Registration Dossier
Registration Dossier
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EC number: 285-562-7 | CAS number: 85117-10-8
Specific investigations: other studies
Administrative data
Link to relevant study record(s)
Description of key information
Ototoxicity is known to occur following repeated inhalation exposures to toluene and ethylbenzene. These effects are considered in the overall risk assessment for repeated dose exposures in section 5.6.3.
Additional information
The specific components toluene and ethylbenzene are recognised as ototoxicants following repeated inhalation exposure.
Repeated inhalation exposure to ethylbenzene causes ototoxicity in rats (Gagnaire et al, 2007). Auditory dysfunction is characterised by an elevation of hearing thresholds in the mid frequency range and loss of cochlear outer hair cells, the sensory cells in the inner ear. Hearing loss and cell damage increased with exposure concentrations. The NOAEC for ototoxicity was extrapolated to be 114 ppm (500 mg/m³) based on destruction of outer hair cells.
Toluene is ototoxic in rats producing loss of cochlea hair cells which is considered to be an irreversible effect. However, effects have been insufficiently documented to enable determination of a NOAEC. Hearing loss has been reported in humans, especially when toluene exposure is associated with high exposure concentrations and a noisy environment. In addition there have been reports of disturbances of colour vision. For both these effects epidemiology studies (Schaper et al, 2003, 2004) have demonstrated that adverse changes do not occur when exposures are maintained below the current indicative occupational exposure limit of 50 ppm (188 mg/m3).
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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