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EC number: 245-876-7 | CAS number: 23779-32-0
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline and in compliance with GLP. Since this study is a read-across from CAS 23843-64-3, the reliability downgraded from RL1 to RL2.
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)
- Version / remarks:
- adopted 1983
- Deviations:
- no
- 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
- IUPAC Name:
- 1-[3-(trimethoxysilyl)propyl]urea
- Details on test material:
- - Name of test material (as cited in study report): Y-11542
- Physical state: clear, viscous liquid
- Substance type: Alkoxysilane
- Storage condition of test material: room temperature; protected from exposure to light
Constituent 1
Method
- Target gene:
- his operon (Salmonella strains); trp operon (E. coli)
Species / strainopen allclose all
- 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:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- Preliminary toxicity assay: 6.7, 10, 33, 67, 100, 333, 670, 1000, 3333, 5000 µg/plate with and without metabolic activation.
Main experiments: 100, 333, 1000, 3333, 5000 µg/plate with and without metabolic activation. - Vehicle / solvent:
- - Vehicle/solvent used: acetone
- Justification for choice of solvent/vehicle: Based on Sponsor´s request and compatibility with target cells.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: +S9: 2-aminoanthracene (1 and 10 µg/plate) -S9: 2-nitrofluorene (1 µg/plate); sodium azide (1 µg/plate); 9-aminoacridine (75 µg/plate); methyl-methanesulfonate (1000 µg/plate)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 60±2 min
- Exposure duration: 48-72 h
NUMBER OF REPLICATIONS: Triplicates each in two independent experiments.
DETERMINATION OF CYTOTOXICITY
- Method: Inspection of the bacterial background lawn
OTHER:
- Positive controls: +S9: 2-aminoanthracene (1 µg/plate) for all Salmonella strains; 10 µg/plate for WP2 uvrA; -S9: 2-nitrofluorene (1 µg/plate) for TA 98; sodium azide (1 µg/plate) for TA 100 and TA 1535; 9-aminoacridine (75 µg/plate) for TA 1537; methyl-methanesulfonate ( 1000 µg/plate) for WP2 uvrA - Evaluation criteria:
- For a positive response, the test article must induce 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 article. Data sets for strains TA1535 and TA1537 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 TA100, TA98, and WP2 uvrA were judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than two times the mean vehicle control value. All cultures must demonstrate the characteristic mean number of spontaneous revertants in the vehicle controls.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium 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
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation occurred up to 5000 µg/plate
RANGE-FINDING/SCREENING STUDIES: No toxicity was observed up to a concentration of up to 5000 µg/plate
COMPARISON WITH HISTORICAL CONTROL DATA: Number of revertant colonies were comparable to historical control data. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Results from the first preincubation test.
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate |
|||||
(μg/plate) |
(average of 3 plates ± Standard deviation) |
||||||
|
Base-pair substitution type |
Frameshift type |
|||||
|
TA 100 |
TA1535 |
WP2 uvrA |
TA98 |
TA1537 |
||
– |
0 |
125 ± 3 |
12 ± 2 |
14 ± 4 |
14 ± 1 |
7 ± 3 |
|
– |
100 |
125 ± 9 |
9 ± 1 |
19 ± 2 |
18 ± 10 |
8 ± 2 |
|
– |
333 |
133 ± 13 |
12 ± 1 |
18 ± 4 |
26 ± 6 |
7 ± 2 |
|
– |
1000 |
139 ± 13 |
11 ± 1 |
20 ± 1 |
21 ± 1 |
6 ± 2 |
|
– |
3333 |
133 ± 8 |
9 ± 5 |
17 ± 1 |
23 ± 3 |
6 ± 3 |
|
– |
5000 |
129 ± 4 |
8 ± 3 |
20 ± 2 |
24 ± 3 |
6 ± 2 |
|
Positive controls, –S9 |
Name |
Sodium azide |
Sodium azide |
MMS |
2-NF |
9-AA |
|
Concentrations (μg/plate) |
1 |
1 |
1000 |
1 |
75 |
||
Mean No. of colonies/plate (average of 3 ± SD) |
910 ± 25 |
673 ± 24 |
610 ± 69 |
523 ± 5 |
736 ± 64 |
||
+ |
0 |
156 ± 3 |
9 ± 2 |
17 ± 3 |
24 ± 2 |
17 ± 3 |
|
+ |
100 |
143 ± 12 |
15 ± 4 |
15 ± 4 |
23 ± 5 |
15 ± 4 |
|
+ |
333 |
159 ± 10 |
11 ± 4 |
20 ± 1 |
30 ± 6 |
20 ± 1 |
|
+ |
1000 |
169 ± 6 |
12 ± 3 |
18 ± 4 |
37 ± 2 |
18 ± 4 |
|
+ |
3333 |
162 ± 35 |
11 ± 3 |
19 ± 4 |
31 ± 2 |
19 ± 4 |
|
+ |
5000 |
169 ± 11 |
14 ± 3 |
15 ± 2 |
31 ± 1 |
15 ± 2 |
|
Positive controls, +S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
|
Concentrations (μg/plate) |
1 |
1 |
10 |
1 |
1 |
||
Mean No. of colonies/plate (average of 3 ± SD) |
2698 ± 89 |
285 ± 2 |
204 ± 14 |
2672 ± 27 |
204 ± 14 |
Table 2: Results from the second (all strains except TA100 without S9) and third (TA100;-S9) preincubation test.
