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EC number: 700-182-8 | CAS number: 134652-60-1
- 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:
- 12 to 15 January 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recent study conducted by a GLP certified laboratory in accordance with a suitable study guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The storage condition was room temperature, under nitrogen, protected from all lights instead of room temperature as it was indicated in the study plan. This deviation is presumed to have no effect on the health of animals or the integrity of the Study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tripropan-2-ylsilyl 2-methylprop-2-enoate
- EC Number:
- 700-182-8
- Cas Number:
- 134652-60-1
- Molecular formula:
- C13 H26 O2 Si
- IUPAC Name:
- Tripropan-2-ylsilyl 2-methylprop-2-enoate
- Details on test material:
- - Name of test material (as cited in study report): TIS-M
- Lot/batch No.: 9925
- Expiration date of the lot/batch: 2 December 2010
- Storage condition of test material: Under Nitrogen at room temperature, protected from light.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: approx. 15 weeks
- Weight at study initiation: 3665-3890 g
- Housing: Individually housed in AAALC approved metal wire rabbit cages (65x65 cm with height of 45 cm,). Cages were of an open wire
structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet: PURINA Base – Lap gr. diet for rabbits ad libitum.
- Water: municipal tap water ad libitum. The drinking water is routinely analysed and is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study. The quality control analysis is performed once every three months and microbiological assessment is performed monthly by Veszprém County Institute of State Public Health and Medical Officer Service (ÁNTSZ, H-8201 Veszprém, József A.u.36., Hungary). Copies of the relevant Certificates of Analysis are retained in the archives at LAB Research Ltd.
- Acclimation period: 34 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.0-20.5°C
- Humidity (%): 30-64 %
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 hrs light (between 6am and 6pm).
IN-LIFE DATES: From: 9 December 2009 To: 15 January 2010.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated skin of each animal served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5ml
- Concentration: undiluted
The test item was used undiluted, as a single dose of 0.5 ml of TIS-M, applied to the test area. The untreated skin of each animal served as a control. - Duration of treatment / exposure:
- The test item was removed after 4 hours.
- Observation period:
- The animals were observed for 72 hours after removal of the test item.
- Number of animals:
- 3 male New Zealand White albino rabbits.
- Details on study design:
- TEST SITE
- Area of exposure: approx 6 cm²
- % coverage:
- Type of wrap if used: plastic
REMOVAL OF TEST SUBSTANCE
- Washing: water
- Time after start of exposure: 4 hours
SCORING SYSTEM: 0-4 for both erythema and edema where 0 indicates no erythema/edema and 4 indicates a severe erythema/edema.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24hrs
- Score:
- 0.67
- Reversibility:
- fully reversible within: 72hrs
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24hrs
- Score:
- 0
- Reversibility:
- fully reversible within: 72hrs
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48hrs
- Score:
- 0.33
- Reversibility:
- fully reversible within: 72hrs
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48hrs
- Score:
- 0
- Reversibility:
- fully reversible within: 72hrs
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72hrs
- Score:
- 0
- Reversibility:
- fully reversible within: 72hrs
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72hrs
- Score:
- 0
- Reversibility:
- fully reversible within: 72hrs
- Irritant / corrosive response data:
- At observation one hour after patch removal, very slight erythema (score 1) was observed in one animal (No:00598).
At observation 24 hours after patch removal, very slight erythema (score 1) was observed in two animals (No:00598, 00508).
At observation 48 hours after patch removal, very slight erythema (score 1) was observed in one animal (No:00508).
At observation 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals. - Other effects:
- There was no effect of treatment on body weight and no treatment-related clinical signs noted. No mortality was oserved during the study.
Any other information on results incl. tables
SCORING OF EDEMA FORMATION:
Animal No./ Sex |
Body weight (g) |
|
|
|
|
|
at the beginning of the study |
at the end of the study |
1 h |
24 h |
48 h |
72 h |
|
00598/ M |
3776 |
3868 |
0 |
0 |
0 |
0 |
00508/M |
3665 |
3783 |
0 |
0 |
0 |
0 |
00581/ M |
3896 |
3972 |
0 |
0 |
0 |
0 |
TOTAL |
- |
- |
0 |
0 |
0 |
0 |
M = male d = day h = hour
SCORING OF ERYTHEMA FORMATION:
Animal No./ Sex |
Body weight (g) |
|
|
|
|
|
at the beginning of the study |
at the end of the study |
1 h |
24 h |
48 h |
72 h |
|
00598/ M |
3776 |
3868 |
1 |
1 |
0 |
0 |
00508/M |
3665 |
3783 |
0 |
1 |
1 |
0 |
00581/ M |
3896 |
3972 |
0 |
0 |
0 |
0 |
TOTAL |
- |
- |
1 |
2 |
1 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The registered substance, according to Directive 2001/59/EC and the UN Globally Harmonised System of Classification and Labelling of Chemicals, does not require classification as a skin irritant.
- Executive summary:
A acute skin irritation study of the substance was carried out according to OECD Guideline 404 using New Zealand White Rabbits. The registered substance was applied to the gauze and then placed onto the hairless skin of the rabbit for 4 hours, and after 72hours the substance was determined not to be a skin irritant.
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