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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 201-557-4 | CAS number: 84-74-2
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well documented, scientifically acceptable study. Comparable to guideline, with certain restrictions
Data source
Reference
- Title:
- No information
- Author:
- NTP Report
- Year:
- 1 995
- Bibliographic source:
- CHEM00324, 29-Mar-1995
Materials and methods
- Objective of study:
- toxicokinetics
- Principles of method if other than guideline:
- Method: other
- GLP compliance:
- yes
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- IUCLID4 Test substance: other TS: Dibutylphthalate, purity: > 99%
TS-Freetext:
Dibutylphthalate, purity: > 99%
Constituent 1
Test animals
- Species:
- other: Wistar Rats, Syrian Hamster, B6C3F1 Mice
Administration / exposure
- Route of administration:
- other: iv or gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Duration and frequency of treatment / exposure:
- 7 day(s)
Results and discussion
Toxicokinetic / pharmacokinetic studies
Toxicokinetic parametersopen allclose all
- Toxicokinetic parameters:
- half-life 2nd:
- Toxicokinetic parameters:
- half-life 1st:
- Toxicokinetic parameters:
- half-life 3rd:
Any other information on results incl. tables
RS-Freetext:
The toxicokinetic studies were conducted to define the oral bioavailability of DBP when administered as a bolus dose in aqueous methylcellulose and to establish a dose range over which plasma kinetics are linear. Based on the ratios of AUC for iv and oral studies, accounting for relative dose, bioavailability was 0.90 (mice), 0 .62 (rats), and 1 .01 (hamsters) at 83, 50, and 67 mg DBP/kg, respectively . Maximum plasma concentrations at these doses were 77, 21, and 40 µg MBP/ml for mice, rats and hamsters, respectively. Based on examination of plasma concentration vs. time profiles and associated kinetic parameters, the mid and high doses appeared to be associated with nonlinear dispositional processes.
For mice, the Cmax and AUC values for the 166 mg/kg oral dose in the toxicokinetic study were 107% and 89%, respectively. Maximum concentrations obtained in the SD rat toxicokinetic study were approximately 3-fold greater than expected but remained lower than predicted by the prestart WF rat study. Plasma concentrations for hamsters in the toxicokinetic studies were well predicted by those observed in the prestart study. Obviously, the greater number of animals used in the toxicokinetic studies (n=3/timepoint) make this data more reliable than the prestart data (1 animal/timepoint) .
In previous studies with diethylhexylphthalate in rats, it was necessary to administer the dose in a plasma vehicle intraarterially versus intravenously to avoid pulmonary toxicity. The pulmonary toxicity' was attributed to trapping of the iv dose in the lung with resultant hemorrhagic lesions. An analogous sequestration phenomenon may have occurred following iv administration of DBP to mice in the prestart study wherein plasma concentrations began to increase 120 min following iv administration . In fact, in all three species, clinical signs of lethargy were observed for various time periods following iv administration (prestart and toxicokinetic studies) despite efforts to deliver as dilute a dosing solution as possible. In both rats and mice, secondary increases in plasma concentrations were apparent in several of the data sets. DBP and MBP are known to undergo extensive enterohepatic recirculation which could account for the observed plasma kinetics.
Applicant's summary and conclusion
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.