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EC number: 250-709-6 | CAS number: 31570-04-4
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Objective of study:
- absorption
- excretion
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Deviations:
- yes
- Remarks:
- Missing residual radioactivity determination in expired air and bile. No residual radioactivity in individual organs.
- GLP compliance:
- yes
- Radiolabelling:
- yes
- Remarks:
- C14
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zentralinstitut für Versuchstiere, Hannover Germany
- Weight at study initiation: 143.9 - 179.1 g
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): 15 g. The day before antioxidant application, however, the standard food ration was reduced to 8 g for each animal. Thereafter the animals got again their normal daily ration of 15 g standard food, but the first ration was given 8 hours after antioxidant application.
- Water (e.g. ad libitum): ad libitum- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- other: gavage and intravenous
- Vehicle:
- other: olive oil (gavage) and propanediol-1,2 (intravenous)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS
The application solutions A, B, and C were only prepared shortly before administration to the test animals. Calculated amounts of C-labeled test material were weighed in homogenization vessels of glass and dissolved at room temperature by means of an ultrasonic homogenizator within1 minute in also defined amounts of various vehicle substances.
Application solution A for oral application of radiolabelled test material to rats of test group I
- Test substance: 14C-labelled test material with the above mentioned properties
- Vehicle liquid: olive oil
- Specific radioactivity: 37.429 μCi/g solution (1384.87 kBq/g solution) ± 0.961 μCi/g solution; s [%] 2.57 (n = 4)
- Concentration of 14C-test material: 2352.6 μg/g solution
Application solution B for oral application ofradiolabelled test material to rats of test group II
- Test substance: 14C-labelled test material with the above mentioned properties
- Vehicle liquid: olive oil
- Specific radioactivity: 1.610 μCi/g solution (59.57 kBq/g solution) ± 0.004 μCi/g; s [%] 0.26 (n = 4)
- Concentration of 14C-test material: 101.2 μg/g solution
Application solution C for intravenous application of radiolabelled test material to rats of test group III
- Test substance: 14C-labelled test material with the above mentioned properties
- Vehicle liquid: propanediol-(1,2)
- Specific radioactivity: 1.386 μCi/g solution (51.28 kBq/g solution) ± 0.006 μCi/g; s [%] 0.40 (n = 4)
- Concentration of 14C-test material: 87.1 μg/g solution
The application solutions with cold test substance for the control groups 0I/II and 0III were produced in the same way. - Duration and frequency of treatment / exposure:
- 72 hours
- Dose / conc.:
- 0.051 mg/kg bw/day (actual dose received)
- Remarks:
- intravenous, single dose
- Dose / conc.:
- 0.26 mg/kg bw/day (actual dose received)
- Remarks:
- gavage, single dose
- Dose / conc.:
- 5.3 mg/kg bw/day (actual dose received)
- Remarks:
- gavage, single dose
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- other: cold material
- Positive control reference chemical:
- none
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces, blood, and carcass
- Time and frequency of sampling: 24 h before dose administration and at 0, 6, 24, 48, and 72 h (urine and faeces). Blood and carcass at 72 h
- Other: storage of the samples of animal materials at -30 °C - Details on excretion:
- Average radioactivity excreted after oral administration:
- group I (0.26 mg/kg bw): 72 hours after dosing 0.116 % (urine), 94.51 % (feces), < LOD (about 0.3 ng test substance/g sample) (blood), and- group II (5.3 mg/kg bw): 72 hours after dosing 0.380 % (urine), 97.12 % (feces), 0.030 % (blood), and n.d. (carcass).
Average radioactivity excreted after intravenous administration:
- group III (0.051 mg/kg bw): 72 hours after dosing 0.328 % (urine), 3.67 % (feces), 0.127 % (blood), and 73.7 % (carcass). - Metabolites identified:
- not measured
- Conclusions:
- No bioaccumulation was found by oral route (at least 94.5 % radioactivity was found in feces). 73.7 % radioactivity was instead found in the bodies of the i.v. treated animals after 72 h.
In conclusion, the orally given antioxidant tris(2,4-ditert-butylphenyl) phosphite (and also its possible metabolites) rests only a short time (72 hours) in male rats and is favouredly excreted nearly quantitatively by faeces (> 94.5 %), but also by renal way (< 0.4 %).
Reference
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
The data after treatment by gavage show that nearly the entire amount of the labelled test substance applied was excreted. Most of the radioactivity was found in the feces and only a small extend was found in the urine. The residual radioactivity found in the blood and in the homogenized rat carcasses was very small.
The data after intravenous treatment show that some radioactivity was eliminated by feces and by urine, but distinctively slower than after oral application. Whereas the residual radioactivity found in the blood was also very small, the majority of the residual radioactivity was found in the homogenised rat carcasses (74 %).
The data collected show that both the resorption by the intestinal tract and the excretion of resorbed test substance via the bile or the renal way occur relatively slowly. They show also that there is no accumulation of test substance given orally.
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