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EC number: 201-557-4
CAS number: 84-74-2
After incubation with test item, no cytotoxicity was observed for the yeast cells.
The values for galactosidase activity and induction ratio of all test item dilutions lay in the same range as the values of the respective control. No dose—response correlation was visible. Dibutyl phthalate showed no endocrine activity, neither in the YES Assay nor in the YAS Assay.
Under the conditions of this test system, the test item Dibutyl phthalate is considered to have neither estrogenic nor androgenic agonistic or antagonistic activity in the YES YAS Assay.
Additional information from genetic toxicity in vitro:
tested in a vitro study (yeast cells, RL1) did not give any indication
for genetic toxicity.
to that result other in vitro studies gave an indication for a
genotoxic effect in one assay,
but in the same experiment, this effect was not seen with other
dialkylphthalates (a.o. diethylphthalate).
No genotoxic effects for dibutylphthalate were observed in in vivo studies
on the data available for dibutylphthalate from a variety of
genotoxicity studies as described
above and taking into consideration the non-genotoxic properties of
other phthalate esters,
dibutylphthalate can be considered as a non-genotoxic substance.(1)
DBP is considered to be non-genotoxic based
on the weight-of-evidence showing no genotoxicity for DBP in most in
vitro and all in vivo tests performed to standard testing guidelines
(IPCS 1997; Kleinsasser et al. 2000; ECB 2004). The in vivo tests
include sex-linked recessive lethal test in Drosophila and micronucleus
assay (according to OECD 474 and comparable standards) in NMRI and
No adequate long-term carcinogenicity
studies with DBP in laboratory animals are available.
Based on the information available for
genotoxicity, DBP is not genotoxic and is not likely to be a genotoxic
carcinogen. Moreover, in several in vitro cell transformation assays,
DBP did not induce cell transformation (Nuodex 1982; Litton Bionetics
1985*; Barber et al. 2000).
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)
Union Risk Assessment Report dibutyl phthalate, Volume 29, p. 6 (2003)
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.
for Official Publications of the European Communities, ISBN
Existing Chemical Assessment Report No. 36, Dibutyl phthalate, November
2013, ISBN 978-0-9874434-4-1, p.84
Government, Department of Health
INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
Box 58, Sydney NSW 2001 AUSTRALIA www.nicnas.gov.au
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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