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Diss Factsheets
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EC number: 271-266-5 | CAS number: 68527-26-4 A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 80°C to 218°C (176°F to 424°F).
- 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
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Specific investigations: other studies
Administrative data
- Endpoint:
- specific investigations: other studies
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-guideline animal experimental study, published in peer-reviewed literature, GLP status unknown, fully adequate for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Brain morphological investigations 8 weeks following exposure. Brainstem auditory-evoked responses used to determine auditory thresholds at different frequencies. The cochlea and organ of Corti examined by light and electron microscopy, respectively.
- GLP compliance:
- not specified
- Type of method:
- in vivo
- Endpoint addressed:
- repeated dose toxicity: inhalation
Test material
- Reference substance name:
- m-xylene
- EC Number:
- 203-576-3
- EC Name:
- m-xylene
- Cas Number:
- 108-38-3
- Molecular formula:
- C8H10
- IUPAC Name:
- m-xylene
- Details on test material:
- Analytical purity: >99%
Source: Acros, Geel, Belgium
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Credo, Domaine des Oncines, Saint-Germain-sur l’Arbresle, France
- Age at study initiation: 14 weeks
- Diet: UAR-Alimentation, Villemoisson, Epinay-sur-Orge, France; sterilized with γ-ray, ad libitum
- Water: Filtered tap water (pore size 0.3 µm) ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C
- Humidity: 55 ± 5% %
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- inhalation: vapour
- Vehicle:
- other: air
- Details on exposure:
- TYPE OF EXPOSURE: whole body
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 200 L stainless steel inhalation chambers designed to maintain a dynamic and adjustable airflow (10-30 m3/hr), maintained at negative pressure (2-3 mm H2O)
- System of generation: An additional airflow was bubbled through xylene and the output vapour was diluted with air to the required concentration before entering the exposure chamber.
- Temperature, humidity, pressure in air chamber: no data
- Air flow rate: 10-30 m3/hr
TEST ATMOSPHERE
- Brief description of analytical method used: m-xylene concentrations in the exposure chambers were continuously monitored using a gas liquid chromatograph. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Achieved exposure concentrations were determined once during each 6 hr exposure period (sample collection on activated charcoal and analysis by gas chromatography).
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 hours/day, 5 days/week
- Post exposure period:
- 8 week recovery period
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 450, 900, 1800 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- 16
- Control animals:
- yes, sham-exposed
- Details on study design:
- Study aim – evaluation of potential ototoxicity in rats of xylene isomer by electrophysiological methods. Auditory thresholds at different frequencies were determined by brainstem auditory evoked responses. A quantitative morphological study (histocochleogram) and scanning electron microscopy of the organ of Corti used to determine whether there were any microscopic alterations.
Dose selection rationale – based on preliminary range-finding studies. The highest exposure concentration was chosen to produce a reduction in body weight gain of less than 10% and no mortality after four weeks of exposure.
Examinations
- Examinations:
- Observations and examinations performed and frequency
CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
NEUROPHYSICAL MEASUREMENTS: Yes
Sacrifice and pathology
GROSS PATHOLOGY: No data
MORPHOLOGY: Yes
Results and discussion
- Details on results:
- No alteration in auditory evoked response or structure/ultrastructure of the organs of hearing at highest dose tested. The NOAEC (ototoxicity) for male rats was >=1800 ppm (equivalent to 7817 mg/m3).
Any other information on results incl. tables
CLINICAL SIGNS AND MORTALITY: No mortality, all rats remained in good health.
BODY WEIGHT AND WEIGHT GAIN: No statistically significant differences.
NEUROPHYSICAL EXAMINATION: No effect on the latency or amplitudes of brainstem auditory evoked responses or audiometric thresholds.
MORPHOLOGICAL STUDY: There was no loss of hair cells either in the inner or outer hair cell rows of the organ of Corti.
Applicant's summary and conclusion
- Conclusions:
- There were no changes in brainstem auditory evoked responses or alterations in structure of the cochlea or ultrastructure of the organ of Corti in male rats 8 weeks after cessation of sub-chronic exposure to m-xylene.
- Executive summary:
Male Sprague-Dawley rats were exposed to m-xylene by inhalation (0, 450, 900 and 1800ppm, 6 hr/day, 5 days/week for 13 weeks) and brainstem auditory-evoked responses were determined 8 weeks after treatment ended. The cochlea and organ of Corti were examined using light or electron microscopy, respectively. No functional or structural alterations were present, with an overall NOAEC of >=1800 ppm for ototoxicity.
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