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Diss Factsheets
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EC number: 221-146-3 | CAS number: 3012-65-5
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not specified
- 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:
- Biocompatibility of EDTA, EGTA and citric acid
- Author:
- de Sousa, S. M. G. et al.
- Year:
- 2 005
- Bibliographic source:
- Braz. Dent. J. 16 (1): 3 - 8.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Thirty-two adult male Wistar rats were used. Their backs were shaved and 2% Evans blue was injected intravenously into the lateral caudal tail vein. Immediately afterwards, 0.1 mL of citric acid solution was injected intradermally into the experimental site. The animals were assigned to 4 groups according to the time period tested. The animals were killed 30 minutes as well as 1, 3 and 6 hours after injection of the solution. The dorsal skin was dissected away and skin lesions were punched out. Each piece of skin containing the lesion was cut into small fragments and the dye was extracted upon immersion in 10 mL formamide. Then, the optical density was measured at 620 μm in a spectrophotometer The total amount of dye extracted from the samples was calculated by means of a standard calibration curve.
- GLP compliance:
- not specified
- Remarks:
- not specified in the publication
Test material
- Reference substance name:
- Citric acid
- EC Number:
- 201-069-1
- EC Name:
- Citric acid
- Cas Number:
- 77-92-9
- Molecular formula:
- C6H8O7
- Test material form:
- other: solution
- Details on test material:
- - State of aggregation: 15 % citric acid solution (supplier: Merck)
- pH: 1.0
Constituent 1
- Specific details on test material used for the study:
- not specified
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: approx. 350 g
Test system
- Type of coverage:
- open
- Preparation of test site:
- shaved
- Vehicle:
- other: deionized water
- Controls:
- yes
- Amount / concentration applied:
- not specified
- Duration of treatment / exposure:
- not applicable
- Observation period:
- 30 minutes as well as 1, 3 and 6 hours after injection of the solutions
- Number of animals:
- 32 male rats (8 animals/observation time point)
- Details on study design:
- NOTE: three further test item solutions were tested with the same animals as used for testing with the citric acid solution.
DOSAGE PREPARATION:
The tested acid solution was freshly prepared at the laboratory. The salt were weighed and diluted in deionized water, and pH was adjusted (pH meter B371, Micronal).
EXPERIMENTAL METHOD:
The rats were anesthetized with sulfuric ether, their backs were shaved. Their tails were washed and dried to facilitate the injections of 2% Evans blue (20 mg/kg) administered intravenously into the lateral caudal vein. Immediately afterwards, 0.1 mL of the test solution was injected intradermally into the experimental site. The animals were assigned to 4 groups according to the time period tested. The animals were killed 30 minutes, 1, 3 and 6 hours after injection of the solution. The dorsal skin was dissected away and skin lesions were punched out with a standard steel punch (3-cm diameter). Each piece of skin containing the lesion was cut into small fragments and the dye was extracted upon immersion in 10 mL formamide for 72 hours at 45 °C. After filtration with glass filter, the optical density was measured at 620 μm in a spectrophotometer (Ultrospec 2000, Pharmacia Biotech). The total amount of dye extracted from the samples was calculated by means of a standard calibration curve. Data were analyzed statistically by two-way ANOVA and Tukey’s HSD test.
Results and discussion
In vivo
Results
- Remarks on result:
- other: see "Remarks"
- Remarks:
- According to the authors, compared to saline (139.55 µg) a larger amount of dye was extracted after citric acid administration (329.81 µg), for all four periods evaluated. Furthermore, considering the time period, a significant difference (p<0.05) was observed between the 3 hour and 6 hour groups, but not between the 30-min and 1 hour groups. Also, the authors stated that there was an enhanced vascular permeability at the 6 hour experimental time. Although a statistically significant difference was seen between citric acid and saline, the means of dye extracted in these groups were numerically close to each other. Lastly, the authors stated that the results indicated that the citric acid solution yielded a continuous irritating potential even after 6 hours.
- Irritant / corrosive response data:
- Compared to saline (139.55 µg) a larger amount of dye was extracted after citric acid administration (329.81 µg), for all four periods evaluated.
Considering the time period, a significant difference (p<0.05) was observed between the 3 hour and 6 hour groups, but not between the 30-min and 1 hour groups. There was an enhanced vascular permeability at the 6 hour experimental time.
Although a statistically significant difference was seen between citric acid and saline, the means of dye extracted in these groups were numerically close to each other.
The results indicated that the citric acid solution yielded a continuous irritating potential even after 6 hours.
Please aslo refer to the field "Any other information on results incl. tables" below.
Any other information on results incl. tables
Table 1: Means (μg) and standard deviations (± SD) of the total amount of dye extracted in the control and experimental groups.
Time |
Citric acid |
Saline |
30 minutes |
280.92 ± 140.84 |
153.93 ± 47.15 |
1 hour |
271.41 ± 135.09 |
115.68 ± 48.57 |
3 hours |
286.43 ± 102.08 |
115.36 ± 58.60 |
6 hours |
480.50 ± 212.34 |
173.23 ± 51.31 |
Applicant's summary and conclusion
- Conclusions:
- According to the authors, compared to saline (139.55 µg) a larger amount of dye was extracted after citric acid administration (329.81 µg), for all four periods evaluated. Furthermore, considering the time period, a significant difference (p<0.05) was observed between the 3 hour and 6 hour groups, but not between the 30-min and 1 hour groups. Also, the authors stated that there was an enhanced vascular permeability at the 6 hour experimental time. Although a statistically significant difference was seen between citric acid and saline, the means of dye extracted in these groups were numerically close to each other. Lastly, the authors stated that the results indicated that the citric acid solution yielded a continuous irritating potential even after 6 hours.
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