17-hydroxy-3-methoxyestra-2,5(10)-diene-17-carbonitrile

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:

Mar - Apr 2000

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:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution 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:

17-hydroxy-3-methoxyestra-2,5(10)-diene-17-carbonitrile

EC Number:

241-083-5

EC Name:

17-hydroxy-3-methoxyestra-2,5(10)-diene-17-carbonitrile

Cas Number:

17006-17-6

Molecular formula:

C20H27NO2

IUPAC Name:

(3aS,3bR,9bS,11aS)-1-hydroxy-7-methoxy-11a-methyl-1H,2H,3H,3aH,3bH,4H,5H,6H,9H,9bH,10H,11H,11aH-cyclopenta[a]phenanthrene-1-carbonitrile

Details on test material:

- Name of test material (as cited in study report): Methoxyestradien-Cyanhydrin
- Analytical purity: 91.3%
- Lot/batch No.: 57046805

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.:

11.5 mg/L

Based on:

DOC

Results and discussion

% Degradation

Parameter:

% degradation (CO2 evolution)

Value:

0 - 16

Sampling time:

28 d

Details on results:

The reference compound sodium acetate was degraded to 80 % on day 14 and to 89 % on day 28.
In the toxicity control, the reference item (sodium acetate) plus the test item ZK 74834, was degraded to 28 % on day 28.

Any other information on results incl. tables

Table 1: Biological degradation (cumulativ) in percent (corrected for CO2 production in the blank control) of ZK74834

			Day of sampling
Test item	Nominal concentration of carbon		1	4	6	8	11	14	18	21	25	28	29
	11,5 mg/l	1 st rep.	2	3	3	2	7	11	13	13	14	16	16
ZK 74834		2 nd rep.	0	1	0	3	7	7	7	8	8	9	11
		3 rd rep.	1	2	1	0	2	1	0	0	0	0	0
Reference		10,2 mg/L	8	34	56	66	72	80	86	86	87	88	89
(sodium acetate)
Toxicity control		11,5 mg/L +	4	20	29	30	31	30	28	27	27	27	28
(ZK 74834 + sodium acetate)		10,2 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Interpretation of results:

inherently biodegradable

Conclusions:

The test item ZK 74834 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 Methoxyestradien-Cyanhydrin (ZK 74834). ZK 74834 is an intermediate of the synthesis of Gestonorone. The study was conducted in agreement with the OECD test guideline no. 301 B.

The test item was incubated in an aqueous solution including nutrients with microorganisms from a municipal sewage treatment plant for 28 days (start of treatment = day 0). The nutrient solutions were made up of phosphates, magnesium sulphate, iron chloride, ammonium chloride and calcium chloride. The test item was incubated at a concentration of 11.5 mg carbon/L (15 mg test item/L) in triplicate. Additionally, a reference item (sodium acetate) was tested at a concentration of 35 mg/L 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 10.2 mg carbon/L (reference item) plus ZK 74834 at 11.5 mg carbon/L representing a toxicity control. Furthermore, a blank control was tested in triplicate without any test or reference item. The biological degradation of the test and reference items was evaluated by measurement of the carbon dioxide (C02) produced during the test period. C02 production was determined on days 1,4, 6, 8, 11, 14, 18, 21, 25, 28 and 29. On day 28 the solutions were acidified in order to expel all dissolved CO2, and C02 was determined on day 29. The CO2 production was calculated as the percentage of total C02 that the test item could theoretically have produced, based on carbon content. The C02 production in the blank control was subtracted for correction.

The test compound was degraded to 0 - 16 % in the triplicates on day 28. The reference compound sodium acetate was degraded to 80 % on day 14 and to 89 % on day 28. In the toxicity control, "the reference item (sodium acetate) plus the test item ZK 74834, was degraded to 28 % on day 28.