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EC number: 245-642-4 | CAS number: 23410-40-4
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- (1981)
- Deviations:
- yes
- Remarks:
- (no constant volume was applied)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Short-Term and Long-Term Toxicology Groups Final Report (December 1979)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine
- EC Number:
- 245-642-4
- EC Name:
- N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine
- Cas Number:
- 23410-40-4
- Molecular formula:
- C9H24N2O2Si
- IUPAC Name:
- N-{3-[dimethoxy(methyl)silyl]-2-methylpropyl}ethane-1,2-diamine
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 Industries
- Weight at study initiation: 250±40 g
- Fasting period before study: 16 h
- Housing: individually in conventional design stainless steel, wire mesh bottom cages
- Diet: Purina Rodent Chow, ad libitum
- Water: fresh water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
not specified (under controlled laboratory conditions)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 250, 500, 1000, and 1600 mg/kg bw (based on the results of a screening test)
- No. of animals per sex per dose:
- 5
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: frequently on the first day of dosing and twice a day thereafter (at least 4 h apart)
- Frequency of weighing: 24 h, 7 and 14 days after dosing
- Necropsy of survivors performed: yes - Statistics:
- The oral median lethal dose, 95% confidence interval, and approximate slope of the dose response curve were calculated by a computerised version of Finney's (1972) Probit Method.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 436 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 210 - 730
- Remarks on result:
- other: Deaths occurred in all dose groups in 1/5 females at 250 mg/kg bw, 3/5 females at 500 mg/kg bw, 5/5 females at 1000 mg/kg bw, and 5/5 females at 1600 mg/kg bw.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 866 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 567 - 1 368
- Remarks on result:
- other: Deaths occurred in 1/5 males at 500 mg/kg bw, 3/5 males at 1000 mg/kg bw, and 5/5 males at 1600 mg/kg bw.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 653 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 447 - 892
- Mortality:
- Deaths occurred in all dose groups with 1/5 females at 250 mg/kg bw, 3/5 females and 1/5 males at 500 mg/kg bw, 5/5 females and 3/5 males at 1000 mg/kg bw and 5/5 males and females each at 1600 mg/kg bw. The females exhibited to be the more sensitive species. The deaths occurred within one and a half hours following dosage in all cases except three animals, which died several hours later.
- Clinical signs:
- other: Surviving animals appeared normal within 48 h. Generally, signs of toxicity exhibited by rats included extreme lethargy, ataxia, convulsions and coma.
- Gross pathology:
- Necropsy of animals that died during the study showed haemorrhagic condition of the gastrointestinal tract. However, terminal sacrifice of surviving animals did not reveal any compound related gross pathological alterations in the tissues and organs examined.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are met, Category 4 classification required according to Regulations (EC) No 1272/2008
- Conclusions:
- The test item was investigated for acute oral toxicity in a study conducted similar to OECD 401, and in compliance with GLP. 5 Sprague Dawly rats per sex received single doses of of 250, 500, 1000, and 1600 mg/kg bw of the test material via gastrointestinal intubation. Deaths occurred in all dose groups with 1/5 females at 250 mg/kg bw, 3/5 females and 1/5 males at 500 mg/kg bw, 5/5 females and 3/5 males at 1000 mg/kg bw and 5/5 males and females each at 1600 mg/kg bw. Signs of toxicity exhibited by surviving rats included extreme lethargy, ataxia, convulsions and coma, but were resolved within 48 h. Food consumption and body weight gains were slightly depressed during the first 24 h following treatment, but appeared normal during the remaining part of the study period. Necropsy of animals that died during the study showed haemorrhagic condition of the gastrointestinal tract. However, terminal sacrifice of surviving animals did not reveal any compound related gross pathological alterations in the tissues and organs examined. Based on the outcome of the study, the LD50 value for males was calculated to be 866 mg/kg bw, whereas the LD50 value for females was determined to be 436 mg(kg bw. The combined LD50 value (male/female) was calculated to be 653 mg/kg bw.
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