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EC number: 618-507-6 | CAS number: 90213-66-4
- 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:
- 21-NOV-2007 to 14-DEC-2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,4-dichloro-7H-pyrrolo[2,3-d]pyrimidine
- EC Number:
- 618-507-6
- Cas Number:
- 90213-66-4
- Molecular formula:
- C6H3Cl2N3
- IUPAC Name:
- 2,4-dichloro-7H-pyrrolo[2,3-d]pyrimidine
- Test material form:
- solid
- Details on test material:
- White to yellow tan colour
Constituent 1
- Specific details on test material used for the study:
- Identification: CP-902684
Description: Solid; tan
Batch Number: E010005632 or 166-TNN-73
Purity: 98%
Stability of Test Item: Stable under storage conditions.
Expiry Date: 21-MAR-2009
Stability of Test Item Dilution: Unknown in PEG 300; is excluded from the statement of compliance.
Storage Conditions: At room temperature (range of 20 ± 5 °C, provided by RCC), light protected.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animals: Rat, Sprague Dawley (SPF)
Rationale: Recognized by international guidelines as a recommended test system.
Breeder: Charles River Deutschland GmbH, Stolzenseeweg 32-36, D-88353 Kisslegg / Germany
Number of Animals per Group: 3 females
Total Number of Animals: 6 females
Age when treated: 11 weeks
Identification: Unique cage number and corresponding color-coded spots on the tail. The animals were marked at acclimatization start.
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
Room Number: 0105 / RCC Ltd, Füllinsdorf
Conditions: Standard Laboratory Conditions. Air-conditioned with 10-15 air changes per hour, and continuously monitored environment with ranges for room
temperature 22 ± 3 °C and for relative humidity between 30-70 % (values above 70 % during cleaning process possible), automatically controlled light cycle of 12 hours light and 12 hours dark, music during the daytime light period.
Accommodation: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: PEG 300
- Details on oral exposure:
- VEHICLE
Identification: Polyethylene glycol 300 (PEG 300)
Description: Colorless viscous liquid
Lot number: 1310049
Source: FLUKA Chemie GmbH, CH-9471 Buchs
Stability of the Vehicle: Stable under storage conditions; expiration date: June, 2009
Concentration in vehicle: The animals received a single dose of the test item by oral gavage administration at 2000 mg/kg. The dosing volume was 10 mL/kg body weight.
Justification for choice of vehicle: PEG 300 was found to be a suitable vehicle. The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. This formulation trial is excluded from the statement of compliance.
MAXIMUM DOSE VOLUME APPLIED: The dosing volume was 10 mL/kg body weight. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3f/dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights- days 1, 8 and 15, observations- first 30 mins, 1, 2, 3, and 5 hours after administration on day 1 and twice daily during days 2-15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ, pathology, mortality/viability - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No clinical signs were observed during the course of the study.
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of CP-902684 after single oral administration to female rats, observed over a period of 14 days is:
LD50 (female rat): greater than 2000 mg/kg body weight - Executive summary:
Two groups, each of three female Sprague Dawley (SPF) rats, were treated with CP-902,684 by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (PEG 300) at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg.
The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study period.
No clinical signs were observed during the course of the study.
Three females (nos. 1, 2, 4) lost body weight during the first week after treatment (female no. 1: 10.2 %, female no. 2: 0.4 % and female no. 4: 2.6 %) and one female did not gain weight during the same time but they recovered until the end of the study. In spite of this body weight loss, the body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were recorded at necropsy.
The median lethal dose of CP-902684 after single oral administration to female rats, observed over a period of 14 days is:
LD50(female rat): greater than 2000 mg/kg body weight
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