N-cyclohexylcyclohexanamine 2-[1-[[[(1R)-1-[3-[(1E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetate

PBT assessment

PBT assessment: overall result

Reference

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.