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EC number: 692-762-1 | CAS number: 166524-65-8
- 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:
- not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test material was administered as a single dose via gavage to three female Fischer 344 rats per dose level. Animals were observed for two weeks post-exposure.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-ethoxy-4,6-difluoropyrimidine
- EC Number:
- 692-762-1
- Cas Number:
- 166524-65-8
- Molecular formula:
- C6H6F2N2O
- IUPAC Name:
- 2-ethoxy-4,6-difluoropyrimidine
- Test material form:
- other: liquid (unspecified)
- Details on test material:
- - Name of test material (as cited in study report): 2-Ethoxy-4,6-difluoropyrimidine
- Appearance: clear liquid
- pH: 3.0
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 weeks
- Weight at study initiation: 129.5 - 146.3 g
- Fasting period before study: Yes. All animals were fasted the night before treatment. Feed was provided to animals following test material administration.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: unchanged or in 0.5 % methocel
- Details on oral exposure:
- Rats received 50 or 100 mg/kg as a 10 % solution in 0.5 % methocel or 500, 1000 or 2000 mg/kg of neat test material by single-dose oral gavage.
- Doses:
- 50, 100, 500, 1000 and 2000 mg/kg bw.
- No. of animals per sex per dose:
- 3 females per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of weighing: individual body weights were recorded on test day 1, 2, 8 and 15
- Necropsy of survivors performed: no data
- Other examinations performed: mortality and clinical signs
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 50 - 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At 1000 and 2000 mg/kg, all three animals were dead within three hours of dosing. At 500 mg/kg, all three animals were dead within six hours of dosing.
At the 100 mg/kg dose level, one animal out of three died by test day two. All animals survived the test period at the 50 mg/kg dose level. - Clinical signs:
- other: Clinical signs indicative of systemic toxicity in the 2000, 1000 and/or 500 mg/kg dose levels consisted of salivation, severe lacrimation, chromorhinorrhea, faecal soiling, loose stool, decreased activity, lateral recumbency, incoordination and muscle twi
Any other information on results incl. tables
Table 1: Individual Rat Body Weights (g)
Dose Level (mg/kg) |
Animal Number |
Test Day |
|||
1 |
2 |
8 |
15 |
||
100 |
93A6466 |
138.0 |
- |
- |
- |
93A6467 |
137.1 |
139.3 |
156.3 |
159.2 |
|
93A6468 |
139.3 |
138.8 |
150.8 |
159.7 |
|
50 |
93A6469 |
145.8 |
147.8 |
166.9 |
175.1 |
93A6470 |
142.4 |
146.0 |
161.7 |
171.6 |
|
93A6471 |
129.5 |
135.2 |
150.2 |
154.1 |
- = Dead animal
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, the acute oral LD50 of the test material was estimated to be between 50 and 500 mg/kg bw. As such, the test material is classified as Category 3 in accordance with EU criteria.
- Executive summary:
A study was conducted to investigate the acute oral toxicity potential in female Fischer 344 rats.
Three fasted female rats per dose level received 50 or 100 mg/kg as a 10 % solution in 0.5 % methocel or 500, 1000 or 2000 mg/kg of the neat test material by single-dose oral gavage. Animals were observed for two weeks following test material administration.
At 1000 and 2000 mg/kg, all three animals were dead within three hours of dosing. At 500 mg/kg, all three animals were dead within six hours of dosing. At the 100 mg/kg dose level, one animal out of three died by test day two. All animals survived the test period at the 50 mg/kg dose level.
Clinical signs indicative of systemic toxicity in the 2000, 1000 and/or 500 mg/kg dose levels consisted of salivation, severe lacrimation, chromorhinorrhea, faecal soiling, loose stool, decreased activity, lateral recumbency, incoordination and muscle twitches. Clinical signs indicative of systemic toxicity at the 100 mg/kg dose level consisted of salivation, lacrimation, chromorhinorrhea, urine soiling and decreased activity. Signs of toxicity began within an hour of dosing through test day two. Both surviving animals from the 100 mg/kg dose group were observed as normal from test day three through the remainder of the observation period. All animals given 50 mg/kg had salivation one hour after dosing and were observed as normal through the remainder of the observation period.
Administration of the test material had no effect on body weight during the two week observation period.
Under the conditions of the study, the acute oral LD50 of the test material was estimated to be between 50 and 500 mg/kg bw. As such, the test material is classified as Category 3 in accordance with EU criteria.
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