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Carcinogenicity

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Description of key information

DBP is not considered to be carcinogenic to humans.

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 study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No adequate long-term toxicity and/or carcinogenicity studies in animals or man are available.

Phthalate esters are known to induce peroxisomal proliferation in the liver of mice and rats. In general the longer chain dialkylphthalates are more potent for the induction of peroxisomal proliferation than the shorter chain ones and branched chain phthalates seemed more potent than straight. Many peroxisome proliferators have been shown to induce hepatocellular tumours when administered at high dose-levels for long periods to mice and rats despite being non-genotoxic.

The mechanisms of induction of carcinogenicity by peroxisome proliferators may be complex but are considered to have a threshold. A variety of independent studies have shown that there are marked species differences in the sensitivity to chemicals that cause peroxisome proliferation. Rats and mice are extremely sensitive, hamsters show a less marked response whilst guinea-pigs, primates and man are rather insensitive or non-responsive. (1)

DBP is not considered to be carcinogenic to humans when taking into account that the mechanisms by which DBP and hypolipidaemic substances induce peroxisome proliferation in rodents are not considered relevant to humans, and the absence of evidence associating DBP exposure to carcinogenic effects in humans.(2)

(1)

European Union Risk Assessment Report dibutyl phthalate, Volume 29, p. 16 (2003)

Editors: B. G. Hansen, S.J. Munn, R. A/Ianou, F. Berthault, J. de Bruin, M. Luotamo, C. Musset, S. Pakalin, G. Pellegrini, S. Scheen S. Vegro.

Office for Official Publications of the European Communities, ISBN 92—894—1276—3

(2)

Priority Existing Chemical Assessment Report No. 36, Dibutyl phthalate, November 2013, ISBN 978-0-9874434-4-1, p.84

Australian Government, Department of Health

NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME

GPO Box 58, Sydney NSW 2001 AUSTRALIA www.nicnas.gov.au

Justification for classification or non-classification