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EC number: 700-334-3 | CAS number: -
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 4 2002 to October 25, 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 10-hydroxy-2,2,4-trimethyl-4-[(trimethylsilyl)oxy]-3,8-dioxa-2,4-disilaundecan-11-yl 2-methylprop-2-enoate; 11-hydroxy-2,2,4-trimethyl-4-[(trimethylsilyl)oxy]-3,8-dioxa-2,4-disilaundecan-10-yl 2-methylprop-2-enoate
- EC Number:
- 700-334-3
- Molecular formula:
- C17H38O6Si3
- IUPAC Name:
- 10-hydroxy-2,2,4-trimethyl-4-[(trimethylsilyl)oxy]-3,8-dioxa-2,4-disilaundecan-11-yl 2-methylprop-2-enoate; 11-hydroxy-2,2,4-trimethyl-4-[(trimethylsilyl)oxy]-3,8-dioxa-2,4-disilaundecan-10-yl 2-methylprop-2-enoate
- Test material form:
- other: liquid
- Details on test material:
- Name: Silyl methacrylate (SiMAA2)
Appearance: Liquid
Purity: 97.0% or higher
Storage condition: Refrigerated (at 10°C or lower).
Storage site: Stored in a test articel storage cabinet (4°C).
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Slc:SD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Rats bred at Japan SPLC, Inc.
- Age at study initiation: 6 weeks old.
- Weight at study initiation: Males: Mean weight of test group = 232.85 g. Females: Mean weight of test group = 166.28 g
- Fasting period before study: None.
- Housing: Stainless steel wire mesh cages (W37 × D47 × H19 cm) equipped with urinary trays and wire mesh bottom were used during the
acclimatization period. Urinary trays were exchanged twice a week with new trays containing autoclaved bedding (Softchip of fir). Aluminum cages (W25 × D40 × H18 cm) were used during the study period. Cages were exchanged twice a week with new ones containing autoclaved fresh and clean bedding. Five animals were housed in a cage during the acclimatization period and one animal after grouping.
- Diet (e.g. ad libitum): Radiation-sterilized pellet diet was fed ad libitum
- Water (e.g. ad libitum): Chlorinated well water was supplied using water bottles ad libitum
- Acclimation period: 7 days prior to study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 27°C
- Humidity (%): 30 - 70%
- Air changes (per hr): approximately 16 times per hour
- Photoperiod (hrs dark / hrs light): illumination for 12 hours/day
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Approximately 24 hours prior to administration, fur was clipped from the dorsal area of the trunk with an electric clipper.
- % coverage: The test article was applied evenly over an area approximately 10% of the body surface area.
- Type of wrap if used: The area was covered with a porous gauze dressing throughout the exposure period of 24 hours and the attachment between the test article and the skin was further secured with non-irritating tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not stated.
- Time after start of exposure: 24 hours.
TEST MATERIAL
Dose concentration: 2000 mg/kg.
The administration volume was calculated individually based on the body weight on the day of administration.
VEHICLE
Not applicable. Since the test article was liquid, it was used as a dosing solution as it was. - Duration of exposure:
- 24 hours.
- Doses:
- 2000 mg/kg.
- No. of animals per sex per dose:
- 5 males and 5 females at 2000 mg/kg.
- Control animals:
- other: A group of 5 males and 5 females were given water for injection only as a control.
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for general condition continuously until 6 hours after administration and once every day thereafter until Day 14. Body weight was measured just prior to administration and on Days 7 and 14 after administration. Day 0 was
defined as the day of administration.
- Necropsy of survivors performed: yes - After 14 days of administration, animals were euthanized by exsanguination under ether anesthesia, and organs and tissues were observed grossly for any abnormalities. - Statistics:
- Group means and standard deviations of body weight were calculated for each group. At statistical analysis, the homogeneity of variance was evaluated using F-test, and then Student’s t-test was applied when the variance was homogeneous; when the variance was heterogeneous, Aspin-Welch t-test was used. Statistical significance of the difference between the control and treated groups was analyzed at the significance level of 5%, and the results were shown as either P < 0.05 (lower than 5%) or P < 0.01 (lower than 1%).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animals died in any group of either sex.
- Clinical signs:
- other: There were no abnormalities in general condition.
- Gross pathology:
- At necropsy conducted at termination of the study, a hepatodiaphragmatic nodule was observed in one male in the 2000 mg/kg group. The lesion was, however, considered incidental because of its severity as well as the fact that the change is frequently observed in the untreated control group. There were no other abnormalities in any group.
Any other information on results incl. tables
Table 1: Mortality and LD50
Route |
Sex |
Dose (mg/kg) |
Mortality |
LD50 (mg/kg) |
Dermal |
Male |
Control |
0/5 |
>2000 |
2000 |
0/5 |
|||
Female |
Control |
0/5 |
>2000 |
|
2000 |
0/5 |
Table 2: Group mean body weight
Sex |
Dose (mg/kg) |
Days after administration |
|||
|
-1 |
7 |
14 |
||
Male |
Control |
N |
5 |
5 |
5 |
Mean |
230.98 |
278.27 |
315.70 |
||
S.D. |
4.55 |
8.90 |
11.65 |
||
2000 |
N |
5 |
5 |
5 |
|
Mean |
232.85 |
286.64 |
329.42 |
||
S.D. |
5.25 |
14.26 |
19.37 |
||
Female |
Control |
N |
5 |
5 |
5 |
Mean |
163.17 |
184.00 |
198.13 |
||
S.D. |
4.59 |
8.76 |
7.68 |
||
2000 |
N |
5 |
5 |
5 |
|
Mean |
166.28 |
187.70 |
200.74 |
||
S.D. |
7.22 |
10.24 |
11.65 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- SiMAA2 was administered once dermally to male and female rats at 2000 mg/kg and its toxicity was evaluated.
No animals died in each group of males and females, and the LD50 was higher than 2000 mg/kg. - Executive summary:
According to the OECD guidelines for acute toxicity studies, no further dose levels are necessary when there are no toxic signs at 2000 mg/kg after single dermal administration.
Therefore, SiMAA2 was administered once dermally to male and female rats at 2000 mg/kg and its toxicity was evaluated.
No animals died in each group of males and females, and LD50 was higher than 2000 mg/kg.
In addition, no treatment-related effects were observed in general conditions, body weight, and anatomy findings.
Under the conditions of the present study, no animals died after single administration of SiMAA2 at 2000 mg/kg, and no other toxicological effects were detected.
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