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EC number: 200-915-7 | CAS number: 75-91-2
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
- Objective of study:
- absorption
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Principles of method if other than guideline:
- This investigation assessed absorption, distribution and blood kinetics of [14C]TBHP in the rat after single sub-cutaneous exposure (nominal dose levels of 5 or 50 mg/kg bwt) and single i.v. administration (nominal dose level of 5 mg/kg bwt). Results for EXCRETION are reported here.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Inspectorate for Health Protection and Veterinary Public Health; Food and Consumer Product Safety Authority; 23 December 1999
Test material
- Reference substance name:
- tert-butyl hydroperoxide
- EC Number:
- 200-915-7
- EC Name:
- tert-butyl hydroperoxide
- Cas Number:
- 75-91-2
- Molecular formula:
- C4H10O2
- IUPAC Name:
- 2-methylpropane-2-peroxol
- Details on test material:
- UNLABELED MATERIAL
- Aqueous solution containing ca. 70wt% TBHP
- Technical grade TBHP-70, lot/batch no.: RB TBHP 1993
LABELED MATERIAL
- [14C]TBHP
- Supplier: TNO Prins Maurits Laboratory (the Netherlands)
- Position of radiolabel: the molecule was uniformly labelled
- Lot no: 01BLY121
- Specific activity: 4.25 mCi/mmol
- Molecular weight: 90.5 (at this specific activity)
- Radiochemical purity: >95%
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- uniformly labelled, 4.25 mCi/mmol
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Body weight 200-300g
Age approx. 12 wk
Administration / exposure
- Route of administration:
- other: subcutaneous or intravenous injection
- Vehicle:
- physiological saline
- Duration and frequency of treatment / exposure:
- Single injection
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Nominal i.v. : 5 mg/kg bwt; actual dose (based on 68.5% TBHP) 3.42 mg/kg bwt
Nominal s.c. : 5 or 50 mg/kg bwt; actual (based on 68.5% TBHP) 3.42 or 34.2 mg/kg bwt
- No. of animals per sex per dose / concentration:
- i.v. : 4 males
s.c. : 5 males and 5 females per dose level - Control animals:
- no
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- No obvious differences in route or extent of excretion of TBHP over 168 hr following i.v. or s.c. injection of 5 mg/kg bwt.
Urine: over 90% of dose
Exhaled air: 7-17% of dose
Faeces: up to 2%
Any other information on results incl. tables
HPLC analysis of radioactivity present in the dosing solutions revealed the presence of 92 -94% TBHP and 4 -5% tert-butanol.
Comparison of results for i.v. and s.c. administration revealed no obvious impact on route or extent of excretion of [14C]TBHP, with around 60 -70% of the dose excreted in urine over 48 hr and up to. 90% over 168 hr. Small amounts of radioactivity were present in exhaled air (7 -17% of dose) with minimal excretion in faeces (up to 2% of dose over 168 hr). [14C]carbon dioxide accounted for one third to one half of the radioactivity present in exhaled air with the remainder was present as uncharacterised volatiles.
Excretion and retention of [14C]TBHP as % of dose: 5 mg/kg bwt i.v.
Urine, 0 -48hr: 74
Urine, 48 -168 hr: 7.4
Faeces: 2.3
Cage wash: 0.4
Exhaled air: 7.5
Total excreted/retained: 91
Tissues residues (carcass, organs combined): 0.8
Excretion and retention of [14C]TBHP as % of dose: 5 mg/kg bwt s.c.
Urine, 0 -48hr: 68 -76
Urine, 48 -168 hr: 2 -11
Faeces: 0.7 -1.9
Cage wash: 0.5 -0.6
Exhaled air: 7.7 -10.9
Total excreted/retained: 98 -91
Tissues residues (carcass, organs combined): 0.7 -1.2
Excretion and retention of [14C]TBHP as % of dose: 50 mg/kg bwt s.c.
Urine, 0 -48hr: 63 -67
Urine, 48 -168 hr: 4 -13
Faeces: 1.3 -1.7
Cage wash: 0.44 -0.48
Exhaled air: 8.4 -17
Total excreted/retained: 87 -90
Tissues residues (carcass, organs combined): 0.9 -1.6
Applicant's summary and conclusion
- Conclusions:
- Urine was the main route of excretion of [14C]TBHP after s.c. administration, with trace amounts in exhaled air and minimal excretion in faeces.
- Executive summary:
- The excretion of [14C]TBHP in the rat after single sub-cutaneous or i.v. administration was investigated in a GLP-compliant guideline (OECD 417) study. Comparison of results for i.v. and s.c. administration revealed no obvious impact on route or extent of excretion of [14C]TBHP, with around 60 -70% of the dose excreted in urine over 48 hr and up to. 90% over 168 hr. Small amounts of radioactivity were present in exhaled air (7 -17% of dose) with minimal excretion in faeces (up to 2% of dose over 168 hr). [14C]carbon dioxide accounted for one third to one half of the radioactivity present in exhaled air with the remainder was present as uncharacterised volatiles.
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