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EC number: 214-490-0 | CAS number: 1135-24-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1987
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- INDUCTION OF FORESTOMACH LESIONSIN RATS BY ORAL ADMINISTRATIONS OFNATURALLY OCCURRING ANTIOXIDANTSFOR 4 WEEKS
- Author:
- Hirose M.
- Year:
- 1 987
- Bibliographic source:
- Japanese Journal of Cancer Research 78, 317- 321.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The effects of naturally occurring antioxidants including ferulic acid on rat forestomach epithelium were compared with those of synthetic antioxidants, butylatedhydroxyanisole (BHA) and butylated hydroxytoluene (BHT), of which the former is a known forestomach carcinogen. Groups of five F344 male rats were given diet containing BHA, BHT, gallic acid, syringic acid, sesamol, caffeic acid, chlorogenic acid, ferulic acid, eugenol or esculin for 4 weeks at a level of 0.7% for BHT or 2% for other compounds.
- GLP compliance:
- no
Test material
- Reference substance name:
- 4-hydroxy-3-methoxycinnamic acid
- EC Number:
- 214-490-0
- EC Name:
- 4-hydroxy-3-methoxycinnamic acid
- Cas Number:
- 1135-24-6
- Molecular formula:
- C10H10O4
- IUPAC Name:
- 4-hydroxy-3-methoxycinnamic acid
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Details on species / strain selection:
- male F344 rats
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- 6-week-old male F344 rats.
Administration / exposure
- Route of administration:
- oral: feed
- Details on route of administration:
- Oriental M powdered basal diet
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The rats had free access to food and water. They were kept in an air-conditionedroom at 22-24°C with a 12 hr-12 hr light-dark cycle.
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Each day over a 4 week period.
- Frequency of treatment:
- The rats had free access to food (2% in diet)
Doses / concentrations
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- Remarks:
- corresponding to 2% in the diet
- No. of animals per sex per dose:
- For ferulic acid one Group of five male.
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- The rats were weighed weekly.
The liver was weighed, and buffered formalin solution was injected into the stomach. Then the anterior and posterior walls of the forestomach were each cut into 6 to 7 strips for histological examination.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The body weights of rats given 2% of ferulic acid were not modified.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- no effect on the liver weight.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Ferulic acid did not induce any abnormal lesion of the stomach.
Histological examinations of the forestomach showed no lesions in rats. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Organ observed: forestomach
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- Organ observed: forestomach
- Other effects:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: induction of forestomach lesions
Target system / organ toxicity
- Critical effects observed:
- no
Any other information on results incl. tables
Ferulic acid did not induce any abnormal lesion of the stomach.
Histological examinations of the forestomach showed no lesions in rats treated with 2% ferulic acid.
Applicant's summary and conclusion
- Conclusions:
- In this study, the induction of forestomach lesions in rats for four weeks by the Ferulic acid was evaluated. The limit dose tested 2000 mg/kg bw/day of Ferulic acid produced no adverse effects.
The NOAEL is therefore determined to be 2000 mg/kg bw/day or higher. - Executive summary:
The effects of naturally occurring antioxidants including ferulic acid on rat forestomach epithelium were compared with those of synthetic antioxidants, butylatedhydroxyanisole (BHA) and butylated hydroxytoluene (BHT), of which the former is a known forestomach carcinogen. Groups of five F344 male rats were given diet containing BHA, BHT, gallic acid, syringic acid, sesamol, caffeic acid, chlorogenic acid, ferulic acid, eugenol or esculin for 4weeks at a level of 0.7% for BHT or 2% for other compounds.
In this study, no effect was observed following an exposure of 4 week of 2% ferulic acid in diet. The NOAEL is therefore determined to be 2000 mg/kg bw/day (corresponding to the2% ferulic acid in diet).
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