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EC number: 640-410-2 | CAS number: 2594-75-4
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No data is available for the target substance Methyl-tris acetonoximo-silane. Thus, available data from the source substance WASOX-MMAC2 was used in a read-across approach.
In a reverse gene mutation assay in bacteria (OECD 471) strains of S. typhimurium (TA97a, TA98, TA100, TA102 and TA1535) were exposed to WASOX-MMAC2 in DMSO at concentrations of 5000, 1667, 556, 185 and 62 µg/plate in the presence and absence of mammalian metabolic activation. There was no evidence of induced mutant colonies over background. This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-09-10 to 2004-12-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21 July 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- - Name: "WASOX-MMAC2"
- Batch No.: 1000024854
- Purity: The test substance is a mixture of mainly 3 components:
MMAC2 (range: 45-80% w/w), accurately 55.0% (GC-% w/w),
MM2AC (range 2-30% w/w), accurately 11.7% (GC-% w/w) and
MAC3 (range 5-30% w/w),accurately 24.0% (GC-% w/w) plus by-products and impurities.
The 3 components act uniformly as hardeners for silicone sealing masses. They polymerise, triggered bv hydrolysis.
- CAS No. (main component): 72122-57-7
- Solubility in water: Poorly soluble. A polymeric, insoluble in water, is formed by hydrolysis. Rapid onset of hydrolysis.
- Solubility in other solvents: Easily soluble in toluene and methylcyclohexane
- Appearance: Solid and liquid parts at room temperature.Yellowish brownish colour.
- Melting point: 30 - 35 °C.
- Conditions of storage: Storage under a nitrogen atmosphere, as the substance reacts with water, even from air humidity. Ambient temperature (theoretically up to approx. 40 °C possible), protected against light (handling without protection against light is acceptable).
- Handling precautions: Exothermic reaction with water or humidity from the air.
- Date of expiry: December 2005 - Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: TA97a, TA98, TA100, TA102 and TA1535
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Prof. Bruce N. Ames, Berkeley, California, USA - Metabolic activation:
- with and without
- Metabolic activation system:
- S9 metabolising system
- Test concentrations with justification for top dose:
- The concentrations for the first experiment were set according to a preliminary toxicity test, The test substance was not toxic up to 5000 µg/petri dish. It was therefore decided to use 5000 µg/plate as the highest eoneentration which is the limit concentration according to the guidelines. Each of the other 4 concentrations was 1/3 of the preceding one. The number and intervals of the concentrations are in accordance with the guidelines.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylsulfoxide
- Justification for choice of solvent/vehicle: The test substance hydrolyses rapidly in water. DMSO is a common vehicle for the Ames test. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-NOPD
- Remarks:
- TA97a (10 µg/plate), without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98 (2 µg/plate), without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100 (2 µg/plate), TA1535 (1 µg/plate), without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: t-Butyl-hydroperoxide
- Remarks:
- TA102 (50 µg/plate), without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- TA97a (10 µg/plate), with S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSo
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA98 (1 µg/plate), TA100 (2 µg/plate), TA1535 (2 µg/plate), with S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1,8-Dihydroxy-anthraquinone
- Remarks:
- TA102 (50 µg/plate), with S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Plate incorporation assay
The exposure was performed according to the 'Plate Incorporation Assay', in which bacteria, test substance (and microsomes) are in contact on the plate without preceding incubation in the liquid state. The number of viable cells in the overnight-cultures is in the range of 2 x 10^8 cells per mL. For each sample the following solutions were combined:
- 0.1 mL of the overnight culture of the bacteria,
- 0.5 mL of S9-mix (or phosphate buffered saline for samples without metabolite activation),
- 0.1 mL of the appropriate test- or reference substance solution and
- 2 mL of top agar.
The combined solutions were mixed and spread over a plate with minimal agar (9 cm diameter). After the top agar had solidified, the plates were incubated at 37 °C until the colonies were visible (2 days).
Counting of colonies
The plates with less than about 50 revertant colonies, i.e. the plates of TA98 and TA1535 with the exception of the positive controls, were counted visually by marking the colonies with a felt tipped pen. The other plates were photographed with a video camera and the picture files were scanned for colonies by a computer program.
Determination of the toxicity
Additionally, to the counting of colonies the bacterial background of the plates was inspected visually. The following signs of toxicity, if present, were recorded:
- A reduced bacterial background lawn (mottled instead of homogeneous).
- Microcolonies of bacteria instead of a homogeneous background lawn.
- No background lawn.
- Clearly reduced numbers of revertant colonies.
NUMBER OF REPLICATIONS: Triplicate repetitions were run for each dose group in each of the two separate experiments that were conducted, for the control groups six-fold repetitions were run. - Evaluation criteria:
- The criteria for a positive result are:
A reproducible increase of the number of revertants to more than the following threshold values for at least one of the concentrations:
- For the strains with a low spontaneous revertant rate i.e. TA98 and TA1535: The 2~fold of the amount of the spontaneous revertants.
- For the strains with a high spontaneous revertant rate i.e. TA97a, TA100 and TA102: The 1.66-fold of the amount of the spontaneous revertants.
These threshold values were derived from the variations in the control sampies of our historic data of the Ames test. - Statistics:
- Means and standard deviations were calculated for the number of mutants in every concentration group.
- Key result
- Species / strain:
- S. typhimurium, other: TA97a, TA98, TA100, TA102, TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Positive Control Substances:
All positive contral substances increased the mutation frequency to more than the threshold values. As 2-aminoanthracene, 1,8-dihydroxy-anthraquinone and 7,12-dimethyl-benzanthracene require metabolie activation for mutagenicity, the results of these substances demonstrate also the efficiency of the metabolising system.
Solubility:
No precipitation of the test substance was seen in any of the concentration groups.
Toxicity:
In the preliminary test and in the main test no toxicity was seen up to 5000 µg/plate.
Mutagenicity:
There was increase in the number of mutants in any of the tested bacterial strains at any of the tested concentrations. The addition of an external metabolising system did not change these results. - Conclusions:
- The test item is not genotoxic in the bacterial reverse gene mutation assay in the presence and absence of mammalian metabolic activation.
- Executive summary:
In a reverse gene mutation assay in bacteria (OECD 471) strains of S. typhimurium (TA97a, TA98, TA100, TA102 and TA1535) were exposed to WASOX-MMAC2 in DMSO at concentrations of 5000, 1667, 556, 185 and 62 µg/plate in the presence and absence of mammalian metabolic activation. The positive controls did induce the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No data is available for the target substance Methyl-tris acetonoximo-silane. Thus, available data from the source substance WASOX-MMAC2 was used in a read-across approach.
In a reverse gene mutation assay in bacteria (OECD 471) strains of S. typhimurium (TA97a, TA98, TA100, TA102 and TA1535) were exposed to WASOX-MMAC2 in DMSO at concentrations of 5000, 1667, 556, 185 and 62 µg/plate in the presence and absence of mammalian metabolic activation. There was no evidence of induced mutant colonies over background. This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
Justification for classification or non-classification
Based on the available data from a suitable read-across partner, the target substance Methyl-tris acetonoximo-silane is considered to be non-mutagenic and no classification is warranted in accordance with CLP Regulation 1272/2008.
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.
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