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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 April 2010 to 22 April 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Recent study conducted by a GLP certified laboratory in accordance OECD, EPA and EU 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- 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
- Storage condition of test material: Room temperature, under nitrogen, continuously protected from all lights
- Date of manufacture: 23 September 2009
- Expiry date: 02 December 2010
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, Hungary
- Age at study initiation: ~11 weeks old (adult)
- Weight at study initiation: Body weight range at the beginning of the life phase: 2633-2728 g end of the life phase: 2823-3055 g
- Fasting period before study: No information
- Housing: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet: Animal received PURINA Base – Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum.
- Water: The animals received municipal tap water, as for human consumption, ad libitum, from an automatic system.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
IN-LIFE DATES: From: 19 April 2010 To: 22 April 2010
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye of each animal served as the control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: Undiluted - Duration of treatment / exposure:
- Not applicable - test material was not removed.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 male animals
- Details on study design:
- Application of the Test Item
Three male animals in acceptable health condition were selected for the test. Care was taken to select only those animals that had a normal eye condition and any with ocular lesions were rejected. An initial test was performed using one animal. The test item was instilled into the conjunctival sac of the left eye. The eyelids were held closed for several seconds to prevent the loss of the test item. The contralateral eye served as the control. Immediately after the administration of the test item, an assessment of the initial pain reaction was made according to a six point scale. After consideration of the ocular responses produced in the first animal, two additional animals were treated.
Clinical Observations
The eyes were examined at 1, 24, 48 and 72 hours after treatment. The duration of the observation period was sufficient to identify reversibility or irreversibility of changes. Any clinical signs of toxicity or signs of ill- health during the study were recorded. At the end of the observation period, each animal was sacrificed by intramuscular injections of CP-Ketamin 10% and CP-Xylazine 2% followed by iv. Euthasol® 40% anaesthesia. Death was verified by checking pupil and cornea reflex, absence of respiration and pulse.
Scoring and Assessment of Local Reaction
The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (24 April 2002).
Measurement of Body Weight
Individual body weight was recorded at the beginning and end of the experiment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- Mean
- Time point:
- other: Overall at 24. 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- Mean
- Time point:
- other: Overall at 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- Mean
- Time point:
- other: Overall at 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Mean
- Time point:
- other: Overall at 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- Mean
- Time point:
- other: Overall at 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- Mean
- Time point:
- other: Overall at 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Mean
- Time point:
- other: Overall at 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- Mean
- Time point:
- other: Overall at 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- Mean
- Time point:
- other: Overall at 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: Overall at 24, 48 and 72 hrs
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: Overall at 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- Mean
- Time point:
- other: Overall at 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Not applicable
- Irritation parameter:
- other: Discharge
- Basis:
- animal #1
- Remarks:
- Mean
- Time point:
- other: Overall at 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Not applicable
- Irritation parameter:
- other: Discharge
- Basis:
- animal #2
- Remarks:
- Mean
- Time point:
- other: Overall at 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Not applicable
- Irritation parameter:
- other: Discharge
- Basis:
- animal #3
- Remarks:
- Mean
- Time point:
- other: Overall at 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: Not applicable
- Irritant / corrosive response data:
- See tables below.
Initial Pain Reaction (IPR) was not observed in the animals. One hour after the application, conjunctival redness (score 1) and conjunctival discharge (score 1) was observed in all animals. At 24 hours after treatment, conjunctival redness (score 1) was observed in one animal. At 48 hours after treatment there were no clinical signs observed. At 72 hours after treatment, there were no clinical signs observed. As there were no clinical signs observed, the study was terminated after the 72 hour observation. During the study, the control eye of all animals was symptom-free. - Other effects:
- None
There was no mortality observed during the study.
The body weight and body weight change were considered to be normal with no indication of treatment related effect.
