Registration Dossier

Administrative data

Description of key information

As far as studies are available DBP is not expected to have significant acute toxicity in humans.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

None of the acute toxicity studies have been performed according to current standards.

Based on the available data DBP is slightly toxic if swallowed (LD50 rat is6,300 mg/kg bw), slightly to moderately toxic by inhalation (LC50 rat15.68 mg/L) and slightly toxic in contact with the skin (LD50 dermal rabbit >20,000 mg/kg bw). (1)

Given the low toxicity observed in the acute oral, inhalation, and dermal studies, the effects observed in the irritation and sensitisation studies and the anticipated occupational exposure levels it is concluded that DBP is of no concern for workers with respect to acute effects, irritation, and skin sensitisation. There are no data available on the possible respiratory sensitisation.(2)

DBP has low acute oral, dermal and inhalation toxicity in rodents with LD50s above 4000 mg/kg bw for oral and above 20,000 mg/kg bw for dermal exposure. LC50 for inhalation exposure in rats is ≥15.68 mg/L/4h. Intravenous and intraperitoneal administration of DBP results in higher acute toxicity than oral or dermal administration. The lowest LD50 for intravenous exposure in mice is 720 mg/kg/bw.

One case report of acute poisoning in humans, due to accidental ingestion of 10 g DBP, showed that the symptoms of the poisoning were completely reversible by 14 days.

Overall, DBP is not expected to have significant acute toxicity in humans. (3)

(1)

European Union Risk Assessment Report dibutyl phthalate, Volume 29, p. 15 (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)

European Union Risk Assessment Report dibutyl phthalate, Volume 29, p. 17 (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

(3)

Priority Existing Chemical Assessment Report No. 36, Dibutyl phthalate, November 2013, ISBN 978-0-9874434-4-1, p.82

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