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EC number: 801-607-0 | CAS number: 302962-49-8
- 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
Short-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2013 to March 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- not applicable
- Remarks:
- Light intensity ranged from 27 to 107 footcandles; slightly outside the acceptable range criteria. This deviation is not considered to have had an impact on the results or interpretation of this study.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-(2-chloro-6-methylphenyl)-2-({6-[4-(2-hydroxyethyl)piperazin-1-yl]-2-methylpyrimidin-4-yl}amino)-1,3-thiazole-5-carboxamide
- EC Number:
- 801-607-0
- Cas Number:
- 302962-49-8
- Molecular formula:
- C22 H26 Cl N7 O2 S
- IUPAC Name:
- N-(2-chloro-6-methylphenyl)-2-({6-[4-(2-hydroxyethyl)piperazin-1-yl]-2-methylpyrimidin-4-yl}amino)-1,3-thiazole-5-carboxamide
- Test material form:
- not specified
- Remarks:
- Purity grade not specified
Constituent 1
- Specific details on test material used for the study:
- Powder form stored at -20 °C.
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- The number of immobilized daphnids in each replicate test vessel was recorded at 0, 24 and 48 hours of exposure. Biological observations and observations of the physical characteristics of each replicate exposure solution and control were also made and recorded at 0, 24 and 48 hours, if applicable. The pH, dissolved oxygen concentration and temperature were measured at 0, 24 and 48 hours in replicate A of each treatment level and control.
Test solutions
- Vehicle:
- yes
- Remarks:
- DMF
- Details on test solutions:
- Exposure was conducted at nominal concentrations of 0.097, 0.21, 0.47, 1.0, 2.3 and 5.0 mg/L.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Age: < 24 hours old at exposure initiation
Source: Smithers Viscient culture facility
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- Not specified
Test conditions
- Hardness:
- Total hardness of dilution water: CaCO3: 180 mg/L
- Test temperature:
- 19 to 21 ºC
- pH:
- pH: 8.1
- Dissolved oxygen:
- c.a. 10mg/L
- Salinity:
- Freshwater
- Conductivity:
- c.a. 620 μS/cm,
- Details on test conditions:
- Nominal: 0.097, 0.21, 0.47, 1.0, 2.3 and 5.0 mg/L
Measured: 0.093, 0.21, 0.47, 1.0, 2.3 and 5.1 mg/L - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 24 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 5.1 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- ca. 3.7 mg/L
- Nominal / measured:
- meas. (not specified)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- Following 48 hours of exposure, 0, 0, 0, 15, 20 and 70% immobilization was observed in the 0.093, 0.21, 0.47, 1.0, 2.3 and 5.1 mg/L treatment levels, respectively. Several daphnids exposed to the 1.0 mg/L treatment level were observed to be lethargic following 48 hours of exposure. All surviving daphnids exposed to the 2.3 and 5.1 mg/L treatment levels were observed to be on the bottom of the test vessel following 48 hours of exposure. Following 48 hours of exposure 5% immobilization was observed among daphnids exposed to the control and no immobilization or adverse effects were observed among daphnids exposed to the solvent control.
Any other information on results incl. tables
Mean Measured Concentration (mg/L) | Cumulative Percent Immobilization (a) | |||||||||
24-hour | 48-hour | |||||||||
A | B | C | D | Mean | A | B | C | D | Mean | |
Control | 0 | 0 | 0 | 0 | 0 | 20 | 0 | 0 | 0 | 5b |
(0) | (0) | (0) | (0) | (1) | (0) | (0) | (0) | |||
Solvent Control | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
(0) | (0) | (0) | (0) | (0) | (0) | (0) | (0) | |||
0.093 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
(0) | (0) | (0) | (0) | (0) | (0) | (0) | (0) | |||
0.21 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
(0) | (0) | (0) | (0) | (0) | (0) | (0) | (0) | |||
0.47 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
(0) | (0) | (0) | (0) | (0) | (0) | (0) | (0) | |||
1 | 0 | 0 | 0 | 0 | 0 | 0 | 20 | 20 | 20 | 15c |
(0) | (0) | (0) | (0) | (0) | (1) | (1) | (1) | |||
2.3 | 0 | 0 | 0 | 0 | 0c | 20 | 40 | 0 | 20 | 20d |
(0) | (0) | (0) | (0) | (1) | (2) | (0) | (1) | |||
5.1 | 0 | 0 | 0 | 0 | 0c | 80 | 60 | 80 | 60 | 70d |
(0) | (0) | (0) | (0) | (4) | (3) | (4) | (3) | |||
a The actual number of immobilized daphnids is presented in parentheses. | ||||||||||
b ASTM (2002) recognizes the limitations of acute toxicity testing, i.e., response less than or equal to 10% is allowable in a control population and is considered within the expected range of naturally occurring variability. | ||||||||||
c Several daphnids were observed to be lethargic. | ||||||||||
d All surviving daphnids were observed to be on the bottom of the test vessel. |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on mean measured concentrations of dasatinib, the 48−hour EC50 value for dasatinib and Daphnia magna was determined to be 3.7 mg/L. The No-Observed-Effect Concentration (NOEC) was determined to be 0.47 mg/L. The highest concentration producing 0% toxicant-related immobilization was 0.47 mg/L. No concentration tested produced 100% immobilization.
- Executive summary:
Based on mean measured concentrations of dasatinib, the 48−hour EC50 value for dasatinib and Daphnia magna was determined to be 3.7 mg/L. The No-Observed-Effect Concentration (NOEC) was determined to be 0.47 mg/L. The highest concentration producing 0% toxicant-related immobilization was 0.47 mg/L. No concentration tested produced 100% immobilization.
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