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Diss Factsheets
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EC number: 202-436-9 | CAS number: 95-63-6
- 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
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Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, non-guideline human experimental study, published in peer reviewed literature, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicokinetics of inhaled trimethylbenzenes in man
- Author:
- Järnberg J, Johanson G and Löf A
- Year:
- 1 996
- Bibliographic source:
- Toxicol Appl Pharmacol 140 (2): 281-8
Materials and methods
- Endpoint addressed:
- basic toxicokinetics
- Principles of method if other than guideline:
- Inhalation study in human volunteers. 1,2,4-trimethyl benzene was determined in blood, urine, and exhaled air.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 1,2,4-trimethylbenzene
- EC Number:
- 202-436-9
- EC Name:
- 1,2,4-trimethylbenzene
- Cas Number:
- 95-63-6
- Molecular formula:
- C9H12
- IUPAC Name:
- 1,2,4-trimethylbenzene
- Reference substance name:
- pseudocumene
- IUPAC Name:
- pseudocumene
- Details on test material:
- - Name of test material (as cited in study report): 1,2,4-Trimethylbenzene
- Analytical purity: >99%
- Source: Fluka, Buchs, Switzerland
Constituent 1
Constituent 2
Method
- Type of population:
- other: Healthy human volunteers
- Subjects:
- - Number of subjects exposed: 10
- Sex: male
- Age: average age 35 years (26-48 years)
- Race: Caucasian
- Demographic information: Not occupationally exposed to solvents
- Known diseases: All reported to be "healthy" - Ethical approval:
- other: The study was approved by the Regional Ethical Committee at the Karolinska Institute, Solna, Sweden.
- Route of exposure:
- inhalation
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- The subjects were exposed to 1,2,4-TMB for 2 hr in an exposure chamber at a constant work load of 50 W on an ergometer bicycle. The subjects were exposed to concentrations of 25 ppm (120 mg/m3) and 2 ppm (11 mg/m3) 1,2,4-TMB.
The volume of the chamber was 20 m3. The solvent was injected into the inflowing airstream by means of a high-performance liquid chromatography pump and completely vaporized before reaching the chamber. Vaporization was achieved by compressed air-mediated aerosol formation combined with evaporation of residual droplets by a metal plate heated to 130°C. The outlet airflow was 320 m3/hr giving an air exchange in the chamber of 16 times/hr. To prevent leakage of solvent the air pressure in the chamber was kept about 5 Pa lower than in the surrounding laboratory. Fans were operating near the ceiling and floor to achieve a uniform distribution of 1,2,4-TMB vapour. - Examinations:
- - Urine analysis: All urine was collected from the onset of exposure until the next morning. Voiding times were before exposure and at 0, 2, 4, 11, and 20 hr post exposure. The total volume of urine was measured and an aliquot of 6 ml from each sample was immediately transferred to a head space vial for gas chromatographic analysis.
- Haematology: Capillary blood (200 µL) was sampled at selected intervals during exposure and until the next morning.
- Lung function: Pulmonary ventilation (L/min) was assessed at 0-2 and 2-6 hrs
- Other: The heart rate was recorded continuously during exposures with a heart rate meter . - Medical treatment:
- None required
Results and discussion
- Clinical signs:
- No irritation or central nervous system effects were reported.
- Results of examinations:
- The respiratory uptake was approximately 64% and was independent of exposure concentration over the range studied.
Less than 0.002% of the respiratory uptake of 1,2,4-TMB was excreted unchanged in urine within 4 hr post-exposure.
Concentration of 1,2,4-TMB in arterial blood increased rapidly without reaching any plateau within the 2 hr exposure period.
Approximately 20% of the respiratory uptake of 1,2,4-TMB was exhaled unchanged during and after exposure.
The kinetics of 1,2,4-TMB were characterised by a large volume of distribution and long terminal elimination half life.
Any other information on results incl. tables
Summary of findings
(table based on Järnberg et al, 1996, Toxicol Appl Pharmacol 140 (2): 281-8 , Tables 1, 2 and 3)
Parameter measured |
25 ppm 1,2,4-TMB |
2 ppm 1,2,4-TMB |
Heart rate (beats/min) 0-2 hr |
80 ± 3 |
84 ± 3 |
Pulmonary ventilation (L/min) 0-2 hr |
23 ± 2 |
24 ± 1 |
Pulmonary ventilation (L/min) 0-2 hr |
11 ± 2 |
12 ± 1 |
Respiratory uptake (%) |
64 ± 3 |
63 ± 2 |
Respiratory excretion (%) |
20 ± 3 |
15 ± 5 |
Urinary excretion (%) |
0.0010 ± 0.0004 |
0.0005 ± 0.0002 |
Volume of distribution (L/kg) |
38±11 |
28±3 |
Total calculated blood clearance (L/hr/kg) |
0.68 ± 13 |
0.87 ± 37 |
Half-life: 4thphase (hr) |
87 ± 27 |
65 ± 20 |
Applicant's summary and conclusion
- Executive summary:
- The respiratory uptake was approximately 64% and was independant of exposure concentration over the range studied. Less than 0.002% of the respiratory uptake of 1,2,4 -TMB was excreted unchanged in urine within 4 hr post-exposure. Concentration of 1,2,4-TMB in arterial blood increased rapidly without reaching any plateau within the 2 hr exposure period. Approximately 20% of the respiratory uptake of 1,2,4-TMB was exhaled unchanged during and after exposure. The kinetics of 1,2,4-TMB were characterised by a large volume of distribution and long terminal elimination half life indicative of distribution into lipid.
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