Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Environmental fate & pathways

Biodegradation in water: screening tests

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Aug to Sep 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to guideline
Guideline:
other: FDA test guideline 3.11 of the Envirnmental Assessment Technical Assistance Handbook; March 1987
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, adapted
Duration of test (contact time):
28 d
Initial conc.:
10 mg/L
Based on:
other: carbon
Parameter:
% degradation (CO2 evolution)
Value:
ca. 69
Sampling time:
28 d
Remarks on result:
other: 1 mg/l carbon
Key result
Parameter:
% degradation (CO2 evolution)
Value:
ca. 65
Sampling time:
28 d
Remarks on result:
other: 10 mg/l carbon
Details on results:
The test compound was degraded to 69% (1 mg/l carbon) and 65% 10 mg/l carbon) on day 28.
50% biodegradation for estradiol as 1 mg/l carbon was reached on day 10 and for estradiol as 10 mg/l carbon on day 17.
The reference substance was degraded to 98% on day 28.
The toxicity control was degraded to 86% on day 28.
50% biodegradation of reference substance and toxicity control was reached on day 6.
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable, but failing 10-day window
Conclusions:
The test substance estradiol is biodegradable to a certain extend under the conditions of the test.
Executive summary:

Estradiol was studied for ready biodegradability in a CO2 evolution tests (according to US FDA test guideline TAD 3.11).

The test substance estradiol was incubated in an aqueous solution including nutrients with microorganisms from a municipal sewage treatment plant for 28 days after the inoculum from the sewage treatment plant was preincubated for 14 days.

The test substance estradiol was incubated in triplicate. Additionally, a reference substance (aniline) was tested according to the same

procedure, in order to verify the viability and activity of the degrading microorganisms. Furthermore, a blank control was tested in triplicate without any test or reference substance. One further set was incubated with aniline plus estradiol representing a toxicity control.

Results: Estradiol showed a degradation of 65-68 %. However, it was not ready biodegradable, since 60 % biodegradation was not reached after 10 days following the start of the degradation (i.e. when 10% degradation was reached). However, estradiol was not toxic to the microbes of activated sludge.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan - Feb 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, non-adapted
Duration of test (contact time):
28 d
Initial conc.:
10 mg/L
Based on:
other: carbon
Key result
Parameter:
% degradation (CO2 evolution)
Value:
68
Sampling time:
30 d
Remarks on result:
other: 28 days of incubation
Details on results:
The degradation of estradiol started after a lag-phase (until day 9).
The reference substance was degradated to 88% on day 30, requiring less than 10 days for degradation of 60%.
The toxic control was degradated up to 84% on day 30.
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable, but failing 10-day window
Conclusions:
Estradiol is not readily biodegradable. Estradiol is mineralised to a relevant extent. It is not toxic to microbes of activated sludge.
Executive summary:

Estradiol was studied for ready biodegradability in a CO2 evolution tests (according to OECD 301B). The test substance estradiol was incubated in an aqueous solution including nutrients with microorganisms from a municipal sewage treatment plant for 28 days. The test substance estradiol was incubated in triplicate. Additionally, a reference substance (sodium acetate) and a blank control was tested 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 plus estradiol representing a toxicity control.

Results: Estradiol showed a degradation of 68 %. However, it was not ready biodegradable, since 60 % biodegradation was not reached after 10 days following the start of the degradation (i.e. when 10% degradation was reached). However, estradiol was mineralized to a significant extent. It was not toxic to the microbes of activated sludge.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: FDA test guideline 3.11 of the Environmental Assessment Technical Assistance Handbook, March 1987
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, adapted
Duration of test (contact time):
28 d
Initial conc.:
10 mg/L
Based on:
other: carbon
Key result
Parameter:
% degradation (CO2 evolution)
Value:
67
Sampling time:
29 d
Details on results:
The test compound was degradated to 67% on day 29.
50% biodegradation was reached on day 11, 60% degradation was reached approx. on day 16. A relatively rapid degradation was observed until day 10, thereafter the degradation was reduced.
The reference substance was degradaded to more than 80% on day 29. The time required for 50% biodegradation was 4 days.
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable, but failing 10-day window
Conclusions:
The test substance estradiol is biodegradable to a certain extend under the conditions of the test.
Executive summary:

Estradiol was studied for ready biodegradability a CO2 evolution tests (US FDA test guideline TAD 3.11). The test substance estradiol was incubated in an aqueous solution including nutrients with microorganisms from a municipal sewage treatment plant for 28 days. The inoculum from the sewage treatment plant is mixed with garden soil and preincubated for 14 days. The test substance estradiol was incubated in triplicate. Additionally, a reference substance was tested according to the same procedure, in order to verify the viability and activity of the degrading microorganisms. Furthermore, a blank control was tested without any test or reference substance.


Results: Estradiol showed a degradation of 69% on day 29 and of 50% on day 11. However, it was not ready biodegradable, since 50% biodegradation was not reached after 10 days following the start of the degradation.

Description of key information

Estradiol was studied for ready biodegradability in three different CO2 evolution tests (according to OECD 301B and US FDA test guideline  TAD 3.11.
The test substance estradiol was incubated in an aqueous solution including nutrients with microorganisms from a municipal sewage treatment plant for 28 days.In the tests under TAD 3.11 the inoculum from the sewage treatment plant is mixed with garden soil and preincubated for 14 days.
The test substance estradiol was incubated in triplicate.Additionally, a reference substance (sodium acetate) was tested according to the same
procedure, in order to verify the viability and activity of the degrading microorganisms. Furthermore, a blank control was tested in triplicate without any test or reference substance. One further set was incubated with sodium acetate plus estradiol representing a toxicity control.
In the tests according to TAD 3.11. the reference substance was aniline.
Results: Estradiol showed a degradation of 67-69 %. However, it was not ready biodegradable, since 60 % biodegradation was not reached after
10 days following the start of the degradation (i.e. when 10% degradation was reached). However, estradiol was mineralized to a significant extent. It was not toxic to the microbes of activated sludge.

Key value for chemical safety assessment

Biodegradation in water:
readily biodegradable but failing 10-day window
Type of water:
freshwater

Additional information

The studies were conducted according to GLP (reports A05658, A05659, A05814)