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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 10-21, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- According to OECD Guideline 405, with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
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
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 2.2 – 2.3 kg
- Housing: Individual caging in metal wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days (animal nº 51) and 14 days (animal nº 52 and nº 53)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 19.0 ºC
- Humidity (%): average of 51.7%
- Photoperiod (hrs dark / hrs light): artificial light from 6 a.m. to 6 p.m.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL of test substance
- Duration of treatment / exposure:
- 72 hours (the treated eyes were not washed)
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after the administration of the test substance
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: eye irritations were scored according to guideline 405
CORNEA
Opacity : degree of density (area most dense is taken for reading).
0 No ulceration or opacity.
1 Scattered or diffuse areas of opacity (except for slight dulling of normal lustre),
details of iris clearly visible.
2 Easily discernible translucent area, details of iris slightly obscured.
3 Nacreous area, no details of iris visible, size of pupil barely discernible.
4 Opaque cornea, iris not discernible through the opacity.
IRIS
0 Normal.
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia
or injection; any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive).
2 No reaction to light, haemorrhage, gross destruction (any of all these or all together).
CONJUNCTIVAE
Redness: (refers to the most severe effect of palpebral and bulbar conjunctivae in comparison to the control eye).
0 Blood vessels normal.
1 Some blood vessels definitely hyperaemic (injected).
2 Diffuse crimson colour, individual vessels not easily discernible.
3 Diffuse beefy red.
Chemosis: lids and/or nictating membranes.
0 No swelling.
1 Any swelling above normal (includes nictating membranes).
2 Obvious swelling with partial eversion of lids.
3 Swelling with lids about half closed.
4 Swelling with lids more than half closed
TOOL USED TO ASSESS SCORE: animals were examined using and otoscope lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity(degree of density)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: mean scores of animals 51, 52, and 53
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: mean scores of animals 51, 52, and 53
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 51
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: mean
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 52
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: mean
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 53
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: mean
- Irritation parameter:
- chemosis score
- Remarks:
- lids and/or nictating membranes
- Basis:
- animal: 51
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Remarks:
- lids and/or nictating membranes
- Basis:
- animal: 52
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Remarks:
- lids and/or nictating membranes
- Basis:
- animal: 53
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: mean
- Irritant / corrosive response data:
- Reversibility of any observed effect: all changes observed were fully reversible within 3 days
After the instillation of the test substance the following findings were made:
- Corneae and irises were not affected.
- Conjunctivae, redness (a score 1) was noted in all animals from 24 h after application (p.a.) onwards until a maximum of 48 h p.a.
- Conjunctivae, chemosis (a score 1) was observed in 2/3 animals only 1 h (p.a.). A scored of 3, later on decreasing to 1, was noted in 1/3 animals from 1h p.a. onwards until 48 h p.a. - Other effects:
- Ocular discharge was noted in 2/3 animals from 1h onwards until a maximum of 24 h after test substance application.
Any other information on results incl. tables
Scores of the test eyes:
Examination of corneae, irises and
conjunctivae. Individual data and means.*
|
|
|
Conjunctivae |
|||||||||
Time after |
Corneae |
Irises |
Redness |
Chemosis |
||||||||
|
51 |
52 |
53 |
51 |
52 |
53 |
51 |
52 |
53 |
51 |
52 |
53 |
1 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
02) |
03) |
1 |
1 |
3 |
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
12) |
0 |
0 |
2 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
mean |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.3 |
0.3 |
0.7 |
0.0 |
0.0 |
1.0 |
2) Discharge with moistening of the lids and hairs just adjacent to the lids.
3) Discharge with moistening of the lids and considerable area around the eye.
*Dermal alterations were scored according to OECD guideline nº 405.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified as eye irritant (CLP Regulation EC no. 1272/2008)
- Conclusions:
- No ocular lesions were observed at 72 hours.
- Executive summary:
The Acute Eye Irritation/Corrosion study for the test substance was performed in New Zealand White rabbits. 0.1 mL of the test material was administrated per animal into the conjunctival sacs of the right eyes. The eyes were held closed for about one second to prevent loss of the test substance. The left eyes remained untreated and served as a control. The administration of the test substance was performed in a sequential manner. The first animal was exposed to the test substance, as no evidence for serious damage to the eye of the animal was found during the initial 72 h observation period, the test substance was administrated to the others two animals. Both whole eyes of the animals were examined (especially the corneae, the irises and the conjunctivae) within 24 h before the instillation and approximately 1, 24, 48, and 72 hours after test substance administration. Eye irritations were scored according to OECD guideline nº 405.
No ocular lesions were observed at 72 hours.
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