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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- - Principle of test: Single-dose study as a pre-test of a carcinogenesis bioassay
- Short description of test conditions: Groups of five mice of each sex were given a single dose of propyl gallate (125, 250, 500, 1000 and 2000 mg/kg) in 20% ethanol in water by gavage. No controls were used.
- Parameters analysed / observed: Animals were observed twice daily for mortality during a 15-day test period. - GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
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:
- TEST MATERIAL
- Name: propyl gallate
- CAS no.: 121-79-9
- Appearance: white, odorless powder, slightly bitter taste
- Purity: >99%
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Source: Harshaw Chemical Co., Philadelphia, PA; lot No.: 2185
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark at 5 °C
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Frederick Cancer Research Center, Frederick, MD
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: 5 weeks
- Weight at study initiation: not specified
- Fasting period before study: not specified
- Housing: Animals were housed in stainless steel cages (Hahn Roofing & Sheet Metal Co., Birmingham, AL); 5 animals per cage
- Diet (e.g. ad libitum): ad libitum, Wayne Lab Blox Allied Mills, Inc. Chicago, IL
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Relative humidity (%): 38-42
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 9 hours of fluorescent light per day
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- ethanol
- Details on oral exposure:
- Propyl gallate was prepared in 20% ethanol in distilled water. Each animal received 10 mL/kg bw.
VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Purity: 20% ethanol in water
MAXIMUM DOSE VOLUME APPLIED: 10 mL/ kg body weight
DOSAGE PREPARATION (if unusual): Propyl gallate was weighed and a solution of 20% ethanol in distilled water were mixed with a plunger attached to a high-speed drill until a suspension was obtained (mixing time was not recorded). - Doses:
- 125, 250, 500, 1000, or 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations: Animals were observed twice daily for mortality and morbidity
- Necropsy of survivors performed: no - Statistics:
- n.a.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1/5 male and 3/5 female mice receiving 2000 mg/kg bw propyl gallate died within 2 hours of dosing.
- Clinical signs:
- other: Survivors in 2000 mg/kg bw group were slightly inactive for 1 day after dosing.
- Gross pathology:
- Not examined
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- One of five male and 3 of 5 female mice receiving 2000 mg/kg body weight propyl gallate died within 2 hours of dosing. The surviving animals in this group were slightly inactive for 1 day after dosing. No death occurred among the 125, 250, 500 or 1000 mg/kg bw dose groups. No other compound-related effects were observed.
- Executive summary:
In a single dose acute toxicity study conducted similar to OECD Guideline 401, 5 male and 5 female mice received 125, 250, 500, 1000, or 2000 mg/kg body weight propyl gallate (98% purity).
The animals were observed for a total of 14 days. One of five male and 3 of 5 female mice receiving 2000 mg/kg body weight propyl gallate died within 2 hours of dosing. The surviving animals in this group were slightly inactive for 1 day after dosing. No death occurred among the 125, 250, 500, or 1000 mg/kg bw dose groups. Moreover, no other compound-related effects were observed. Based on the results, the LD50 can be considered to be greater than 1000, but lower than 2000 mg/kg bw in female mice.
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