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EC number: 700-253-3 | CAS number: 115258-10-1
- 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:
- 2009-10-26 to 2010-01-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed GLP study according to OECD technical guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate is attached to full study report.
Test material
- Reference substance name:
- N-(3-{1,1,1,5,5,5-hexamethyl-3-[(trimethylsilyl)oxy]trisiloxan-3-yl}propyl)prop-2-enamide
- EC Number:
- 700-253-3
- Cas Number:
- 115258-10-1
- Molecular formula:
- C15H37NO4Si4
- IUPAC Name:
- N-(3-{1,1,1,5,5,5-hexamethyl-3-[(trimethylsilyl)oxy]trisiloxan-3-yl}propyl)prop-2-enamide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Supplied by: Elevage de Gérome (Quartier Labaste, F-40260 Linxe)
- Acclimitsation period: 5 days
- Weight at beginning of test: 2.23 - 2.75kg
- Sex: male
- Age at beginning of test: 11 or 12 weeks
- Each animal was kept in an individual box installed in conventional air conditioned animal husbanding
- Temperature: 17-23°C
- Relative humidity: 30-70%
- Air exchange rate was approximately 15 timer per hour
- Housing was illuminated by aritificial light in a 12hrs lighting / 12hrs darkness cycle
- Drinking water: tap-water from public distribution system, ad libitum
- Foodstuff: SDS-C15, ad libitum
- Microbial and chemical analyses of the water were carried out once every six months by the IPL, Santé, Environment Durables - Atlantique
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: On the opposite flank, an untreated area served as the control
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 4hrs
- Observation period:
- 1, 24, 48, 72hrs after patch removal
- Number of animals:
- Three animals (initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated accordingly).
- Details on study design:
- - 24hrs prior to testing, the rabbit's back and flanks were shorn using electric clippers
- An area of 6cm2 was shorn
- No tissue destruction was observed after a treatment during 3min and 1hr
- The test item was applied as supplied at a dose of 0.5g on an undamaged skin area of one flank of each animal
- Patch was secured in position with a strip of surgical adhesive tape under a semiocclusive dressing
- After removal of the patch, the treated area was rinsed with distilled water
- On the opposite flank an untreated area served as control
- Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were tested accordingly
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animals 1-3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: See Table 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animals 1-3
- Time point:
- other: 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: See Table 1
Any other information on results incl. tables
Scoring according to OECD 404
Table 1: Individual data
OBSERVATIONS |
INDIVIDUAL DATA |
Total of |
||||||
Skin |
Observation |
Animal n° |
Weight (kg) |
Animal n° |
Weight (kg) |
Animal n° |
Weight (kg) |
|
A9849 |
Start : 2.23 |
A9853 |
Start : 2.42 |
A9854 |
Start : 2.64 |
|||
End : 2.34 |
End : 2.55 |
End : 2.75 |
||||||
Erythema |
24 hours |
0 |
0 |
0 |
0 |
|||
48 hours |
0 |
0 |
0 |
0 |
||||
72 hours |
0 |
0 |
0 |
0 |
||||
Total |
0 |
0 |
0 |
|
||||
Mean |
0.0 |
0.0 |
0.0 |
|
||||
Oedema |
24 hours |
0 |
0 |
0 |
0 |
|||
48 hours |
0 |
0 |
0 |
0 |
||||
72 hours |
0 |
0 |
0 |
0 |
||||
Total |
0 |
0 |
0 |
|
||||
Mean |
0.0 |
0.0 |
0.0 |
|
||||
CLASSIFICATION |
According to the calculated means, the item is not be classified. |
|||||||
CLASSIFICATION |
According to the calculated means, the item is not be classified. |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No cutaneous reactions (erythema and oedema) were observed, on the treated area, whatever the examination times (i.e. 1, 24, 48 and 72 hours after the patch removal) were.
- Executive summary:
The test item N-[3 -tris(trimethylsilyloxypropyl]prop-2 -enamide was applied, as supplied, at the dose of 0.5g, under semi-occlusive dressing during 4 hours on an undamaged skin area of three rabbits. The experimental protocol was established from the O.E.C.D. guideline n° 404 dated April24th, 2002 and the test method B.4 of the Council regulation No 440/2008.
No cutaneous reactions (erythema and oedema) were observed, on the treated area, whatever the examination times (ie 1, 24, 48 and 72 hours after the patch removal) were.
The results obtained, under these experimental conditions, enable to conclude that the test item N-[3 -tris(trimethylsilyloxypropyl]prop-2 -enamide is not to be classified according to the criteria for classification, packaging and labelling of dangerous substances and preparations in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. No symbol and risk phrase are required.
In accordance with the Globally Harmonized System (Regulation (EC) No 1272/2008), the test item is not to be classified. No signal word and hazard statement are required.
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