reaction mass of: tetrasodium 4-amino-6-(5-(2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(sulfatoethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate;tetrasodium 4-amino-6-(5-(4,6-difluoropyrimidin-2-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-sulfatoethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate

Biodegradation in water: screening tests

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-03-04 to 1998-04-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.4-B (Determination of the "Ready" Biodegradability - Modified OECD Screening Test)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 301 E (Ready biodegradability: Modified OECD Screening Test)

GLP compliance:

yes

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic (adaptation not specified)

Details on inoculum:

- Source of sewage effluent: secondary effluent of a domestic sewage treatment plant (Odenthal)
- Treatment given: separation of coarse particles by filtration (SOP 2030-6600202-96 D)
- Concentration of effluents in reaction mixture: 0,5 ml/L (SOP 2030-6600202-96 D)

Duration of test (contact time):

28 d

Initial conc.:

14.8 mg/L

Based on:

DOC

Parameter followed for biodegradation estimation:

DOC removal

Details on study design:

TEST CONDITIONS
- Composition of medium: mineral medium
- Test temperature: 22 ± 2 °C
- Continuous darkness: yes

CONTROL AND BLANK SYSTEM
- Inoculum blank: yes
- Toxicity control: Test and reference substance plus inoculum

Reference substance:

aniline

Key result

Parameter:

% degradation (DOC removal)

Value:

0

Sampling time:

28 d

Details on results:

Points of degradation plot (test substance):
0 % degradation after 7 d
0 % degradation after 14 d
0 % degradation after 21 d
0 % degradation after 27 d
0 % degradation after 28 d

Results with reference substance:

Points of degradation plot (reference substance):
100 % degradation after 7 d
97 % degradation after 14 d
97 % degradation after 21 d
99 % degradation after 27 d
99 % degradation after 28 d

Validity criteria fulfilled:

yes

Interpretation of results:

under test conditions no biodegradation observed

Conclusions:

Reactive Navy FC63805 is not readily biodegradable in this test system.

Executive summary:

A study was performed according to EU method C.4-B. The test substance was suspended in a mineral medium, inoculated with a mixed population of aquatic microorganisms and incubated for 28 days under aerobic conditions in the dark at 22 ± 2 °C. During this period, the biodegradation of the test substance is determined on the basis of the reduction of DOC. The test substance did not show toxic effects to bacteria. Within the test period of 28 days, a degradation of 0 % was determined for Reactive Navy FC63805.

Reference 2

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-04-27 to 1998-08-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method C.4-F (Determination of the "Ready" Biodegradability - MITI Test)

GLP compliance:

yes (incl. QA statement)

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge (adaptation not specified)

Details on inoculum:

- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): Chemical Biotesting Center, Chemicals Inspection and Testing Institute, Japan
- Concentration of sludge: 30 mg/L

Duration of test (contact time):

28 d

Initial conc.:

85.9 mg/L

Based on:

test mat.

Initial conc.:

ca. 28.6 mg/L

Based on:

DOC

Parameter followed for biodegradation estimation:

DOC removal

Parameter followed for biodegradation estimation:

test mat. analysis

Parameter followed for biodegradation estimation:

other: BOD

Details on study design:

TEST CONDITIONS
- Composition of medium: basal medium
- Test temperature: 25 ± 1 °C

TEST SYSTEM
- Culturing apparatus: Closed system oxygen consumption measuring apparatus
- Number of culture flasks/concentration:
Bottle 1: aniline + sludge + basal medium (activity check of sludge);
Bottle 2: sludge+ basal medium(basal respiration of sludge)
Bottles 3-5: test substance+ sludge+ basal medium (biodegradation of test substance)
Bottle 6: test substance+ pure water (stability of test substance in water)
- Measuring equipment: Closed system oxygen consumption measuring apparatus, Ohkura Electric Co., Model OM-2001; Total organic carbon (TOC) analyzer, Shimadzu Corporation, Model TOC-500
- Test performed in open system: no

SAMPLING
- Sampling frequency: BOD: day 7, 14, 21, and 28; test material analysis: day 28; DOC removal: day 28

CONTROL AND BLANK SYSTEM
- blank included

Reference substance:

aniline

Parameter:

% degradation (O2 consumption)

Value:

0

Sampling time:

28 d

Parameter:

% degradation (DOC removal)

Value:

2

Sampling time:

28 d

Parameter:

% degradation (test mat. analysis)

Value:

>= 2 - <= 8

Sampling time:

28 d

Details on results:

From the degradability results based on the BOD (average 0 %) and the DOC (average 2 %) on day 28, it can be concluded that the test substance is not readily biodegradable under the conditions prescribed. From the results of the HPLC analysis, it can be concluded that the ester from component of the test substance is partly converted to the vinyl form.

Validity criteria fulfilled:

yes

Interpretation of results:

under test conditions no biodegradation observed

Conclusions:

A study was performed according to OECD guideline 301 C and in compliance with GLP. Reactive Navy FC63805 was found to be not readily biodegradable.

Executive summary:

The study was conducted in accordance with the standard procedure "Ready biodegradability, Modified MITI test (I)" in the OECD Guidelines for Testing of Chemicals No. 301 C (1992). From the degradability results based on the BOD (average 0 %) and the DOC (average 2 %) on day 28, it can be concluded that the test substance is not readily biodegradable under the conditions prescribed. From the results of the HPLC analysis, it can be concluded that the ester from component of the test substance is partly converted to the vinyl form component.

Description of key information

Two GLP guideline studies were performed, one following EU Method C.4-B (Determination of the "Ready" Biodegradability - Modified OECD Screening Test), and the other following OECD guideline 301C (Ready Biodegradability: Modified MITI Test(I)). No biodegradation was observed.

Key value for chemical safety assessment

Biodegradation in water:

under test conditions no biodegradation observed

Type of water:

freshwater

Additional information

A study was performed to assess the ready biodegradability of test substance Reactive Navy FC63805 according to EU Method C.4-B (Determination of the "Ready" Biodegradability - Modified OECD Screening Test) in compliance with GLP. The test substance was dissolved in a mineral medium and inoculated with a mixed population of aquatic organisms and subsequently incubated for 28 d under aerobic conditions. During this period biodegradation was determined by reduction of DOC. The results (0 % DOC removal after 28 days) indicate that Reactive Navy FC63805 is not readily biodegradable.

An additional study was performed following the OECD guideline 301C (Ready Biodegradability: Modified MITI Test(I)), also under GLP. The test substance was exposed to activated sludge for 28 days and degradation was measured by the biochemical oxygen demand and dissolved organic carbon content. The results (0 % degradation based on BOD, 2 % degradation based on DOC) indicate that Reactive Navy FC63805 is not readily biodegradable.