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EC number: 258-469-4 | CAS number: 53306-54-0
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Urinary metabolite excretion after oral dosage of bis(2-propylheptyl) phthalate (DPHP) to five male volunteers – Characterization of suitable biomarkers for human biomonitoring
- Author:
- Leng, G. et al.
- Year:
- 2 014
- Bibliographic source:
- Toxicology letters 231.2 (2014): 282-288.
Materials and methods
- Objective of study:
- excretion
- Principles of method if other than guideline:
- Oral dosing of 5 volunteers with 50mg labelled DPHP
Urine sampling for 48h
Selective determination of the three main DPHP urinary metabolites by HPLC-NESI-MS/MS - GLP compliance:
- no
Test material
- Reference substance name:
- Bis(2-propylheptyl) phthalate
- EC Number:
- 258-469-4
- EC Name:
- Bis(2-propylheptyl) phthalate
- Cas Number:
- 53306-54-0
- Molecular formula:
- C28H46O4
- IUPAC Name:
- 1,2-bis(2-propylheptyl) benzene-1,2-dicarboxylate
- Test material form:
- liquid
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- ringdeuterated DPHP-d4
Test animals
- Species:
- human
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- age: 27 - 49 years
body weight: 77- 94 kg
no occupational exposure to DPHP or other plasticizers
Administration / exposure
- Route of administration:
- other: oral
- Vehicle:
- other: dissolved in 0.25mL ethanol and mixed in edible waffle cup with a chocolate sufarce containing tea or coffee during breakfast
- Duration and frequency of treatment / exposure:
- single treatment
Doses / concentrations
- Dose / conc.:
- 0.6 mg/kg bw/day
- Remarks:
- 0.54 - 0.66 mg/kg/day
50mg per person
- No. of animals per sex per dose / concentration:
- 5
- Control animals:
- other: pre-exposure values
- Details on study design:
- - Dose selection rationale: considerably below the lowest NOAEL for DPHP and comparable to the doses used in previous DINP and DINCH human metabolism studies, but several orders of magnitute above expected background exposure. Stable isotope labelled DPHP-d4 was used to fully exclude influences of background DPHP levels.
- Details on dosing and sampling:
- - Tissues and body fluids sampled: urine
- Time and frequency of sampling: from 10:00 am pre-dosing for the next 48h. Times of sampling were recorded. 20 - 29samples per volunteer.
- Method type(s) for identification HPLC-NESI-MS/MS
- Limits of detection
0.1 mg/l for cx-MPHxP-d4
0.2 mg/l for OHMPHP-d4
0.2mg/l for oxo-MPHP-d4
- Limit of quantification
0.3 mg/l for cx-MPHxP-d4
0.5 mg/l for OHMPHP-d4
0.5mg/l for oxo-MPHP-d4 - Statistics:
- Exponential regression modeling
Metabolic half-time is given by the natural logarithm of two over k
Results and discussion
Main ADME results
- Type:
- metabolism
- Results:
- Main metabolites were oxo-MPHP (13.5%) and OH-MPHP (10.7%). Fractions as percentage of total oral dose excreted in urine within 48h.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- mono(propyl-6-oxo-heptyl) phthalate (oxo-MPHP)
mono(propyl-6-hydroxyheptyl) phthalate (OH-MPHP)
mono(propyl-6-carboxyhexyl)- phthalate (cx-MPHxP)
Any other information on results incl. tables
Predominant metabolites are OH-MPHP and oxo-MPHP. After 24h, 12.6% of the oral dose were excreted as oxo-MPHP, followed by OH-MPHP (9.9%), but only 0.42% as cx-MPHxP. The maximum in excretion was reached after 3.6 - 4h, depending on metabolite, but though excretion was rapid, all metabolites could still be detected after 48h. Summed up for all three measured metabolites 22.94% were excreted within 24h, which increased to 24.7% after 48h.
DPHP is metabolized to MPHP, which is in turn metabolized to OH-MPHP and to a much lesser extent to cx-MPHxP. OH-MPHP can be further metabolized to oxo-MPHP.
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.
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