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EC number: 422-460-5 | CAS number: 137234-87-8 UK-103,442
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1996-05-29 to 1996-06-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 6-ethyl-5-fluoro-4(3H)-pyrimidone
- EC Number:
- 422-460-5
- EC Name:
- 6-ethyl-5-fluoro-4(3H)-pyrimidone
- Cas Number:
- 137234-87-8
- Molecular formula:
- C6 H7 F N2 O
- IUPAC Name:
- 6-ethyl-5-fluoro-3,4-dihydropyrimidin-4-one
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Batch No: Chichibu Lot No. 950704
Purity: 95.7%
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan U.K. Ltd, Bicester, Oxon, England.
- Females nulliparous and non-pregnant: yes
- Age at study initiation: four to seven weeks
- Weight at study initiation: 92 to 106 g
- Fasting period before study: overnight prior to and approximately 4 hours after dosing.
- Housing: housed in groups of up to five rats of the same sex in metal cages with wire mesh floors
- Diet: standard laboratory rodent diet, ad libitum
- Water: ad libitum
- Acclimation period: five day
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Humidity (%): 30-70
- Air changes (per hr): 10 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours) in each 24-hour period.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 5% w/v
- Amount of vehicle (if gavage): 10 mL/kg bodyweight - Doses:
- 500 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality: Cages of rats were checked at least twice daily for any mortalities
Clinical signs: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of four hours). On subsequent days animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only).
Bodyweight: recorded on Days 1 (prior to dosing), 2, 3, 4, 8 and 15.
- Necropsy of survivors performed: yes, all animals were killed on Day 15 by cervical dislocation and subjected to macroscopic examination.
Results and discussion
- Preliminary study:
- A preliminary study was carried out by dosing one female rat at 500 and 2000 mg/kg bodyweight respectively.
The results of the preliminary study indicated that the acute lethal oral dose to female rats of test item was between 500 and 2000 mg/kg bodyweight.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: Piloerection was observed in all rats within three minutes of dosing. This sign persisted and was accompanied in all rats on days 1, 2 and 3 by hunched posture. There were no other clinical signs and recovery was complete in all instances by Day 6.
- Gross pathology:
- Macroscopic examination revealed no abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The discriminating oral dose to rats of test item was established to be 500 mg/kg bodyweight.
- Executive summary:
A study was performed to assess the acute oral toxicity of test item to the rat following the method described in EC B.1.
A group of ten fasted rats (five males and five females) was given a single dose by oral gavage of the test substance, formulated in distilled water and administered at a dose level of 500 mg/kg bodyweight.
There were no deaths in the main study. Clinical signs of reaction to treatment were confined to piloerection and hunched posture, seen in all rats. Recovery was complete in all instances by Day 6.
All rats achieved satisfactory bodyweight gains throughout the study.
Macroscopic examination of animals killed on Day 15 revealed no abnormalities.
The discriminating oral dose to rats of test item was established to be 500 mg/kg bodyweight.
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