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EC number: 253-153-2 | CAS number: 36673-16-2
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- According to hydrolysis test results, this substance is hydrolytically unstable with hydrolysis rate estimated to be less than 30 minutes. The hydrolysis products have been identified to be 2-propanol, triethanolamine and titanium dioxide. The discussion of toxicokinetics is based on the hydrolysis/degradation products.
- 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:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- 2-propanol and triethanolamine are two main hydrolysis prodcuts of the target substances.
- Objective of study:
- absorption
- distribution
- excretion
- metabolism
- Qualifier:
- according to guideline
- Guideline:
- other: See explanations
- Principles of method if other than guideline:
- Groups of four female mice received a single intravenous dose of 3 mg/kg [14C]-triethanolamine. Expired radioactivity was trapped and quantitated and urine and feces were collected from all B6C3F1 mice dosed intravenously up to 72 hours after dosing. Tissue samples at 72 hours after dosing were also examined.
- GLP compliance:
- no
- Radiolabelling:
- yes
- Remarks:
- 14C
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Single intravenous doses contained approximately 6 μCi radiolabel for mice, an appropriate amount of nonradiolabeled triethanolamine, and isotonic saline as a vehicle that delivered a total dosing volume of 2 mL/kg to mice. Intravenous doses were drawn into a syringe equipped with a Teflon®-tipped plunger (Hamilton) and a 30 gauge hypodermic needle. Excess dose formulation was wiped off the needle before weighing the filled dosing syringe. Intravenous doses were injected into one lateral tail vein. After dosing, the needle was wiped clean with a Kimwipe®, and the empty syringe was reweighed. The Kimwipe® was placed into a vial containing 2 mL ethanol and analyzed by liquid scintillation spectrometry. Each dose was calculated as the difference between the weights of the filled and empty dosing apparatus less the amount found in the Kimwipe®. To determine the concentration of [14C]-triethanolamine in the dose formulation, two weighed aliquots were taken before, two after, and one during dosing.
- Route of administration:
- intravenous
- Vehicle:
- acetone
- Duration and frequency of treatment / exposure:
- 72 hr
- Dose / conc.:
- 3 mg/kg bw/day (nominal)
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- no
- Positive control reference chemical:
- no
- Details on study design:
- METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: urine, faeces, tissues, cage washes, CO2
- Time and frequency of sampling: 24, 48, 72 hrs - Details on distribution in tissues:
- The distribution of radioactivity present in tissue samples from female mice showed that the heart, kidney, liver, lung, and spleen contained higher concentrations of triethanolamine equivalent relative to blood.
- Details on excretion:
- 26% of the dose was recovered in the urine within 24 hours.
An average of 62% of the dose was recovered in the urine within 72 hours after dosing, and 27.6% was recovered in the feces during this time. - Metabolites identified:
- no
- Conclusions:
- Intravenously administered triethanolamine was rapidly excreted by female rats and mice, primarily in the urine.
Less than 1% of the dose was present in tissues sampled 72 hours after dosing. In both species, the heart, kidney, liver, lung, and spleen contained higher concentrations of triethanolamine equivalents than did blood.
After intravenous and dermal dosing in female rats and mice, triethanolamine was excreted, for the most part, unchanged in urine. Two additional polar peaks, each less than or equal to 5% of the total, were present in the urine. At least one of these polar peaks may have originated from impurities in the [14C]-triethanolamine stock, which were better resolved from the test article peak during development of HPLC onditions for metabolite analysis. - Executive summary:
As the target substance hydrolyses rapidly (half-life < 30 minutes) the intrinsic properties are related to hydrolysis products of the target substance. This information is used as a supporting evidence on the toxicity of the target substance in CSA.
- 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:
- comparable to guideline study
- Justification for type of information:
- 2-propanol and triethanolamine are two main hydrolysis prodcuts of the target substances.
