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EC number: 605-260-4 | CAS number: 161599-46-8
- 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
- Study period:
- Oct 1995 - Jan. 1996
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.42
- Principles of method if other than guideline:
- Six healthy New Zealand Albino rabbits, free from evidence of ocular irritation and corneal abnormalities, were dosed with the substance.
The test article (0.1 ml equivalent) was placed into the conjunctival sac of one eye of each rabbit. The eyes were not washed.
The eyes were examined and scored by the Draize technique days 1, 2 and 3. Body weights were recorded pretest.
The primary eye irritation score for each rabbit, each time period, was calculated. - GLP compliance:
- not specified
Test material
- Reference substance name:
- (2R,3R,4R,5R)-4-(acetyloxy)-5-(4-amino-5-fluoro-2-oxo-1,2-dihydropyrimidin-1-yl)-2-methyloxolan-3-yl acetate
- EC Number:
- 605-260-4
- Cas Number:
- 161599-46-8
- Molecular formula:
- C13 H16 F N3 O6
- IUPAC Name:
- (2R,3R,4R,5R)-4-(acetyloxy)-5-(4-amino-5-fluoro-2-oxo-1,2-dihydropyrimidin-1-yl)-2-methyloxolan-3-yl acetate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- White powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals were received from Ace Animals, Boyertown, PA on 4/25 and 5/02/95. Following a quarantine of at least one week, six healthy
New Zealand Albino rabbits, free from evidence of ocular irritation, were selected for this test from a larger group.
The animals were born the weeks of 2/12 through 2/26/95. The pretest body weight range was 2,2 - 2,6 kg.
The animals were identified by cage notation and a uniquely numbered metal eartag. The animals were housed 1/cage in suspended cages.
Bedding was placed beneath the cages and changed at least three times/week. Fresh Purina Rabbit Chow (Diet #5321), supplied by Davis Feed
of Bucks County, Perkasie, PA was provided daily. Water was available ad libitum.
The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12 hour light/dark cycle and was kept clean and vermin free.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Contralateral eye served as a control
- Amount / concentration applied:
- 0,1 ml equivalent
- Observation period (in vivo):
- Examination on days 1, 2 and 3
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The test article (0,1 ml equivalent) was placed by syringe or syringe-type applicator into the conjunctival sac which was formed by gently
pulling the lower eyelid away from the eye.
After instillation, the lids were held together briefly to insure adequate distribution of the test article.
One eye of each rabbit was dosed.
The contralateral eye served as a control.
The treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva on days 1, 2 and 3.
Ocular reactions were graded according to the numerical Draize technique.
The irritation potential was determined by counting the number of rabbits with positive irritation on days 1, 2 or 3.
Positive irritation is defined as any score for opacity or iritis, or 2 or more
for redness or chemosis.
The test article is an irritant if 4 or more rabbits had a positive score at any time period.
Body weights were recorded pretest.
The general health of the animals was monitored at each observation time.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- other: Day 3
- Score:
- ca. 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Time point:
- other: Day 3
- Score:
- ca. 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Time point:
- other: Day 3
- Score:
- ca. 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- overall irritation score
- Basis:
- animal #4
- Time point:
- other: Day 3
- Score:
- ca. 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- overall irritation score
- Basis:
- animal #5
- Time point:
- other: Day 3
- Score:
- ca. 0
- Reversibility:
- other: Not applicable
- Irritation parameter:
- overall irritation score
- Basis:
- animal #6
- Time point:
- other: Day 3
- Score:
- ca. 0
- Reversibility:
- other: Not applicable
- Irritant / corrosive response data:
- The test article is not an eye irritant as defined in 16 CFR 1500.42
- Other effects:
- Not applicable
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: 16 CFR 1500.42
- Conclusions:
- The test article is not an eye irritant as defined in 16 CFR 1500.42
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