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EC number: 287-401-6
CAS number: 85507-79-5
Little information is available on the substance itself. However, the
phthalate esters are thought to exhibit similar behaviour. A phthalate
ester of similar chain length – diisodecylphthalate (DIDP) which is an
C-10 alcohol ester rather than a C-11 ester - has been extensively
examined and the data reviewed by ECHA (Evaluation of new scientific
evidence concerning DINP and DIDP in relation to Entry
52 of Annex XVII to Regulation (EC) No. 1907/2006 (REACH)).
Absorption of DIDP from the gastro-intestinal tract has been observed to
decrease with increasing dose (56% at a low dose of 0.1 mg/kg, 46% at a
dose of 11.2 mg/kg and 17% at a dose of 1,000 mg/kg suggesting that
absorption may be via a saturable mechanism.
Absorption via the dermal route is regarded as low. Elsisi
et al describe the dermal absorption of a number of phthalate diesters
in rats (Fund. Appl. Toxicol., 12(1): 70-77, 1989). Dimethyl, diethyl,
dibutyl, diisobutyl, dihexyl, di(2-ethylhexyl), diisodecyl, and benzyl
butyl phthalate were examined, being applied to an area of skin area on
the back of male F344 rats. Animals were housed for 7 days in a
metabolic cage that allowed separate collection of urine and faeces
which were collected every 24 hours. The amount of 14C excreted was
taken as an index of the percutaneous absorption. As the length of the
alkyl side chain increased, the amount of 14C excreted in the first 24
hours decreased significantly. The cumulative percentage dose excreted
in 7 days was greatest for diethyl, dibutyl, and diisobutyl phthalate
(approximately 50–60% of the applied 14C; and intermediate (20–40%) for
benzyl butyl, and dihexyl phthalate. Urine was the major route of
excretion of all phthalate diesters except for diisodecyl phthalate
which was poorly absorbed and showed almost no urinary excretion. After
7 days, the percentage dose for each phthalate remaining in the body was
minimal and showed no specific tissue distribution with most of the
unexcreted dose remaining in the area of application. These findings
support the (Q)SAR calculations for the substance itself using the
SkinPerm model which indicates a maximum dermal absorption of 6.00E-7
When inhaled as an aerosol DIDP appears readily absorbed although it can
be assumed that some particles are cleared from the nasopharyngeal
region and swallowed and that the mucociliary transport system in the
tracheobronchial tree transfers deposited particles upward to the
oropharynx where they are swallowed and pass through the
In tissues, DIDP or its metabolites are mainly recovered in the
gastro-intestinal tract, liver and kidneys, following absorption by the
oral or inhalation routs. In contrast, muscle and adipose tissue contain
most of the dose remaining in the body following dermal exposure.
Those phthalate esters that have been examined indicate that, for all
the investigated substances, the first step in systemic metabolism of
any absorbed di-ester is rapid hydrolysis to the mono-ester, which can
be then followed by further hydrolysis and/or oxidation and
glucuronidation (Arch. Toxicol. (2003), 77: 561-567, 2003).
The phthalate esters are considered to be eliminated from the organism
in a few days, and none of them is considered to accumulate in the
organism (Critical Reviews in Toxicology, 36: 695-726, 2006).
The ECHA evaluation report on DIDP indicates no parent DIDP or its
mono-ester but only metabolites of the mono-ester and phthalic acid to
have been found in urine. DIDP was not detected in bile extracts 24 and
72 hours following dosing. In faeces the oxidative derivative of the
mono-ester and unchanged DIDP were detected. Metabolic pathway(s)
resulting in complete hydrolysis leading to phthalic acid is saturable,
and that consequently monoester elimination is increased with increasing
exposure. DIDP is rapidly eliminated and not accumulated in tissues
with less than 1% of administered
radioactivity being recovered in tissues after 72 hours. By both oral
and inhalation routes, excretion is shared between urine and faeces. By
dermal exposure, only faecal elimination appears to occur but this may
be a reflection of the low rate of absorption resulting
in low recovery of the administered dose.
Kato et al. (Toxicology 236: 114-122, 2007) have
observed rapid clearance of DIDP metabolites in a study with rats
administered a single oral dose of 300 mg/kg DIDP. The half-life of all
metabolites was estimated to be around 14 hours.
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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