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EC number: 457-690-5 | CAS number: 23432-65-7
- 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:
- 20 Nov 2003 - 07 Jan 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 1997
- Deviations:
- yes
- Remarks:
- 2-aminoanthracene was used as the sole indicator of the efficacy of the S9-mix
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, München, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- methyl N-{[dimethoxy(methyl)silyl]methyl}carbamate
- Cas Number:
- 23432-65-7
- Molecular formula:
- C6H15NO4Si
- IUPAC Name:
- methyl N-{[dimethoxy(methyl)silyl]methyl}carbamate
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- His operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Phenobarbital/beta-Naphtoflavone.
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000, 2500, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the bacteria and the S9 activity.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine (4-NOPD), 2-aminoanthracene (2-AA)
- Remarks:
- Without S9: sodium azide (10 µg/plate for TA 100 and TA 1535); 4-NOPD (10 and 40 µg/plate for TA 98 and TA 1537); MMS (1 µL/plate for TA 102); With S9: 2-AA (2.5 µg/plate for TA 98, TA 100, TA 1535, TA 1537; 10 µg/plate for TA 102)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 plates per concentration in two independent experiments (plate incorporation and preincubation)
DETERMINATION OF CYTOTOXICITY
- Method: reduced background lawn, reduction in the number of revertants, degree of survival of treated cultures
METABOLIC ACTIVATION
The S9 fraction was stored in liquid nitrogen. The S9 mix was freshly prepared on the day of the test according to AMES (1933): containing 15% S9 and the following components (final concentrations):
- 8 mM MgCl2
- 33 mM KCI-salt solution
- 5 mM glucose-6-phosphate
- 5 mM NADP
in 100 mM phosphate buffer, pH 7.4 - Evaluation criteria:
- A test item is considered as mutagenic if:
- a dose-related increase in the number of revertants occurs and/or
- a reproducible biologically relevant positive response for at least one of the dose groups occurs in at least one strain with or without metabolic activation
A biologically relevant increase is described as follows:
- if in strains TA 100 and TA 102 the number of reversions is at least twice as high
- if in strains TA 1535, TA 1537 and TA 98 the number of reversions is at least three times higher
as compared to the spontaneous reversion rate. - Statistics:
- Mean values and standard deviation were calculated
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium 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
- Key result
- Species / strain:
- S. typhimurium TA 102
- 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation was reported
RANGE-FINDING/SCREENING STUDIES:
In a preliminary toxicity test TA 98 and TA 100 were treated with the test item up to 5000 µg/plate. No toxicity was observed up to 5000 µg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: no data given
Any other information on results incl. tables
Table 1: Test results of main test 1 (Plate incorporation test).
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate in the plate incorporation test |
|||||
(μg/plate) |
