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EC number: 246-466-0 | CAS number: 24800-44-0
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - dermal (%):
- 86
Additional information
Oral route of exposure
One well-conducted and well-reported study on tripropylene glycol and its structural homologue monopropylene glycol was available for assessment (Dow Chemical Company, 1995). In this study, two groups of 5 male rats were administered a single oral dose of either radiolabeled (14C) tripropylene glycol or non-radiolabeled monopropylene glycol by gavage in water at target concentrations 40 mg/kg bw and 50 mg/kg bw, respectively. The excreta were collected for ca. 24 hours post-dosing. After sacrifice 24 hours post-dosing the remaining radioactivity in tissues was determined for the first group and urine was analyzed for free and acid-abile conjugates of mono-, di- and tripropylene glycol for both groups.
Absorption
Based on the average recovery of ca. 91% of the14C label administered from excreta, CO2, skin, tissues and carcass after ca. 24 hours post-dosing sacrifice, it was concluded that tripropylene glycol is rapidly adsorbed if administered by gavage. The absorption of tripropylene glycol via oral route was calculated to amount to at least 86%, based on 5% of the administered dose recovered in faeces.
Distribution
Approximately 10% of the radiolabeled dose was recovered in tissues and carcass, with the liver and kidney having the greatest amount of radiolabel per gram of tissue 24 hours after dosing (ca. 0.2 and 0.1%, respectively). The14C concentration in blood was approximately 6.4 and 2.8 -fold lower than in liver and kidney, respectively.
Metabolism
Twenty-four hours after administration of a single oral dose of 40 mg/kg bw to male rats, 53% of the administered dose was eliminated in the urine. Only 5.8% of the dose was recovered as unmetabolized parent compound in the urine, while 7.2% was recovered as acid-labile conjugates of tripropylene glycol, 5.1% and 3.3% as free and acid-labile conjugates of dipropylene glycol and 3.3% and 0.6% as free and acid-labile conjugates of monopropylene glycol, respectively. Unidentified metabolites in the urine accounted for approximately 26% of the dose. A large fraction (21%) of the14C- tripropylene glycol dose was catabolized all the way to14CO2, indicating considerable complete breakdown of tripropylene glycol. A lesser fraction was recovered in the feces (5%) and tissues (10%). The cage wash yielded 3%. The unidentified metabolism of tripropylene glycol most likely stems from entry of oxidized metabolites, such as pyruvate and lactate, both documented metabolites of monopropylene glycol, into intermediary metabolism via monopropylene glycol formation. Monopropylene glycol itself, is excreted as CO2at about 25% of administered dose 24 h after administration. Overall, the data indicate tripropylene glycol is readily biotransformed to dipropylene glycol and monopropylene glycol which are then either conjugated or further oxidized to CO2. The data of the animals administered monopropylene glycol indicate that approximately 11% of the monopropylene glycol administered was recovered in the urine as free monopropylene glycol with < 1% of the dose recovered as acid-labile conjugates.
Inhalation route of exposure
No toxicokinetic studies on tripropylene glycol using inhalatory route of exposure were available for assessment. However, based on a very low vapour pressure of tripropylene glycol (0.26 Pa), this route of exposure is not considered to be relevant for human toxicological risk assessment.
Dermal route of exposure.
No toxicokinetic studies on tripropylene glycol using dermal route of exposure were available for assessment. However, Article 13 of the REACH legislation states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests,i. e.applying alternative methods such asin vitrotests, QSARs, grouping and read-across.
Anin vitroskin penetration study (El du Pont de Nemours and Company, 2007; Fasano et al, 2011) with the structural homologue dipropylene glycol, using human cadaver skin and performed under infinite dose conditions, was available for assessment. A nominal dose of 1200 µL/cm2(ca. 1.2 g/cm2) of the neat substance was applied for 24 hours under occlusive conditions to 7 skin replicates representing 4 human subjects. By the conclusion of the 24-hour exposure interval, only a negligible portion of the applied dose of neat dipropylene glycol (0.075%) had penetrated through the skin into the receptor fluid. In general, dipropylene glycol was detected in receptor fluid within about an hour of application (lag time = 1 hour and 3 minutes; 1.05 hours); steady-state penetration, which was represented by no less than 10 data points, was determined to be 39.3 µg/cm2/h (r2=0.999). This represents the maximum flux for neat dipropylene glycol.
Based on the slope at steady-state (39.3 µg/cm2/h) and the concentration of dipropylene glycol in the applied solution, taken as its density (1,020,000 µg/cm3), the permeability coefficient for neat dipropylene glycol was calculated to be 3.85×10-5cm/h.
Based on the results of the study, a value of 40% for dermal absorption has been chosen by expert judgment to be used in the risk assessment and DNEL derivation. This value has been chosen as an average value between the percentage of dermal absorption obtained in the study and the maximal oral absorption (corresponding to 86%), and is considered to represent a worst-case approach.
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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