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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-553-2 | CAS number: 84-69-5
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
Only limited information is available on uptake and fate of diisobutyl phthalate (DIBP) in vivo, however supporting information is available for the homologues dibutyl phthalate (DBP) and diethylhexyl phthalate (DEHP).
DIBP is absorbed by rat skin (Elsisi et al., 1989) with around 50-60% of the applied dose excreted over 7 days, primarily in urine. No information is available on uptake following oral or inhalation exposure.
Information summarized in the EU risk assessment report for DPB (EU, 2003) indicates rapid uptake and excretion after oral administration, with greater than 90% excreted in urine within 24-48 hr by rats and hamsters; faecal excretion is low. After dermal exposure, rats excreted around 60% of an applied dose of DBP within 7 days with around 12% of the dose found in faeces.
DEHP is similarly well absorbed from the gut (EU, 2008) with recovery of around 50% of the dose from rats, non-human primates and humans given up to about 200 mg/kg bw; at higher doses, absorption in non-human primates is dose-limited in contrast to rodents. Limited data on toxicokinetics following inhalation or dermal exposure indicate that DEHP can be absorbed through the lungs whereas absorption through the skin appears to be limited, with route-dependent uptake of 75% and 50%, respectively (EU, 2008). In vitro data (Scott et al., 1989) indicate that rat skin is approx. 2-fold more permeable than is human skin to topically applied DEHP.
The metabolism of phthalate esters is typified by rapid hydrolysis to the mono ester and the corresponding alcohol within the gut (EU 2003; 2008), although further hydrolysis is reported in the liver and kidneys for DBP. In vitro studies with DIBP demonstrate hydrolysis to monoisobutyl phthalates by carboxyesterases (Mentelin and Butte, 1989).
Information on DBP shows that it is initially excreted in the bile and subsequently enters the enterohepatic with subsequent metabolism. Monobutyl phthalate forms MBP-glucuronide, and undergoes subsequent omega- and omega-1 oxidation.
Phthalate esters are not associated with accumulation in body tissues.
For the purposes of risk characterisation of DIBP, it is proposed to assume 100% absorption for human oral and inhalation exposures. For dermal absorption, information indicating excretion of approximately 60% of an applied dose by rats together with other findings suggesting that human skin is less permeable to phthalate diesters than is rat skin leads to a conservative estimate of 50% uptake by human skin.
EU (2003) European Union Risk Assessment Report: dibutyl phthalate, volume 29. Office for Official Publications of the European Communities, Luxembourg.
EU (2008) European Union Risk Assessment Report: bis(2-ethylhexyl) phthalate, volume 80. Office for Official Publications of the European Communities, Luxembourg.
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.