Any other information on results incl. tables
INDIVIDUAL SCORES FOR OCULAR IRRITATION
Table 1. Time of Observation: Day 0
Time |
Animal No. |
Score of irritation |
IPR |
|||||||
Conjunctivae |
Opacity of cornea |
Iris |
Control eye |
Other sign |
||||||
R |
CH |
D |
OD |
OE |
R |
|||||
1 hour |
00805 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
- |
0 |
00849 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
- |
0 |
|
00848 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
- |
0 |
Table 2. Time of observation: Day 1
Time |
Animal No. |
Score of irritation |
|||||||
Conjunctivae |
Opacity of cornea |
Iris |
Control eye |
Other sign |
|||||
R |
CH |
D |
OD |
OE |
R |
||||
24 hours |
00805 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
00849 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
00848 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
Table 3. Time of observation: Day 2
Time |
Animal No. |
Score of irritation |
|||||||
Conjunctivae |
Opacity of cornea |
Iris |
Control eye |
Other sign |
|||||
R |
CH |
D |
OD |
OE |
R |
||||
48 hours |
00805 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
00849 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
00848 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
Table 4. Time of observation: Day 3
Time |
Animal No. |
Score of irritation |
|||||||
Conjunctivae |
Opacity of cornea |
Iris |
Control eye |
Other sign |
|||||
R |
CH |
D |
OD |
OE |
R |
||||
72 hours |
00805 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
00849 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
|
00848 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
- |
MEAN VALUES OF EYE IRRITATION (24, 48, 72 hour reading)
Table 5. Mean values
Animal Number |
Sex |
Cornea Opacity |
Iris |
Conjunctivae |
||
Redness |
Chemosis |
Discharge |
||||
00805 |
male |
0.00 |
0.00 |
0.33 |
0.00 |
0.00 |
00849 |
male |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
00848 |
male |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
Abbreviations:
R = Redness, CH = Chemosis, D = Discharge, NT = Can not be scored, OD = Opacity degree of density, OE = Extension of opaque area, IPR = Initial pain reaction, - = No data
Table 6. Body weight data
Animal Number |
Beginning of study(g) |
At the end of study(g) |
Body weight gain(g) |
00805 |
2728 |
3030 |
302 |
00849 |
2633 |
2823 |
190 |
00848 |
2701 |
3055 |
354 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item TIS-M, applied to rabbit eye mucosa, caused significant conjunctival irritant effects at one hour which were reduced at 24 hours after application. The effects were fully reversible within 48 hours. According to Regulation (EC) No 1272/2008, TIS-M does not require classification as an eye irritant.
- Executive summary:
An acute eye irritation study of the test item TIS-M was performed in New Zealand White rabbits. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 405, 2002).
The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. A volume of 0.1 mL of the test item was administered as a single dose. The eyes were examined at 1, 24, 48 and 72 hours after the application. Initial Pain Reaction (IPR) was not observed in the animals. One hour after the application, conjunctival redness (score 1) and conjunctival discharge (score 1) was observed in all animals. At 24 hours after treatment, conjunctival redness (score 1) was observed in one animal. At 48 hours after treatment there were no clinical signs observed. At 72 hours after treatment, there were no clinical signs observed. As there were no clinical signs observed, the study was terminated after the 72 hour observation. During the study, the control eye of all animals was symptom-free. The general state and behavior of animals were normal throughout the study period. The body weight and body weight change were considered to be normal with no indication of treatment related effect.
The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows: chemosis : 0.00, 0.00, 0.00 discharge : 0.00, 0.00, 0.00 redness : 0.33, 0.00, 0.00 cornea opacity : 0.00, 0.00, 0.00 iris : 0.00, 0.00, 0.00.
The test item TIS-M, applied to the rabbits eye mucosa, caused significant conjunctival irritant effects at one hour which were reduced at 24 hours after application. The effects were fully reversible within 48 hours. According to Regulation (EC) No 1272/2008, TIS-M does not require classification as an eye irritant.
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