O-6-deoxy-α-L-mannopyranosyl-(1→4)-O-β-D-glucopyranosyl-(1→6)-β-D-glucopyranosyl (2α,3β,4α)-2,3,23-trihydroxyurs-12-en-28-oate

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:

2017/12/20 to 2018/03/29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

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:

O-6-deoxy-α-L-mannopyranosyl-(1→4)-O-β-D-glucopyranosyl-(1→6)-β-D-glucopyranosyl (2α,3β,4α)-2,3,23-trihydroxyurs-12-en-28-oate

EC Number:

240-851-7

EC Name:

O-6-deoxy-α-L-mannopyranosyl-(1→4)-O-β-D-glucopyranosyl-(1→6)-β-D-glucopyranosyl (2α,3β,4α)-2,3,23-trihydroxyurs-12-en-28-oate

Cas Number:

16830-15-2

Molecular formula:

C48H78O19

IUPAC Name:

[6-[[3,4-dihydroxy-6-(hydroxymethyl)-5-(3,4,5-trihydroxy-6-methyloxan-2-yl)oxyoxan-2-yl]oxymethyl]-3,4,5-trihydroxyoxan-2-yl] 10,11-dihydroxy-9-(hydroxymethyl)-1,2,6a,6b,9,12a-hexamethyl-2,3,4,5,6,6a,7,8,8a,10,11,12,13,14b-tetradecahydro-1H-picene-4a-carboxylate

Test material form:

solid: particulate/powder

Details on test material:

Batch 170430040156
Manufacturing date 15 February 2017
Expiry date 15 February 2020
Supplier SEPPIC
Appearance White powder
Packaging Plastic bag
Date of receipt 16 November 2017
Storage In darkness at room temperature
Identification number of the test item 17-300

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, non-adapted

Details on inoculum:

The inoculum was prepared from activated sludge sampled in the aeration tank treatment plant receiving predominantly domestic sewage (Montataire - (60) France). After setting and washing, activated sludge was used as inoculum.
Activated sludge collected on: 18 January 2018
- Dry matter of activated sludge: 3.1 g/L
- Concentration of inoculum:
- Dry matter: 0.9 g/L
- Approximately 107 - 108 cells/L
- Organic carbon content: 85.3 mg/L
- Turbidity: 120 NTU

Duration of test (contact time):

ca. 28 d

Initial test substance concentration

Initial conc.:

ca. 52.9 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

Test system:
-Respirometric OxiTop® measuring system: the measuring system consists of reaction vessels (12 test flasks of 500 mL), each with a CO2 absorber, a magnetic stirring and a measuring head (the measuring heads record and save the pressure difference semi-continuously throughout the experiment).
-Vessel: cylindrical glass vessel of 500 mL capacity containing 305 mL of test medium (except toxicity control: 215 mL).
-Inoculum: prepared from activated sludge receiving predominantly domestic sewage, not pre-adapted to the test item.
-Test item: containing the test item “O-6-deoxy-α-L-mannopyranosyl-(1→4)-O-β-D-glucopyranosyl-(1→6)-β-D-glucopyranosyl (2α,3β,4α)-2,3,23-trihydroxyurs-12-en-28-oate” at the concentration of 52.9 mg/L in inoculated medium – 4 vessels;
-Controls: - blank control (inoculated medium) – 2 vessels
- procedure control: reference item to check the activity of the inoculum – 1 vessel
- toxicity control: to check any inhibitory effect of the compound (test item and reference item) – 2 vessels
- abiotic sterile control: to check any abiotic degradation (sterilising agent) – 2 vessels
- sterile control: test medium and sterilising agent – 1 vessel

Reference substance

Reference substance:

aniline

Results and discussion

% Degradation

Key result

Parameter:

% degradation (O2 consumption)

Value:

ca. 75.1

St. dev.:

8.6

Sampling time:

28 d

Details on results:

VALIDITY CRITERIA
- Percentage biodegradation of reference item (Aniline) in control flasks FC was 80.2% of ThOD within 14-day period (OECD 301 F pass level = 60% within 14-day period).
- The percentage of biodegradation in the test vessel F Inh. was 84.3% of ThOD after 14 days of incubation. The test item is not assumed to be inhibitory towards inoculum at this concentration according the OECD 301 F pass level.
- For the test item, the difference between the extreme degradation values was less than 20% at the end of the test.
- The oxygen uptakes of inoculum blanks at the end of the test were less than 60 mg/L medium.
- The pH values were 7.3 at the end of the experiment for test item flasks.
All the criteria are fulfilled, the test is considered as valid.

