Registration Dossier
Registration Dossier
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EC number: 265-099-7 | CAS number: 64741-98-6 A complex combination of hydrocarbons obtained as the extract from a solvent extraction 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 90°C to 220°C (194°F to 428°F).
Carcinogenicity
Administrative data
Description of key information
Based on carcinogenicity studies in animals and lack of evidence of carcinogenicity in humans toluene is considered not to be carcinogenic.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 4 522 mg/m³
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- The available data provide information that is adequate for the purpose of hazard assessment
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Dermal application (50 µL, twice per week for up to 2 years) gave no increase in any tumour type.
Justification for classification or non-classification
Toluene is considered not to be carcinogenic and therefore does not warrant classification under GHS / CLP.
Additional information
Non-human information
Inhalation studies in rats and mice (Huff, 1990; Gibson and Hardisty 1983) and a supporting study in mice using skin application (Broddle et al, 1996), are considered relevant for the risk assessment. Inhalation exposures for 6 or 6.5 h/day, 5 days/week for up to 2 years at concentrations up to 1200 ppm (4522 mg/m3) were used. The dermal application study involved application of 50 µL toluene twice a week for up to 2 years. No statistically significant increase in any tumour type was seen in any study.
Human information
According to the EU RAR (2003), “the only useful epidemiological cancer study which has been found does not show an excess of tumours in toluene-exposed workers". Toluene has also been evaluated by IARC in 1989 and 1999 and considered to be not classifiable as to carcinogenicity to humans.
Justification for selection of carcinogenicity via inhalation
route endpoint:
Inhalation studies in rats and mice of up to 2 years duration, and
using exposure concentrations up to 1200 ppm (4522 mg/m3), indicate no
increase in tumours.
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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