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EC number: 270-736-7 | CAS number: 68477-53-2 A complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists of unsaturated hydrocarbons having carbon numbers predominantly in the range of C5 through C12.
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-guideline, non-GLP, human experimental study, published in peer-reviewed literature. Well-documented with respect to end-point.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- acute toxicity: inhalation
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Volunteers were exposed in an exposure chamber, once to 50 ppm toluene and once to air for a period of 4.5 hours. Sleepiness was assessed by the Pupillographic Sleepiness Test (PST) before and after exposure.
- GLP compliance:
- no
Test material
- Details on test material:
- Toluene high purity solvent, supplied by Fluka AG, Buchs, Switzerland
Constituent 1
Method
- Type of population:
- other: Healthy non-smoking male volunteers
- Subjects:
- - Number of subjects exposed: 20
- Sex: male
- Age: 30.5 (± 5.2) years
- Volunteers were exposed in an exposure chamber, once to 50 ppm toluene and once to air for a period of 4.5 hours. Sleepiness was assessed by the Pupillographic Sleepiness Test (PST) before and after exposure. Acute neurobehavioural symptoms were assessed by a questionnaire based on the Swedish Performance Evaluation System (SPES) self-assessment questionnaire completed, once before and during exposure (2, 60 and 265 minutes). - Ethical approval:
- confirmed and informed consent free of coercion received
- Route of exposure:
- inhalation
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- Exposure carried out in a 18 m3 chamber. 270 minute exposure period. Mean toluene concentration 51.5 ppm (+1.02 S.D.) by infrared-spectroscopy. Mean temperature: 21.0 °C (+0.4 S.D.), maen humidity: 52.0% (+0.65 S.D.). Air exchange: 6/hour.
Biological monitoring: 50 ppm toluene for 270 min resulted in a mean toluene blood concentration of 0.5 mg/L (±0.12 S.D.). After exposure to air mean toluene blood concentration was 0.01 mg/L (±0.005 S.D.). - Examinations:
- Pupillographic sleepiness test (PST): Once before and once after exposure. Spontaneous pupillary movements were recorded for 11 min. The Pupillary-Unrest-Index (PUI in mm/min) was calculated automatically by the PST-machine. PUI is based on cumulative changes in pupil diameter.
Assessment of acute symptoms: A questionnaire based on the Swedish Performance Evaluation System (SPES) self-assessment questionnaire was completed, once before and during exposure (2, 60 and 265 minutes).
Blood analyses: Just before exposure began and immediately after exposure.
Urine analyses: Just before exposure began.
Results and discussion
- Clinical signs:
- "Sensation of bad smell" and "irritation to the throat" were recorded during exposure but no residual or period effects were seen. No other statistically significant differences in clinical signs were recorded.
Subjective symptoms: "sensation of bad smell" and "irritation to the throat" were recorded during exposure but no residual or period effects were seen. The score for "irritation to the throat" was statistically significant raised at 265 min. The solvent odour was identified correctly, instantly and sustained by the subjects. No other effects were statistically different.
PST: The statistical analysis performed on the logarithmic PUI values gave no evidence for any residual, period or treatment effects. - Results of examinations:
- There was no effect of toluene exposure on Pupillographic Sleepiness Test (PST) or other acute symptoms (headache, dizziness, nausea, tiredness, pain or pressure on the chest, coughing spells, shortness of breath, irritation to the eyes, watering eyes, blurred vision, irritation to the nose, running nose, sensation of unpleasant taste, irritation to the skin, feeling of fainting or vertigo) in human volunteers exposed at 50 ppm (188 mg/m3) for 4.5 hours.
Any other information on results incl. tables
Parametric cross-over analysis of logarithmic Pupillary Unrest Index (PUI) values did not show an effect of toluene exposure. In a nonparametric cross-over analysis of SPES-scores a significant increase of the scores of unpleasant smell and irritation to the throat, but not of tiredness was found. In conclusion, acute exposure to 50 ppm toluene did not increase sleepiness.
Applicant's summary and conclusion
- Conclusions:
- The NOAEC for acute neurobehavioural effects in man was 50 ppm (188 mg/m3) toluene.
- Executive summary:
Twenty healthy men were exposed to a constant level of 50 ppm toluene. The Pupillographic Sleepiness Test (PST) was performed before and after 4.5 h of exposure. Acute symptoms were assessed with the Swedish Performance Evaluation System (SPES) self-assessment questionnaire, once before and 3 times during exposure. There was no effect of toluene exposure on PST or tiredness but scores for unpleasant smell and irritation to the throat were increased.
In conclusion, a NOAEC of 50 ppm (188mg/m3) can be determined for acute neurobehavioural effects.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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