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EC number: 221-329-8 | CAS number: 3068-78-8
- 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:
- 04 - 21 Aug 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- (1992)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-[3-(trimethoxysilyl)propylcyclohexylamine]
- EC Number:
- 221-329-8
- EC Name:
- N-[3-(trimethoxysilyl)propylcyclohexylamine]
- Cas Number:
- 3068-78-8
- Molecular formula:
- C12H27NO3Si
- IUPAC Name:
- N-[3-(trimethoxysilyl)propyl]cyclohexanamine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 6 - 10 weeks
- Weight at study initiation: 203 - 219 g (males), 174 - 193 g (females)
- Fasting period before study: animals were fasted from about 16 h before to 3 - 4 h after treatment.
- Housing: animals were housed in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals.
- Diet: ssniff R/M-H (V 1534), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL (20% solution)
- Amount of vehicle: 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 2000 mg/kg bw (main study)
500, 1000 and 2000 mg/kg bw (range finding study) - No. of animals per sex per dose:
- 5 (main study)
1 (range finding study) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs were recorded twice daily (in the morning and afternoon) and once daily on weekends and public holidays. The animals were weighed at weekly intervals.
- Necropsy of survivors performed: yes
Results and discussion
- Preliminary study:
- In a dose range finding study groups of one rat of each sex were administered the test material at dose levels of 500, 1000 and 2000 mg/kg bw via oral gavage as a 20% solution in sesame oil. The animals were observed for clinical signs of toxicity for 14 days. No mortality and no clinical signs of toxicity were recorded during the study period up to and including the highest dose tested. Body weight gain was within the expected range and no abnormalities were observed at necropsy.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality and no clinical signs of toxicity were observed
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- No clinical signs of toxicity were observed during the study period.
- Body weight:
- Body weight gain was within the expected range during the study period.
- Gross pathology:
- Gross pathology revealed no abnormalities.
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 an acute oral toxicity study according to OECD guideline 401 and in compliance with GLP, no mortality and no clinical signs of toxicity were observed at 2000 mg/kg bw. In conclusion, a LD50 >2000 mg/kg bw was derived.
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