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EC number: 605-935-3 | CAS number: 181525-38-2
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-11-17 (date test substance was received) to 2004-10-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 9-hydroxy-3-(2-hydroxyethyl)-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one
- EC Number:
- 605-935-3
- Cas Number:
- 181525-38-2
- Molecular formula:
- C11H12N2O3
- IUPAC Name:
- 9-hydroxy-3-(2-hydroxyethyl)-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Sponsor's identification : RT 002416
Description : Off-white solid
Batch number : 00414101
Date received : 2003-11-17
Storage conditions : Room temperature, in the dark
Test animals
- Species:
- mouse
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS: no data
ENVIRONMENTAL CONDITIONS: no data
IN-LIFE DATES: no data
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: arachis oil
- Justification for choice of solvent: not indicated - Duration of treatment / exposure:
- single intraperitonal administration
- Frequency of treatment:
- once
- Post exposure period:
- Animals were killed 24 or 48 hours after administration, the bone marrow was extracted, and smear preparations made and stained.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Remarks:
- 24-hour sampling time
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- 24-hour sampling time
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Remarks:
- 24-hour and 48-hour sampling time
- No. of animals per sex per dose:
- - 7 mice/dose level of test substance.
- 7 mice administered vehicle only (administered IP)
- 5 mice administered positive control (cyclophosphamide administered orally) - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - cyclophosphamide
- Justification for choice of positive control(s): no data
- Route of administration: orally
- Doses / concentrations: 50 mg/kg
Examinations
- Tissues and cell types examined:
- 2000 bone marrow cells were scored to measure polychromatic (PCE) and normochromatic (NCE) erythrocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
- A range-finding test was performed to find suitable dose levels of the test substance, route of administration and to investigate to see if there was a marked difference in toxic response between the sexes. There was no marked difference in toxicity of the test substance between the sexes; therefore the main test was performed using only male mice.
- In the range-finding test no evidence of toxicity was observed in animals dosed with test substance via the oral route and, therefore systemic absorption could not be confirmed using this dose route. In the range finding test animals dosed with the test substance via the intraperitoneal route premature deaths occurred at and above 400 mg/kg, no clinical signs were observed.
TREATMENT AND SAMPLING TIMES (in addition to information in specific fields):
- The micronucleus test was conducted using the intraperitoneal route in groups of seven mice (males) at the maximum tolerated dose (MTD) 200 mg/kg and with 100 and 50 mg/kg as the two lower dose levels. Animals were killed 24 or 48 hours later, the bone marrow was extracted, and smear preparations made and stained.
- Further groups of mice were given a single intraperitoneal dose of arachis oil (7 mice) or dosed orally with cyclophosphamide (5 mice), to serve as vehicle and positive controls respectively. Vehicle control animals were killed 24 or 48 hours later, and positive control animals were killed after 24 hours.
- Evaluation criteria:
- No data
- Statistics:
- No data
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: not indicated
- Solubility: no data
- Clinical signs of toxicity in test animals: deaths occurred at and above 400 mg/kg, no clinical signs were observed
- Evidence of cytotoxicity in tissue analyzed: no data
- Rationale for exposure: In the range-finding test no evidence of toxicity was observed in animals dosed with test material via the oral route and, therefore systemic absorption could not be confirmed using this dose route.
In the range finding test animals dosed with the test material via the intraperitoneal route premature deaths occurred at and above 400 mg/kg, no clinical signs were observed.
- Harvest times: no data
- High dose with and without activation: not applicable
RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): no data
- Induction of micronuclei: There were no statistically significant increases in the frequency of micronucleated PCEs in any of the test material dose groups when compared to their concurrent vehicle control groups. The positive control substance induced a marked increase in the incidence of micronucleated polychromatic erythrocytes hence confirming the sensitivity of the system to the known mutagenic activity of cyclophosphamide under the conditions of the test.
- Ratio of PCE/NCE: There was a statistically significant decrease in the PCE/NCE ratio in the 48-hour 200 mg/kg test material group when compared to the concurrent vehicle control group. This was taken to indicate that systemic absorption had occurred and exposure to the bone marrow achieved.
- Appropriateness of dose levels and route: not indicated
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
The test substance was found not to produce a significant increase in the frequency of micronuclei in polychromatic erythrocytes in male mice under the conditions of the test and was therefore considered to be non-genotoxic under the conditions of the test.
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