Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 09 June 2005 to 18 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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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 2.9 ± 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- As possible irritant effects were anticipated, the test material was first administered to a single animal; it was then evaluated on two other animals.
A single dose of the test material was introduced into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lower and upper eyelids were held together for about one second to avoid any loss of test material. - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Irrigation was not performed.
SCORING SYSTEM: The day before treatment, the eyes of each animal were examined in order to check the absence of any signs of ocular irritation, ocular defects or pre-existing corneal injury. The eyes were examined approximately 1, 24, 48 and 72 hours after administration. Conjunctival reactions, iritis and corneal opacification were evaluated daily for each animal. Any other lesions observed were noted. The numerical scale is presented in Table 1.
TOOL USED TO ASSESS SCORE: For the evaluation of corneal opacification (presence or absence, affected area), the eyes were examined under a UV lamp after instillation of one or two drops of 0.5 % sodium fluorescein solution (a clear fluorescence is visible in the areas of opacification). This evaluation was performed on day 2 and repeated thereafter whenever necessary.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- A very slight chemosis was noted in all three animals on day 1; it persisted up to day 3 in one of them. A moderate redness of the conjunctiva was observed in all the animals on day 1. A slight redness of the conjunctivae was noted on day 2 in all three animals; it persisted on day 3 in one of them. No other ocular reactions were noted during the study.
Mean scores calculated for each animal over 24, 48 and 72 hours were 0.7, 0.0 and 0.0 for chemosis, 0.3, 0.7 and 0.3 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.
Any other information on results incl. tables
Table 2: Summary of Individual Results
Rabbit Number |
Ocular Reaction |
Time point (h) |
Mean irritation score* |
Interpretation |
|||
1 |
24 |
48 |
72 |
||||
113 |
Chemosis |
1 |
1 |
1 |
0 |
0.7 |
Negative |
Redness |
2 |
1 |
0 |
0 |
0.3 |
Negative |
|
Discharge |
0 |
0 |
0 |
0 |
0.0 |
|
|
Iris |
0 |
0 |
0 |
0 |
0.0 |
Negative |
|
Corneal opacity |
0 |
0 |
0 |
0 |
0.0 |
Negative |
|
Other |
Su |
* |
* |
* |
|
|
|
Fluorescein |
/ |
U |
/ |
/ |
|
|
|
479 |
Chemosis |
1 |
0 |
0 |
0 |
0.0 |
Negative |
Redness |
2 |
1 |
1 |
0 |
0.7 |
Negative |
|
Discharge |
0 |
0 |
0 |
0 |
0.0 |
|
|
Iris |
0 |
0 |
0 |
0 |
0.0 |
Negative |
|
Corneal opacity |
0 |
0 |
0 |
0 |
0.0 |
Negative |
|
Other |
Su |
* |
* |
* |
|
|
|
Fluorescein |
/ |
U |
/ |
/ |
|
|
|
480 |
Chemosis |
1 |
0 |
0 |
0 |
0.0 |
Negative |
Redness |
2 |
1 |
0 |
0 |
0.3 |
Negative |
|
Discharge |
0 |
0 |
0 |
0 |
0.0 |
|
|
Iris |
0 |
0 |
0 |
0 |
0.0 |
Negative |
|
Corneal opacity |
0 |
0 |
0 |
0 |
0.0 |
Negative |
|
Other |
Su |
* |
* |
* |
|
|
|
Fluorescein |
/ |
U |
/ |
/ |
|
|
*Mean of 24, 48 and 72 h scores
* = none
Su = residual test material
U = fluorescein applied
/ = fluorescein not used
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 eyes.
- Executive summary:
The potential of the test material to cause eye irritation was investigated in accordance with the standardised guidelines OECD 405 and EU Method B.5 under GLP conditions.
The test material was first administered to a single male New Zealand White rabbit. Since the test material was not severely irritating on the first animal treated, it was then evaluated in two other animals. A single dose of 100 mg of the test material in its original form was introduced into the left conjunctival sac. The right eye was not treated and served as control. The eyes were not rinsed after administration of the test material. Ocular reactions were observed approximately 1, 24, 48 and 72 hours after the administration. Mean scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal.
A very slight chemosis was noted in all three animals on day 1 and it persisted up to day 3 in one of them. A moderate redness of the conjunctiva was observed in all the animals on day 1. A slight redness of the conjunctivae was noted on day 2 in all three animals; it persisted on day 3 in one of them. No other ocular reactions were noted during the study. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.7, 0.0 and 0.0 for chemosis, 0.3, 0.7 and 0.3 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity.
Under the conditions of this study, the test material was determined to be not irritating to the eyes.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.