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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 Mar - 10 Apr 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- 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): Y-11542
- Physical state: clear, colorless, slightly viscous liquid
- Lot/batch No.: 2131UG060495
- 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: Crl:CD BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, MI, USA
- Age at study initiation: young adults
- Weight at study initiation: 242 - 295 g
- Housing: animals were housed individually in suspended mesh-bottom cages
- Diet: Purima Certified Rodent Chow #5002 diet, ad libitum
- Water: municipal water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.9 - 22.3
- Humidity (%): 34.4 - 40.5
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The test material was applied to the dorsal skin of each animal.
- % coverage: 18 - 23
- Type of wrap if used: The test substance was held in contact with the skin with gauze bandaging. The bandage was secured with nonirritating tape. Collars were applied and remained on the rats for the duration of the exposure to prevent the ingestion of the test material and/or wrappings during the 24 h exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing: The application sites were wiped with disposable paper towels moistened with tepid tap water after the exposure period.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied: 1.75 ml/kg bw - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed at approximately 1, 3 and 4 hours post-exposure on day 0 and twice daily for mortality (morning and afternoon) and once daily for clinical observations thereafter for 14 days, respectively. Body weights were obtained and recorded on study days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: The application sites were examined for erythema, edema and other dermal findings beginning approximately 30 - 60 min after bandage removal and daily thereafter for 13 days. The areas of application were clipped free of hair to facilitate dermal observations on study days 7 and 14.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: neither erythema nor edema were observed
- Mortality:
- No deaths were observed during the study.
- Clinical signs:
- other: Clinical findings were limited to dried red material around the nose and/or forelimb(s) for three rats and wet and dried yellow urogenital staining for two female rats. These findings are typically noted in association with the bandage/collar application
- Gross pathology:
- A dilated renal (right) pelvis was noted for one female rat at the terminal necropsy. This is considered to be a common, spontaneous finding in rats and was not considered to be related to the test material. There were no other gross necropsy findings for any examined tissues.
- Other findings:
- - Dermal observations: Six rats showed desquamation. Neither erythema nor edema or other dermal findings were recorded. All dermal responses completely subsided by day 13 or earlier.
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:
- In conclusion, under the conditions chosen for this acute dermal toxicity study conducted according to OECD 402 at the limit concentration of 2000 mg/kg bw no clinical signs of toxicity or mortalities were observed. Therefore, the test substance does not need to classified according to Regulation (EC) No 1272/2008.
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