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Diss Factsheets
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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
Eye irritation
Administrative data
- Endpoint:
- eye 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 870.2400 (Acute Eye Irritation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 12-Nousan-8147
- 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%
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Robinson Services Inc., Mocksville, NC
- Age at study initiation: Young adult (11-14 weeks)
- Weight at study initiation: 1940.0-2839.1 grams
- Housing: The animals were singly housed in suspended stainless steel caging which conforms to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals. Enrichment (e.g., toy) was placed in each cage. Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet (e.g. ad libitum): A designated amount of the diet (approximately 150 grams/day) and alfalfa hay cubes (Grainland Select Alfalfa Cubes) were available to each rabbit
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 or 21 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-23ºC; Temperature was below the targeted lower limit for four days during the study. These excursions were considered minor and had no impact on this study.
- Humidity (%): 58-95%; Humidity was above the targeted upper limit for three days 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
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- test substance was instilled as received
- Controls:
- yes
- Amount / concentration applied:
- 0.1 mL (0.066 g)
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 1, 24, 48, and 72 hours post-instillation
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize method of scoring at 1, 24, 48, and 72 hours post-instillation; fluorescein dye evaluation procedure used in treated eye at 24 hours to verify absence of corneal damage; individual scores recorded for each animal; in addition to observations of cornea, iris and conjunctivae, any other observed lesions were noted; average score for all rabbits at each scoring period calculated to aid in data interpretation.
TOOL USED TO ASSESS SCORE: white light source
Prior to instillation, 1-2 drops of ocular anesthetic (tetracaine hydrochloride ophthalmic solution USP, 0.5%) was placed into both treated and control eye of each animal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- No corneal opacity or iritis was observed. Conjunctival chemosis (score of one) and conjunctival redness (score of 1) were noted in two treated eyes within one hour after instillation. Irritation cleared in the treated eye of both rabbits at 48 hours.
- Other effects:
- All animals appeared active and healthy. Although one animal lost body weight, the two remaining animals gained body weight during the study. Apart from the eye irritation, there were no other clinical signs observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No corneal opacity or iritis was observed from the test substance Conjunctival chemosis (score of one) and conjunctival redness (score of 1) were noted in two treated eyes within one hour after instillation. Irritation cleared in the treated eye of both rabbits at 48 hours. The test substance is not an eye irritant.
- Executive summary:
A primary eye irritation test was conducted with rabbits to determine the potential of the test substance to produce irritation from a single instillation via the ocular route. One-tenth of a milliliter (0.066 grams) of the test substance was instilled into the right eye of three healthy rabbits. The left eye remained untreated and served as a control. Ocular irritation was evaluated by the Draize method of scoring. No corneal opacity or iritis was observed. Conjunctival chemosis (score of one) and conjunctival redness (score of 1) were noted in two treated eyes within one hour after instillation. Irritation cleared in the treated eye of both rabbits at 48 hours. The test substance is not an eye irritant.
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