Thieno[3,2-c]pyridine-5(4H)-acetic acid, .alpha.-(2-chlorophenyl)-6,7-dihydro-, methyl ester, (.alpha.S)-, (1R,4S)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptane-1-methanesulfonate (1:1)

Biodegradation in water: screening tests

Administrative data

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented study according to international accepted guidelines and GLP compliant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

[(1R)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl]methanesulfonic acid; methyl (2S)-2-(2-chlorophenyl)-2-{4H,5H,6H,7H-thieno[3,2-c]pyridin-5-yl}acetate

EC Number:

601-680-7

Cas Number:

120202-68-8

Molecular formula:

C16H16ClNO2S.C10H16O4S

IUPAC Name:

[(1R)-7,7-dimethyl-2-oxobicyclo[2.2.1]heptan-1-yl]methanesulfonic acid; methyl (2S)-2-(2-chlorophenyl)-2-{4H,5H,6H,7H-thieno[3,2-c]pyridin-5-yl}acetate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

CAS number: 120202-68-8
EC number: 601-680-7
Molecular formula: C16H16ClNO2S.C10H16O4S
Molecular weight: 552.14 g/mol
Batch number 648038N (0090D94)
Storage: At temperature of 15 to 30 °C, protected from light and moisture

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
250.0 ml inoculum test culture with 1.0 g/L dry substance was made by mixing 27 ml of stock culture with 223 ml mineral medium.

Duration of test (contact time):

28 d

Parameter followed for biodegradation estimation

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

The principle of the determination of BOD by OxiTop® - system is based on the measurement of the consumption of oxygen by a pressure sensor in the top of the tightly closed test vessels.

Test vessels with the test item solution and mixed bacterial culture, so called inoculum, are under continuous stirring in an incubator at 21 ± 1 °C for 28 days. The carbon dioxide which is evolved during the biodegradation is absorbed by sodium hydroxide granulates.
The reduced amount of oxygen causes definite pressure changes in the test vessels which are measured by the apparatus. The amount of oxygen taken up by microorganisms during biodegradation of the test item is expressed as a percentage of theoretical oxygen demand (ThOD).

Reference substance

Reference substance:

acetic acid, sodium salt

Results and discussion

% Degradation

Parameter:

% degradation (O2 consumption)

Value:

-1

Sampling time:

28 d

Details on results:

The percentage of biodegradability of the test item is calculated on the base of quotient of 28-day biochemical oxygen demand (BOD28) and theoretical oxygen demand.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

other: not ready biodegradable

Conclusions:

According to this biodegradability of "Clopidogrel camphorsulphonic acid salt" (CAS No. 120202-68-8) the results indicated that the test item is not ready biodegradable in the aquatic environment.