Registration Dossier
Registration Dossier
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: 204-800-2 | CAS number: 126-73-8
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
- Objective of study:
- metabolism
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 795.2280 (Oral/Dermal Pharmacokinetics)
- Principles of method if other than guideline:
- The distribution, metabolism, and excretion of TBP was studied in Sprague-Dawley rats using 14C-labeled TBP. The test substance was given to the animals via the following routes and schedules: 1. intravenous 2. dermal 3. single oral dose 4. multiple oral dose. Urine, feces, and expired air were collected from all dose groups at 6, 12, 24, 48, and 72 h after dosing. Urine and feces were then collected at 96, 120, 144, and 168 h after dosing. After the least collection, all of the rats in a dose group were sacrificed for tissue distribution analysis. The excreta of 2 males and 2 females from each dose group were also analyzed for metabolites.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tributyl phosphate
- EC Number:
- 204-800-2
- EC Name:
- Tributyl phosphate
- Cas Number:
- 126-73-8
- Molecular formula:
- C12H27O4P
- IUPAC Name:
- tributyl phosphate
- Details on test material:
- purity of the labeled TBP was 99%, specific activity was 112.6 µCi/mg
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- 14C-TBP
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- other: intravenous, dermal, single or multiple oral
- Vehicle:
- unchanged (no vehicle)
- Duration and frequency of treatment / exposure:
- 168 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
intravenous: 5 mg/kg
dermal: 10 or 350 mg/kg
single oral: 10 or 350 mg/kg
multiple oral: 10 or 350 mg/kg
- No. of animals per sex per dose / concentration:
- 4males + 4 females/group/dose
- Control animals:
- not specified
Results and discussion
- Preliminary studies:
- no data
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Urine, feces, expired air, and various organs and tissues were collected and analyzed for radioactivity. Recovery was about 90% or above in all treated groups except for the dermal dose groups. Dermal dose recovery was lower and ranged from 66% to 80%.
- Details on distribution in tissues:
- The radioactive dose residing in the tissues in all groups is very small and did not exceed 1% of dose for any tissue.
- Details on excretion:
- The major excretory route for the radio label was the urine. Urinary excretion always exceeded the secondary route of excretion, the faces, from 4-fold (iv dose-males) to 14-fold (multiple-oral high dose-females).
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- The results indicated that phase I metabolism (oxidation and hydrolysis) represented the major biotransformation pathway. Significant and representative metabolites identified in urine sample included dibutyl hydrogen phosphate (DBP), butyl hydroxybutyl hydrogen phosphate, and butyl butanoic acid hydrogen phosphate. Fifteen other metabolites were also observed which contained oxidized (acid, keto, hydroxyl) tri, di, and monobutyl substituted phosphoric acids. The parent chemical was typically less than 1% of the excreted dose. Phase II metabolism was not considered a significant route of biotransformation of TBP.
Any other information on results incl. tables
Analysis of samples by GC and HPLC indicated individual animal variability in the production of specific metabolites. Because of this variability, neither the concentration nor the specific structure of the metabolites was concluded to be dependent on dose, route, dosing regimen, or sex of the animal.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
- Executive summary:
The distribution, metabolism, and excretion of TBP was studied in sprague-Dawley rats using 14C-labeled TBP. The test substance was given to the animals via the following routes and schedules: 1. intravenous 2. dermal 3. single oral dose 4. multiple oral dose. Urine, feces, and expired air were collected from all dose groups at 6, 12, 24, 48, and 72 h after dosing. Urine and feces were then collected at 96, 120, 144, and 168 h after dosing. After the least collection, all of the rats in a dose group were sacrificed for tissue distribution analysis. The excreta of 2 males and 2 females from each dose group were also analyzed for metabolites.
The results indicated that phase I metabolism (oxidation and hydrolysis) represented the major biotransformation pathway. Significant and representative metabolites identified in urine sample included dibutyl hydrogen phosphate (DBP), butyl hydroxybutyl hydrogen phosphate, and butyl butanoic acid hydrogen phosphate. Fifteen other metabolites were also observed which contained oxidized (acid, keto, hydroxyl) tri, di, and monobutyl substituted phosphoric acids. The parent chemical was typically less than 1% of the excreted dose. Phase II metabolism was not considered a significant route of biotransformation of TBP.
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.