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate |
|||||
(μg/plate) |
(average of 3 plates ± Standard deviation) |
||||||
|
Base-pair substitution type |
Frameshift type |
|||||
|
TA 100 |
TA1535 |
WP2 uvrA |
TA98 |
TA1537 |
||
– |
0 |
116 ± 5 |
8 ± 0 |
12 ± 3 |
13 ± 2 |
6 ± 2 |
|
– |
100 |
114 ± 3 |
7 ± 2 |
8 ± 4 |
13 ± 2 |
2 ± 1 |
|
– |
333 |
116 ± 16 |
9 ± 3 |
10 ± 2 |
12 ± 3 |
2 ± 2 |
|
– |
1000 |
132 ± 4 |
7 ± 4 |
9 ± 1 |
16 ± 1 |
4 ± 2 |
|
– |
3333 |
125 ± 10 |
5 ± 3 |
10 ± 3 |
17 ± 2 |
5 ± 1 |
|
– |
5000 |
137 ± 17 |
5 ± 2 |
11 ± 4 |
14 ± 4 |
5 ± 2 |
|
Positive controls, –S9 |
Name |
|
Sodium azide |
MMS |
2-NF |
9-AA |
|
Concentrations (μg/plate) |
1 |
1 |
1000 |
1 |
75 |
||
Mean No. of colonies/plate (average of 3 ± SD) |
638 ± 63 |
227 ± 87 |
369 ± 15 |
248 ± 18 |
226 ± 35 |
||
+ |
0 |
98 ± 30 |
10 ± 4 |
11 ± 2 |
15 ± 4 |
4 ± 2 |
|
+ |
100 |
84 ± 15 |
9 ± 2 |
9 ± 3 |
15 ± 1 |
3 ± 2 |
|
+ |
333 |
97 ± 6 |
8 ± 2 |
10 ± 4 |
16 ± 3 |
4 ± 1 |
|
+ |
1000 |
82 ± 5 |
9 ± 4 |
13 ± 2 |
16 ± 4 |
4 ± 3 |
|
+ |
3333 |
95 ± 21 |
9 ± 3 |
11 ± 3 |
19 ± 2 |
4 ± 2 |
|
+ |
5000 |
92 ± 15 |
11 ± 1 |
10 ± 3 |
18 ± 3 |
5 ± 2 |
|
Positive controls, +S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
|
Concentrations (μg/plate) |
1 |
1 |
10 |
1 |
1 |
||
Mean No. of colonies/plate (average of 3 ± SD) |
891 ± 66 |
134 ± 9 |
45 ± 5 |
876 ± 44 |
147 ± 55 |
2-NF = 2-nitrofluorene
MMS = methyl methanesulfonate
9AA = 9-aminoacridine
2AA = 2-aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
In a bacterial mutagenicity assay according to OECD 471 and GLP, no mutagenic effect was observed for the test substance tested up to limit concentration in any of the test strains in two independent experiments without and with metabolic activation. Appropriate solvent and positive controls were included and gave expected results. The test substance is non-mutagenic in the test strains used.
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