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EC number: 204-498-2 | CAS number: 121-79-9
- 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, other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Scientific Opinion on the re-evaluation of propyl gallate (E 310) as a food additive
- Author:
- European Food Safety Authority (EFSA)
- Year:
- 2 014
- Bibliographic source:
- EFSA Journal 12(4), 3642
- Reference Type:
- publication
- Title:
- Influence of dosing vehicles on the preclinical pharmacokinetics of phenolic antioxidants
- Author:
- Vora J. et al.
- Year:
- 1 999
- Bibliographic source:
- Research Communications in Molecular Pathology Pharmacology, 104, 93-106
- Reference Type:
- publication
- Title:
- The metabolic fate of gallic acid and related compounds
- Author:
- Booth A. N. et al.
- Year:
- 1 959
- Bibliographic source:
- J Biol Chem, 234, 3014-3016
- Reference Type:
- publication
- Title:
- Participation of intestinal bacteria in metabolism - metabolism of propyl gallate by the intestinal bacteria in the rat
- Author:
- Niimura T.
- Year:
- 1 986
- Bibliographic source:
- Journal of the Food Hygienic Society of Japan, 27(2), 163-170
- Reference Type:
- publication
- Title:
- Comparative metabolism of BHA, BHT and other phenolic antioxidants and its toxicological relevance
- Author:
- Conning D. M., Phillips J. C.
- Year:
- 1 986
- Bibliographic source:
- Food and Chemical Toxicology, 24(10-11), 1145-1148
- Reference Type:
- publication
- Title:
- Metabolic pathway of phenolic antioxidants
- Author:
- Dacre J. C.
- Year:
- 1 960
- Bibliographic source:
- Journal of the New Zealand Institute of Chemistry, 24 (1960), p. 161-171
- Reference Type:
- publication
- Title:
- Studies on the toxicity of propyl gallate and of antioxidant mixtures containing propyl gallate
- Author:
- Orten J. M. et al.
- Year:
- 1 948
- Bibliographic source:
- Food Technol. 2:308–316
- Reference Type:
- review article or handbook
- Title:
- Food antioxidants: Technological, toxicological Health perspective
- Author:
- Madhavi D. L. et al.
- Year:
- 1 996
- Bibliographic source:
- New York: Marcel Dekker
- Reference Type:
- other: Website
- Title:
- unknown title
- Author:
- Tullberg
- Year:
- 2 004
- Bibliographic source:
- UK Food Standards Agency. http://www.foodbase.org.uk//admintools/reportdocuments/124-1-200_T01017.pdf (accessed: unknown)
Materials and methods
Test material
- Reference substance name:
- Propyl 3,4,5-trihydroxybenzoate
- EC Number:
- 204-498-2
- EC Name:
- Propyl 3,4,5-trihydroxybenzoate
- Cas Number:
- 121-79-9
- Molecular formula:
- C10H12O5
- IUPAC Name:
- propyl 3,4,5-trihydroxybenzoate
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Several studies on toxicokinetics of Propyl gallate are available for different species including mice, rats, rabbits, dogs, pigs and humans.
- Executive summary:
Several studies on toxicokinetics of Propyl gallate are available for different species.
Mice
A mouse study by Vora et al. (1999) compared the toxicokinetics of Propyl gallate when administered in 2 different vehicles: an ethanol:saline solution (2:3, 0.9 % w/v) and a solution of the inclusion complex hydroxypropyl-beta-cyclodextrin (concentration not specified) in saline (0.9 % w/v). No dosing volumes were specified. Harlan Sprague-Dawley mice (4-6 animals/group; 20-30 g in bw) were administered 100 mg Propyl gallate/kg bw p.o. and sacrificed in groups at various post-dosing time-points (0-180 minutes) for blood collection and plasma separation. The results suggested that the rate of absorption of Propyl gallate was slower in the ethanol:saline solution. This might be explained by the effects of ethanol on blood flow to the gastrointestinal tract and liver. However, the overall absorption of approximately 5 % was not different between the 2 vehicles. No data on the distribution of Propyl gallate to organs has been identified.