(average of 3 plates±standard deviation) |
||||||
|
Base-pair substitution type |
Frameshift type |
|||||
|
TA 100 |
TA 102 |
TA 1535 |
TA1537 |
TA98 |
||
– |
A. dest. |
124±8 |
327±6 |
27±4 |
12±7 |
31±3 |
|
– |
Solvent control |
99±11 |
273±16 |
28±7 |
11±6 |
33±2 |
|
– |
31.6 |
106±19 |
286±16 |
24±5 |
14±6 |
36±2 |
|
– |
100 |
109±4 |
279±11 |
22±6 |
15±5 |
27±8 |
|
– |
316 |
104±9 |
301±7 |
23±5 |
15±2 |
33±6 |
|
– |
1000 |
115±4 |
294±8 |
21±4 |
17±3 |
27±2 |
|
– |
2500 |
103±14 |
319±26 |
19±4 |
12±3 |
28±8 |
|
– |
5000 |
116±5 |
308±19 |
24±9 |
12±6 |
30±8 |
|
Positive controls, –S9 |
Name |
sodium azide |
MMS |
sodium azide |
4-NOPD |
4-NOPD |
|
Concentrations (μg/plate) |
10 |
1 µL/plate |
10 |
40 |
10 |
||
Average of 3 plates±sd |
402±28 |
1724±129 |
1032±46 |
179±11 |
774±59 |
||
+ |
A. dest. |
124±22 |
355±56 |
12±2 |
15±4 |
46±9 |
|
+ |
Solvent control |
116±13 |
289±31 |
11±3 |
13±1 |
36±7 |
|
+ |
31.6 |
116±7 |
330±28 |
15±7 |
17±2 |
38±2 |
|
+ |
100 |
108±16 |
369±40 |
21±1 |
14±1 |
41±4 |
|
+ |
316 |
116±14 |
330±23 |
16±7 |
13±9 |
38±12 |
|
+ |
1000 |
113±17 |
360±19 |
16±4 |
19±3 |
35±1 |
|
+ |
2500 |
128±4 |
352±5 |
11±3 |
13±4 |
34±4 |
|
+ |
5000 |
130±9 |
375±23 |
15±6 |
13±3 |
38±6 |
|
Positive controls,+S9 |
Name |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
|
Concentrations (μg/plate) |
2.5 |
10 |
2.5 |
2.5 |
2.5 |
||
Average of 3 plates±sd |
1991±36 |
804±20 |
226±29 |
282±9 |
1207±142 |
Table 2: Test results of main test 2 (Pre-incubation test).
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate in the pre-incubation test |
|||||
(μg/plate) |
(average of 3 plates±standard deviation) |
||||||
|
Base-pair substitution type |
Frameshift type |
|||||
|
TA 100 |
TA 102 |
TA 1535 |
TA1537 |
TA98 |
||
– |
A. dest. |
113±11 |
192±19 |
21±4 |
17±6 |
35±5 |
|
– |
Solvent control |
99±5 |
141±8 |
17±4 |
11± |
27±4 |
|
– |
31.6 |
128±3 |
166±12 |
16±4 |
17±7 |
25±4 |
|
– |
100 |
115±18 |
159±11 |
20±1 |
17±4 |
26±3 |
|
– |
316 |
117±21 |
151±1 |
24±2 |
15±4 |
25±3 |
|
– |
1000 |
114±1 |
154±20 |
17±4 |
17±1 |
25±3 |
|
– |
2500 |
123±5 |
131±9 |
24±1 |
17±2 |
24±5 |
|
– |
5000 |
123±10 |
166±6 |
23±3 |
17±1 |
31±4 |
|
Positive controls, –S9 |
Name |
sodium azide |
MMS |
sodium azide |
4-NOPD |
4-NOPD |
|
Concentrations (μg/plate) |
10 |
1 µL/plate |
10 |
40 |
10 |
||
Average of 3 plates±sd |
540±49 |
2246±80 |
1168±84 |
152±15 |
848±29 |
||
+ |
A. dest. |
143±12 |
304±32 |
16±6 |
24±8 |
45±5 |
|
+ |
Solvent control |
128±9 |
211±39 |
11±2 |
11±0 |
39±11 |
|
+ |
31.6 |
132±10 |
258±15 |
18±2 |
13±3 |
38±10 |
|
+ |
100 |
127±12 |
246±1 |
13±6 |
18±8 |
43±12 |
|
+ |
316 |
120±8 |
223±17 |
15±3 |
14±2 |
33±4 |
|
+ |
1000 |
128±3 |
221±25 |
19±4 |
11±4 |
42±2 |
|
+ |
2500 |
122±25 |
209±12 |
12±6 |
15±4 |
38±8 |
|
+ |
5000 |
122±22 |
233±31 |
21±3 |
16±2 |
35±9 |
|
Positive controls,+S9 |
Name |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
2-aminoanthracene |
|
Concentrations (μg/plate) |
2.5 |
10 |
2.5 |
2.5 |
2.5 |
||
Average of 3 plates±sd |
2373±144 |
839±197 |
178±31 |
204±44 |
2033±238 |
MMS - Methylmethanesulfonate
4 -NOPD - 4 -nitro-o-phenylene-diamine
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results::
negative
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