L-Glutamic acid, N-acetyl-, compd. with (.alpha.S)-.alpha.-(2-methylpropyl)-2-(1-piperidinyl)benzenemethanamine (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

Study period:

11 November 1998 - 8 April 1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD 301 D) and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.4-E (Determination of the "Ready" Biodegradability - Closed Bottle Test)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 835.3110 (Ready Biodegradability)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(S)-3-Methyl-1-(2-piperidine-1-phenyl)butylamine compound with N-Acetyl-L-glutamic acid

EC Number:

606-883-4

Cas Number:

219921-94-5

Molecular formula:

C16-H26-N2 x C7-H11-N-O5

IUPAC Name:

(S)-3-Methyl-1-(2-piperidine-1-phenyl)butylamine compound with N-Acetyl-L-glutamic acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): AGEE 623 Glutaminate; L-Glutamic acid, N-acetyl-, compd. with (S)-alpha-(2)-methylpropyl)-2-(1-piperidinyl)-benzenemethanamine
- Molecular formula (if other than submission substance): C16H26N2 * C7H11NO5
- Molecular weight (if other than submission substance): 435.57 g/mol
- Structural formula attached as image file (if other than submission substance): see reference substance
- Physical state: solid white powder
- Analytical purity: 100% (4% of (R)-(-) enantiomer
- Purity test date: 28 October 1998
- Lot/batch No.: T29725
- Expiration date of the lot/batch: 31 December 1999
- Stability under test conditions: pure: see epiry date; in water: for at least 2 hours
- Storage condition of test material: in original container, at room temperature, in the dark

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic (adaptation not specified)

Details on inoculum:

- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): supplied by sewage plant Groß-Zimmern, Germany

The activated sludge used for this study was washed by centrifugation and the supernatant liquid phase was decanted. The solid material was resuspended in tap water and again centrifuged. This procedure was repeated twice. An aliquot of the final sludge to its dry weight was determined. Based on this ratio, calculated aliquots of washed sludge suspension, corresponding to 4 g dry material per litre were mixed with test water and then areated until use. Before use the sludge was filtered through cotton wool.

Duration of test (contact time):

28 d

Initial test substance concentration

Initial conc.:

2.14 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

TEST CONDITIONS
- Composition of medium: grade salts were added to deionised water to give stock solutions. Stock solutions were diluted in deionised water, aerated for 20 minutes and allowed to stand for 20 hrs at the test temperature. Dissolved oxygen concentration was about 8.6 - 9.2 mg/L prior to starting the test.
- Test temperature: 21.3 - 22.3°C
- pH: 7.4 - 7.5

TEST SYSTEM
- Culturing apparatus: 250 ml flasks with glass stoppers
- Number of culture flasks/concentration: 16 bottles containing the test substance and inoculum; 16 bottles containing the reference compound Aniline and Inoculum (procedure control); 16 bottles containing only inoculum (inoculum control); 10 bottles containing the test substance, reference compound Aniline and inoculum (toxicity control)
- Method used to create aerobic conditions: inoculum and medium solutions were sufficiently aerated prior to the start of the test.
- Measuring equipment: O2 electrode
- Test performed in closed vessels: yes

SAMPLING
- Sampling frequency: oxygen was measured at days 0, 2, 5, 7, 12, 14, 21 and 28 after the start of the test.
- Sampling method: no sampling was performed for oxygen analysis, the oxygen concentrations were measured with an oxygen meter with a stirring O2 electrode.
- Sterility check if applicable: no
- Sample storage before analysis: no

CONTROL AND BLANK SYSTEM
- Inoculum blank: yes
- Abiotic sterile control: no
- Toxicity control: yes

Reference substance

Reference substance:

aniline

Results and discussion

% Degradation

Parameter:

% degradation (O2 consumption)

Value:

26.1

Sampling time:

28 d

Details on results:

The residual oxygen concentration did not drop below 0.5 mg O2/L at any time. The difference in duplicate samples was less than 20%.

BOD5 / COD results

Results with reference substance:

The percentage biodegradation of the reference compound confirms the suitability of the used activated sludge inoculum. According to the test guidelines the test substance can be assumed to be not inhibitory on the activated sludge micro organisms because degradation was >25% within 14 days.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

other: not readily biodegradable

Conclusions:

The percentrage biodegradation did not exceed 60% within the 10 day window. The test substance can therefore not considered to be readily
biodegrdable