Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4th October 2002 to 25th October 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Principles of method if other than guideline:
- The test material was evaluated following a single oral administration to male and female Slc:SD rats. The oral route and a single dose of 2000 mg/kg were selected. 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.
- GLP compliance:
- not specified
- Test type:
- acute toxic class 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: Animals bred at Japan SLC, Inc
- Age at study initiation: 4 weeks old
- Weight at study initiation: Mean body weight of 124.65-126.12g for males and 109.54-110.90g for females
- Fasting period before study: 16 hours of fasting
- Housing: Animal room 2207 in the animal building II, in the barrier-sustained facility. Animals were housed in Stainless steel, wire mesh cages (W37cm x D47cm x H19cm) equipped with urinary trays and a wire mesh bottom were used throughout the acclimatisation and study periods. Five animals were housed in a cage
- Diet: Radiation-sterilized pellet diet Labo stock (Nosan Corporation) was fed ad libitum
- Water: Chlorinated well water supplied using water bottles ad libitum
- Acclimation period: 7 days, 5 animals per cage.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-27 deg C
- Humidity (%): 30-70
- Air changes (per hr): Ca 16 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours per day (7:00 am - 7:00 pm)
- Urinary trays were exchanged twice a week, with new trays containing autoclaved bedding
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: No verchile was used. the substance is a liquid, hence was used as a dosing soultion
DOSAGE PREPARATION (if unusual): 2000 mg/kg of neat substance
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 2000 mg/kg dose: 5 males/5 females
Control (group given water for injection only): 5 males/5 females - Control animals:
- yes
- 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-Wlch t-test was used. Statistical significance of the difference between 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:
- No abnormalities were detected in any group at anatomy conducted at termination of the study.
Any other information on results incl. tables
Results of motality and LD50. Administration of test material via oral route:
Sex | Dose (mg/kg) | Mortality | LD50 (mg/kg) |
Male | Contol | 0/5 | |
Male | 2000 | 0/5 | >2000 |
Female | Control | 0/5 | |
Female | 2000 | 0/5 | >2000 |
Mortality: Number of dead rats/number of treated rats
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, no animals died after single administration of SiMAA2 at 2000 mg/kg and no other toxicological effects were detected.
- 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 oral administration.
Therefore, SiMAA2 was administered once orally 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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.