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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
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Montelukast dicyclohexylamine salt
- Type of composition:
- legal entity composition of the substance
- State / form:
- solid: particulate/powder
- Reference substance:
- Montelukast dicyclohexylamine salt
- PBT status:
- the substance is not PBT / vPvB
- Justification:
One key study was completed according to a OECD 301B Ready Biodegradation Carbon Dioxide (C02) Evolution Test (Modified Sturm Test) of Montelukast Dicyclohexylamine salt.
The test material attained 3 and 7% degradation (bottle A and B respectively) after 28 days and therefore cannot be considered to be readily biodegradable under the strict terms and conditions of OECD Guideline No 301B. Based screening criteria in Annex VIII for P/vP the substance would be considered to fullfil the screening criteria as potentially P.
One key study was completed for partition coefficient according to EC A.8 and OECD method 107 following GLP. As the substance is a salt a log Kow value was determined for the cationic and anioic portion of the substance. Based on Dicyclohexylamine the log Pow Value is 0.2 and based on Montelukast the log Pow is 4.9 at 20°C by the shake flask method. As a result the screening criteria for B as per Annex VIII could be considered as been meet based on the LogKow for Montelukast.
There is no short or long term aquatic studies available for Montelukast Dicyclohexylamine salt however the substance comprises of a salt of dicyclohexylamine (DCHA) and Montelukast salt. The substance can be expected to dissociate in physiological fluids to its component ions. Aquatic effects have been predicted on the results of studies conducted on the consituent ions. Studies are available for for both Montelukast Sodium Salt and DCHA separately. Montelukast Sodium Salt Acute Daphnia (EC50 >0.0675mg/L limit of solubility), Algae (>100mg/L nominal value) and Fish (EC50 >0.0778 mg/L Limit of Solubility).
Acute studies are also available for DCHA: Acute Daphnia (EC50 >1mg/L, NOEC 0.016 mg/L), Algae (EC50 0.38 mg/l, NOEC 0.016 mg/L) and Fish (EC50 12 mg/L) with Daphnia being considered the most sensitive species.
Long term studies for Montelukast Sodium Salt are available for Daphnia (EC50 0.51mg/L, NOEC 0.23mg/L) and Fish ELS (NOEC 0.073mg/L) while a Daphnia study is available for DCHA (EC50 0.14 mg/L, NOEC 0.016 mg/L). Based on the Long-term studies for both the Montelukast and the DCHA the T criteria for the aquatic would not be fulfilled. In addition the substance is not classified as a CMR or STOT.
Reference
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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