7-Cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide

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:

Feb - April 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.4-C (Determination of the "Ready" Biodegradability - Carbon Dioxide Evolution Test)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide

EC Number:

807-111-0

Cas Number:

1211441-98-3

Molecular formula:

C23H30N8O

IUPAC Name:

7-cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide

Test material form:

solid: bulk

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, adapted

Details on inoculum:

The freshly obtained sludge was kept under continuous aeration until further treatment. The concentration of suspended solids was determined to be 4.6 g/l in the concentrated sludge. Before use, the sludge was allowed to settle (79 minutes) and the supernatant liquid was used as inoculum at the amount of 10 ml/l of mineral medium.

Duration of test (contact time):

ca. 28 d

Initial test substance concentration

Initial test substance concentration 1

Initial conc.:

ca. 19 mg/L

Based on:

test mat.

Initial test substance concentration 2

Initial conc.:

ca. 12 mg/L

Based on:

TOC

Parameter followed for biodegradation estimation

Parameter followed for biodegradation estimation:

CO2 evolution

Results and discussion

Preliminary study:

The ThCO2 of LEE011-A4 was calculated to be 2.33 mg CO^2/mg.
The ThCO2 of sodium acetate was calculated to be 1.07 mg CO^2/mg.

% Degradation

Key result

Parameter:

% degradation (test mat. analysis)

Value:

>= 5 - <= 14

Sampling time:

28 d

Details on results:

The relative biodegradation values calculated from the measurements performed during the test period revealed 5 % and 14% biodegradation of LEE011-A4, for the duplicate bottles tested. Thus, the criterion for ready biodegradability (at least 60% biodegradation within a 10-day window) was not met.
In the toxicity control, more than 25% biodegradation occurred within 14 days (33%, based on ThCO2). Therefore, the test substance was assumed not to inhibit microbial activity.
Functioning of the test system was checked by testing the reference substance sodium acetate, which showed a normal biodegradation curve.

Any other information on results incl. tables

The temperature recorded in a vessel with water in the same room varied between 21.7 and 22.3°C.

The pH values of the different test media are 7.5 - 7.8

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

not readily biodegradable

Conclusions:

LEE011-A4 was not readily biodegradable under the conditions of the modified Sturm test presently performed.