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EC number: 433-360-6 | CAS number: 34036-80-1
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-03-02 to 1999-03-11
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test method according to EEC method B4, OECD guideline 404 with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 433-360-6
- EC Name:
- -
- Cas Number:
- 34036-80-1
- Molecular formula:
- C18H29N3O3Si
- IUPAC Name:
- 6-{[(butan-2-ylidene)amino]oxy}-3,9-dimethyl-6-phenyl-5,7-dioxa-4,8-diaza-6-silaundeca-3,8-diene
- Reference substance name:
- 2-butanone-O,O',O''- (phenylsilylidyne)trioxime
- IUPAC Name:
- 2-butanone-O,O',O''- (phenylsilylidyne)trioxime
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report):Phenyltris-(methylethylketoximino)silane
- Physical state: Clear liquid
- Analytical purity: >92%
- Lot.: M-350B
- Expiry: 12 February 2000
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Ltd, Margate, Kent, England.
- Age at study initiation: at least 14 weeks of age
- Weight at study initiation: 2.9 to 3.4 kg
- Housing: Individually in stainless steel cages with perforated floors.
- Diet: ad libitum
- Water: ad libitum
-Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS:
-Temperature: 19 to 20°C
- Humidity: 35 to 48%
- Photoperiod: 12 hours of artificial light (0700 - 1900 hours) in each 24 hours period.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Examination of the treated skin was made on Day 1, 2, 3 and 4. Additional observations were made for two animals on Days 5 through 10.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
-Area of exposure: 25 mm x 25 mm of dorso-lumbar region
-Type of wrap if used: gauze pad under "Elastoplast" elastic adhesive dressing
REMOVAL OF TEST SUBSTANCE:
- Washing (if done): Yes, washed with warm water (36ºC) and blotted dry with absorbent paper.
- Time after start of exposure: 4 hours
SCORING SYSTEM: According to guidelines
ERYTHEMA AND ESCHAR FORMATION
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) or eschar formation (injuries in depth) preventing erythema reading: 4
OEDEMA FORMATION
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well-defined by definite raising): 2
Moderate oedema (edges raised approximately 1 millimetre): 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure): 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: Mean 24-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: Mean 24-72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: Mean 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: Mean 24-72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: Mean 24-72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: Mean 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Slight to well-defined dermal initation (erythema with oedema up to Grade 2) was seen in two animals following removal of the dressings and over the following days, resolving completely by Day 10. In addition, desquamation of the stratum corneum (characterised by dryness and sloughmg) was observed in one of these rabbits. No dermal initation was observed in the remaining rabbit throughout the study.
Any other information on results incl. tables
Dermal reactions:
Rabbit |
E= Erythema O= Oedema |
Day |
Mean 24-72h |
|||||||||
1* |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
|||
1933 Male |
E |
1 |
1 |
1 |
1 |
2 |
2 |
1 |
1 |
1 |
0 |
1.0 |
O |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.3 |
|
Other |
- |
- |
A |
a |
a |
a |
a |
a |
a |
- |
- |
|
1934 Male |
E |
1 |
2 |
2 |
2 |
2 |
2 |
1 |
1 |
1 |
0 |
2.0 |
O |
1 |
2 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1.3 |
|
Other |
- |
- |
A |
a |
a |
a, b |
a, b |
a, b |
a, b |
b |
- |
|
1935 Male |
E |
0 |
0 |
0 |
0 |
- |
- |
- |
- |
- |
- |
0.0 |
O |
0 |
0 |
0 |
0 |
- |
- |
- |
- |
- |
- |
0.0 |
|
Other |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
*: Approximately 30 minutes after removal of the dressing
a: Patchy response
b: Desquamation of the stratum comeurn (characterised by dryness and sloughing)
-: Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to CLP Regulation, the test item is not classified as irritating to the skin.
- Executive summary:
A skin irritation study was performed with test item in accordance with EEC Method B4 and OECD Guideline 404. Three rabbits were each administered a single dermal dose of 0.5 ml of the test substance (as received) for four hours under semi-occlusive conditions and observed for up to ten days. Slight to well-defined dermal initation (erythema with oedema up to Grade 2) was seen in two animals following removal of the dressings and over the following days, resolving completely by Day 10. The mean 24 -72 hours erythema scores were 1.0, 2.0 and 0.0 and the mean 24 -72 oedmea scores 0.3, 1.3 and 0.0 for each animal respectively. In addition, desquamation of the stratum corneum (characterised by dryness and sloughmg) was observed in one of these rabbits. No dermal initation was observed in the remaining rabbit throughout the study. According to CLP Regulation, the test item is not classified as irritating to the skin.
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