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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
- Remarks:
- Read across data
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is taken from a secondary source
Data source
Reference
- Reference Type:
- other: Secondar source
- Title:
- SIDS Initial Assessment Report For SIAM 17
- Author:
- OECD-SIAM
- Year:
- 2 003
- Bibliographic source:
- OECD SIDS, SIAM, 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1966
- Principles of method if other than guideline:
- The study appears to be similar to OECD TG 402, but the level of detail in the report is such that this cannot be confirmed.
- GLP compliance:
- not specified
- Test type:
- standard acute method
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:
- (2-Aminoethyl)(3-(trimethoxysilyl)propyl)amine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Not specified
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable) No data Avaiable
- Source: Epona Associates, LLC
- Females (if applicable) nulliparous and non-pregnant: [yes/no] No data Avaiable
- Rationale for use of males (if applicable) No data Avaiable
- Age at study initiation: three to five months
- Weight at study initiation: No data Avaiable
- Fasting period before study: No data Avaiable
- Housing: No data Avaiable
- Historical data: No data Avaiable
- Diet (e.g. ad libitum): No data Avaiable
- Water (e.g. ad libitum): No data Avaiable
- Acclimation period: No data Avaiable
- Microbiological status when known No data Avaiable
- Method of randomisation in assigning animals to test and control groups No data Avaiable
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data Avaiable
- Humidity (%): No data Avaiable
- Air changes (per hr): No data Avaiable
- Photoperiod (hrs dark / hrs light): No data Avaiable
IN-LIFE DATES: From: To:
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure:
- % coverage:
- Type of wrap if used: polyethylene sheeting
REMOVAL OF TEST SUBSTANCE
- Washing (if done): done
- Time after start of exposure: 24 hrs
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 16.0 (2 animals) or 8.0 (4 animals) ml/kg
- Concentration (if solution): No data avaiable
- Constant volume or concentration used: yes/no No data avaiable
- For solids, paste formed: yes/no
VEHICLE
- Amount(s) applied (volume or weight with unit): No data avaiable
- Concentration (if solution): No data avaiable
- Lot/batch no. (if required): No data avaiable
- Purity:No data avaiable - Duration of exposure:
- 24 hours
- Doses:
16 and 8 ml/kg bw- No. of animals per sex per dose:
- 8 ml/kg: 4
16 ml/kg: 2 - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: No data avaiable
- Necropsy of survivors performed: yes
- Clinical signs including body weight No data avaiable
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Statistics:
average method based
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 16 mL/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 8 - <= 16
- Remarks on result:
- other: Effective level was found to be 16 ml/kg bw
- Mortality:
- THe LD50 was found to be 16mL/kg bw
- Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- The surviving animal dosed at 16.0 mg/kg and three of the four animals dosed at 8.0 mg/kg gained weight during the study
- Gross pathology:
- Gross Pathology observations included congested lungs, liver and spleen, and pale kidneys
- Other findings:
- Not specified
Any other information on results incl. tables
Table No 1 Mortality Rate
Dose (ml/kg) | Death | Days to Death |
16 | 1/2 | 7 |
8 | 0/4 | Not applicable
|
Applicant's summary and conclusion
- Interpretation of results:
- other: Not Classified
- Conclusions:
- The LD50 for N-(3-(trimethoxysilyl)propyl)ethylenediamine ( CAS number: 1760-24-3) was at least 16.0 ml/kg body weight in male rabbits in an acute dermal toxicity study reported as a summary, but similar to OECD 402 (not GLP, reliability score 4).
- Executive summary:
In accordance with guideline 402, an acute dermal toxicity of 1,2-ethanediamine, N-[3-(trimethoxysilyl)propyl] (CAS number: 1760-24-3)was conducted using Rabbit New Zealand species at dose levels 16 and 8 ml/kg bw.
The RA sample was applied to all animals in groups 16ml/kg bw (2 animals) and 8 ml/kg bw (4 animals ) mortality was noted one out of two animals was found to be dead on 7th day of observation at a dose range of 16ml/kg bw, while all the 4 animals were survived at a dose range of 8 ml/kg bw
Necropsy findings, including Gross Pathology observations, included congested lungs, liver and spleen, and pale kidneys
The LD50 value of the test sample was 16.0 ml/kg bw for animals. Hence the test chemical cannot be classified according to CLP criteria.
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