Any other information on results incl. tables

% biodegradation (ThOD) after 28 days:

 

Vessels	Test item: O-6-deoxy-α-L-mannopyranosyl-(1→4)-O-β-D-glucopyranosyl-(1→6)-β-D-glucopyranosyl (2α,3β,4α)-2,3,23-trihydroxyurs-12-en-28-oate				Reference item: Aniline
	FE1 52.9 mg/L	FE2 52.9 mg/L	FE3 52.9 mg/L	FE4 52.9 mg/L	FC 41.6 mg/L
% ThOD	81.0%	80.2%	76.7%	62.6%	100%
	Mean: 75.1%				/

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

readily biodegradable

Conclusions:

The average level of biodegradation achieved for the test item is: 75.1% of ThOD after 28 days of incubation and 60% of ThOD has been reached in a 10-d window, criteria for good evidence of “ready biodegradability” were reached under test conditions (i.e. the pass level for ready biodegradability is 60% of ThOD and this value has to be reached in a 10-day window within the 28-day of the test).
So, the test item “O-6-deoxy-α-L-mannopyranosyl-(1→4)-O-β-D-glucopyranosyl-(1→6)-β-D-glucopyranosyl (2α,3β,4α)-2,3,23-trihydroxyurs-12-en-28-oate” can be considered as readily biodegradable, according to the OECD Guideline 301 for the testing of chemicals.

Executive summary:

Test purpose

Evaluation, in an aqueous mineral medium inoculated with microbial flora from activated sludge, of the ready biodegradability of the test item “O-6-deoxy-α-L-mannopyranosyl-(1→4)-O-β-D-glucopyranosyl-(1→6)-β-D-glucopyranosyl (2α,3β,4α)-2,3,23-trihydroxyurs-12-en-28-oate”, according to the test procedure described in the OECD Guideline for the testing of chemicals 301 F, in conformity with the clauses recommended in the study plan of 20 December 2017, signed by the sponsor representative on 04 January 2018.

 

Test method

OECD Guideline for the testing of chemicals 301 F: Manometric respirometry (17 July 1992)

 

Test item

O-6-deoxy-α-L-mannopyranosyl-(1→4)-O-β-D-glucopyranosyl-(1→6)-β-D-glucopyranosyl (2α,3β,4α)-2,3,23-trihydroxyurs-12-en-28-oate

 

Test concentration

52.9 mg/L (100 mg ThOD_NH3)

 

Reference item

Aniline, 41.6 mg/L (100 mg ThODNH3)

 

Inoculum

Prepared from activated sludge from a treatment plant receiving predominantly domestic sewage.

 

Duration

28 days of incubation

 

Results

- % biodegradation (ThOD) after 28 days:

 

Vessels	Test item: O-6-deoxy-α-L-mannopyranosyl-(1→4)-O-β-D-glucopyranosyl-(1→6)-β-D-glucopyranosyl (2α,3β,4α)-2,3,23-trihydroxyurs-12-en-28-oate				Reference item: Aniline
	FE1 52.9 mg/L	FE2 52.9 mg/L	FE3 52.9 mg/L	FE4 52.9 mg/L	FC 41.6 mg/L
% ThOD	81.0%	80.2%	76.7%	62.6%	100%
	Mean: 75.1%				/

Conclusion

The average level of biodegradation achieved for the test item is: 75.1% of ThODafter 28 days of incubation and 60% of ThODhas been reached in a 10-d window,criteria for good evidence of “ready biodegradability” were reached under test conditions (i.e. the pass level for ready biodegradability is 60% of ThOD and this value has to be reached in a 10-day window within the 28-day of the test).

So, the test item “O-6-deoxy-α-L-mannopyranosyl-(1→4)-O-β-D-glucopyranosyl-(1→6)-β-D-glucopyranosyl (2α,3β,4α)-2,3,23-trihydroxyurs-12-en-28-oate” can be considered as readily biodegradable, according to the OECD Guideline 301 for the testing ofchemicals.