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EC number: 446-560-3 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-08-09 to 2002-08-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 22 March 1996
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 446-560-3
- EC Name:
- -
- Cas Number:
- 213265-83-9
- Molecular formula:
- C4HCl2FN2
- IUPAC Name:
- 4,6-dichloro-5-fluoropyrimidine
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HsdCpb:WU
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, District of Paderborn
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: males approx. 10 weeks and females approx. 9 weeks
- Weight at study initiation: males: 242-266 g; females: 172-188 g
- Fasting period before study: not reported
- Housing: grouped, conventionally in polycarbonate cages; the bedding consisted of low-dust wood granules type BK 8/15 (supplier: Ssniff, Spezialdiäten GmbH, Soest/Westphalia).
- Diet (e.g. ad libitum): ad libitum, "NAFAG Ò No. 9441 W 10" (manufacturer: Eberle Nafag AG, Gossau)
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° +/- 2°C
- Humidity (%): 55 +/- 5
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: The test substance was formulated in demineralized water with the aid of 2 % Cremophor EL before administration.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200, 20 and 2.5 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD (if applicable) acute toxic class
- Rationale for the selection of the starting dose: as required by the test guideline - Doses:
- 2000, 200 and 25 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The body weights of the rats are recorded on day 1 before administration and then weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Classification is based on cut-off values as indicated in the OECD guideline.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 30 - < 50 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals of the 2000 mg/kg bw and the 200 mg/kg bw group died within 5 to 50 min and 20 min to 2 h, respectively.
- Clinical signs:
- irregular respiration
- observations of tremors
- salivation
- other:
- Body weight:
- other body weight observations
- Remarks:
- The body weight and the body weight development of males and females were not affected by the treatment.
- Gross pathology:
- In animals that died during the observation period the following changes were detected:
Dark-red discoloration of liver
Slightly collapsed lung
Pale discoloration of kidneys
Pale discoloration of spleen
No gross pathologic changes were observed in animals sacrificed at the end of the study period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 based on GHS criteria
- Conclusions:
- In the present study conducted according to OECD test guideline 423 (1996) three animals were administered a single dose of either 2000, 200 or 25 mg/kg bw of the test substance and observed for further 14 days. All animals of the 2000 mg/kg bw and the 200 mg/kg bw groups died at least within 2h. None of the animals of the 25 mg/kg bw group died, thus the LD50 value was determined at > 30 < 50 mg/kg bw.
- Executive summary:
In an acute oral toxicity study according to OECD guideline 423, adopted 22 March 1996, 6 female, fasted, 9 weeks old Wistar strain rats and 3 male, fasted, 10 weeks old Wistar strain rats were given a single oral dose of 4,6-dichlor-5-fluorpyrimidinbe in demineralized water containing 2% Cremophor by gavage at a dose of 2000, 200 (females) and 25 mg/kg bw (males and females) and observed for 14 days.
6/6 animals of the 2000 and 200 mg/kg bw groups died 50 min and 2h after dosing, respectively. Clinical signs shown by the animals found dead included decreased, uncoordinated gait, labored breathing, increased salivation, narrowed palpebral fissures, and temporary tremor,. lateral position, temporary convulsions, reddened skin, increased motility, and tachypnea.
A dose of 25 mg/kg body weight was tolerated by male and female rats without mortalities and clinical signs.
The body weight and the body weight development of males and females were not affected by the treatment.
In animals that died during the observation period the following changes were detected:
Dark-red discoloration of liver
Slightly collapsed lung
Pale discoloration of kidneys
Pale discoloration of spleen
No gross pathologic changes were observed in animals sacrificed at the end of the study period.
Oral LD50 (rat, combined) > 30< 50 mg/kg bw
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