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EC number: 270-728-3 | CAS number: 68477-39-4 A complex combination of hydrocarbons obtained by distilling cracked stripped steam-cracked distillates. It consists of hydrocarbons having carbon numbers in the range of C8 through C10 and boiling in the range of approximately 129°C to 194°C (264°F to 382°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
Endpoint summary
Administrative data
Description of key information
There are data for repeat exposure to one low benzene naphtha streams representing the inhalation route of exposure and a related stream representing the dermal route. These do not indicate any specific target organ toxicity which would warrant classification. However, there are substantial data on the repeated dose toxicity of toluene which demonstrates significant target organ toxicity and, when present at concentrations greater than or equal to 10%, this component substance will influence classification due to mammalian toxicity effects.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 625 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Adequate information is available on the marker substance toluene to characterise the long-term hazards of these streams after ingestion.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEC
- 1 131 mg/m³
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Adequate information is available on the marker substance toluene to characterise the long-term systemic hazards of these streams after inhalation.
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEC
- 1 131 mg/m³
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Adequate information is available on the marker substance toluene to characterise the long-term local hazards of these streams after inhalation.
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 2 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rabbit
- Quality of whole database:
- Adequate information is available for a representative stream to characterise the long-term systemic hazards of these streams after skin contact.
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 200 mg/cm²
- Study duration:
- subacute
- Species:
- rabbit
- Quality of whole database:
- Adequate information is available for a representative stream to characterise the long-term local hazards of these streams after skin contact.
Additional information
Non human data
Repeat dose studies have been conducted for representative low benzene naphtha streams via the dermal and inhalation routes of exposure and indicate no significant target organ toxicity. It is noted that kidney effects in male rats in these studies are consistent with a well studied phenomenon known as light hydrocarbon nephropathy (Alden, 1986)." This phenomenon has been extensively evaluated and is a male rat-specific phenomenon and has no relevance for human risk assessment.”
Toluene (Classification: EU - Harmful Xn, R48/20; GHS/CLP - STOT-RE Category 2, H373): Toluene exposure can produce central nervous system pathology in animals after high oral doses. Repeated inhalation exposure can produce ototoxicity in the rat and high concentrations are associated with local toxicity (nasal erosion). In humans neuropsychological effects and disturbances of auditory function and colour vision have been reported, particularly when exposures are not well controlled and/or associated with noisy environments. The NOAEC for subchronic oral toxicity in rats is 625 mg/kg/day based on neuropathology (Huff, 1990). The NOAEC for inhalation toxicity in the rat is 300 ppm (1131 mg/m3) based on effects on body weight, mortality and adverse local effects (nasal erosion) (Gibson and Hardisty, 1983). The NOAEC for neuropsychological effects, auditory dysfunction and disturbances of colour vision in humans is 26 ppm (98 mg/m3) (Seeber et al, 2004; Schaper et al, 2003, 2004).
References
Alden CL (1986) A Review of Unique Male Rat Hydrocarbon Nephropathy. Toxicologic Pathology14 (1).
Schaper M, Demes P, Kiesswetter E, Zupanic M and Seeber A (2004). Colour vision and occupational toluene exposure: results of repeated examinations. Toxicology Letters 151, 193-202.
Schaper M, Demes P, Zupanic M, Blaszkewicz M and Seeber A (2003). Occupational toluene exposure and auditory function: results from a follow-up study. Ann. Occup. Hyg., Vol 47, No 6, pp493-502.
Seeber A, Schaper M, Zupanic M, Blaskewicz M, Demes P, Kiesswetter E and van Thriel C (2004). Toluene exposure below 50 ppm and cognitive function: a follow-up study with four repeated measurements in rotogravure printing plants. Int Arch Occup Environ Health, 77, 1-9.
Justification for selection of repeated dose toxicity via oral
route - systemic effects endpoint:
No repeat dose oral toxicity data are available for members of this
category, however rats receiving high treatments of the key marker
substance toluene for 13 wk showed signs of neuropathological changes
with a NOAEL of 625 mg/kg bw/d.
Justification for selection of repeated dose toxicity inhalation -
systemic effects endpoint:
Information available for the key component toluene indicates a
potential auditory impairment and effects on the nervous system. The
NOAEC for systemic inhalation toxicity in the rat is 300 ppm (1131
mg/m3) based on effects on body weight and mortality.
Justification for selection of repeated dose toxicity inhalation -
local effects endpoint:
Information available for the key component toluene indicates a
NOAEC for local inhalation toxicity in the rat of 300 ppm (1131 mg/m3)
based on adverse local effects (nasal erosion).
Justification for selection of repeated dose toxicity dermal -
systemic effects endpoint:
Information available for a representative stream indicate a
systemic NOAEL of 2000 mg/kg/day, the highest dose tested.
Justification for selection of repeated dose toxicity dermal - local
effects endpoint:
Information available for a representative stream indicate a local
LOAEL of 200 mg/kg, reflecting slight to moderate skin irritation.
Repeated dose toxicity: via oral route - systemic effects (target
organ) neurologic: central nervous system
Repeated dose toxicity: inhalation - systemic effects (target organ)
other: all gross lesions and masses
Justification for classification or non-classification
There are sufficient data available to conclude that streams within this category which contain less than 10% toluene do not require a label for this endpoint.
After repeated dose exposure, toluene causes a number of adverse effects including impairment of auditory function and morphological evidence of cell loss in the rat cochlea, neuron loss in the central nervous system of animals and in humans neuropsychological effects, auditory dysfunction and effects on colour vision have been reported. Consequently low benzene naphtha streams containing ≥ 10% toluene should be classified Cat 2, H373 according to CLP.
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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