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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
Endpoint summary
Administrative data
Description of key information
Two studies are available to evaluate the repeated doses toxicity of ferulic acid by oral route.
In a study (Hirose et al 1987), 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 the other compounds.
Thus following an exposure of 4 weeks of 2% ferulic acid in diet, no effect was observed. The NOAEL was therefore determined to be 2000 mg/kg bw/day or higher for effect on forestomach (corresponding to the 2% ferulic acid in diet).
The second study (Tanaka et al 1993), was initially performed to investigate the protective effect of the plant phenolic antioxidants caffeic acid , ellagic acid ,chlorogenic acid and ferulic acid on the induction of tongue carcinogenesis induced by 4-NQO (4-nitroquinoline-l-oxide). However, this study was useful to assessment the repeated dose toxicity since Ferulic acid was administrated alone during 7 weeks at 500 ppm in diet. After these7 weeks, Ferulic acid did not show change in body, liver and relative livers weight. In addition, no tongue neoplasms and no pre-neoplastic lesions of the tongue were observed.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- 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
- 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
- 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.
- 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)
- 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
- 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. - 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
- 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
- Critical effects observed:
- no
- 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).
- Endpoint:
- repeated dose toxicity: oral, other
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1993
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other:
- Remarks:
- Study not detailed enough and only few information on effect of ferulic acid alone, as it was not the aim of this study.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The modifying effects of dietary administration of the plant phenolic antioxidants caffeic acid (CA), ellagic acid (EA), chlorogenic acid (CGA) and ferulic acid (FA) during the initiation phase on 4-nitroquinoline-l-ojdde (4-NQO)-induced tongue carcinogenesis and on the number and area of silver stained nucleolar organizer region proteins (AgNORs), a new cell proliferation marker, of the tongue squamous epithelium were investigated in male F344 rats. Rats were fed the diet containing 500 ppm CA, 400 ppm EA, 250 ppm CGA or 500 ppm FA for 7 weeks. One week after the commencement of the diets, 4-NQO (20 ppm) was administered in the drinking water for 5 weeks.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Details on species / strain selection:
- Male F344 rats obtained at 4 weeks of age from Japan SLC Inc., Hamamatsu City, Shizuoka, Japan were used.
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Male F344 rats obtained at 4 weeks of age from Japan SLC Inc., Hamamatsu City, Shizuoka, Japan were used. After being acclimatized for 2 weeks with free access to basal diet CE-2 (Clea Japan Inc., Tokyo), they were transferred to the holding room and randomized into experimental and control groups. Rats were housed three or four to a wire cage. The holding room was maintained at 23 ± 2°C, 50 ± 10% humidity, and a 12 h light/dark cycle.
- Route of administration:
- oral: feed
- Details on oral exposure:
- 8 rats were fed the diets containaing 500 ppm of Feriulic acid for 7 weeks starting at 6 weeks of age, and were then maintained on the basal diet during the subsequent experimental period.
- Dose / conc.:
- 500 ppm
- No. of animals per sex per dose:
- 8
- Dose descriptor:
- NOEL
- Effect level:
- 500 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: body, liver and relative livers weight
- Critical effects observed:
- no
- Conclusions:
- After 7 weeks, rat fed with diet containing 500 ppm of Ferulic acid, did not show change in body, liver and relative livers weight. No tongue neoplasms and no pre-neoplastic lesions of the tongue were observed.
- Executive summary:
Initiality, this study was performed in order to determine the protective effect of the plant phenolic antioxidants caffeic acid (CA), ellagic acid (EA), chlorogenic acid (CGA) and ferulic acid (FA) on the induction of tongue carcinogenesis induced by 4-NQO (4-nitroquinoline-l-oxide).
However, in this study Ferulic acid was administrated alone during 7 weeks at 500 ppm in diet. After 7 weeks Ferulic acid, did not show modification in body, liver and relative livers weight. No tongue neoplasms and no pre-neoplastic lesions of the tongue were observed.
Also, the study conclusion is that affeic acid (CA), ellagic acid (EA), chlorogenic acid (CGA) and ferulic acid (FA) inhibited the tongue carcinogenesis induced by 4-NQO when they were administered concurrently with the carcinogen.
Referenceopen allclose all
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.
For the ferulic acid, no toxic clinical signs were observed during the experiment. Body, liver and relative liver weights (g/100 g body wt) in ferulic acid alone group at the termination of the study were almost the same of the control.
No histopathological findings indicating toxicity due to test chemicals were seen in liver, kidney and lung.
No neoplasms of tongue were found in rats.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Justification for classification or non-classification
Based on this two studies ferulic acid showed low systemic effect even if only some parameters were investigated in these two studies.
Based on these two studies no classification is proposed.
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