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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1998-11-25 to 1998-12-09
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- 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.: 960509
Purity: not specified
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: eight to eleven weeks
- Weight at study initiation: 224 to 258 g
- Housing: They were housed individually in metal cages (RS Biotech Sub-Dividable Rodent Cages - polished stainless steel (20cm high x 39cm wide x 39cm long)). The cages were fitted with grid floors to ensure rapid removal of waste material to undertrays. The cages were suspended in mobile stainless steel racks. The animals were returned to group housing on Day 8 of the study.
- Diet: standard laboratory rodent diet, ad libitum
- Water: ad libitum
- Acclimation period: six day at minimum
ENVIRONMENTAL CONDITIONS
- Temperature: 20-21 °C
- Humidity (%): 30-57
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours) in each 24-hour period.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- methylcellulose
- Details on dermal exposure:
- TEST SITE
One day prior to treatment, hair was removed from the dorso-lumbar region of each rat with electric clippers taking care to avoid damaging the skin, exposing an area equivalent to approximately 10% of the total body surface area.
The test substance was applied by spreading it evenly over the prepared skin. The treatment area (approximately 50 mm x 50 mm) was covered with porous gauze held in place with a non-irritating dressing and further covered by a waterproof dressing encircled firmly around the trunk of the animal.
REMOVAL OF TEST SUBSTANCE
At the end of the 24 hours exposure period the dressings was carefully removed and the treated area of skin was washed with warm water (38°C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3 mL/kg bodyweight
- Concentration (if solution): 66.67% w/v in 1% aqueous methylcellulose
VEHICLE
- Concentration (if solution): 1% aqueous methylcellulose - Duration of exposure:
- 24 h
- Doses:
- 2000 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: at least twice daily
Clinical signs: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days animals were observed on at least two occasions during the day (once in the morning and again at the end of the experimental day, with the exception of the day of study termination - morning only).
Dermal responses: Local dermal irritation at the treatment site was assessed daily
Bodyweight: recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes, All animals were killed by cervical dislocation at study termination (Day 15) and subjected to macroscopic examination
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths
- Clinical signs:
- other: no evidence of systemic response in any animal
- Gross pathology:
- No macroscopic abnormalities were observed
- Other findings:
- - Dermal responses: Slight to well defined erythema with or without slight oedema was observed in three males and five females, resolving completely in all males by Day 4 and in all females by Day 8. In addition, localised spots and/or scabbing was observed in one male and one female rat. No dermal irritation was seen in the remaining two animals.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute lethal dermal dose to rats of test item was demonstrated to be greater than 2000 mg/kg bodyweight.
- Executive summary:
A study was performed to assess the acute dermal toxicity of test item to the rat following the method described in OECD 402.
A group oftenrats (five males and five females) received a single topical application of the test substance formulated at a maximum practical concentration in 1% aqueous methylcellulose at a dosage of 2000 mg/kgbodyweight (EEC and OECD limit dosage). All animals were killed as scheduled at study termination (Day 15) and subjected to a macroscopic examination.
There were no clinical signs of reaction to treatment observed in any animal throughout the study.
Slight to well defined erythema with or without slight oedema was observed in eight rats, resolving completely by Day 8. In addition, localised spots and/or scabbing was observed in two of these animals. No dermal irritation was seen in the remaining two animals.
No bodyweight gain was observed in one animal on Day 8. All other animals were considered to have achieved satisfactory bodyweight gains throughout the study.
No macroscopic abnormalities were observed in any of the animals killed at study termination.
The acute lethal dermal dose to rats of test item was demonstrated to be greater than 2000 mg/kg bodyweight.
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