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EC number: 664-402-3 | CAS number: 5177-27-5
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 Oct 2018 - 18 Jan 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted in compliance with Method B1 bis of Council Regulation (EC) No 440/2008 and OECD Guidelines for Testing of Chemicals, Method 420 (adopted 17 December 2001).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Method B1 bis of Council Regulation (EC) No 440/2008
- Deviations:
- not specified
- GLP compliance:
- yes
- Remarks:
- including Compliance Statement and signatur page
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 2,4-Dichlor-pyrimidin-5-ylamine
- EC Number:
- 664-402-3
- Cas Number:
- 5177-27-5
- Molecular formula:
- C4H3Cl2N3
- IUPAC Name:
- 2,4-Dichlor-pyrimidin-5-ylamine
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Female (nulliparous, non-pregnant) Crl:WI(Han) strain rats were obtained from Charles
River (UK) Ltd., Margate
- The rats were in a body weight range of 154 to 192 g on Day 1.
- Rats were approximately 8 to 10 weeks old on Day 1.
CONDIDITIONS
- Mains water was provided ad libitum via water bottles
- Animals had access to 5LF2 EU Rodent Diet 14%, which was freely
available to the animals at all times, except for a period of fasting from the evening of the day
prior to dosing (Day-1) until approximately 3 hours after dosing.
- The animal rooms were designed to permit 15 to 20 air changes per hour. The target
temperature and humidity ranges were 20 to 24°C and 45 to 65% respectively.
- Fluorescent lighting was controlled automatically to give a cycle of 12 hours light and
12 hours dark.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Doses were administered orally, by gavage, using plastic syringes and rubber catheters. Each
rat was dosed once on Day 1, by passing the tip of a catheter along the oesophagus and
instilling the test article into the gastric lumen. - Doses:
- 300 mg/kg bw and 2000 mg/kg bw
dose volume: 10 mL/kg - No. of animals per sex per dose:
- 1 female per 300mg/kg bw (sighting study)
1 female per 2000mg/kg bw (sighting study)
4 females per 2000mg/kg bw (main study)
4 females per 300mg/kg bw (main study) - Control animals:
- no
- Details on study design:
- All animals were observed at the beginning and the end of the working day for signs of ill
health or overt toxicity.
Treated rats were observed closely for clinical signs of reaction to treatment. Clinical signs
were recorded immediately post-dose, at approximately 15 and 30 minutes post-dose, hourly
between 1 and 4 hours post-dose (inclusive), twice daily on Days 2, 3 and 4 and once daily
from the fifth to last day of the observation period. Individual records of clinical signs were
maintained for each treated rat.
Rats were weighed on Day-1 (day before dosing) and on Days 1, 4, 8 and 15.
Results and discussion
- Preliminary study:
- In the preliminary study female fasted rats were given the test article as a single dose on
Day 1 by oral gavage at dose levels of 300 and 2000 mg/kg.
Since there were no deaths in the preliminary study at a dose level of 2000 mg/kg, a further
four fasted females were given a single oral dose of test article at a dose level of 2000 mg/kg
body weight.
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- < 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two animals treated at 2000 mg/kg were found dead 3 hours after dosing, with a further two
found dead 4 hours after dosing. One animal treated at 300 mg/kg was found dead on Day 2. - Clinical signs:
- other: Clinical signs noted in animals treated at 2000 mg/kg were decreased activity, ataxia, lethargy, hunched posture, piloerection, ptosis and prone posture. These clinical signs developed from 15 minutes after dosing and lasted up to Day 4.
- Gross pathology:
- No abnormalities were noted at necropsy except for pale pituitary noted in one animal treated
at 300 mg/kg and pale and distended colon noted in one other animal treated at this dose
level.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The test article, CD 314, was classified as Category 4 in respect of its acute oral toxicity
according to the Globally Harmonized System of Classification and Labelling of Chemicals
(GHS).
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