Reaction mass of Ethyl 3-(cyclohex-1-en-1-yl) propanoate and Ethyl 3-(cyclohex-2-en-1-yl) propanoate

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:

This study was conducted between 07 December 2016 and 04 January 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Reliability 1 is assigned because the study conducted according to OECD TG 301F in compliance with GLP, without deviations that influence the quality of the results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

EC No. 440/2008

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 835.3110 (Ready Biodegradability)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Ethyl 3-(cyclohex-1-en-1-yl) propanoate and Ethyl 3-(cyclohex-2-en-1-yl) propanoate

EC Number:

949-881-1

Molecular formula:

C11H18O2

IUPAC Name:

Reaction mass of Ethyl 3-(cyclohex-1-en-1-yl) propanoate and Ethyl 3-(cyclohex-2-en-1-yl) propanoate

Test material form:

liquid

Specific details on test material used for the study:

Information as provided by the Sponsor. A Certificate of Analysis supplied by the Sponsor is available.
Identification: FRET 11-0078
Trade Name: IFF FRET 11-0078 (multi-constituent)
IPC Number: 090309
Physical state/Appearance: clear colorless liquid
IUPAC Names of Constituents Ethyl 3-(cyclohex-1-en-1-yl) propanoate Ethyl 3-(cyclohex-2-en-1-yl) propanoate
CAS Number: 65173-43-5 109976-49-0
CAS Name of Constituents: 1-Cyclohexene-1-propanoic acid, ethyl ester 2-Cyclohexene-1-propanoic acid, ethyl ester
Batch/Lot Number: NG342-12
Molecular Formula: C11H18O2 C11H18O2
Molecular Weight: 182.12 182.12
Concentration of Tested Sample: 96.6%
Expiry Date: 01 September 2017
Storage Conditions: approximately 4 °C in the dark
Intended use/Application: fragrance ingredient

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, non-adapted

Details on inoculum:

A mixed population of sewage treatment micro-organisms was obtained on 1 December 2016 from the final effluent stage of the Severn Trent Water Plc sewage treatment plant at Loughborough, Leicestershire, UK, which treats predominantly domestic sewage.

Preparation of Inoculum
The sample of effluent was filtered through coarse filter paper (first approximate 200 mL discarded) and maintained on aeration in a temperature controlled room at 21 ± 1 ºC prior to use.

Duration of test (contact time):

28 d

Initial test substance concentration

Initial conc.:

100 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation

Parameter followed for biodegradation estimation:

other: Biological Oxygen Demand (BOD)

Details on study design:

Dissiminated (delete when editing): Look into puzzle pieces and add what is necessary to evaluate the test

Reference substance

Reference substance:

other: Dissiminated (delete when editing) add what is applicable

Results and discussion

% Degradation

Key result

Parameter:

% degradation (O2 consumption)

Value:

ca. 21

Sampling time:

28 d

BOD5 / COD results

Results with reference substance:

The toxicity control attained 26% biodegradation after 14 days and 43% biodegradation after 28 days thereby confirming that the test item was not toxic to the sewage treatment micro-organisms used in the test.
Aniline (procedure control) attained 69% biodegradation after 14 days and 67% biodegradation after 28 days thereby confirming the suitability of the inoculum and test conditions.

Any other information on results incl. tables

Percentage Biodegradation Values:

Day	% Bioodegradation
	Procedure Control	Test Item (mean value, n=2)	Toxicity Control
0	0	0	0
1	0	1	1
2	0	1	1
3	-1	0	0
4	-4	0	3
5	6	0	9
6	25	0	19
7	43	0	22
8	52	1	23
9	54	2	23
10	62	4	23
11	64	8	24
12	66	9	24
13	68	10	25
14	69	11	27
16	69	12	28
17	69	13	29
18	69	14	30
19	69	15	31
20	68	16	32
21	68	17	66
22	68	18	64
23	68	19	35
24	68	20	37
25	68	20	38
26	67	21	40
27	67	21	42
28	67	21	43

 Validation Criteria

The mean BOD of the inoculated mineral medium (control) was 46.35 mg O2/L after 28 days and therefore satisfied the validation criterion given in the OECD Test Guidelines.

The pH of the inoculated test item vessels on Day 28 ranged from 7.5 to 7.6 and hence satisfied the validation criterion given in the OECD Test Guidelines.

The difference between extremes of replicate BOD values at the end of the test was less than 20% and therefore satisfied the validation criterion given in the OECD Test Guidelines.

Biodegradation

The test item attained 21% biodegradation after 28 days, calculated from the oxygen consumption values, and therefore cannot be considered to be readily biodegradable under the strict terms and conditions of OECD Guideline No. 301F.

The toxicity control attained 26% biodegradation after 14 days and 43% biodegradation after 28 days thereby confirming that the test item was not toxic to the sewage treatment micro-organisms used in the test.

Aniline (procedure control) attained 69% biodegradation after 14 days and 67% biodegradation after 28 days thereby confirming the suitability of the inoculum and test conditions.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

All validation criteria were satisfied

Interpretation of results:

not readily biodegradable

Conclusions:

The substance showed 21% biodegradation in an OECD TG 301F test and is considered to be not readily biodegradable.

Executive summary:

The study was performed to assess the ready biodegradability of the test item in an aerobic aqueous media.  The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No. 301F, “Ready Biodegradability; Manometric Respirometry Test” referenced as method C.4-D of Commission Regulation (EC) No. 440/2008 and US EPA Fate, Transport, and Transformation Test Guidelines OCSPP 835.3110 (Paragraph (q)).

Methods

The test item at a concentration of 100 mg/L was exposed to sewage treatment micro-organisms with mineral medium in sealed culture vessels in diffuse light at temperatures of between 19 to 21 ºC for 28 days.

The biodegradation of the test item was assessed by the measurement of daily oxygen consumption values on Days 0 to 28.  Control solutions with inoculum and the reference item, aniline, together with a toxicity control were used for validation purposes.

 Results

The test item attained 21% biodegradation after 28 days and therefore cannot be considered to be readily biodegradable under the strict terms and conditions of OECD Guideline

No. 301F.