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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 August to 29 August 2005
- 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:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
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.: 3301 MS-0505-4
- Storage condition of test material: Under nitrogen at room temperature, in the dark.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: The bodyweights fell within an interval of +/- 20% of the mean initial bodyweight of the first treated group.
- Fasting period before study: Overnight. There was also a 3 to 4 hour fasting period after dosing.
- Housing: Animals were housed in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: Certified Rat and Mouse Diet (Code 5LF2) Supplied by BCM IPS Limited, London, UK; ad libitum.
- Water: Mains drinking water; ad libitum.
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15.
- Photoperiod: 12 hours light: 6am-6pm
IN-LIFE DATES: From: 9 August 2005 To: 23 August 2005.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Method:
A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level. The test material was administered orally undiluted. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level. Clinical signs and bodyweight development were monitored during the study.
All animals were dosed once only by gavage, using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted bodyweight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each group to confirm the survival of the previously dosed animals.
At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities for examiniation of major organs. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Doses:
- One dose applied: 2000mg/kg.
- No. of animals per sex per dose:
- 3 initial at 2000 mg/kg
3 additional at 2000 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations made after 30mins, 1hr, 2hrs and 4hrs on the day of dosing (day 0); daily from days 1-14 and weighings made on days 7 and 14 (weekly), as well as prior to dosing.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- Signs of systematic toxicity noted during the study were hunched posture, lethargy, ataxia and decreased respiratory rate. one animal appeared normal throughout the study and the reaming five animals appeared normal one or two days after dosing.
- Body weight:
- All animals showed expected gains in bodyweight over the study period.
- Gross pathology:
- No abnormalities were noted at necropsy.
Any other information on results incl. tables
Evaluation of Data:
Data evaluations included the relationship, if any, between the exposure of animal to the test material and the incidence and severity of all abnormalities including behavourial and clinical observations, gross lesions, bodyweight changes, mortality and any other toxicological effects. Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test material was made: > 2500 mg/kg bodyweight.
Table 1: Mortality Data:
Dose Level m/kg |
Sex |
Number of Animals treated |
Deaths During Day of Dosing (Hours) |
Deaths During Period After Dosing (Days) |
Deaths |
||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8-14 |
||||
2000
|
Female Female |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0/3 |
Table 2: Individual Clinical Observations:
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing (Hours) |
Effects Noted During Period After Dosing (Days) |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
1-0 Female |
0 |
0 |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1-1 Female |
0 |
0 |
H |
H |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
1-2 Female |
HA Rd |
HLA Rd |
HLA Rd |
HA Rd |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-0 Female |
0 |
0 |
0 |
0 |
HA |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-1 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-2 Female |
0 |
0 |
0 |
HRd |
HA Rd |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 = No signs of systemic toxicity
A = Ataxia
H = Hunched posture
L = Lethargy
Rd = Decreased respiratory rate Table 3: Individual Bodyweights and Weekly Bodyweight Changes:Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
1-0 Female |
221 |
253 |
269 |
32 |
16 |
1-1 Female |
223 |
243 |
269 |
20 |
26 |
|
1-2 Female |
223 |
254 |
268 |
31 |
14 |
|
2-0 Female |
233 |
266 |
280 |
33 |
14 |
|
2-1 Female |
228 |
265 |
280 |
37 |
15 |
|
2-2 Female |
238 |
262 |
275 |
24 |
13 |
Table 4: Individual Necropsy Findings:
Dose Level mg/kg |
Animal Number and Sex |
Time of Death |
Macroscopic Observations |
2000 |
1-0 Female |
Killed Day 14 |
No Abnormalities Detected |
1-1 Female |
Killed Day 14 |
No Abnormalities Detected |
|
1-2 Female |
Killed Day 14 |
No Abnormalities Detected |
|
2-0 Female |
Killed Day 14 |
No Abnormalities Detected |
|
2-1 Female |
Killed Day 14 |
No Abnormalities Detected |
|
2-2 Female |
Killed Day 14 |
No Abnormalities Detected |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the registered substance in the female Sprague-Dawley CD strain rat was estimated to be greater than 2500mg/kg bodyweight (GHS Category 5 >2000 - 5000 mg/kg bodyweight). However, in accordance with CLP criteria, the substance is not classified, as it does not fall within the definitions of Categories 1 to 4.
- Executive summary:
An acute oral toxicity study of the substance was carried out according to OECD Guideline 423 using Sprague-Dawley CD Strain rats. The registered substance was applied undiluted and by gavage, and after 14 days it was determined that the acute oral median lethal dose (LD50) was greater than 2500 mg/kg/bw. The registered substance was classified as being in GHS Category 5 (>2000 - 5000 mg/kg bodyweight). However, in accordance with CLP criteria, the substance is not classified, as it does not fall within the definitions of Categories 1 to 4.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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