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EC number: 201-134-4 | CAS number: 78-70-6
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not indicated publication
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- An OECD guideline does not exist for this type of study
Data source
Reference
- Reference Type:
- publication
- Title:
- Preparation, characterization and pharmacokinetic studies of linalool-loaded nanostructured lipid carriers
- Author:
- Feng Shi*, Yingying Zhao*, Caleb Kesse Firempong and Ximing Xu
- Year:
- 2 016
- Bibliographic source:
- PHARMACEUTICAL BIOLOGY, 2016 VOL. 54, NO. 10, 2320–2328 http://dx.doi.org/10.3109/13880209.2016.1155630
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Linalool was suspended in 0.5% carboxymethylcellulose and applied via oral gavage to SD rats. Blood was drawn at several timepoints to prepare plasma. The concentration of Linalool in the plasma was analysed using a HPLC-UV method. The toxicokinetic parameters were calculated using BAPP 2.3 software package.
- GLP compliance:
- no
Test material
- Reference substance name:
- Linalool
- EC Number:
- 201-134-4
- EC Name:
- Linalool
- Cas Number:
- 78-70-6
- Molecular formula:
- C10H18O
- IUPAC Name:
- 3,7-dimethylocta-1,6-dien-3-ol
- Details on test material:
- - Name of test material (as cited in study report): Linalool
- Substance type: Unsaturated racemic monoterpene alcohol
Constituent 1
- Specific details on test material used for the study:
- Linalool (98%) from J&K Scientific Ltd. (Beijing, China)
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- Healthy male Sprague-Dawley rats (weight 300 ± 20 g) were obtained from Laboratory Animal Center of Jiangsu University (Jiangsu, China).
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- The rats were fed with standard food pellets and maintained under standard laboratory conditions with a dark/light cycle of 12 h. All rats were fasted overnight before the experiments, but allowed access to water ad libitum. The use and care protocols of rats were reviewed and approved by the Ethic Committee of Jiangsu University.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- Six male Sprague-Dawley rats received Linalool as a suspension in 0.5% (w/v) sodium carboxymethylcellulose at a dose level of 300 mg/kg bw.
- Duration and frequency of treatment / exposure:
- single dose
Doses / concentrations
- Dose / conc.:
- 300 mg/kg bw (total dose)
- No. of animals per sex per dose / concentration:
- 6
- Control animals:
- no
- Positive control reference chemical:
- No details given
- Details on study design:
- Six healthy male Sprague-Dawley rats (weighing approximately 300 g) were given Linalool via oral gavage using 0.5% CMC as vehicle.
- Details on dosing and sampling:
- After oral administration, blood samples (0.6 mL) were collecated at several time points (5, 10, 15, 20, 30, 40, 50, 60, 120, 180, 240, 300, 360 and 480 min) into heparinized centrifuge tubes. Plasma was prepared and analysed for Linalool using a HPLC-UV method. The HPLC apparatus included a pump (LC-10ADVP; Shimadzu), an UV detector (SPD-20A; Shimadzu) and a Symmetric C18 column (5 microm, 4.6x150 mm) at a detection wavelength of 210nm at 30 °C, and the injection volume was 20 microL. The mobile phase consisted of acetonitrile-water (47:53) at a flow rate of 1.0mL/min.
- Statistics:
- n.a.
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- not investigated
- Details on distribution in tissues:
- not investigated
- Details on excretion:
- not investigated
Toxicokinetic parametersopen allclose all
- Key result
- Toxicokinetic parameters:
- AUC: 76003.40 ng/min/mL
- Key result
- Toxicokinetic parameters:
- Cmax: 1915.45 ng/mL
- Key result
- Toxicokinetic parameters:
- Tmax: 40 min
- Key result
- Toxicokinetic parameters:
- half-life 1st: 44.72 min
Metabolite characterisation studies
- Metabolites identified:
- not measured
Enzymatic activity
- Enzymatic activity measured:
- not measured
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- not investigated
Applicant's summary and conclusion
- Conclusions:
- Linalool is rapidly taken up upon oral bolus administration even at relatively high doses with the Cmax being observed already after 40 min. Linalool is rapidly eliminated from plasma with a half-life of approximately 45 min. Linalool could not be detected anymore in the plasma after 240 min.
- Executive summary:
Six healthy male Sprague-Dawley rats (weighing approximately 300 g) were given Linalool via oral gavage using 0.5% CMC as vehicle. After oral administration, blood samples (0.6 mL) were collected at several time points into heparinized centrifuge tubes: 5, 10, 15, 20, 30, 40, 50, 60, 120, 180, 240, 300, 360 and 480 min. Plasma was prepared and analysed for Linalool using a HPLC-UV method. The HPLC apparatus included a pump (LC-10ADVP; Shimadzu), an UV detector (SPD-20A; Shimadzu) and a Symmetric C18 column (5 microm, 4.6 x 150 mm) at a detection wavelength of 210 nm at 30 °C, and the injection volume was 20 µL. The mobile phase consisted of acetonitrile-water (47:53) at a flow rate of 1.0mL/min. Toxicokinetic parameters were investigated using BAPP 2.3 pharmacokinetic software package (supplied by the Center of Drug Metabolism and Pharmacokinetics, China Pharmaceutical University).
Linalool is rapidly taken up upon oral bolus administration even at relatively high doses with the Cmax (1915.45 ng/mL) being observed already after 40 min. Linalool is rapidly eliminated from plasma with a half-life of approximately 45 min. Linalool could not be detected anymore in the plasma after 240 min. The AUC(0 -t) was 76003.40 ng/min/mL.
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