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EC number: 267-051-0 | CAS number: 67774-74-7
- 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

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 6 Aug 1992 to 25 Feb1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Gathering information on ADME parameters of UVCB in vivo is particularly challenging because of technical difficulties with radiolabeling of the test substance. Therefore, the ADME properties of a representative substance, 2-phenyldodecane, were examined as surrogate for the whole UVCB substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
- Objective of study:
- distribution
- excretion
- metabolism
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A single intravenous dose of test substance was given to 5 male and 5 female rats. Samples of urine and faeces were taken at pre-dose, 0.5, 4, 8, 24, 72, and 96 hrs post-dose. Whole body autoradiography was done for 1 animal of each sex at 0.5, 4, 8, 24, and 96 hrs after dosing.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-phenyldodecane
- IUPAC Name:
- 2-phenyldodecane
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- other: Crl: CD(SD)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Ltd
- Age at study initiation: 8 weeks of age
- Weight at study initiation: males 201 -2 65 g, females 178 - 220 g
- Housing: individual all-glass cages suitable for collecting urine and feces, identified with ear notching
- Individual metabolism cages: yes
- Diet: SQC Rat and Mouse Maintenance Diet No. 1, Expanded, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): 40 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 6 Aug 1992 to 25 Feb 1993
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- other: ethanol: polyethylene glycol 400 (5:95, v/v)
- Details on exposure:
- HOMOGENEITY AND STABILITY OF TEST MATERIAL:
Test material was tested for stability for 24 h using TLC - Duration and frequency of treatment / exposure:
- 1 intravenous injection
Doses / concentrations
- Dose / conc.:
- 1 mg/kg bw/day
- Remarks:
- 1 mg/kg bw equals 10 μCi
- No. of animals per sex per dose / concentration:
- 5
- Control animals:
- no
- Details on dosing and sampling:
- - Tissues and body fluids sampled: Urine and faeces were collected using suitable vessels surrounded by solid CO2. Cage washings and cage debris were also collected. Whole-body autoradiography was done for 1 animal of each sex at 0.5, 4, 8, 24, and 96 hrs after dosing. Sections obtained include the exorbital lachrymal gland or ovaries, intra-orbital lachrymal gland, Harderian gland, adrenal gland, thyroid, and brain and spinal cord.
- Time and frequency of sampling: Urine and faeces: pre-dose, 0.5, 4, 8, 24, 72, and 96 hrs post-dose
- Method type(s) for identification: Liquid scintillation counting and TLC, urine and faeces were pooled by time point and sex
- Limits of detection and quantification: for LSC the limit of detection was twice the background disintegration rate obtained from the measurement of the pre-dose samples.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- Highest levels were observed early in the liver and kidneys. The radioactivity was widely distributed early in the experiment, but was largely gone by 24 hrs after dosing. The Steno's gland, however, still contained radioactivity. Tissues with high lipid content and those with oily secretions still showed low but persistent radioactivity. No radioactivity was noted in the blood after 4 hrs in males, and 8 hrs in female.
- Details on excretion:
- 79.88 % of the test substance was excreted by male rats, and 85.87 % by the female rats within 96 hrs. The main route of excretion was the urine (75.97 % female, 57.94 % males) and mostly within the first 24 hrs (72.15 % female, and 53.19 % males). The amount excreted in the faeces was 8.865 % for males and 5.285 % in females.
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- Parent compound was a major component of radiation in the faeces. The test compound appeared to be rapidly eliminated from the body via the urine. Up to 9 different metabolites were resolved by TLC. A volatile fraction that was most likely parent compound was noted at the first time point. This was no longer evident at later time points.
Any other information on results incl. tables
No clinical signs were observed during the experiment.
Applicant's summary and conclusion
- Conclusions:
- The test substance was rapidly eliminated from the majority of tissues, though some remained in fatty tissues. Metabolism of the test substance was rapid, and it was eliminated mostly through the urine.
- Executive summary:
A single intravenous dose of test substance was given to 5 male and 5 female rats. Samples of urine and faeces were taken at pre-dose, 0.5, 4, 8, 24, 72, and 96 hrs post-dose. Whole body autoradiography was done for 1 animal of each sex at 0.5, 4, 8, 24, and 96 hrs after dosing. No clinical signs were observed during the study. The test substance was rapidly eliminated from the majority of tissues, though some remained in fatty tissues. Metabolism of the test substance was rapid, and it was eliminated mostly through the urine.
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