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Registration Dossier
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EC number: 222-217-1 | CAS number: 3388-04-3
- 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

Endpoint summary
Administrative data
Description of key information
An acute oral LD50 of 12.3 ml/kg bw (equivalent to approximately 13161 mg/kg based on a density of 1.07 g/cm3), is reported in a study conducted according to a protocol equivalent to guideline but not in compliance with GLP (Mellon, 1962).
No reliable data are available for the inhalation route.
An acute dermal LD50 of 6.30 ml/kg bw (equivalent to 6741 mg/kg bw, based on a density of 1.07 g/cm3), is reported in a study conducted according to a protocol equivalent to guideline but not in compliance with GLP (Mellon, 1962).
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 13 161 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 6 741 mg/kg bw
- Quality of whole database:
- The study was conducted according to a protocol equivalent to current guideline, but not in compliance with GLP.
Additional information
An acute oral LD50 of 12.3 ml/kg bw (equivalent to approximately 13161 mg/kg based on a density of 1.07 g/cm3), is reported in a study conducted according to a protocol equivalent to guideline but not in compliance with GLP (Mellon, 1962). The animals became prostrate soon after test material administration, with most deaths occurring shortly after dosing. At necropsy, congested lungs, kidneys, stomachs, intestines and pale mottled livers with prominent acini were evident.
An acute dermal LD50 of 6.30 ml/kg bw (equivalent to 6741 mg/kg bw based on a density of 1.07 g/cm3), is reported in a study conducted according to a protocol equivalent to guideline but not in compliance with GLP Mellon, 1962).Five male rabbits were exposed to the registered substance for 24 hours under occlusive coverage. Three out of five rabbits had convulsions on the first and second day after application. Deaths occurred on the first and second day after application. At necropsy, hemorrhage and congestion of the lungs, pale mottled livers with prominent acini, pale spleens, and pale mottled kidneys were evident. Bloody discharge was present around the nose and mouth of two animals.
A reliability 4 acute inhalation study is also available for the registered substance, which was conducted according to a scientifically acceptable protocol but is missing the analytical verification of exposure concentrations (Mellon, 1962). However, the study supports the low acute toxicity of the registered substance, with no reported deaths.
To support the approach for the oral repeated dose toxicity endpoint which uses the analogous substance beta-(3,4-epoxycyclohexyl) ethyltriethoxysilane (CAS 10217-34-2) as read-across, a supporting acute oral toxicity study (WIL, 1996) with the read-across substance is included to demonstrate that the registered substance and the read across substance have comparable toxicological profiles. The study reports an LD50 value of >5000 mg/kg in rat (WIL 1996). Clinical signs observed during the study were dried red material around the eye(s), nose and/or mouth (7/10); wet and/or dried yellow urogenital and/or ventral abdominal staining (6/10) and hypoactivity (5/10). There were no other clinical findings and all animals appeared normal by day 4 or earlier and throughout the remainder of the study. There were no effects on body weight and no adverse necropsy findings.
Please refer to Section 7.5 Repeated dose toxicity for a more comprehensive discussion of read-across justification.
Justification for selection of acute toxicity – oral endpoint
The study was conducted according to a protocol equivalent to current guideline, but not in compliance with GLP.
Justification for classification or non-classification
Based on the available information, no classification and labelling is required for acute toxicity for 2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane in accordance with Regulation (EC) No 1272/2008.
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