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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 June 2005 to 10 June 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: The animals were 2 to 4 months old on the day of treatment
- Weight at study initiation: The animals had a mean body weight ± standard deviation of 2.8 ± 0.1 kg
- Housing: The animals were housed individually in polystyrene cages (48.2 x 58 x 36.5 cm). Each cage was equipped with a food container and a water bottle.
- Diet: ad libitum access to 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: 18 ± 3 °C
- Humidity: 30 to 70 % (relative)
- Air changes: Approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod: 12 hours of light / 12 hours of darkness
IN-LIFE DATES: Not reported
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- The test material was first evaluated on a single animal; the durations of exposure were 3 minutes, 1 hour and 4 hours. It was then applied for 4 hours to two additional animals.
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Flank. The day before treatment, both flanks of each animal were clipped using electric clippers and the skin of each animal was examined in order to check the absence of any signs of skin irritation. Doses were applied to the anterior left flank (application for 3 minutes), the anterior right flank (application for 1 hour) or the posterior right flank (application for 4 hours) of the animals.
- Type of wrap if used: The test material was placed on a gauze pad moistened with purified water. The gauze pad was held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No washing was done, however after removal of the dressing any residual test material was wiped off by means of a dry cotton pad.
- Time after start of exposure: After the 3 minute and 1 and 4 hour exposure periods.
OBSERVATION TIME POINTS: The skin was examined approximately 1, 24, 48 and 72 hours after removal of the dressing.
SCORING SYSTEM: Dermal irritation was evaluated for each animal according to the following scale:
- Erythema and Eschar Formation
0 = No erythema
1 = Very slight erythema (barely perceptible)
2 = Well-defined erythema
3 = Moderate to severe erythema
4 = Severe erythema (beet redness) to slight eschar formation (injuries in depth)
- Oedema Formation
0 = No oedema
1 = Very slight oedema (barely perceptible)
2 = Slight oedema (edges of area well-defined by definite raising)
3 = Moderate oedema (edges raised approximately 1 mm)
4 = Severe oedema (raised more than 1 mm and extending beyond the area of exposure)
Any other lesions were noted.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- After the 3-minute and 1-hour exposures in one animal, no cutaneous reactions were observed.
After the 4-hour exposure in all three animals, a very slight erythema (grade 1) was noted in 2/3 animals on day 1; it persisted on day 2 in 1/3 animals. No other cutaneous reactions were recorded.
Mean scores over 24, 48 and 72 hours for each animal were 0.3, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for oedema.
Any other information on results incl. tables
Table 1: Summary of Individual Results After the 4 Hour Exposure
Rabbit Number |
Dermal Irritation |
Time point (h) |
Mean irritation score* |
Interpretation |
|||
1 |
24 |
48 |
72 |
||||
113 |
Erythema |
1 |
1 |
0 |
0 |
0.3 |
Negative |
|
Oedema |
0 |
0 |
0 |
0 |
0.0 |
Negative |
|
Other |
- |
- |
- |
- |
|
|
479 |
Erythema |
0 |
0 |
0 |
0 |
0.0 |
Negative |
|
Oedema |
0 |
0 |
0 |
0 |
0.0 |
Negative |
|
Other |
- |
- |
- |
- |
|
|
480 |
Erythema |
1 |
0 |
0 |
0 |
0.0 |
Negative |
|
Oedema |
0 |
0 |
0 |
0 |
0.0 |
Negative |
|
Other |
- |
- |
- |
- |
|
|
*Mean of 24, 48 and 72 h scores
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- Under the conditions of this study, the test material was determined to be not irritating to the skin.
- Executive summary:
A dermal irritation study was conducted in accordance with the standardised guidelines OECD 404 and EU Method B.4 under GLP conditions.
The test material was first applied for periods of 3 minutes, 1 hour and 4 hours to a single male New Zealand White rabbit. Since the test material was not severely irritating to the first animal, it was then applied for 4 hours to two other animals. A single dose of 500 mg of the test material in its original form was applied to the closely-clipped skin of one flank. The test material was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1, 24, 48 and 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated for each animal.
After the 3-minute and 1-hour exposures in one animal, no cutaneous reactions were observed. After the 4-hour exposure in all three animals, a very slight erythema (grade 1) was noted in 2/3 animals on day 1; it persisted on day 2 in 1/3 animals. No other cutaneous reactions were recorded.
Mean scores over 24, 48 and 72 hours for each animal were 0.3, 0.0 and 0.0 for erythema and 0.0, 0.0 and 0.0 for oedema.
Under the conditions of this study, the test material was determined to be not irritating to the skin.
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