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EC number: 611-575-8 | CAS number: 577953-88-9
- 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:
- September 16 to 18, 2003
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[1-[[1-[3-[2-[(7-Chloro-2-quinolyl)]vinyl]phenyl]-3-[2-(1-hydroxy-1-methyl-ethyl)phenyl]-propyl]sulfanylmethyl]cyclopropyl]acetic acid sodium salt
- EC Number:
- 604-813-7
- Cas Number:
- 151767-02-1
- IUPAC Name:
- 2-[1-[[1-[3-[2-[(7-Chloro-2-quinolyl)]vinyl]phenyl]-3-[2-(1-hydroxy-1-methyl-ethyl)phenyl]-propyl]sulfanylmethyl]cyclopropyl]acetic acid sodium salt
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Montelukast sodium; Purity as is 98.8%, fine white powder
Received in Amber glass bottles, dessicated, stored at room temperature and was stored in the dark at room temperature
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Test substance concentrations were determined in the control and test treatments at test initiation and termination. On test day 0, 100-mL samples were pipetted from the composite treatments before distribution to the test chambers. At test termination, all replicate chambers for each test concentration were pooled and 100-mL samples were pipetted from each composite.
Test solutions
- Vehicle:
- yes
- Remarks:
- DMF
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Daphnia magna used for testing were obtained from Toxikon cultures, which originated from animals received from Aquatic Research Organisms, Hampton, New Hampshire in July 2002. A subculture of adults was isolated from these cultures and maintained prior to testing. Test organisms were taken from lot number DM 03-9-16 for the definitive test. The cultures were fed the green alga, Selenastrum capricornutum, and a solution leaves (Cerophyll®) and trout chow daily.
Less than 24 hours prior to tet initiation the adults were re-isolated in food-free dilution water. Neonates {<24 hours old) were collected for test initiation on September 16, 2003. Daphnia magna were cultured and isolated in moderately hard freshwater (dilution water). No ephippia were produced during culture and the organisms appeared in good physical condition at test initiation.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Test temperature:
- 20.l to 20.5°C
- pH:
- ranged from 7.5 to 7.8 for the duration of the 48-hour exposure
- Dissolved oxygen:
- Inital range were 8.9 to 9. 0, ranged from 8.3 to 8.5 mg/L (92 to 94 percent of saturation} at termination
- Nominal and measured concentrations:
- Nominal concentrations (µg/L) : 6.25, 12.5, 25, 50, 100
Mean Measured (µg/L): 5.03, 7.31, 15, 31.3, 67.5
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 0.068 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: NOEC was the maximium dissolved concentration
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 48-hour EC50 could not be calculated due to lack of significant mortality at the specified time and can be stated to be greater than the highest concentration tested or > 67.5µg Montelukast sodium Salt . The 48- hour no observable-effect concentration (NOEC) was therefore the maximum dissolved concentration or 67.5 µg Montelukast sodium Salt /L.
- Executive summary:
A static freshwater toxicity test was conducted at Toxikon Corporation, Jupiter, Florida, to determine the acute toxicity of (Montelukast sodium Salt) to the water flea, Daphnia magna. The criterion for effect was death or immobilization (i.e., animals unable to swim within 15 seconds after gentle agitation of the test chamber). Results of the test are expressed .as a 48- hour median effective concentration (EC50), the concentration of Montelukast sodium Salt estimated to result in immobilization or death to 50 percent of the test population at the specified time.
The 48-hour EC50 could not be calculated due to lack of significant mortality at the specified time and can be stated to be greater than the highest concentration tested or> 67.5 µg Montelukast sodium Salt . The 48- hour no observable-effect concentration (NOEC) was therefore the maximum dissolved concentration or 67.5 µg Montelukast sodium Salt /L.
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