Registration Dossier

Toxicological information

Carcinogenicity

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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.