 |
16 |
No |
67 |
129 |
105 |
No |
12 |
16 |
No |
100 |
140 |
109 |
No |
8 |
12 |
No |
333 |
127 |
112 |
No |
12 |
16 |
No |
667 |
111 |
119 |
No |
5 |
13 |
No |
1000 |
125 |
120 |
No |
12 |
12 |
No |
3333 |
133 |
129 |
No |
10 |
12 |
No |
5000 |
144 |
121 |
No |
13 |
14 |
No |
*solvent control with Acetone
MA: metabolic activation (S9 -mix)
Table 3: Experiment 1 Mutagenicity Assay Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1535 |
||||||
Conc.µg/plate |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
14 |
24 |
No |
125 |
156 |
No |
12 |
9 |
No |
100 |
18 |
23 |
No |
125 |
143 |
No |
9 |
15 |
No |
333 |
26 |
30 |
No |
133 |
159 |
No |
12 |
11 |
No |
1000 |
21 |
37 |
No |
139 |
169 |
No |
11 |
12 |
No |
3333 |
23 |
31 |
No |
133 |
162 |
No |
9 |
11 |
No |
5000 |
24 |
31 |
No |
129 |
169 |
No |
8 |
14 |
No |
Positive control |
523 |
2672 |
No |
910 |
2698 |
No |
673 |
285 |
No |
*solvent control with Acetone
MA: metabolic activation (S9 -mix)
Table 4: Experiment 1 Mutagenicity Assay Number of revertants per plate (mean of 3 plates)
|
TA1537 |
WP2uvrA |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
7 |
9 |
No |
14 |
17 |
No |
100 |
8 |
7 |
No |
19 |
15 |
No |
333 |
7 |
10 |
No |
18 |
20 |
No |
1000 |
6 |
10 |
No |
20 |
18 |
No |
3333 |
6 |
10 |
No |
17 |
19 |
No |
5000 |
6 |
10 |
No |
20 |
15 |
No |
Positive control |
736 |
424 |
No |
610 |
204 |
No |
*solvent control withAcetone
MA: metabolic activation (S9 -mix)
Table 5: Experiment 2 Mutagenicity Assay Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
13 |
15 |
No |
116 |
98 |
No |
8 |
10 |
No |
100 |
13 |
15 |
No |
114 |
84 |
No |
7 |
9 |
No |
333 |
12 |
16 |
No |
116 |
97 |
No |
9 |
8 |
No |
1000 |
16 |
16 |
No |
232 |
82 |
No |
7 |
9 |
No |
3333 |
17 |
19 |
No |
125 |
95 |
No |
5 |
9 |
No |
5000 |
14 |
18 |
No |
137 |
92 |
No |
5 |
11 |
No |
Positive control |
248 |
876 |
No |
638 |
891 |
No |
227 |
134 |
No |
*solvent control withAcetone
MA: metabolic activation (S9 -mix)
Table 6: Experiment 2 Mutagenicity Assay Number of revertants per plate (mean of 3 plates)
|
TA1537 |
WP2 uvrA |
||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
0* |
6 |
4 |
No |
12 |
11 |
No |
100 |
2 |
3 |
No |
8 |
9 |
No |
333 |
2 |
4 |
No |
10 |
10 |
No |
1000 |
4 |
4 |
No |
9 |
13 |
No |
3333 |
5 |
4 |
No |
10 |
11 |
No |
5000 |
5 |
5 |
No |
11 |
10 |
No |
Positive control |
226 |
147 |
No |
369 |
45 |
No |
*solvent control withAcetone
MA: metabolic activation (S9 -mix)
Applicant's summary and conclusion
- Conclusions:
- Under test conditions with GLP, no mutagenic effect and no cytotoxicity was observed for the test substance tested up to limit concentration in any of the test strains without and with metabolic activation in the Ames test. The test substance is non mutagenic in the strains used.
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