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EC number: 215-535-7 | CAS number: 1330-20-7
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, non-guideline animal experimental study, published in peer reviewed literature, minor restrictions in reporting but otherwise adequate for assessment.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- The role of toxicokinetics in xylene-induced ototoxicity in the rat and guinea pig
- Author:
- Gagnaire F, Marignac B, Blachere V, Grossman S and Langlais C
- Year:
- 2 007
- Bibliographic source:
- Toxicology 231, 147-158
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- not specified
Test material
- Reference substance name:
- p-xylene
- EC Number:
- 203-396-5
- EC Name:
- p-xylene
- Cas Number:
- 106-42-3
- Molecular formula:
- C8H10
- IUPAC Name:
- p-xylene
- Details on test material:
- - Source: Acros, Geel, Belgium
- Purity: 99% (for all)
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Credo, Saint-Germain-sur-l'Arbresle, France
- Age at study initiation: approx. 7 wk
- Housing: group housed, 4/cage in polypropylene cages with woodchip bedding
- Diet : UAR-Alimentation, Epinay-sur Orge, France, sterilised by gamma irradiation ad libitum
- Water : filtered tap water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C
- Humidity: 50-60%
- Photoperiod (lights on): 07.00 - 19.00 hr
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- Each isomer was administered to 60 rats by gavage at a single dose of 8.47 mmol/kg, dissolved in olive oil and given at a volume of 4 mL/kg bw.
- Duration and frequency of treatment / exposure:
- Single dose
Doses / concentrations
- Remarks:
- Doses / Concentrations:
8.47 mmol/kg
- No. of animals per sex per dose / concentration:
- 60
- Control animals:
- no
- Details on study design:
- Blood and brain concentrations of ortho, meta and para-xylene (one isomer per experiment) were determined in SD rats following oral administration of a single dose of 8.47 mmol/kg bw. Results for p-xylene only are reported here. Comment: 8.47 mmol p-xylene / kg bw shown previously to cause histological lesions in the organ of Corti in rats whereas m- and o-xylenes ineffective (see Gagnaire and Langlais (2005) Arch. Toxicol. 79, 346-354).
- Details on dosing and sampling:
- - Tissues and body fluids sampled: blood (abdominal aorta), brain
- From how many animals: 6-8 per timepoint
- Time and frequency of sampling: 10, 20 and 30 min; 1, 2, 5, 8, 11, 15 and 24 hr
- Other: samples taken under deep anaesthesia (sodium pentobarbital) and stored frozen until analysis
- Method type(s) for identification: GC-FID - Statistics:
- Elimination half-life was estimated during the linear phase post-treatment. Maximum blood and brain concentrations were compared by one-way ANOVA followed by Scheffe's multiple range test if results were significant.
Results and discussion
Toxicokinetic / pharmacokinetic studies
Toxicokinetic parametersopen allclose all
- Toxicokinetic parameters:
- Cmax: Blood: p-xylene = 73 µg/mL
- Toxicokinetic parameters:
- Cmax: Brain: p-xylene = 210 µg/g
- Toxicokinetic parameters:
- half-life 1st: Blood: p-xylene = 188 min
- Toxicokinetic parameters:
- half-life 1st: Brain: p-xylene = 142 min
- Toxicokinetic parameters:
- AUC: Blood: p-xylene = 45807
- Toxicokinetic parameters:
- AUC: Brain: p-xylene = 110589
Any other information on results incl. tables
Graphical data showed that all 3 isomers appeared rapidly in blood and the brain but there were notable differences in time-course:
- concentrations of o-xylene in both tissues peaked after 2 hr, remained steady for 3 hr and then declined steadily over time
- blood m-xylene was maximal 30 min after administration, remained steady for 11 hr then decreased. Concentrations in brain paralleled those in the blood but with two peaks at 30 min and 5 hr
- concentrations of p-xylene in blood and brain peaked after 30 min then decreased sharply at 1 hr followed by a more steady decline.
The maximal concentration in blood and brain differed significantly between the isomers, and was always greatest for p-xylene.
Applicant's summary and conclusion
- Conclusions:
- All three isomers (o-, p-, m-) exhibited similar kinetics (Cmax, half-life, AUC) following gavage administration (8.47 mmol/kg bw) to young adult male rats although tissue concentrations of p-xylene were generally higher, and half-lives slightly shorter, than those of o-xylene and m-xylene. Levels of p-xylene in brain (Cmax, AUC) were around 2 to 3-fold greater than those for blood.
- Executive summary:
Blood and brain concentrations of o-, m- and p-xylene were determined in young adult male Sprague-Dawley rats following oral gavage administration of 8.47 mmol/kg of each isomer. Levels of p-xylene in blood and brain (Cmax, AUC) were approx. double, and tissue half-lives slightly shorter, compared to those found for o- and m-xylene. Levels of p-xylene in brain (Cmax, AUC) were around 2 to 3-fold greater than those for blood. The results indicate slight toxicokinetic differences for the three xylene isomers in the rat following acute oral exposure.
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