1,2,3,6-tetrahydrophthalimide

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: GLP compliant study to recognised international guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,2,3,6-tetrahydrophthalimide

EC Number:

201-602-8

EC Name:

1,2,3,6-tetrahydrophthalimide

Cas Number:

85-40-5

Molecular formula:

C8H9NO2

IUPAC Name:

2,3,3a,4,7,7a-hexahydro-1H-isoindole-1,3-dione

Details on test material:

- Name of test material (as cited in study report): THPI D4
- Physical state: Solid
- Analytical purity: 97.91%
- Lot/batch No.: STI4208324
- Expiration date of the lot/batch: 2009-11-21
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, non-adapted

Details on inoculum:

- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): Municipal sewage treatnment plant at d-31137 Hildesheim, receiving principally domestic sewage
- Pretreatment: Received sludge washed with sterile water, settled, then re-suspended in mineral salts medium. Maintained in aerobic condition by aeration for 4 hours, After this the sludge was homogenised in a blender, the supernatant decanted and mainatined under aerobic conditions for 5 days
- Initial cell/biomass concentration: 10E+7 - 10E+8 CFU/L

Duration of test (contact time):

28 d

Initial test substance concentration

Initial test substance concentration 1

Initial conc.:

40 mg/L

Based on:

test mat.

Initial test substance concentration 2

Initial conc.:

70 mg/L

Based on:

ThOD/L

Parameter followed for biodegradation estimation

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

TEST CONDITIONS
- Composition of medium: Mineral salts medium as described in OECD test guideline 310F
- Additional substrate: None
- Solubilising agent (type and concentration if used): None
- Test temperature: 20.5 - 22.0 Deg C
- pH: 7.31 - 7.60
- pH adjusted: No
- Aeration of dilution water: No
- Suspended solids concentration: To give 10E+7 - 10E+8 CFU/L in test vessels
- Continuous darkness: Yes



TEST SYSTEM
- Culturing apparatus: Brown glass bottles
- Number of culture flasks/concentration: 2
- Method used to create aerobic conditions: Continuous stirring
- Measuring equipment: Automated system (OxiTop) measuring pressure differences following adsorption of carbon dioxide
- Test performed in closed vessels due to significant volatility of test substance: No
- Details of trap for CO2 and volatile organics if used: Soad lime trap



SAMPLING
- Sampling frequency: For oxygen consumption - every 112 minutes for 28 days
- Sampling method: Automated
- Sterility check if applicable: Not applicable
- Sample storage before analysis: Not applicable
:


CONTROL AND BLANK SYSTEM
- Inoculum blank: Yes - 2 vessels
- Abiotic sterile control: No
- Toxicity control: Yes - 1 vessel
- Other: Functional (positive) control - 1 vessel


STATISTICAL METHODS: None used

Reference substance

Reference substance:

benzoic acid, sodium salt

Results and discussion

% Degradation

Parameter:

% degradation (O2 consumption)

Value:

30

St. dev.:

7.1

Sampling time:

28 d

BOD5 / COD results

BOD5 / COD

Parameter:

BOD5

Value:

70 mg O2/g test mat.

Results with reference substance:

>60% biodegradation achieved after 2 days,

Any other information on results incl. tables

	Biodegradation (%)
Day	Positive control	Test substance		Toxicity control
		1	2
0	0	0	0	0
1	53	0	0	28
2	67	2	0	37
3	7	2	0	44
4	82	4	4	48
5	85	5	3	49
6	85	1	1	50
7	88	2	2	51
8	90	2	2	51
9	89	3	0	52
10	91	3	0	53
11	92	2	0	53
12	95	3	1	54
13	97	3	3	54
14	99	4	4	55
15	100	4	4	55
16	100	3	9	56
17	100	4	10	56
18	100	6	10	57
19	100	9	9	58
20	100	11	9	59
21	100	15	11	59
22	100	19	11	59
23	100	26	14	58
24	100	35	13	59
25	97	36	16	58
26	100	38	28	57
27	97	32	22	48
28	98	35	25	48

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

inherently biodegradable

Conclusions:

Substance is not readily biodegradable

Executive summary:

Substance is not readily biodegradable