Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 287-401-6 | CAS number: 85507-79-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
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
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 mg/cm2/hour.
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 gastro-intestinal tract.
Distribution
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.
Metabolism
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).
Excretion
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)