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EC number: 271-138-9 | CAS number: 68516-20-1 A complex combination of hydrocarbons produced by the distillation of products from a steam-cracking process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 130°C to 220°C(266°F to 428°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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Endpoint summary
Administrative data
Description of key information
Toluene is of low acute toxicity by the oral (LD50 > 5000 mg/kg), dermal (LD50> 5000 mg/kg) and inhalation (4 hour LC50 >20 mg/L) routes. In humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen following acute exposure ≥ 75 ppm. The NOAEC of 50 ppm (192 mg/m3) for acute neurobehavioural effects in humans is taken into account in the risk characterisation of acute neurotoxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The available data provide information that is adequate for the purpose of hazard assessment
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 192 mg/m³ air
- Quality of whole database:
- The available data provide information that is adequate for the purpose of hazard assessment
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The available data provide information that is adequate for the purpose of hazard assessment
Additional information
The acute toxicity of toluene was reviewed and reported in the EU RAR (2003). No additional relevant animal data has been sourced in the updated literature review.
Non-human information
Acute toxicity: oral
The acute oral toxicity of toluene is considered to be low (LD50> 5000 mg/kg). Withey and Hall (1975) performed what is considered to be the key study using a method which resembles that of EU guideline B1 (Acute toxicity (oral)). Groups of 20 male rats, were fasted overnight, dosed with 4000, 4560, 5200, 5930, or 6760 mg/kg of toluene and observed three times daily for at least 7 days after dosing. Rats dosed at high levels with toluene exhibited hind-limb paralysis and petechial bleeding, especially from the urinary tract, eyes and nose. The LD50 was calculated to be 5580 mg/kg. Similar oral LD50values (approximately 5600 mg/kg and 6400 mg/kg for younger and older adult rats, respectively) were reported by Kimura et al (1971).
Acute toxicity: inhalation
Acute 4 hour inhalation toxicity was investigated in groups of 10 male and female rats (BASF, 1980). Exposure concentrations were 6.08, 20.00, 23.98, 38.87 and 61.80 mg/L. The LC50 was calculated to be > 20 mg/L (28.1 mg/L in males and females; 25.7 mg/L in males and 30 mg/L in females). According to the EU RAR (2003), animals showed watery discharge from eyes and nose, unrest, increased respiration, rocking gait, narcosis, startling movements and hyperaemia of the ears and extremities. In the highest exposure group, salivation was observed. In the group exposed to 6.08 mg/L of toluene, no adverse clinical signs were observed. All surviving rats appeared normal after 3 days following the exposure.
Acute toxicity: dermal
A single acute dermal toxicity study on toluene in the rabbit has been found (Smyth et al, 1969). Fur was removed from the entire trunk by clipping and the dose held in contact with the skin for 24 hours (retained by impervious plastic film). The 4 animals per group were immobilised during the contact period, after which the film was removed and the rabbits caged for a 14 day observation period. The LD50 value was reported to be 14.1 mL/kg, corresponding to 12267 mg/kg (using a density of 0.87). No information on clinical signs or mortality pattern was provided.
Human information
The acute effects of toluene inhalation exposure have been investigated in a number of human experimental studies in volunteers. These studies indicate that toluene produces a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance at concentrations ≥ 75 ppm (EU RAR, 2003). Muttray et al (2005) exposed twenty healthy men to a constant level of 50 ppm toluene. The Pupillographic Sleepiness Test (PST) was performed before and after 4.5 hours 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.
When reviewing critical health effects underpinning an indicative occupational exposure limit (IOELV) for toluene, SCOEL noted that while human neurological changes were reported at high exposures the data supported a NOAEC of 80 ppm (300 mg/m3) for 4.5 hr. Since toxicokinetic information indicated that steady-state levels of toluene in blood were achieved after exposures of around 25 min of exposure, SCOEL concluded that a 15 min exposure to 100 ppm (384 mg/m3) would not lead to acute neurological effects. Furthermore, the IOELV-STEL was likely to protect against other short-term (subjective, irritative) effects.
Justification for selection of acute toxicity – oral endpoint
The available key and supporting studies indicate that the acute
oral toxicity of toluene is low (LD50 >5000 mg/kg)
Justification for selection of acute toxicity – inhalation endpoint
The available animal data indicate that the acute inhalation
toxicity of toluene is low (LC50 >20000 mg/m3). Information supporting
the IOELV indicates that no adverse neurological effects are expected
following short-term (15 min) exposure to 100 ppm (384 mg/m3) toluene.
CNS depression is apparent at higher exposures.
Justification for selection of acute toxicity – dermal endpoint
The available data indicate that the acute dermal toxicity of
toluene is low (LD50 >12000 mg/kg)
Justification for classification or non-classification
Toluene is of low acute toxicity by the oral, dermal, and inhalation routes with LD50/LC50 values exceeding the doses which would warrant classification under GHS / CLP.
Since data from experimental exposure of human volunteers show that dizziness and sleepiness are experienced at air levels < 20 mg/L for 4h and rocking gait and narcosis were observed in rats in the BASF study at this same concentration then toluene justifies classification as STOT-SE 3 (H336) under GHS / CLP.
The low viscosity of toluene (dynamic viscosity of 0.56 mPa s at 25°C and a surface tension of 27.93 nM at 25°C) justifies classification under GHS / CLP, Aspiration toxicity Category 1 assigned H304.
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.
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