Registration Dossier

Administrative data

Description of key information

Various studies in animals suggest that DBP causes no or only minimal irritation to eye and skin resp.  is not irritating to the respiratory system.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin irritation:

Studies performed according to current standards were available. DBP appeared to be not irritating for the skin. (1)

A study in rabbits with undiluted DBP (OECD Guideline 404) revealed slight erythema in 2 out of 3 animals immediately after exposure and after 24 hours. No oedema was seen. Erythema disappeared 48 hours after exposure. DBP was not considered a skin irritant (BASF 1990a*).

Greenough et al. (1981*) reported mild reactions 24 hours after 0.5 mL of undiluted Vestinol C (DBP trade name) was applied to intact and abraded rabbit skins. The positive control was reported as 10 % laurylsulphate. No reaction was observed after 72 hours at any treatment site. The irritation index was calculated as 0.54/8.

A study cited in an NTP-CERHR report on DBP (CERHR 2003) reported minor irritation in rabbit dermal occlusion studies at 520 mg/kg bw/d.

These studies suggest that DBP causes minimal skin irritation in rabbits. (2)

Eye irritation:

Studies performed according to current standards wereavailable. DBP appeared to be not irritating for the eye. (1)

In a study in rabbits with undiluted DBP (OECD Guideline 405), prominent conjunctival redness was observed after one hour and 24 hours in all animals, which reduced in severity after 48 hours and was completely reversed by 72 hours. DBP was not considered an eye irritant (BASF, 1990b*).

Undiluted 0.1 mL of Vestinol C (trade name of DBP) was applied to rabbit eyes (3/sex), which were not rinsed post administration. After one hour, three out of six animals showed mild redness and the balance (three animals) exhibited extremely mild redness. After 24 hours, very mild redness was observed in two out of six animals. Iris or corneal effects were not observed. The irritation index was calculated as 0.11/110. DBP was not considered an eye irritant (Greenough et al. 1981*).

These studies suggest that DBP causes minimal eye irritation in rabbits.(2)

Respiratory irritation

In a 28-day inhalation study in rats adverse local effects in the upper respiratory tract were observed but no signs of inflammation. Hence, DBP is not irritating to the respiratory system.(1)

Irritation of nasal mucous membranes was observed in cats after 5.5 hours exposure to 1 mg DBP/L (1000 mg/m3) and in mice after two hours’ exposure to 0.25 mg/L (250 mg/m3). No additional data were available (BIBRA, 1987*; BUA, 1987*).

A 28-day repeat-dose toxicity study using Wistar rats (Gamer et al. 2000*), described in detail in section 6.2.4, suggests that DBP has a low irritation potential. At the highest exposure concentration of 509 mg/m3, red crust formation at the snout was observed after cessation of daily exposure, but the rats recovered within 18 hours. The epithelium in the respective areas of the nasal cavity was regular, the infoldings were absent, and signs of inflammation were missing in the whole nasal cavity.

These studies suggest that DBP causes minimal respiratory irritation in animals. (2)

Available human data are limited and ambiguous.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

Justification for classification or non-classification