Gona-1,3,5(10)-trien-17-ol, 13-ethyl-3-methoxy-, (17.beta.)-

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:

Jan - Feb 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD guideline under GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

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 relevant

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-Methoxy-18-methyl-1,3,5(10)-estratrien-17 beta-ol

EC Number:

609-222-8

Cas Number:

3625-82-9

Molecular formula:

C20 H28 O2

IUPAC Name:

3-Methoxy-18-methyl-1,3,5(10)-estratrien-17 beta-ol

Details on test material:

- Name of test material (as cited in study report): D-ET-Trienol
- Analytical purity: 101.4%
- Lot/batch No.: 21545002

Study design

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic (adaptation not specified)

Duration of test (contact time):

28 d

Initial test substance concentration

Initial conc.:

200 mg/L

Based on:

ThOD/L

Results and discussion

% Degradation

Parameter:

% degradation (O2 consumption)

Value:

9

Sampling time:

28 d

Details on results:

The reference compound sodium acetate was degraded to 79% on day 6 and to 86% on day 29 (28 days of incubation).
In the toxicity control, the reference compound (sodium acetate) plus the test compound
ZK 46060, was degraded to 49% on day 29 (~ 28 days of incubation), which reflected the
degradation in the individual sets.

Any other information on results incl. tables

Table 1: Biological degradation (cumulative) in percent (corrected for blank O2 consumption) of ZK 46060

Test compound	Concentration	Day of sampling (selected time points)
	expressed in theoretical O2	2	6	10	14	18	22	26	29
	demand
ZK46060	200 mg/L	5	6	7	8	8	9	9	9
Reference	200 mg/L	32	79	82	84	85	85	86	86
(sodium acetate)
Toxicity control	100 mg/L +	29	43	45	46	47	47	48	49
(ZK 46060 + sodium acetate)	100 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

inherently biodegradable

Conclusions:

In accordance with the OECD, the test compound ZK 46060 is not readily biodegradable
under the conditions of the test and it was not toxic to the microbes of activated sludge.

Executive summary:

The purpose of this study was to determine the ready biodegradability of D-ET-Trienol (ZK 46060), which is an intermediate ofthe synthesis of Norgestrel. The study was conducted in agreement with the OECD test guideline no. 301F.

The test substance was incubated in an aqueous solution including nutrients with microorganisms from a municipal sewage treatment plant for 28 days (start of treatment = day 1). The nutrient solutions were made up of phosphates, magnesium sulphate, iron chloride, ammonium chloride and calcium chloride. The test substance was incubated at a concentration of 200 mg theoretical oxygen demand (ThOD) per litre. Additionally, a reference substance (sodium acetate) was tested in a single set according to the same procedure, in order to verify the viability and activity of the degrading microorganisms. One further set was incubated with sodium acetate at 100 mg ThOD/L (reference substance) plus test compound at 100 mg ThOD/L representing a toxicity control. Furthermore, a blank control was tested in triplicate without any test or reference substance. The biological degradation of the test and reference substances was evaluated by measurement of the O2 consumption during the test period. O2 consumption was continuously monitored and recorded by an automated device. The O2 consumption was calculated as the percentage of total O2 that the test material could theoretically have consumed, based on the molecular formula. The blank O2 consumption was subtracted for correction.