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EC number: 435-030-7 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 435-030-7
- EC Name:
- -
- Cas Number:
- 26452-81-3
- Molecular formula:
- C5H5N2OCl
- IUPAC Name:
- 4-chloro-6-methoxypyrimidine
- Test material form:
- other: solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: Males: 354 - 418 g; Females 222 - 238 g
- Fasting period before study: overnight
- Housing: Max 5 rats per cage, sexes separately, in cages suitable for animals of this strain and the weight range expected during the course of the study.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: ≥5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): ≥15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg - Doses:
- 500 mg/kg
- 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: Prior to the dosing, all rats were examined to ensure that they were physically normal and exhibited normal activity. The animals were observed for signs of systemic toxicity at least twice following dosing on day 1. Subsequent observations were made daily, up to day 15. The animals were weighed prior to fasting on the day before dosing (day 0), immediately before dosing (day 1) and on days 8 and 15.
- Necropsy of survivors performed: yes; macroscopic examination
Results and discussion
- Preliminary study:
- Following a dose of 2000 mg/kg in one female animal, the animal was killed in extremis approximately 5 hours after dosing on day 1. There were no macroscopic abnormalities at examination post mortem.
Following a dose of 500 mg/kg in one female animal, the animal showed signs of evident toxicity, with complete recovery by day 6.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Following a dose of 500 mg/kg, none of the animals died.
- Clinical signs:
- other: There were signs of evident toxicity in all animals. These signs included decreased activity, piloerection, (signs of) salivation, subdued behaviour and reduced breathing rate in all animals. Upward curvature of the spine was observed in all female animal
- Gross pathology:
- There were no treatment-related findings at examination post mortem.
One male had red areas in the thymus. This is considered to be a spontaneous finding which is incidental to treatment.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The highest fixed dose of test substance administered in this test without causing any lethality (ie the discriminating dose-level), was 500 mg/kg to male and female rats.
- Executive summary:
In this GLP compliant fixed dose oral toxicity study, performed according to OECD guideline 420, Alpk:APrSD (Wistar-derived) rats were administered the test substance by oral gavage followed by a 14 -day observation period. In a sighting phase, single female animals received a single oral dose of 2000 or 500 mg/kg of test substance and were assessed daily for 6 days for any signs of systemic toxicity. Following a dose of 2000 mg/kg, the animal was killed in extremis on day 1. Following a dose of 500 mg/kg, the animal showed signs of evident toxicity, with complete recovery by day 6. From the results of the sighting phase of the study, a single fixed dose level of 500 mg/kg was selected for the main phase of the study. A group of five male and five female rats was dosed once and assessed daily for 14 days for any signs of systemic toxicity. Their body weights were recorded at intervals throughout the study. At the end of the study all the animals were killed and subjected to a macroscopic examination. Following a dose of 500 mg/kg, none of the animals died. There were signs of evident toxicity in all animals, with complete recovery by day 4. All the males and two of the females showed an overall body weight gain during the study. Three females showed a slight overall weight loss. There were no treatment-related abnormalities at examination post mortem. In conclusion, the highest fixed dose of the test substance administered in this test without causing any lethality (i.e. the discriminating dose-level), was 500 mg/kg to male and female rats.
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