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EC number: 473-810-9 | CAS number: -
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 June 2005 to 22 June 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 473-810-9
- EC Name:
- -
- Cas Number:
- 1480-96-2
- Molecular formula:
- Hill formula: C5H5FN2O2 CAS formula: C5H5FN2O2
- IUPAC Name:
- 5-fluoro-2-methoxy-3,4-dihydropyrimidin-4-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: white powder
- Storage conditions of test material: at room temperature, protected from humidity and under nitrogen gas
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Sprague-Dawley Rj: SD (IOPS Han)
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: Approximately 8 weeks old
- Weight at study initiation: Animals had a mean body weight ± standard deviation of 347 ± 7 g for the males and 217 ± 6 g for the females.
- Fasting period before study: No
- Housing: The animals were housed in polycarbonate cages with stainless steel lid (48 x 27 x 20 cm). Each cage contained one to seven animals of the same sex during the acclimation period and a single rat during the treatment period. Each cage contained autoclaved sawdust.
- Diet: ad libitum. All the animals had free access to adapted pelleted diet
- Water: Drinking water filtered by an FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: At least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 30 to 70 % (relative)
- Air changes: approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod: 12 hour light/12 hour dark cycles
IN-LIFE DATES: Not reported
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal area of each animal. On the day before treatment, the dorsal area of each animal was clipped using an electric clipper. Only animals with healthy intact skin were used for the study.
- % coverage: Approximately 10 % of the total body surface of the animals (approximately 5 x 7 cm for males and 5 x 6 cm for females)
- Type of wrap if used: The test material and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage. This dressing prevented ingestion of the test material by the animal.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None. On removal of the dressing, any residual test material was removed using a dry cotton pad.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: No; the test material was placed on a hydrophilic gauze pad (pre-moistened with 2 mL of purified water) - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days.
- Frequency of observations and weighing: The animals were observed frequently during the hours following administration of the test material, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day until day 15. From day 2 any local cutaneous reaction was recorded. The animals were weighed individually just before administration of the test material on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: Yes. On day 15, all surviving animals were killed by carbon dioxide asphyxiation. All study animals were subjected to a macroscopic examination as soon as possible after death. After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- Piloerection was observed in all animals within 1 hour of treatment. No more clinical signs were noted thereafter, until the end of the observation period (day 15).
No cutaneous reactions were observed during the study. - Body weight:
- The body weight gain of the treated animals was similar to that of historical control animals.
- Gross pathology:
- Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of the study, the LD50 has been determined to be greater than 2000 mg/kg in the rat.
- Executive summary:
A study was conducted to investigate the acute dermal toxicity potential of the test material in accordance with the standardised guidelines OECD 402 and EU Method B.3 under GLP conditions.
The test material in its original form was applied to the clipped skin on the dorsal area of one group of ten Sprague-Dawley rats (five males and five females). The application was performed with a limit dose of 2000mg/kg. The test site was then covered by a semi-occlusive dressing for 24 hours. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test material. At the end of the 14 day treatment period, all animals were subjected to necropsy.
No deaths were observed during the study. Piloerection was observed in all animals within 1 hour of treatment. No more clinical signs were noted thereafter, until the end of the observation period (day 15). No cutaneous reactions were observed during the study. The overall body weight gain of the animals was not considered to be affected by treatment with the test material. No apparent abnormalities were observed at necropsy in any animal.
Under the conditions of the study, the LD50 has been determined to be greater than 2000 mg/kg in the rat.
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