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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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- 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:
- Positive rates to propyl gallate on patch testing: a change in trend
- Author:
- Perez A. et al.
- Year:
- 2 008
- Bibliographic source:
- Contact Dermatitis, 58(1), 47-48
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- - Principle of test: To assess the prevalence of allergic contact dermatitis to propyl gallate via patch test
- Short description of test conditions: From 1988 to 2005, 9529 patients were patch tested to the face series, 6973 were females and 2556 were males. Patch tests were read at 2 D and 4 D.
- Parameters analysed / observed: Scoring of positive reactions (negative, +, ++ and +++) - GLP compliance:
- not specified
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:
- Propyl gallate was used at a 1% petrolatum (pet.).
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 9529 (6973 females and 2556 males)
- Sex: males & females - Clinical history:
- not specified
- Controls:
- not specified
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive / semiocclusive /other: not specified
- Description of patch: Finn Chambers are used and mounted on Scanpor tape.
- Vehicle / solvent: Propyl gallate was used at a 1% petrolatum (pet.)
- Testing/scoring schedule: Patch tests were read at 2 D and 4 D.
EXAMINATIONS
- Grading/Scoring system: Positive reactions were scored as per International Contact Dermatitis Research Group recommendations as negative, +, ++, and +++ reactions
- Statistical analysis: Chi-square test
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: not specified
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 55 patients (0.57%), 46 were female (0.65%) and 9 were male (0.33%).
- Number of subjects with negative reactions: 9474 patients
- Number of subjects with equivocal reactions: not specified
- Number of subjects with irritating reactions: not specified
RESULT OF CASE REPORT: There was a significant difference (P < 0.05) in the positivity rates between the 1988-96 period (0.45%) and the 1997-2005 period (0.77%). A review of face series performed in the last 18 years has shown a statistically significant increase in propyl gallate-positive rates on patch testing over the last decade. An increase in its use in the cosmetic industry may well be the explanation for this.
Any other information on results incl. tables
The authors assumed that an increase in its use in the cosmetic industry may well be the explanation for the significant increase in propyl gallate-positive rates on patch testing over the last decade. Furthermore, a concomitant reduction of propyl gallate as an antioxidant in food, with oral tolerance being less likely to develop, may also be a contributing factor in the increasing trend of allergic contact dermatitis caused by propyl gallate.
Applicant's summary and conclusion
- Conclusions:
- In a human patch test reported by Perez et al. (2008), positive reactions were observed in 0.57% of the patients (55 out of 9529 patients). There was a significant difference (P < 0.05) in the positivity rates between the 1988-96 period (0.45%) and the 1997-2005 period (0.77%). Furthermore, a statistically significant increase in propyl gallate-positive rates on patch testing over the last decade was observed. The authors assumed that an increase in its use in the cosmetic industry may well be the explanation for this. Also, a concomitant reduction of propyl gallate as an antioxidant in food, with oral tolerance being less likely to develop, may also be a contributing factor in the increasing trend of allergic contact dermatitis caused by propyl gallate.
- Executive summary:
In a human patch test reported by Perez et al. (2008), the prevalence of allergic contact dermatitis to propyl gallate was investigated in 9529 patients (6973 females and 2556 males) from 1988 to 2005. Patch tests were read at 2 D and 4 D. Positive reactions were scored as per International Contact Dermatitis Research Group recommendations as negative, +, ++, and +++ reactions. Propyl gallate was used at a 1% petrolatum (pet.). Out of 9529 patients, a total of 55 patients (0.57%) had positive reactions to propyl gallate, which 46 of them were females (0.65%) and 9 were males (0.33%). There was also a significant difference in the positivity rates between the 1988-96 period (0.45%) and the 1997-2005 period (0.77%). A review of face series performed in the last 18 years has shown a statistically significant increase in propyl gallate-positive rates on patch testing over the last decade. An increase in its use in the cosmetic industry may well be the explanation for this. Nevertheless, a concomitant reduction of propyl gallate as an antioxidant in food, with oral tolerance being less likely to develop, may also be a contributing factor in the increasing trend of allergic contact dermatitis caused by propyl gallate.
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