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Diss Factsheets
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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 fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 22 to 26th September 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 203 (Fish, Acute Toxicity 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:
- Prior to initiation of the definitive test, water samples were collected from the exposure tanks to verify test concentrations and proper chemical delivery system function. During the test, water samples (SO mL in volume from each replicate) were collected from the controls and test solution and composited prior to analysis to verify actual exposure concentrations. The primary DMF stock utilized during the definitive test was also sampled and analyzed at test initiation
Test solutions
- Vehicle:
- yes
- Remarks:
- DMF
- Details on test solutions:
- A single primary stock was prepared for the limit test at a nominal concentration of 10,000 mg Montelukast Sodium Salt in DMF by diluting 1.0123 g of test substance in 10.0 mL DMF (Mallinckrodt Lot# 5356 N26437). The measured stock concentration was 10,700 mg. During the test, a total volume of 42 µL of stock was injected into the chemical mixing box (total volume of 4,160 mL) during each diluter cycle to provide a high nominal test concentration
Test organisms
- Test organisms (species):
- Pimephales promelas
- Details on test organisms:
- Juvenile fathead minnow, Pimephales promelas, were received on September 10, 2003 at Toxikon Corporation from Aquatox Inc., Hot Springs, Arkansas. P. promelas were maintained in filtered laboratory freshwater for a 12-day period prior to test initiation. P. promelas appeared to be in good physical condition at test initiation. Mortality during the 7-day period prior to test initiation was zero percent.
P. promelas used for the definitive test ranged from 1.0 to 1.4 centimeters (cm) total length (mean and standard deviation: 1.2 ± 0.1 cm) and from 0.0051 to 0.0141 grams (g) wet weight (mean and standard deviation: 0.0093 ± 0.0031 g) as measured from the control fish at test termination. Loading was calculated to be 0.0062 g of fish tissue per liter of test solution.
Study design
- Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- Survival was monitored daily and fish were also monitored for any abnormal behaviour or appearances
Test conditions
- Hardness:
- Filtered freshwater with an initial hardness of 60 mg/L as CaC03
- Test temperature:
- Measure daily and ranged between 21.9 - 23 degree
- pH:
- measured daily and ranged between 7.1-7.4
- Dissolved oxygen:
- measured daily and ranged from 6.2 to 7 mg/L
- Salinity:
- initial alkalinity of 11 mg/L
- Conductivity:
- Initial conductivity of 350 µS
- Nominal and measured concentrations:
- Nominal Concentration 100 µg/L
Measured Concentration 77.8 µg/L - Details on test conditions:
- Studies were previously conducted with the test substance in saltwater, which gave recoveries at around 100 µg Montelukast Sodium Salt /L the limit of aqueous solubility (Toxikon Study numbers 02J0038b, 02J0038c). The highest concentration tested in the freshwater studies was therefore 100 µg Montelukast Sodium Salt./L.
- Reference substance (positive control):
- no
Results and discussion
Effect concentrations
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 0.778 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: limit of solubility
- Details on results:
- The diluter functioned properly during the entire definitive test based upon daily calculations and observations of test substance delivery. The mean measured concentration of the single test treatment was 77.8 µg Montelukast Sodium Salt /L, which was 77.8% of the nominal concentration. Chemical recovery ranged between 74.8 and 82.3 µg Montelukast Sodium Salt /L during the 96-hour exposure. The solution appeared clear and colorless and the concentration remained stable throughout the test.
Mortality of fathead minnow exposed for 96 hours to Montelukast Sodium Salt was zero percent in the control, solvent control and in the single test concentration (Table 2). The 96-hour LCso could not be calculated due to a lack of significant mortality during the exposure period. The 96-hour NOEC can be stated to be the limit of solubility, which was the highest test concentration used, or 77.8 µg Montelukast Sodium Salt/L
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 96-hour LC50 could not be calculated due to the lack of significant mortality at the specified time, and therefore can be stated to be greater than the limjt of solubility or> 77.8 µg SINGULAIR /L. The no-observable-effect ¥oncentration (NOEC) was 77.8 µg SINGULAIR /L based on the lack of significant mortality at this test concentration.
- Executive summary:
A flow-through freshwater toxicity test was conducted at Toxikon Corporation, Jupiter, Florida, to determine the acute toxicity of Montelukast sodium salt to fathead minnow, Pimephales promelas, in accordance with OECD guideline 203. The criterion for effect was death. Results of the test are expressed as a 96-hour median lethal concentration (LC50), the concentration of Montelukast sodium salt
calculated to result in death to SO percent of the test population at the specified time.
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