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Diss Factsheets
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EC number: - | 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:
- no data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Removed from study report
- Age at study initiation: 12 weeks
- Weight at study initiation: 2428-2661 g
- Fasting period before study: Not mentioned in report so assumed no fasting.
- Housing: Individually in suspended metal cages with perforated floors.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23.5
- Humidity (%): 31-45
- Air changes (per hr): 18
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 100 x 100 mm
- Coverage: approximately 10% of the total body surface area.
- Type of wrap if used: the treatment area was covered with porous gauze held in place with a non-irritating dressing and further covered by a waterproof dressing encircled firmly around the trunk of the animal.
REMOVAL OF TEST SUBSTANCE
- At the end of the 24 hour exposure period the dressings were carefully removed and the treated area of skin wiped with a towel moistened with warm water at 39°C to remove residual test substance.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.802 mL/kg
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw/day
- No. of animals per sex per dose:
- Five
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rabbits were observed at least twice daily for mortality and morbidity. The body weight of each animal was recorded on days 1 (prior to dosing), 8 and 15. Animals were observed immediately after dosing and at approximately hourly intervals for the remainder day 1 (approximately six hours). On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of day 15 - morning only). The nature and severity of the clinical signs and time were recorded at each observation. All animals were observed for 14 days after dosing.
- Necropsy of survivors performed: yes. After the final observation, all the rabbits were sacrificed and subjected to a macroscopic examination which consisted of examination of the treated skin site and underlying tissue, and opening the cranial, thoracic and abdominal cavities. The macroscopic appearance of all examined organs was recorded.
- Other examinations performed: The treated skin of each rabbit was examined once daily on day 2 through to day 15. At each interval, dermal irritation was assessed for erythema, eschar formation, oedema and any other lesion. Dermal responses were assessed using the Draize scoring system. Animals were clipped as needed to evaluate dermal responses. The nature and severity of the clinical signs and time were recorded at each observation. All animals were observed for 14 days after dosing. - Statistics:
- Group mean body weights were calculated. No other statistical analyses were carried out.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: No clinical signs were observed in any animal.
- Gross pathology:
- No abnormalities found.
- Other findings:
- Dermal responses: A predominantly well-defined level of irritation (erythema/oedema grade 2) was evident in all rabbits following removal of the dressings. A similar level of response was persistent during the first week of the study. By week two of the study, reactions had ameliorated in the majority of animals and although some erythema/oedema was still evident in five animals at study termination (day 15), reactions had resolved in the remaining five animals by the day of termination. These reactions were accompanied by some localised including necrosis, spots/scabbing and desquamation. These latter responses were still evident in nine of the ten animals at study termination.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The key study for acute dermal toxicity, conducted according to OECD TG 402 and in compliance with GLP (Dow Corning Corporation, 2000b), LD50 for alkoxy exchange product of vinyltriacetoxysilane and glycidoxypropyltrimethoxysilane was greater than 2000 mg/kg bw/day. The dermal reactions suggested that the test substance might cause severe irritation/corrosion following prolonged occlusive exposure.
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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