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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-10-04 to 2004-11-17
- 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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 24 April 2002
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- A mixture of: propan-2-one-O,O'-(methoxymethylsilandiyl)dioxime; propan-2-one-O-(dimethoxymethylsilyl)oxime; propan-2-one-O,O',O''-(methylsilantriyl)trioxime
- EC Number:
- 460-110-3
- EC Name:
- A mixture of: propan-2-one-O,O'-(methoxymethylsilandiyl)dioxime; propan-2-one-O-(dimethoxymethylsilyl)oxime; propan-2-one-O,O',O''-(methylsilantriyl)trioxime
- IUPAC Name:
- A mixture of: propan-2-one-O,O'-(methoxymethylsilandiyl)dioxime; propan-2-one-O-(dimethoxymethylsilyl)oxime; propan-2-one-O,O',O''-(methylsilantriyl)trioxime
Constituent 1
- 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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other:
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelman GmbH, 33176 Borchen, Germany
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: About 8 weeks at the first administration
- Weight at study initiation: 17.0-19.9 g
- Housing: Single caging in Makrolon cages type II
- Diet (e.g. ad libitum): Yes, Altromin maintenance diet for rats and mice, item No.1324forte
- Water (e.g. ad libitum): Yes, tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Average of 21.8
- Humidity (%): Average of 48.2
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50 and 100%
- No. of animals per dose:
- 5
- Details on study design:
- MAIN STUDY
The test substance was administered in 3 concentrations to the dorsal surfaces of the ears of the animals of the test substance groups. In a manner identical to that of animals in the treatment groups animals of one negative control group and one positive control group were treated with AOO and HCA respectively. Each animal was treated for 3 consecutive days. 3 days after the last administration the proliferation of the Iymphocytes of the draining Iymph nodes was measured by the determination of the amounts of incorporated 3HTdR.
Administration of the test substance:
Route of Administration: epicutaneous administration to the dorsal surface of each ear
Administration volume: 25 µL
Incorporation of 3H-methyl thymidine in vivo:
5 days after the first topical administration, each animal received 20 µCi 3HTdR by slow intravenous administration. The injection solution containing nominal 80 µCi/mL 3HTdR was prepared by the dilution of 1.152 mL 3HTdR (amersham pharmacia biotech, Kat. Nr.:TRA 310, batch 315, specific activity 2.0 Ci/mmol, radioactive concentration 1 mCi/mL, radiochemical purity 98.6%, thymine content 0.2%) with 13.248 mL PBS. Several minutes prior to 3HTdR administration the animals were kept restrained in Plexiglas-tubes and the tail veins were visualised by placing the tails in warm water. Then 250 µL of the injection solution were intravenously administered to each animal.
Preparation of single cell suspensions and determination of incorporated 3H-methyl thymidine:
Approximately 5 hours after 3HTdR injection all animals were sacrificed by carbon dioxide asphyxiation and the draining auricular lymph nodes were rapidly excised. The Iymph nodes of each group were pooled in PBS. A single cell suspension (SCS) of Iymphnode cells (LNC) nwas prepared by gentle mechanical disaggregation of the pooled Iymph nodes through a 70 µm cell strainer. The SCSs were then transferred into centrifuge tubes and LNC were pelleted by centrifugation (4 °C, max. 200 g, 10 min). Afterwards supernatants were removed by aspiration. Then the LNC were resuspended and washed twice with PBS. After the final washing the supernatants were removed leaving just a small volume < 0.5 mL) and
macromolecules were precipitated by incubation with 5 % trichloroacetic acid (TCA) at 4 °C overnight. Each precipitate was pelleted by centrifugation (4 °C, max. 200 g, 10min) and resuspended in 1 mL TCA. This suspension was transferred into scintillation vials containing 10 mL scintillation cocktail (Packard Bioscience: Ultima Gold, Bestellnr. 6013329) and 3HTdR incorporation was determined with a ß-scintillation counter.
INVESTIGATIONS
General observations: All animals were observed at least once daily for behavioural changes or signs of toxicity
Body masses: The body mass of each animal was recorded on Days 1 and 6
Skin reactions: The application sites were visually checked for local irritations once a day from Days 1-6. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Calculation of the stimulation indices (Sls):
Results are presented as test/control ratio (Stimulation index), calculated as dpm test group/dpm negative control group.
(dpm = disintegrations per minute, corrected by the subtraction of the background)
Results and discussion
- Positive control results:
- Application of 25% HCA in AOO resulted in an SI of 10.2. This result proves the sensitivity of the strain of animals used and the reliability of the experimental technique.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 25%
- Remarks on result:
- other: no indication of sensitisation
- Key result
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- 50%
- Remarks on result:
- other: no indication of sensitisation
- Key result
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- 100%
- Remarks on result:
- other: no indication of sensitisation
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
: The SIs of the test substance groups were between 0.7 and 1. For detailed results please refer to table 1 in box "Any other information on results incl. tables".
SKIN REACTIONS: No local skin irritations were observed at the application sites of all animals of all test substance groups and both control groups throughout the whole study.
MORTALITY: No mortality occurred
GENERAL OBSERVATIONS: One animal of the high dose group had reduced motoric activities on Day 6. In all other animals no abnormal behaviour or clinical signs were detected during the experiment.
BODY MASS: Body masses and body mass gains of all animals were in the range to be expected from animals of the same strain, sex and age.
Any other information on results incl. tables
Table 1: DPM results and calculated SIs
Test group |
DPM |
SI |
Negative control |
4197 |
1 |
Low dose |
4217 |
1.0 |
Mid dose |
3536 |
0.8 |
High dose |
2919 |
0.7 |
Positive control |
42767 |
10.2 |
Rationale for selection of the concentrations:
In a range finding study the test substance as it is (100%) was administered to two animals. In this study the animals were treated in the same manner as in a main study with 25 µL test substance on the dorsum of each ear on three consecutive days. None of the animals showed overt systemic toxicity, excessive local skin irritation or an increase in ear thickness in the range finding study. Therefore, 100% was chosen as highest test substance concentration and ear thickness measurement was not performed in the main study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance "WASOX-MMAC2" is not sensitizing under the conditions of this LLNA study (OECD 429).
- Executive summary:
In a dermal sensitization study conducted according to OECD 429 with "WASOX-MMAC2" suspended in AOO (4:1 v/v acetone/olive oil), young adult female CBA/CaOlaHsd mice (5 per dose group) were tested at concentrations of 25% (v/v), 50% (v/v) and 100% (undiluted) in a local lymph node assay (LLNA). There was no mortality nor clinical observations nor effects on body weights observed. None of the tested concentrations of the test substance reached the stimulation index (SI) threshold of 3. Therefore, no EC3 value could be determined. Application of the positive control substance hexyl cinnamic aldehyde (25%) resulted in a SI of 10.2. This result proves the sensitivity of the strain of animals used and the reliability of the experimental technique. In this study, the test substance is not a dermal sensitizer.
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