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EC number: 458-680-3 | CAS number: 797751-44-1 WASOX-VMAC2
- 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:
- October 12-19, 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- According to OECD Guideline 429, with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- 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'(methoxyvinylsilandiyl)dioxime; propan-2-one-O-(dimethoxyvinylsilyl)oxime; propan-2-one-O,O',O''-(vinylsilantriyl)trioxime
- EC Number:
- 458-680-3
- EC Name:
- A mixture of: propan-2-one-O,O'(methoxyvinylsilandiyl)dioxime; propan-2-one-O-(dimethoxyvinylsilyl)oxime; propan-2-one-O,O',O''-(vinylsilantriyl)trioxime
- Cas Number:
- 797751-44-1
- Molecular formula:
- not applicable, multiconstituent substance
- IUPAC Name:
- 3-ethenyl-3-methoxy-6-methyl-2,4-dioxa-5-aza-3-silahept-5-ene; 5-ethenyl-2,8-dimethyl-5-{[(propan-2-ylidene)amino]oxy}-4,6-dioxa-3,7-diaza-5-silanona-2,7-diene; 5-ethenyl-5-methoxy-2,8-dimethyl-4,6-dioxa-3,7-diaza-5-silanona-2,7-diene
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelman
- Age at study initiation: 8 weeks
- Weight at study initiation: 16.8 – 20.1 g
- Housing: single caging. Makrolon cages type II
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.8 ºC (average)
- Humidity (%): 48.2% (average)
- Photoperiod (hrs dark / hrs light): only artificial light from 6.00 a.m. to 6.00 p. m.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- High dose: 100% test substance (as it is).
Mid dose: 50% (v/v) solution of the test substance in acetone:olive oil.
Low dose: 25% (v/v) solution of the test substance in acetone:olive oil. - No. of animals per dose:
- five female mice/dose level.
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Solubility testing showed that the test substance solves for at least 50% (v/v) in vehicle AOO.
- Irritation: about 24 hours after the last administration of the test substance as it is (100%) little increase in ear thickness was observed.
TREATMENT PREPARATION AND ADMINISTRATION:
Administration was performed epicutaneously to the dorsal surface of both ears, once a day on three consecutive days. The volume administered was 25 µL per ear. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- The positive control result was: 42767 dpm (desintegrations per minute); and a SI (Stimulation Index) of 10.2
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Negative control
- Key result
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- Low dose
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Mid dose
- Key result
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- High dose
- Key result
- Parameter:
- SI
- Value:
- 10.2
- Test group / Remarks:
- Positive control
Any other information on results incl. tables
Body masses
The body mass of each animal was recorded on days 1 and 6.
Individual body masses (b.m.) and body mass gains in g of all animals. Means, standard deviations (SD) and number of animals per group (n).
group K negative control |
|
group A (low dose) |
group B (mid dose) |
group C (high dose) |
group P (positive control) |
||||||||||||||
|
|||||||||||||||||||
animal |
b.m. on Day |
b.m. |
animal |
b.m. on Day |
b.m. |
animal |
b.m. on Day |
b.m. |
animal |
b.m. on Day |
b.m. |
animal |
b.m, on Day |
b.m. |
|||||
No. |
1 |
6 |
gain |
No. |
1 |
6 |
gain |
No. |
1 |
6 |
gain |
No. |
1 |
6 |
oain |
No. |
1 |
6 |
gain |
1 |
18.9 |
21,1 |
2.2 |
31 |
20.1 |
19.6 |
-0.5 |
36 |
18.8 |
20.7 |
1.9 |
41 |
17,7 |
19,2 |
1.5 |
21 |
18.3 |
19.0 |
0.7 |
2 |
18.7 |
20.3 |
1.6 |
32 |
18.1 |
19.4 |
1.3 |
37 |
18.0 |
18.6 |
0.6 |
42 |
20.0 |
20.5 |
0.5 |
22 |
19.9 |
21.3 |
1.4 |
3 |
19.4 |
20.0 |
0.6 |
33 |
19.2 |
20.1 |
0.9 |
38 |
18.8 |
20.4 |
1,6 |
43 |
16.8 |
17.8 |
1.0 |
23 |
17.3 |
18.9 |
1.6 |
4 |
17.8 |
17.8 |
0.0 |
34 |
18.5 |
20.1 |
1.6 |
39 |
18.6 |
19.9 |
1.3 |
44 |
18.6 |
19.7 |
1.1 |
24 |
18.0 |
18.9 |
0.9 |
5 |
19.7 |
21.3 |
1.6 |
35 |
19.5 |
20.2 |
0.7 |
40 |
19,3 |
21.2 |
1.9 |
45 |
19.7 |
21.8 |
2.1 |
25 |
19.3 |
19.8 |
0.5 |
mean |
18.9 |
20.1 |
1.2 |
mean |
19.1 |
19.9 |
0.8 |
mean |
18.7 |
20.2 |
1.5 |
mean |
18.6 |
19.8 |
1,2 |
mean |
18.6 |
19.6 |
1.0 |
SD |
0.7 |
1.4 |
0.9 |
SD |
0.8 |
0.4 |
0.8 |
SD |
0.5 |
1.0 |
0.5 |
SD |
1.3 |
1.5 |
0.6 |
SD |
1.0 |
1.0 |
0.5 |
n |
5 |
5 |
5 |
n |
5 |
5 |
5 |
n |
5 |
5 |
5 |
n |
5 |
5 |
5 |
n |
5 |
5 |
5 |
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.
Body weight loss was noted in 1/5 animals in group A.
Evidence of sensitisation of each challenge concentration:
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)
dpm results and calculated SIs
|
dpm |
SI |
Group K (negative control) |
4197 |
1 |
Group A (low dose) |
4964 |
1.2 |
Group B (mid dose) |
4383 |
1.0 |
Group C (high dose) |
2736 |
0.7 |
Group P (positive control) |
42767 |
10.2 |
SI: dpm test group/dpm negative contro) group
The stimulation indices of each of the 3 test substance concentrations were below 3: 1.2 at the low concentration, 1.0 at the mid concentration, and 0.7 at the high concentration.
theow concentration, concentration The stimulation index of the positive control was 10.2.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified for skin sensitization (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The test substance is regarded as a non sensitiser in the "Skin Sensitisation: Local Lymph Node Assay", since the SIs of all examined test substance concentrations were clearly smaller than 3.
- Executive summary:
The "Skin Sensitisation: Local Lymph Node Assay" for the test substance was performed in five groups of 5 female CBA mice( According to OECD Guideline 429). The doses tested were 100% of test material (as it is); 50% (v/v) and 25 % (v/v). The vehicle used was acetone:oil (4:1, v/v) (AOO). A positive control (25% solution of hexyl cinnamic aldehyde in AOO) and a negative control (AOO) were included on the test. Both control substances were administrated under identical conditions as the test substance. The Administration was performed epicutaneously to the dorsal surface of both ears, once a day on three consecutive days. The volume administrated was 25 µl per ear. 5 days after the first topical administration, each animal received 20 µlCi3HTdR by intravenous administration. Approximately 5 hour after 3HTdR injection all animals were sacrificed and the3HTdR incorporation determinate. The application sites were visually checked for local irritations at least once a day. Body weight was recorded on days 1 and 6 after the administration.
The test substance is regarded as a not sensitising, since the SIs of all examined test substance concentrations were clearly smaller than 3.
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