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EC number: 255-207-0 | CAS number: 41078-70-0
- 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:
- 2006-03-29 to 2006-05-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate from the Swiss GLP monitoring authorities.
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 3-(2-chloroethyl)-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one
- EC Number:
- 255-207-0
- EC Name:
- 3-(2-chloroethyl)-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one
- Cas Number:
- 41078-70-0
- Molecular formula:
- C11H11ClN2O
- IUPAC Name:
- 3-(2-chloroethyl)-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): JNJ-559728-AAA (T001250)
- Physical state: solid (powder)
- Appearance: White powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Janssen Pharmaceutical N.V.; 00443418 RT001250G4a661
- Expiration date of the lot/batch: Unknown, excluded from statement of compliance
- Purity: 100%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (range of 20 +/- 5 C), light protected
- Stability under test conditions: Stable under storage conditions
- Solubility and stability of the test substance in the solvent/vehicle: unknown in Peg 300
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The dose formulations were made shortly before each dosing occassion using a magnetic stirrer, a spatula and an Ultra-Turrax as homogenizers. The test item was weighed into a tared glass beaker on a suitable precision balance and the vehicle added. Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
Test animals
- Species:
- rat
- Strain:
- other: HanRcc:WIST (SPF)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd.., Laboratory Animal Services CH-4414 Fullinsdorf / Switzerland
- Age at study initiation: 12 weeks
- Weight at study initiation: 187.7 - 203.9 grams
- Fasting period before study: no data
- Housing: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding ('Lignocel' Schill AG, CH-4132 Muttenz/Switzerland).
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 001/06 (Provimi Kliba AG, CH-4303 Kaiseraugst/Switzerland) ad libitum.
- Water (e.g. ad libitum): community tap water from Fullinsdorf ad libitum
- Acclimation period: 6 to 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 22 +/- 3 deg C
- Humidity (%): 30-70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12, with music played during light cycle
IN-LIFE DATES:
From: 2006-04-05 To: 2006-04-19 (1st 300 mg/kg treatment)
From: 2006-04-11 To: 2006-04-11 (2000 mg/kg treatment)
From: 2006-04-20 To: 2006-05-04 (2nd 300 mg/kg treatment)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL/kg body weight
- Justification for choice of vehicle: The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date.
- Lot/batch no. (if required): 120471944705164
MAXIMUM DOSE VOLUME APPLIED:
- 2000 mg/kg-bw - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- Three females/group, 9 animals total (3 groups)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
Observation: During the acclimatization period, and the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1
(with the clinical signs) and twice daily during days 2-15.
Weighing: on days 1 (prior to test), 8, and 15
- Necropsy of survivors performed: yes - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Mortality:
- All animals tested at a concentration dose of 2000 mg/kg died spontaneously or were killed in extremis for ethical reasons approximately 7.5 hours after treatment. All of the animals treated with 300 mg/kg survived until the end of the study period.
- Clinical signs:
- irregular respiration
- salivation
- other:
- Body weight:
- greater than 10% body weight loss
- Remarks:
- The body weight of all animals treated with 300 mg/kg was found diminished (3% to 17%) one week after treatment. The animals recovered the lost weight until the end of the study.
- Gross pathology:
- At the unscheduled necropsy, one 2000 mg/kg treated animal had collapsed lungs, a stomach with liquid contents and the duodenum and jejunum were filled with yellowish liquid. The other two animals treated at the same dose showed a stomach with yellowish liquid contents and a distended urinary bladder filled with yellowish urine. No macroscopic findings were recorded in the 300 mg/kg treated groups at the scheduled necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The median lethal dose of the test substance after single oral administration to female rats, observed over a period of 14 days was: 300 mg/kg < LD50 (female rat) < 2000 mg/kg body weight.
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