3,5-Pyridinedicarboxylic acid, 2-[[2-[(2-carboxybenzoyl)amino]ethoxy]methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester

Biodegradation in water: screening tests

Administrative data

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 d

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-[(2-{[4-(2-chlorophenyl)-3-(ethoxycarbonyl)-5-(methoxycarbonyl)-6-methyl-1,4-dihydropyridin-2-yl]methoxy}ethyl)carbamoyl]benzoic acid

EC Number:

608-671-7

Cas Number:

318465-73-5

Molecular formula:

C28H29ClN2O8

IUPAC Name:

2-[(2-{[4-(2-chlorophenyl)-3-(ethoxycarbonyl)-5-(methoxycarbonyl)-6-methyl-1,4-dihydropyridin-2-yl]methoxy}ethyl)carbamoyl]benzoic acid

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, non-adapted

Details on inoculum:

Type of inoculum: aerobic mixed bacterial culture
Source: Municipal wastewater treatment plant, Esztergom-Kertváros
Date of arriving: 03 July 2017

Duration of test (contact time):

28 d

Details on study design:

Aerobic biodegradation of the test item was determined by measuring oxygen consumption in an inoculum containing aerobic mixed bacterial culture originated from a municipal wastewater treatment plant and maintained at laboratory conditions. The bacterial culture was not adapted to the test item.
The Biochemical Oxygen Demand for 28 days (BOD28) of test item were determined by the manometric respiratory - OxiTop® system. Blank controls, a positive control (reference item), a toxic control and an abiotic control treatment were also included in the study. The test duration was 28 days. Sodium acetate was used as reference item.

Reference substance

Reference substance:

acetic acid, sodium salt

Results and discussion

Test performance:

This study was performed to evaluate the ready biodegradability of Amlodipine phthalamidic acid in an aerobic aqueous medium. The study was performed according to OECD 301 guideline for testing chemicals (Ready Biodegradability), method F: Manometric Respirometry.
Aerobic biodegradation of the test item was determined by measuring oxygen consumption in an inoculum containing aerobic mixed bacterial culture originated from a municipal wastewater treatment plant and maintained at laboratory conditions. The bacterial culture was not adapted to the test item.
The Biochemical Oxygen Demand for 28 days (BOD28) of test item were determined by the manometric respiratory - OxiTop® system. Blank controls, a positive control (reference item), a toxic control and an abiotic control treatment were also included in the study. The test duration was 28 days. Sodium acetate was used as reference item. The measured BOD values for test item, positive and toxicity controls were corrected with the results of blank controls.
According to OECD guideline the test item should be classified as readily biodegradable if the percentage biodegradation reaches 60% of theoretical oxygen demand within 28 day period in a 10-day window. Based on ready biodegradability testing results the Amlodipine phthalamidic acid is not readily biodegradable.

% Degradation

Key result

Parameter:

% degradation (O2 consumption)

Value:

-1

Remarks on result:

other: mean of two replicates

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

not readily biodegradable

Conclusions:

According to OECD guideline the test item should be classified as readily biodegradable if the percentage biodegradation reaches 60% of theoretical oxygen demand within 28 day period in a 10-day window. Based on ready biodegradability testing results the Amlodipine phthalamidic acid is not readily biodegradable.