Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Concerning sensitisation one study in animals performed according to current standards and a study performed under GLP conditions were available. DBP did not reveal skin sensitising properties in these animal studies.

The available case studies in man are not appropriate for a definite conclusion with respect to the possible induction of sensitization by DBP. (1)

No signs of sensitisation were observed for DBP treatment in two guinea pig maximisation studies performed according to OECD Guideline 406 and a GLP-approved FDA recommended method (Greenough et al. 1981*; BASF 1990c*).

Similarly, no sensitisation was observed in a non-GLP repeated patch test in rabbits (BASF 1957*). (2)

Overall, DBP is not expected to have eye or skin irritation, or skin sensitising potential, in humans. (2, p.82)

(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)

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

Australian Government, Department of Health

NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME

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

Migrated from Short description of key information:

According available studies DBP has no skin sensitation potential.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Migrated from Short description of key information:

There are no data regarding the respiratory sensitisation potential of DBP.

Justification for classification or non-classification