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EC number: 213-050-5 | CAS number: 919-31-3
- 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
Endpoint summary
Administrative data
Description of key information
In
the key acute oral toxicity study, available from an IUCLID summary and
claimed to be conducted using a protocol comparable to the now deleted
OECD Test Guidelines 401, but predating GLP (Mellon Institute, 1956),
the LD50 for 3-(triethoxysilyl)propiononitrile was 5600 mg/kg bw in male
Wistar rats.
In the key acute dermal toxicity study, available from an IUCLID summary and claimed to be conducted using a protocol comparable to the OECD Test Guidelines 402, but predating GLP (Mellon Institute, 1956), the LD50 for 3-(triethoxysilyl)propiononitrile was 5753 mg/kg bw in male New Zealand White rabbits.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1956
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- other: LD50
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 5 to 6 weeks
- Weight at study initiation: 90-120 grams
- Fasting period before study: not fasted - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- T52-003: 10% dilution in corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: as a 10% dilution
MAXIMUM DOSE VOLUME APPLIED: ca. 5 for 7.95 g/kg dose and ca. 8ml for 3.98 g/kg dose
- Doses:
- 7950 and 3980 mg/kg bw
- No. of animals per sex per dose:
- 3.98 g/kg bw: 5 rats
7.95 g/kg bw: 4 rats - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data available
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: no data available - Statistics:
- Thompson's method of calculating the median-effective dose (LD50) was applied to the 14-day mortality data.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 5 600 mg/kg bw
- Based on:
- test mat.
- Remarks:
- median-effect dose, calculated from the 14-day mortality data
- Remarks on result:
- other: No range is given because there was 100% mortality at 7.95 g/kg bw and 100% survival at 3.98 g/kg bw
- Mortality:
- All animals administered the higher dose died. No mortalities were seen at the lower dose.
- Clinical signs:
- other: 3.98 g/kg bw: no data available At 7.95 g/kg bw: Violent convulsions followed the administration of the doses and death ensued in a few hours.
- Gross pathology:
- 3.98 g/kg bw: no data available
At 7.95 g/kg bw: Lungs were hemorrhaged, livers and kidneys mottled and adrenals slightly congested at autopsy. - Other findings:
- No data available.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study available from an IUCLID summary, claimed to be conducted using a protocol comparable to the now deleted OECD Test Guidelines 401, but predating GLP, the LD50 was determined to be 5600 mg/kg bw/day in male Wistar rats.
Reference
Table 1: Number of animals dead and time range within which mortality occured
Dose |
Mortality (# dead/total) |
Time range of deaths (day) |
||
Male |
Female |
Combined |
||
3.98 |
0/5 |
- |
0/5 |
- |
7.95 |
4/4 |
- |
4/4 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 600 mg/kg bw
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1956
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 3 to 5 months
- Weight at study initiation: mean 2.5 kg - Type of coverage:
- not specified
- Vehicle:
- other: undiluted
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the trunk
- Type of wrap if used: "Vinylite" sheeting was used to retain the dose in contact with the clipped skin of the trunk
No other details on dermal exposure available. - Duration of exposure:
- 24 hours
- Doses:
- 5.0 and 10.0 ml/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No details available.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: No details available. - Statistics:
- Thompson's method of calculating the LD50 was used.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 5 753 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals died within one day at the 10.0 ml/kg bw dose level, one animal died on the first day at the 5.0 ml/kg bw dose level.
- Clinical signs:
- other: Skin erythema with slight necrosis in several cases resulted from these covered applications.
- Gross pathology:
- Dosage: 10.0 ml/kg bw: The lungs were slightly congested, the kidneys pale and pitted, and livers mottled.
Dosage: 5.0 ml/kg bw: None reported. - Other findings:
- No other findings reported/available.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute dermal toxicity study available from an IUCLID summary, claimed to be conducted using a protocol comparable to the OECD Test Guideline 402 , but predating GLP, the LD50 was determined to be value of 5753 mg/kg bw/day in male New Zealand White rabbits.
Reference
Table 1: Number of animals dead and time range within which mortality occurred
Dose |
Mortality (# dead/total) |
Time range of deaths (day) |
||
Male |
Female |
Combined |
||
5.0 |
1/3 |
- |
1/3 |
1 |
10.0 |
3/3 |
- |
3/3 |
1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 753 mg/kg bw
Additional information
In the key acute oral toxicity study available from an IUCLID summary and claimed to be conducted using a protocol comparable to the now deleted OECD Test Guidelines 401, but predating GLP (Mellon Institute, 1956), the LD50 for 3(triethoxysilyl)propiononitrile was 5600 mg/kg bw in male Wistar rats. At the upper dose level of 7950 mg/kg, clinical signs included violent convulsions prior to death, and haemorrhagic lungs, mottled livers and kidneys and slightly congested adrenals were seen at necropsy. There were no deaths, clinical signs or necropsy findings at the lower dose level of 3980 mg/kg bw.
In the key acute dermal toxicity study available from an IUCLID summary and claimed to be conducted using a protocol comparable to the OECD Test Guidelines 402 , but predating GLP (Mellon Institute, 1956), the LD50 for 3(triethoxysilyl)propiononitrile was 5753 mg/kg bw in male New Zealand White rabbits. At the high dose of 9669 mg/kg bw, slightly congested lungs, pale and pitted kidneys and mottled livers were seen at necropsy. No clinical signs were reported, although there were signs of local irritation and necrosis.
The LD50 values in both key studies were well in excess of the upper limit for acute toxicity testing according to current EU guidelines of 2000 mg/kg bw.
The acute inhalation test did not meet current guideline requirements but adds weight of evidence to the low acute toxicity of the substance. It has therefore been assigned reliability 4 and used as supporting information only.
Justification for classification or non-classification
Based on the available measured LD50 values, 3-(triethoxysilyl)propiononitrile does not meet the criteria for classification for acute toxicity according to Regulation (EC) No 1272/2008.
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