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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- The comet assay with 8 mouse organs: results with 39 currently used food additives
- Author:
- Sasaki Y.F. et al.
- Year:
- 2 002
- Bibliographic source:
- Mutation Research 519, 103-119
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
- Principles of method if other than guideline:
- - Principle of test: Comet assay in mice similar to OECD guideline 489
- Short description of test conditions & parameters analysed / observed: Mice were exposed to the limit dose of 2000 mg/kg and eight organs (glandular stomach, colon, liver, kidney, urinary bladder, lung, brain, and bone marrow) were removed and were afterwards processed to be analysed in a Comet assay. - GLP compliance:
- not specified
- Type of assay:
- mammalian comet assay
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
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Kanto Chemical Co. Inc., Tokyo, Japan
Test animals
- Species:
- mouse
- Strain:
- other: ddY
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC Co., Shizuoka, Japan
- Age at study initiation: 7 weeks of age and used after 1 week of acclimatization.
- Assigned to test groups randomly: [no/yes, under following basis: ] not specified
- Fasting period before study: no
- Diet (e.g. ad libitum): commercial pellets MF (Oriental Yeast Industries Co., Tokyo, Japan), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- - Vehicle(s)/solvent(s) used: olive oil
- Duration of treatment / exposure:
- Once orally
- Frequency of treatment:
- once
- Post exposure period:
- not specified
Doses / concentrations
- Dose / conc.:
- 2 000 mg/kg bw/day
- No. of animals per sex per dose:
- 4 males
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- not specified
Examinations
- Tissues and cell types examined:
- Eight organs (glandular stomach, colon, liver, kidney, urinary bladder, lung, brain, and bone marrow)
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The oral dose of 2000 mg/kg was determined via preliminary simple acute toxicity experiment on 4-5 animals. No death was observed at 2000 mg/kg, so the LD50 was defined at >2000 mg/kg.
TREATMENT AND SAMPLING TIMES (in addition to information in specific fields): Animals were sacrificed 3 or 24 hours after treatment.
DETAILS OF SLIDE PREPARATION: The liver, kidney, lung, and brain were minced, suspended in 4 ml chilled homogenizing solution (pH 7.5) containing 0.075 M NaCl and 0.024 M Na2EDTA, and then homogenized gently using a Potter–Elvehjem type homogenizer at 500–800 rpm, in ice. The glandular stomach, colon, and urinary bladder were opened and rinsed with physiological saline; the mucosa was scraped into 4 mL chilled homogenizing buffer and homogenized gently using a Potter–Elvehjem type homogenizer at 500–800 rpm, in ice. To obtain nuclei, the homogenate was centrifuged at 700×g for 10 min at 0 °C, and the precipitate was re-suspended in chilled homogenizing buffer at 1 g organ weight/mL. of the covering slide. Finally, 75 L of agarose GP-42 was quickly layered on again. Slides prepared from nuclei isolated by homogenization were placed in a chilled lysing solution (2.5 M NaCl, 100 mM Na2EDTA, 10 mM Trizma, 1% sarkosyl, 10% DMSO, and 1% Triton X-100, pH 10) and kept at 0 °C in the dark for about 1 night, then in chilled alkaline solution (300 mM NaOH and 1 mM Na2EDTA, pH 13) for 10 min in the dark at 0 °C. Electrophoresis was conducted at 0 °C in the dark for 15 min at 25 V (0.96 V/cm) and approximately 250 mA. The slides were neutralized and then stained with 50 L of 20 g/mL ethidium bromide.
METHOD OF ANALYSIS: 50 nuclei per slide at 200× magnification with the aid of a fluorescence microscope were examined and photographed. The length of the whole comet and the diameter of the head were measured for 50 nuclei per organ per animal. - Evaluation criteria:
- not specified
- Statistics:
- Mean migration of 50 nuclei from each organ was calculated for each individual animal. The differences between the averages of four treated animals and the untreated control animals were compared with the Dunnett test after one-way ANOVA. A P value less than 0.05 was considered statistically significant.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Remarks on result:
- other: no in vivo positive control included in the experiment
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
- Propyl gallate did not increase DNA damage in any of the organs studied. Additionally, no death, morbidity, or clinical signs were observed.
Applicant's summary and conclusion
- Conclusions:
- This experimental study in a small group of male mice shows that a single oral 2000 mg/kg exposure to propyl gallate did not increase DNA damage in any of the organs studied at 3 hours and 24 hours after the exposure.
- Executive summary:
In a ddY mouse comet assay conducted similar to OECD guideline 489, 4 male mice were once orally treated with propyl gallate at a dose of 2000 mg/kg bw. All mice were euthanized at 3 hours and 24 hours after exposure, at which time organs (glandular stomach, colon, liver, kidney, urinary bladder, lung, brain, and bone marrow) were removed and processed to be analyzed in a Comet assay. The length of the whole comet and the diameter of the head were measured for 50 nuclei per organ per animal. Migration was calculated as the difference between length and diameter for each 50 nuclei. Mean migration of 50 nuclei from each organ was calculated for each individual animal. The differences between the averages of four treated animals and the untreated control animals were compared. The results of this study indicate that propyl gallate did not increase DNA damage in any of the organs studies at 3 hours and 24 hours after exposure.
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