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EC number: 687-893-6 | CAS number: 1150560-54-5
- 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:
- 4th June 2018 to 29th October 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Acute Dermal Toxicity (TG402) published by the Ministry of Environmental Protection of Peoples Republic of China in the year 2013
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 1-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-5-iodo-6-methyl-1,2,3,4-tetrahydropyrimidine-2,4-dione
- EC Number:
- 687-893-6
- Cas Number:
- 1150560-54-5
- Molecular formula:
- C13H9F4IN2O2
- IUPAC Name:
- 1-{[2-fluoro-6-(trifluoromethyl)phenyl]methyl}-5-iodo-6-methyl-1,2,3,4-tetrahydropyrimidine-2,4-dione
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Physical check up and acclimation were made to all animals on arrival. Healthy young animals were acclimatised to the laboratory conditions and housed two per cage in the facility of Room D101 for 7 days prior to the test. All animals were weighed and marked on the hair. Clinical observations were performed daily until grouping. Animals were raised in suspended stainless steel cages. Animals were housed individually during the test.
Temperature: 20-25oC
Humidity: 40-70%
Light sequence: 12 hour light / 12 hour dark
Food: Sterilised diet with complete nutrition (Beijing keaoxieli Feed Co. Ltd.)
Water: ad libitum
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- According to body weights, the theoretical amounts of the test item were calculated.
Theoretical Weighed Test Item (mg/animal) = Body Weight (kg) x Dose (mg/kg)
The test item was weighed on a piece of gauze (6cm x 6cm) stuck on a small piece of medical tape (non-irritating) moistened with 0.5ml vehicle. Approximately 24 hours before the test, fur was removed from the dorsal area of the trunk of the test animal by clipping. Only animals with healthy and intact skin were used. The gauze was placed over the treatment area and wrapped with a piece of self-adhesive bandage. Shortly after dosing, the dressings were examined to ensure that the animals cannot ingest test item. - Duration of exposure:
- 14 days
- Doses:
- One dose
- No. of animals per sex per dose:
- 5 males
5 females - Details on study design:
- Clinical observations were performed once during the first 30 mins and at 1, 2 and 4 hours, then once each day for 14 days.
Careful observations and records of fur changes, eye & mucosa, respiratory, circulatory, nervous system, limb activity and behavioural changes.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: There were no abnormal findings during the test
- Gross pathology:
- There were no findings during gross necropsy in any of the animals at the end of study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results, the acute dermal toxicity of Methyl iodourcil was estimated to be above 2000 mg/kg and therefore classified as a Hazard Category of 5 according to Globally Harmonized System (GHS). However, since category 5 for acute dermal tox has not been adopted by the EU, the classification will be GHS criteria not met.
- Executive summary:
Objective
The study was performed to assess the acute dermal toxicity of methyl iodouracil in the Sprague Dawley rat. The method was designed to meet the guidelines for the Testing of Chemicals - Acute Dermal Toxicity (TG402) published by the Ministry of Environmental Protection of Peoples Republic of China in the year 2013.
General Procedure
A limit test at one dose level of 2000 mg/kg bw was carried out via a dermal route in a group of 10 animals (5 male, 5 female). Clinical observations were performed once during the first 30 mins and at 1, 2 and 4 hours, then once each day for 14 days. Individual weights were determined within 24 hours after arrival, at grouping, on Day 0, Day 7 and Day 14. At the end of the test, a gross necroscopy was performed on all animals under test.Results
Mortality: No deaths or moribund states were observed during the study.
Clinical observations: There were no abnormal findings during the study.
Skin Reactions: No signs of dermal irritation were observed during the study.
Body Weights:All animals gained weight over the course of the study.
Gross necropsy: There were no findings during gross necropsy.
Conclusions: Based on the results, the acute dermal toxicity of Methyl iodourcil was estimated to be above 2000 mg/kg and therefore classified as a Hazard Category of 5 according to Globally Harmonized System (GHS).
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