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EC number: 217-164-6 | CAS number: 1760-24-3
- 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:
- 14.09.1998 to 25.02.2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
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:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- N-(3-(trimethoxysilyl)propyl)ethylenediamine
- EC Number:
- 217-164-6
- EC Name:
- N-(3-(trimethoxysilyl)propyl)ethylenediamine
- Cas Number:
- 1760-24-3
- Molecular formula:
- C8H22N2O3Si
- IUPAC Name:
- N-(3-(trimethoxysilyl)propyl)ethylenediamine
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: No data
- Age at study initiation: At least 12 weeks
- Weight at study initiation: 2494-2828 kg
- Fasting period before study: No
- Housing: Individually in suspended metal cages with perforated floors
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 40-65
- Air changes (per hr): 15-19
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 24.09.1998 To: 08.10.1998
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: lumbar region
- % coverage: approximately 10%
- Type of wrap if used: porous (< 8 ply) gauze held in place with a non irritating dressing, and further covered by a waterproof dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):1.982 mL/kg bw - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All rabbits were observed twice daily for mortality and morbidity. The bodyweight 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 of Day 1. On subsequent days animals were observed twice.
- Necropsy of survivors performed: yes
- Other examinations performed: Dermal responses were examined on Day 2 to 15. Skin reactions were scored according to the Draize scoring system. A gross macroscopic examination of each animal was conducted. - Statistics:
- Mean body weights were calculated. No other statistical analyses were conducted.
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: No deaths.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: There were no treatment-related clinical signs of toxicity, except fecal disturbance in one female rabbit.
- Gross pathology:
- No abnormal findings.
- Other findings:
- Persistent slight to moderate irritation (erythema with or without oedema up to Grade 3) was evident in all rabbits following removal of the dressings and over the following days. These reactions had notably ameliorated by the second week of the study with resolution in all but three animals complete by Day 15. In the remaining rabbits slight erythema (Grade 1) was still evident at study termination. Also notable in all rabbits during the first days following treatment was a very dry texture to the skin over the treatment site, desquamation of the skin on the treatment site (all rabbits and present in six rabbits at study termination) and in one rabbit localised necrosis/blanching evident throughout the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute dermal toxicity study conducted to EPA OPPTS 870.1200 (Acute Dermal Toxicity) and to GLP (reliability score 1) the LD50 for N-(3-(trimethoxysilyl)propyl)ethylenediamine was at least 2000 mg/kg bw in rabbits. No deaths occurred at this dose. There were no clinical signs, macroscopic findings, or significant effects on bodyweight. The only findings were irritation at the application site.
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