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EC number: 221-328-2 | CAS number: 3068-76-6
- 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:
- 24 Feb 1994 - 15 Dec 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- N-[3-(trimethoxysilyl)propyl]aniline
- EC Number:
- 221-328-2
- EC Name:
- N-[3-(trimethoxysilyl)propyl]aniline
- Cas Number:
- 3068-76-6
- Molecular formula:
- C12H21NO3Si
- IUPAC Name:
- N-[3-(trimethoxysilyl)propyl]aniline
- Details on test material:
- - Name of test material (as cited in study report): Dow Corning SZ-6083 Silane
- Physical state: clear colourless liquid
- Analytical purity: 97%
- Lot/batch No.: 71968NT
- Storage condition of test material: sealed container at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CDF(F-344)Crl:BR VAF/PLUS
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, MI, USA
- Age at study initiation: young adult
- Weight at study initiation: 144-175 g
- Fasting: 18-20 h prior to dosing until 3-4 h after dosing
- Housing: individual housing in wire-mesh cages
- Diet: Purina Certified Rodent Chow #5002, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5±1.5
- Humidity (%): 20-66
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1.92 mL/kg
- Doses:
- 500, 1000, 2000 mg/kg bw (0.48, 0.96, 1.92 mL/kg)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed 1, 3, and 4 h post-dose on day of appplication (day 0) and once daily thereafter. Body weights were obtained on the day before treatment, the day of treatment and on days 7 and 14.
- Necropsy of survivors performed: yes (major organ systems of the cranial, thoracic and abdominal cavities were examined for all animals)
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 809 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 590 - 1 109
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 704 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 499 - 993
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 969 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 831 - 1 130
- Mortality:
- 500 mg/kg bw: 1/5 males (day 2) and 0/5 females
1000 mg/kg bw: 4/5 males (day 1-3) and 3/5 females (day 2-3)
2000 mg/kg bw: 5/5 males (day 1) and 5/5 females (day 1-2) - Clinical signs:
- other: 500 mg/kg bw: Males: wet yellow urogenital staining (1/5) Females: hypoactivity (2/5), wet yellow urogenital staining (3/5) 1000 mg/kg bw: Males: hypoactivity (5/5), ataxia (4/5), ocular discharge (3/5), tremors (4/5), prostration (2/5), hypothermia (2/
- Gross pathology:
- Animals that were found dead:
Gastrointestinal abnormalities were observed for the majority of the rats that died during the study. Reddened kidneys and/or reddened/white renal cortico-medullary junctions were observed. Five rats had reddened or dark red adrenal glands. Hemorrhages in the thymus glands were noted. Other findings at a low incidence included an oedematous abdominal cavity and congenital accessory splenic tissue. Various external surface mattings were observed.
Animals sacrificed at end of study:
White areas in the kidneys (1/5 males, 500 mg/kg bw) and dark red lungs (1/5 females, 1000 mg/kg bw)
Any other information on results incl. tables
Table 1: Body weights of the animals in the acute oral toxicity study.
Dose group [mg/kg bw] |
|
BW±SD [g] |
|
|
|
|
|
day -1 |
day 0 |
day 7 |
day 14 |
2000 |
male |
178±9 |
156±7 |
- |
- |
|
female |
159±3 |
145±2 |
- |
- |
1000 |
male |
187±2 |
171±3 |
206±0 |
220±0 |
|
female |
165±3 |
155±3 |
161±1 |
173±1 |
500 |
male |
173±5 |
152±4 |
179±23 |
210±15 |
|
female |
165±4 |
149±4 |
161±6 |
168±4 |
Table 2: Clinical signs of the male animals in the acute oral toxicity study.
Clinical findings (number out of 5 animals) |
Males |
|
|
|
500 mg/kg bw |
1000 mg/kg bw |
2000 mg/kg bw |
Found dead |
1 |
4 |
5 |
Hypoactive |
0 |
5 |
5 |
Clear ocular discharge |
0 |
3 |
5 |
Wet brown urogenital staining |
0 |
1 |
2 |
Labored respiration |
0 |
1 |
2 |
Body cool to touch |
0 |
2 |
1 |
Ataxia |
0 |
4 |
5 |
Prostrate |
0 |
2 |
2 |
White frothy salivation |
0 |
0 |
3 |
Dried brown urogenital staining |
0 |
0 |
1 |
Convulsions |
0 |
0 |
1 |
Tremors |
0 |
4 |
2 |
Wet yellow urogenital staining |
1 |
0 |
1 |
Dried red material around nose |
0 |
1 |
1 |
Dried red material around mouth |
0 |
2 |
1 |
Clear wet matting around mouth |
0 |
3 |
1 |
Table 3: Clinical signs of the female animals in the acute oral toxicity study.
Clinical findings (number out of 5 animals) |
Females |
|
|
|
500 mg/kg bw |
1000 mg/kg bw |
2000 mg/kg bw |
Found dead |
0 |
3 |
5 |
Hypoactive |
2 |
5 |
5 |
Clear ocular discharge |
0 |
4 |
5 |
Wet brown urogenital staining |
0 |
5 |
3 |
Labored respiration |
0 |
2 |
5 |
Body cool to touch |
0 |
3 |
5 |
Ataxia |
0 |
5 |
5 |
Prostrate |
0 |
3 |
5 |
White frothy salivation |
0 |
1 |
3 |
Dried brown urogenital staining |
0 |
4 |
4 |
Tremors |
0 |
1 |
0 |
Wet yellow urogenital staining |
3 |
4 |
0 |
Dried red material around nose |
0 |
5 |
0 |
Dried red material around mouth |
0 |
3 |
3 |
Clear wet matting around mouth |
0 |
1 |
0 |
Table 4: Necropsy findings of the male and female animals in the acute oral toxicity study.
Necropsy findings (number out of 5 animals) |
Males |
|
|
Females |
|
|
|
500 mg/kg bw |
1000 mg/kg bw |
2000 mg/kg bw |
500 mg/kg bw |
1000 mg/kg bw |
2000 mg/kg bw |
Adrenal Glands - reddened - dark red |
0 0 |
1 1 |
2 0 |
0 0 |
1 0 |
0 0 |
Intestine - dark red contents |
0 |
2 |
5 |
0 |
3 |
4 |
Kidneys - reddened cortico-medullary junction - reddened - white cortico-medullary junction |
0
0 0 |
0
2 1 |
2
3 0 |
0
0 0 |
1
0 0 |
2
2 0 |
Lungs - mottled |
0 |
0 |
4 |
0 |
0 |
1 |
Spleen - accessory |
0 |
1 |
0 |
0 |
0 |
0 |
Stomach - dark red area - dark red content |
0 0 |
1 2 |
1 0 |
0 0 |
1 3 |
3 0 |
Thymus gland - hemorrhagic |
0 |
1 |
0 |
0 |
0 |
3 |
External surface - yellow matting - red matting - brown matting - clear matting - green matting |
0 0 0 0 0 |
0 2 0 1 0 |
4 5 2 0 0 |
0 0 0 0 0 |
1 2 2 0 1 |
1 2 1 1 1 |
Abdominal cavity - oedematous |
0 |
0 |
0 |
0 |
0 |
0 |
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
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