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EC number: 245-904-8 | CAS number: 23843-64-3
- 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:
- 05 Feb 1996 - 28 June 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- [3-(trimethoxysilyl)propyl]urea
- EC Number:
- 245-904-8
- EC Name:
- [3-(trimethoxysilyl)propyl]urea
- Cas Number:
- 23843-64-3
- Molecular formula:
- C7H18N2O4Si
- IUPAC Name:
- [3-(trimethoxysilyl)propyl]urea
- Details on test material:
- - Name of test material (as cited in study report): Silquest Y-11542, gamma-ureidopropyltrimethoxysilane
- Physical state: clear, colorless, slightly viscous liquid
- Lot/batch No.: 2131UG060495
- Expiration date of the lot/batch:
- Specific gravity: 1.14 glml, as determined by WIL Research Laboratories, Inc. pharmacy personnel)
- Storage conditions: original container at room temperature
- Stability under test and storage conditions: Test material stability data are the responsibility of
the Sponsor. Under the conditions employed during the testing of this material, the Sponsor has indicated that the material is stable, provided the sample is not contaminated, is properly sealed, and stored under normal conditions as dictated by good manufacturing practice.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Crl:CD BR
- Source: Charles River Breeding Laboratories, Inc. Portage, MI, USA
- Age at study initiation: young adult
- Weight at study initiation: 231-300 g
- Fasting period before study: 18-20 h prior to dosing
- Housing: Individual in suspended wire-mesh cages
- Diet: Purim@ Certified Rodent Chow@ #5002, ad libitum. Analysis of feed was performed and provided by the manufacturer.
- Water: municipal water, ad libitum. Water was analysed in accordance with Standard Operating Procedures.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.0-22.3 (71.6-72.1 °F)
- Humidity (%): 43.7-50.0
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 4.39 ml/kg bw
DOSAGE PREPARATION:
A sufficient amount of test material was transferred from the original container to a labeled storage vessel. A stir bar was added, and the test material was maintained on a magnetic stir plate prior to dispensation and throughout the dosing procedure.
RATIONALE FOR DOSE SELECTION:
Prior to initiation of the main study, a range-finding study was conducted in which groups of one male and one female rat were dosed at levels of 500, 1000, 2000, 3500 and 5000 mg/kg bw. There were no deaths during the range-finding study. Based on these results, 5000 mglkg was selected as the first level on the main study. - Doses:
- Range-finding test: 500, 1000, 2000, 3500 and 5000 mg/kg bw
Main study: 5000 mg/kg bw - No. of animals per sex per dose:
- Range-finding test: 1
Main study: 5 - Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: The rats were observed at approximately 1.0, 3.0 and 4.0 hours post-dose on Day 0 and twice daily (morning and afternoon) thereafter for 14 days.
- Frequency of weighing: Body weights were obtained and recorded on study days -1, 0 (initiation), 7 and 14 (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and gross pathology (major organ systems of the cranial, thoracic and abdominal cavities for all animals)
Results and discussion
- Preliminary study:
- There were no deaths during the range-finding study. Based on these results, 5000 mg/kg bw was selected as the first level on the main study.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occurred.
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- other: Three rats had wet and/or dried yellow urogenital staining. Yellow urogenital staining is a common, non-specific finding in acute studies that, in isolation, is not evidence of significant toxicity. Clear ocular discharge and mucoid feces were noted for o
- Gross pathology:
- At the terminal necropsy, dark red lungs were noted for three rats. This finding was not considered to be test material-related as it is often noted in animals that have been euthanised by carbon dioxide inhalation. There were no other gross necropsy findings.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- The test material was investigated for acute oral toxicity according to the OECD TG 401, and in compliance with GLP. The undiluted test material was administered once via oral gavage to 5 Crl:CD BR rats per sex at a dose of 5000 mg/kg bw. No mortality occurred and clinical signs were only noted in one female (reversible within 3 days) throughout the study period. Based on these findings, classification for acute oral toxicity according to Regulation (EC) No 1272/2008 is not warranted.
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