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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
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, 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:
- The toxicity of the antioxidants propyl-, octyl-, and dodecylgallate
- Author:
- Van Esch G.J.
- Year:
- 1 955
- Bibliographic source:
- Voeding 16, 683–686
- Reference Type:
- publication
- Title:
- Elementary raw fats containing phenolic antioxidants, an evaluation from the point of hygiene
- Author:
- Karplyuk I.A.
- Year:
- 1 960
- Bibliographic source:
- Voprosy Pitaniya 19(1), 67-72
- Reference Type:
- publication
- Title:
- Studies on the toxicity of propyl gallate and of antioxidant mixtures containing proply gallate
- Author:
- Orten J.M. et al.
- Year:
- 1 948
- Bibliographic source:
- Food Technology 2, 308-316
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:
- Based on the presented data in the EFSA publication "Scientific Opinion on the re-evaluation of propyl gallate (E310) as a food additive" from 2014 it can be concluded that propyl gallate does not warrant classification for reproductive toxicity.
- Executive summary:
In the EFSA publication "Scientific Opinion on the re-evaluation of propyl gallate (E310) as a food additive", 2014 several reproductive toxicity studies conducted with propyl gallate were presented.
For rats, the results from the study reported by van Esch, 1955 were summarized. In this study, rats were fed propyl gallate in the diet at concentrations equivalent to doses of 18.2, 104 or 260 mg/kg bw/day for 2 successive generations. No effects on reproduction performance nor on indices of reproduction were reported, and at autopsy no abnormalities were observed in the organs or tissues of the rats.
In the CIR review, 2007 data from van Esch, 1955 was cited. It was reported that rats were fed propyl gallate in the diet at concentrations equivalent to 31.5, 180 or 450 mg/kg bw/day for more than 3 months until a few litters had been produced. Propyl gallate was reported not to have produced any significant changes in growth or reproduction and no significant abnormalities were attributed to treatment at necropsy. At 31.5 mg/kg bw/day, organ weights and hematological values did not differ significantly from control.
At doses of 4 mg/kg bw/day in rats for 6 months followed by 8 mg propyl gallate per kg bw/day for a further 6 months, degenerative changes in the testes were observed (Karplyuk, 1960). This study was judged to be inadequately reported and thus not considered for the assessment.
For guinea pigs, the results from the study reported by Orten et al., 1948 were provided. Male and female guinea pigs (14 males and 6 females/group, 3-4 weeks old) were dosed in the diet with 0 or 4.68 mg propyl gallate/kg bw/day. After 12 months, the six females in each group were mated with males from the same group. Only one litter with three offspring was obtained from the six control females while three litters of three offsprings were obtained from the six dosed females. There was no effect on gross appearance or rate of growth and no gross abnormalities were found at autopsy. Histological examination of liver, kidney, spleen, testes ovaries, adrenals, heart and lungs did not disclose any pathological effects. It was not specified if mothers and/or offspring were examined. There was no compound effect on the growth of one litter of the dosed females when compared to one litter of the control animals.
For pigs, the results provided by van Esch, 1955 were reported in the EFSA review publication. Pigs fed with propyl gallate in the diet with concentrations of 0.0035, 0.2 or 200 mg/kg diet for more than three months until a few litters had been produced. Propyl gallate was reported not to have produced significant changes in growth or reproduction and no significant abnormalities were attributed to treatment at necropsy. At 14 mg/kg bw/day 0.0035 diet, organ weights and hematological values did not differ significantly from control.
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