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Toxicological information

Carcinogenicity

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Description of key information

There is no information on the carcinogenicity of members of the low benzene naphtha category, however there is no evidence of genotoxicity in a number of in vitro and in vivo assays.  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

Additional information

There are no data on low benzene naphtha streams, however data are available for the specific component toluene.

Non-human information

Inhalation studies with toluene 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.

References  

Broddle WD, Dennis MW, Kitchen DN and Vernot EH (1996). Chronic dermal studies of petroleum streams in mice. Fundamental and Applied Toxicology 30, 47-54.

EU RAR (2003). Toluene risk assessment report. European Union Risk Assessment Report, Volume 30.

IARC (1989) IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Vol. 47, Some Organic Solvents, Resin Monomers and Related Compounds, Pigments and Occupational Exposures in Paint Manufacture and Painting, Lyon, pp. 79–123

IARC (1999) http: //www. inchem. org/documents/iarc/vol71/030-toluene. html

Justification for classification or non-classification

There is no evidence that low benzene naphtha streams are carcinogenic and therefore they do not warrant classification under DPD or GHS.