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EC number: 200-718-6 | CAS number: 69-89-6
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The test item solubility was tested in acetonitrile, water, 1: 1 (v:v) acetonitrile:water, isopropanol, methanol, ethanol, 1,4-butandiol, N,N-dimethylformamide (DMF) and tertbutanol at 100 mM. The test item was not soluble in any of these solvents. Therefore, in vitro studies could not be performed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 12-Nousan-8147
- Version / remarks:
- 2000
- GLP compliance:
- yes
Test material
- Reference substance name:
- Purine-2(3H),6(1H)-dione
- EC Number:
- 200-718-6
- EC Name:
- Purine-2(3H),6(1H)-dione
- Cas Number:
- 69-89-6
- Molecular formula:
- C5H4N4O2
- IUPAC Name:
- xanthine
Constituent 1
- Specific details on test material used for the study:
- Purity: > 99% purity
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services, Inc.
- Age at study initiation: Young adult (12-13 weeks)
- Weight at study initiation: 2517.2- 2726.9 grams
- Housing: Individually housed in suspended stainless steel caging.
- Diet: PMI 5326 High Fiber Rabbit Diet; designated amount of diet (approximately 150 grams/day) and alfalfa hay cubes (Grainland Select Alfalfa Cubes) available to each rabbit.
- Water: ad libitum
- Acclimation period: 8 or 14 days
- Other: Elizabethan collars placed on rabbits after removal of patches.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-24ºC (Temperature was below the targeted lower limit for eight days during the study. These excursions were considered minor and had no impact on this study.)
- Humidity (%): 53-80%, (Humidity was above the targeted upper limit for one day during the study. A portable dehumidifier was used to lower the humidity levels during this time. These excursions were considered minor and had no impact on this study.
- Air changes (per hr): 12
- Photoperiod (hrs dark/ hrs light): 12-hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- test substance applied as a dry paste (70% w/w mixture in distilled water).
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.71 g of test mixture
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at room temperature.
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: Test substance was expected to be stable for the duration of testing.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): To ensure adequate contact with skin, test substance was applied as dry paste (70% w/w mixture in distilled water).
- Preliminary Toxicity Testing: Initial testing conducted on one rabbit to determine irritation/corrosion potential of test substance. Three dose sites, each approximately 6-cm2, were delineated on rabbit. Five-tenths of a gram of test substance (0.71 g of test material) was placed on 1-inch x 1-inch, 4-ply gauze pad and applied to each dose site. Pads and entire trunk of animal were wrapped with semi-occlusive tape. After removal of 3-minute patch, rabbit returned to designated cage. Pads were removed at appropriate intervals (3 minutes, 1 hour, and 4 hours). All dose sites were evaluated for corrosion 30-60 minutes after patch removal. Subsequent evaluations were performed approximately 24, 48, and 72 hours after removal of four-hour patch. Since there was no corrosion observed at any of dose sites for this animal, two additional rabbits (each with one patch only for a 4-hour exposure period), were selected for further testing and treated in same manner. - Duration of treatment / exposure:
- 3 minutes, 1 hour, or 4 hours
- Observation period:
- 30-60 minutes after patch removal (all exposures) and 24, 48, and 72 hours after patch removal (4-hour exposure)
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Approximately 6 cm2
- Coverage: Five-tenths of a gram of test substance (0.71 g of the test mixture) placed on gauze and applied to each dose site.
- Type of wrap if used: Pads and entire trunk of animal wrapped with semi-occlusive 3-inch tape to avoid dislocation of patches.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Cleansed with a 3% soap solution followed by tap water and a clean paper towel to remove any residual test substance.
- Time after start of exposure: After the 3-minute, 1-hour, and 4-hour exposure periods.
OBSERVATION TIME POINTS
24-, 48-, and 72-hour observation time points
SCORING SYSTEM:
- Method of calculation: Individual dose sites were scored according to the Draize scoring system immediately following patch removal (initial rabbit only) and at approximately 30-60 minutes, 24, 48, and 72 hours after patch removal in addition to evaluation for corrosion at these intervals for the first animal only. Mean values for each lesion (erythema and edema) were calculated for each animal separately from numerical scores obtained at the 24-, 48-, and 72-hour observations.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Remarks:
- (mean score for dermal response)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- (mean score for dermal response)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- (mean score for dermal response)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- (mean score for dermal response)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- (mean score for dermal response)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- (mean score for dermal response)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No visible necrosis (corrosion) of the skin tissue was observed at the 3-minute, 1-hour and 4-hour dose sites during the study. No dermal irritation was noted at the 3-minute exposure site for first animal. In one animal, within 30-60 minutes of patch removal, very slight erythema (score of 1) and very slight edema (score of 1) was noted at 1-hour exposure site, which resolved by 24 hours. One animal exhibited very slight erythema (score of 1) within 30-60 minutes of patch removal after 4-hour exposure, which resolved by 24 hours.
- Other effects:
- In-Life Observations: While some minimal weight loss was observed, all animals stayed active and healthy throughout study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No visible necrosis (corrosion) was observed. Very slight irritation which resolved by 24 hours was observed. The test substance is not a skin irritant.
- Executive summary:
A primary skin irritation test was conducted with rabbits to determine the potential for the test substance to produce irritation after a single topical application. Initially, one rabbit was tested to determine the irritation/corrosion potential of the test substance. Three dose sites, each approximately 6-cm2, were delineated on this animal. Five-tenths of a milliliter of the neat test substance was applied to the skin of each dose site. The pads and entire trunk of the animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the patches. The patches were removed at the appropriate intervals (3 minutes, 1 hour, and 4 hours). All dose sites were evaluated for skin irritation according to the Draize method of scoring and for corrosion 30-60 minutes after the appropriate patch removal. Since there was no corrosion observed at any of the dose sites for this animal, two additional rabbits were selected for testing and had the test substance applied for 4 hours only. All dose sites were evaluated for skin irritation according to the Draize scoring system at 30-60 minutes, and 24, 48, 72 hours and at 7 days after patch removal. No visible necrosis (corrosion) of the skin tissue was observed at the 3-minute, 1-hour and 4-hour dose sites during the study. No dermal irritation was noted at the 3-minute exposure site for the first animal. Within 30-60 minutes of patch removal, very slight erythema and very slight edema was noted at the exposure site in one animal, which resolved by 24 hours. Within 30-60 minutes of patch removal, one treated site exhibited very slight erythema, which resolved by 24 hours. The test substance is not a skin irritant.
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