Hydroxychloroquine

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:

guideline study

Justification for type of information:

Guideline study to GLP standards with no deviations

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Hydroxychloroquine

EC Number:

204-249-8

EC Name:

Hydroxychloroquine

Cas Number:

118-42-3

Molecular formula:

C18H26ClN3O

IUPAC Name:

2-({4-[(7-chloroquinolin-4-yl)amino]pentyl}(ethyl)amino)ethan-1-ol

Test material form:

solid

Remarks:

white solid powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material:
HYDROXYCHLOROQUINE (CAS N°118-42-3) – Batch 5U054 (Synonym: PLAQUENIL)

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, non-adapted

Details on inoculum:

- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): Rouen system treatment plant on March 15th, 2016.
- Method of cultivation: This sludge was pre-conditioned to the experimental conditions, but not pre-adapted to the test substance. The pre-conditioning consisted of aerating activated sludge (in mineral medium) for 7 days at the test temperature. The inoculum was taken from the supernatant of this pre-conditioned activated sludge.

Duration of test (contact time):

28 d

Parameter followed for biodegradation estimation

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

TEST CONDITIONS
- Test temperature: 21°C +/- 1°C
- Continuous darkness: no

SAMPLING
- Sampling frequency: 0.1 days
- Sampling method: The BOD (Biological Oxygen Demand) values were given by OXITOP OC 110 Controller

CONTROL AND BLANK SYSTEM
- Inoculum blank: 2
- Abiotic sterile control: 1
- Toxicity control: 1
- Other: Procedure control: One flask

Reference substance

Reference substance 1

Reference substance:

other: Nitrite

Reference substance 2

Reference substance:

other: Nitrate

Reference substance 3

Reference substance:

benzoic acid, sodium salt

Results and discussion

Preliminary study:

None

Test performance:

Validity criteria were fulfilled.

% Degradation

Key result

Parameter:

% degradation (O2 consumption)

Value:

< 1

Sampling time:

28

Remarks on result:

other: Zero degradation recorded

Details on results:

Not Readily Biodegradable

BOD5 / COD results

Results with reference substance:

95% biodegradation after 28 days

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

not readily biodegradable

Conclusions:

The reliable OECD 301F Guideline study on ready biodegradability reported a degradation rate of the test item of 0% after 28 days. Therefore, the test item is considered to be not readily biodegradable.

Executive summary:

The reliable OECD 301F Guideline study on ready biodegradability reported a degradation rate of hydroxychloroquine of 0% after 28 days. Therefore, hydroxychloroquine is considered to be not readily biodegradable.