Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 236-828-6 | CAS number: 13501-76-3
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-05-03 to 1995-06-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline, with acceptable restrictions. The restrictions were that the range of strains does not comply with the current guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only 4 strains used
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (3-chloropropyl)diethoxymethylsilane
- EC Number:
- 236-828-6
- EC Name:
- (3-chloropropyl)diethoxymethylsilane
- Cas Number:
- 13501-76-3
- Molecular formula:
- C8H19ClO2Si
- IUPAC Name:
- (3-chloropropyl)(diethoxymethyl)silane; (3-chloropropyl)diethoxymethylsilane; (4-chloro-1,1-diethoxybutyl)silane
Constituent 1
Method
- Target gene:
- His operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: rfa, uvrB (TA 98 & TA 100: pKM 101)
- 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:
- 50, 160, 500, 1000 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Solubility properties and relative non-toxicity to bacteria
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without metabolic activation: TA 98: 2.5 µg/plate in DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation: TA 100 & TA 1535: 2.5 µg/plate in aqua bidest
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation: TA 1537: 25 µg/plate in DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with metabolic activation: All strains: 2.5 µg/plate in DMSO
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:in agar (plate incorporation)
DURATION
- Expression time (cells in growth medium): 72 hours
NUMBER OF REPLICATIONS: 3 plates for each test concentration
DETERMINATION OF CYTOTOXICITY
- Method: Background lawn assessment, revertant colony counts
Metabolic activation: Male Wistar rats recieved single i.p. injection of Aroclor 1254 ( 500 mg/kg body weight) in olive oil 5 days prior to the preparation of the S9 fraction. One part of S9 fraction was mixed with 9 parts of a cofactor solution resulting in the following mixture:
-10 % S9 fraction
-33 mM KCl
-8 mM MgCl2
-5 mM glucose-6-phosphate
-4 mM NADP, 100 mM Na2HPO4/NaH2PO4, pH 7.4.
0.5 ml of S9 mix were added to a total volume of 2.7 ml, giving a final concentration of approximately 1% - Evaluation criteria:
- Solvent control data must be within range of historical data.
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 four non-toxic dose levels are required to evaluate assay data.
For a test substance to be considered positive, it must cause at least a doubling in the mean revertants per plate of at least one tester strain.
The increase must be accompanied by a dose response towards increasing concentrations of the test article.
Cytotoxicity is defined by a reduction in the number of revertant colonies and / or a clearing of the background lawn.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: 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:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Results were within range of 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 2: Experiment 1 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
Negative control** |
29 |
41 |
No |
146 |
135 |
No |
11 |
14 |
No |
0* |
27 |
54 |
No |
135 |
114 |
No |
10 |
11 |
No |
50 |
26 |
42 |
No |
125 |
127 |
No |
9 |
17 |
No |
160 |
26 |
44 |
No |
122 |
140 |
No |
15 |
23 |
No |
500 |
26 |
40 |
No |
133 |
155 |
No |
23 |
43 |
No |
1600 |
25 |
41 |
No |
160 |
154 |
No |
64 |
93 |
No |
5000 |
28 |
27 |
No |
179 |
178 |
No |
112 |
141 |
No |
Positive control |
129 |
553 |
No |
412 |
1952 |
No |
337 |
184 |
No |
*solvent control with DMSO
**negative control with water
Table 2: Experiment 1 Preincubation Number of revertants per plate (mean of 3 plates)
|
TA1537 |
||
Conc. |
— MA |
+ MA |
Cytotoxic |
Negative control** |
23 |
14 |
No |
0* |
18 |
12 |
No |
50 |
21 |
14 |
No |
160 |
14 |
13 |
No |
500 |
14 |
12 |
No |
1600 |
15 |
12 |
No |
5000 |
13 |
13 |
No |
Positive control |
54 |
250 |
No |
*solvent control with DMSO
**negative control with water
Table 3: Experiment 2 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA98 |
TA100 |
TA1535 |
||||||
Conc. |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
— MA |
+ MA |
Cytotoxic |
Negative control** |
21 |
43 |
No |
129 |
138 |
No |
8 |
12 |
No |
0* |
22 |
47 |
No |
123 |
129 |
No |
12 |
10 |
No |
50 |
21 |
41 |
No |
114 |
127 |
No |
11 |
9 |
No |
160 |
29 |
41 |
No |
126 |
139 |
No |
16 |
21 |
No |
500 |
24 |
47 |
No |
143 |
135 |
No |
27 |
38 |
No |
1600 |
28 |
42 |
No |
167 |
149 |
No |
64 |
83 |
No |
5000 |
32 |
31 |
No |
193 |
184 |
No |
108 |
131 |
No |
Positive control |
112 |
1984 |
No |
428 |
1711 |
No |
275 |
198 |
No |
*solvent control with DMSO
**negative control with water
Table 3: Experiment 2 Plate incorporation Number of revertants per plate (mean of 3 plates)
|
TA1537 |
||
Conc. |
— MA |
+ MA |
Cytotoxic |
Negative control** |
14 |
20 |
No |
0* |
11 |
16 |
No |
50 |
12 |
21 |
No |
160 |
12 |
18 |
No |
500 |
8 |
19 |
No |
1600 |
9 |
15 |
No |
5000 |
9 |
16 |
No |
Positive control |
80 |
120 |
No |
*solvent control with DMSO
**negative control with water
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with and without metabolic activation
In a bacterial reverse mutation assay according to OECD 471 and to GLP, (3-chloropropyl)diethoxymethylsilane induced a mutagenic effect in Salmonella typhimurium strains: TA 1535 with and without metabolic activation. Appropriate solvent and positive controls were used and gave expected results. The test substance is considered to be a direct-acting mutagen, inducing base pair mutations.
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.

EU Privacy Disclaimer
Sellel veebilehel kasutatakse küpsiseid, et tagada lehe parim kasutus.