Registration Dossier
Registration Dossier
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EC number: 611-575-8 | CAS number: 577953-88-9
Endpoint summary
Administrative data
Description of key information
There is no short or long term aquatic studies available for Montelukast DCHA however the substance comprises of a salt of dicyclohexylamine (DCHA) and montelukast acid. 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 seperately. 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 Solubilty).
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).
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 above available information the Lowest NOEC value from the long term DCHA Daphnia (NOEC 0.016 mg/L) studies was selected as the point of departure of the PNEC evaluation
Additional information
Montelukast DCHA is classified for the environment as Acute and Chronic Toxicity 1 based on the DCHA and as the montelukast DCHA is not readily biodegradable
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