- Objective of study:
- excretion
- metabolism
- toxicokinetics
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Deviations:
- no
- GLP compliance:
- not specified
- Radiolabelling:
- yes
- Remarks:
- 14C
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Route of administration:
- inhalation: vapour
- Vehicle:
- unchanged (no vehicle)
- Duration and frequency of treatment / exposure:
- single exposure for 6 hr
- Dose / conc.:
- 500 ppm
- Remarks:
- low dose group
- Dose / conc.:
- 5 000 ppm
- Remarks:
- high dose group
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- no
- Positive control reference chemical:
- none
- Type:
- absorption
- Results:
- rapid absorption
- Type:
- distribution
- Results:
- widely distributed without any accumulation
- Type:
- metabolism
- Results:
- major metabolites were acetone and carbon dioxide
- Type:
- excretion
- Results:
- predominant elimination pathway is exhaled breath
- Details on absorption:
- The concentration of radiolabel in the blood increased rapidly following the initiation of inhalation exposure at either concentration. The concentration of radiolabel appeared to still be rising at the end of the exposure to 500 ppm but appeared to have plateaued by the end of the exposure to 5000 ppm IPA.
- Details on distribution in tissues:
- Widely distributed among the tissues following nose only inhalation exposure to nominal concentrations of 500 and 5000 ppm. No evidence was observed to indicate that IPA or its radiolabeled metabolites accumulated in any tissue with the possible exception of kidney and liver, which had slightly elevated concentrations of radiolabel relative to the blood.
- Details on excretion:
- Following nose only inhalation of IPA the breath is, by far, the predominant route of excretion of radiolabel by both sexes. The excretion of the absorbed dose was rapid, with greater than 90% of the absorbed radiolabel being excreted from the breath, urine, and feces within 72 h of the beginning of the inhalation exposure. Exhalation in the breath accounted for a total of about 83% of the absorbed dose at the low exposure level while it accounted for just under 88% following the high exposure level. Even though total excretion of radiolabel in the breath was practically the same following either inhalation exposure, the distribution of radiolabel that appeared in the breath was dramatically different. Following exposure to 500 ppm males and females exhaled an average of 49% of the absorbed radiolabel as carbon dioxide in the breath. Following exposure to 5000 ppm, only 22% of the radiolabel present in the exhaled breath was found to be 14CO2. While the exhaled breath was the major route of excretion following both exposure levels, urine was a minor route of elimination of radiolabel and excretion in the feces was negligible.
- Metabolites identified:
- yes
- Details on metabolites:
- Acetone was found to be the primary radiolabeled metabolite of IPA. In the exhaled breath acetone accounted for 75-100% of the radiolabeled organic volatile compounds being exhaled. The balance of the exhaled radioactivity was accounted for by CO2 and IPA itself. A third radiolabeled metabolite (accounting for less than 5% of the total dose) was found when the urine was analyzed by HPLC; this urinary metabolite was identified as isopropyl glucuronic acid.
- Bioaccessibility (or Bioavailability) testing results:
- not reported.
- Conclusions:
- No bioaccumulation potential of 2-propanol based on the test results.
Pharmacokinetics of propan-2-ol (IPA) was studied in rats. Animals were exposed by inhalation for 6 hours to IPA vapor. Total exhalation of radiolabel (as CO2, acetone, propan-2-ol) was 83%-87% of the administered dose. Urine and feces accounted for excretion approximately 7% and 1%, respectively. No single tissue contained greater than 1.6% of recovered dose.
Referenceopen allclose all
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
No studies were conducted on the target substance. As the target substance hydrolyses rapidly (half-life < 30 minutes) the intrinsic properties are related to hydrolysis products of the target substance. The hydrolysis products include 2 -propanol, triethanolamine and non-hazardous titanium dioxide. This information is used as a supporting evidence on the toxicity of the target substance in CSA.
Toxicokinetics of triethanolamine
Intravenously administered triethanolamine was rapidly excreted by female rats and mice, primarily in the urine. Less than 1% of the dose was present in tissues sampled 72 hours after dosing. In both species, the heart, kidney, liver, lung, and spleen contained higher concentrations of triethanolamine equivalents than did blood.
Dermal exposure: Only 20% to 30% of dermally applied 68 and 276 mg/kg triethanolamine was absorbed by female rats within 72 hours.
After intravenous and dermal dosing in female rats and mice, triethanolamine was excreted, for the most part, unchanged in urine. Two additional polar peaks, each less than or equal to 5% of the total, were present in the urine. At least one of these polar peaks may have originated from impurities in the [14C]-triethanolamine stock, which were better resolved from the test article peak during development of HPLC conditions for metabolite analysis.
Toxicokinetics of titanium dioxide
Titanium dioxide is insoluble in water and most ingested titanium is eliminated unabsorbed.
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