Rats
Adult albino rats were administered 100 mg Propyl gallate per animal by gavage (vehicle not specified) in a study by Booth et al. (1959). The major metabolite detected in urine was 4-O-methyl-gallic acid. Gallic acid, 2-Methoxypyrogallol and glucuronides of the methoxylated products were minor metabolites. This indicates hydrolysis of the ester followed by 4-O-methylation of Gallic acid.
In a study in which rats were given 100 mg Gallic acid per animal either by gavage or by intraperitoneal (i.p.) injection (vehicles not specified) or fed a diet containing 0.5 % (equivalent to 600 mg/kg bw) Gallic acid, urinary excretion of 4-O-methyl gallic acid as well as Gallic acid was reported. In rats given the i.p. injection of Gallic acid, an additional metabolite, suspected to be Pyrogallol, was also detected along with trace levels of 2-O-methyl-pyrogallol.
Metabolism of Propyl gallate by intestinal bacteria in the rat was investigated in a study by Niimura et al. (1986). Several strains were isolated from the faeces of rats, which converted Propyl gallate to Gallic acid and then further decarboxylated to produce Pyrogallol.
Rabbits
4-O-methyl-gallic acid, and Pyrogallol were found in the urine of New Zealand White rabbits (weighing approximately 2 kg) fed 0.5% (equivalent to approximately 150 mg/kg bw/day) Gallic acid in the diet (duration not specified) in a study by Booth et al. (1959).
In rabbits fed 1 g Propyl gallate, the major urinary metabolite was a glucuronide conjugate hypothesised to be 4-O-methyl galloyl-β:D-glucosiduronic acid (72.0 % of the dose administered) and unconjugated phenols: 4-O-methyl gallate, Gallic acid and Pyrogallol (6.7 % of the dose administered) (Dacre, 1960). In rabbits fed Gallic acid for 10 days, most of the dose was excreted in the urine unchanged although some 4-O-methyl-gallic acid and Pyrogallol were also detected (Conning et al., 1986).
Dogs
No Propyl gallate was detected in the urine of dogs fed 0.0117 % Propyl gallate in the diet for 14 months (Orten et al., 1948).
Pigs
Madhavi (1996) reported that the metabolism of gallic esters in the pig is similar to that in rats.
Rat and human comparison
In a project for the UK Food Standards Agency, Tullberg and colleagues (2004) compared the kinetics of four food additives (BHT, Curcumin, Propyl gallate and Thiabendazole) in vivo in rats and humans and in hepatocytes from human and rat to examine the adequacy of the kinetic uncertainty factors.
The plasma concentration-time curves for Propyl gallate in rats showed rapid absorption and elimination with significantly higher concentrations in males than in females. The plasma concentrations in humans dosed at the current group ADI (0.5 mg/kg bw) were close to the limit of quantification, whereas more reliable data were obtained at a dose of 10 times the ADI. The kinetics were essentially linear in both rats and humans at the doses studied. The data indicated that the default uncertainty factors for interspecies differences and human variability would be adequate for Propyl gallate. Studies with Octyl gallate and Dodecyl gallate showed the presence of extremely low plasma concentrations, which, combined with the low ADI values for these food additives, meant that further in vivo studies were impracticable.
In vitro studies on Propyl gallate using rat and human liver preparations showed that there were minor species differences in the rates of metabolism and in the estimated Vmax and Km values for the BHT, Propyl gallate and TBZ metabolising enzyme systems. The estimated interspecies adjustment factors based on Vmax/Km were 2.4 for Propyl gallate compared with in vivo values of 2.0 for Propyl gallate (at dose equivalence). The in vitro values do not take into account differences in organ blood flow, and such analyses would require the development of a full PBPK model. Interestingly the Km values for Propyl gallate were considerably higher than the in vivo plasma levels, indicating little likelihood of saturation of metabolism (Tullberg et al, 2004).
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