Tetra(sodium/potassium)-7-[(E)-{2-acetamido-4-[(E)-(4-{[4-chlor-6-({2-[(4-fluor-6-{[4-(vinylsulfonyl)phenyl]amino}-1,3,5-triazin-2-yl)amino]propyl}amino)-1,3,5-triazin-2-yl]amino}-5-sulfonato-1-naphthyl)diazenyl]-5-methoxyphenyl}diazenyl]-1,3,6-naphthalintrisulfonate

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:

Experiment start date - 24 July 2006; Experiment completion date - 22 August 2006; Study completion date - 25 September 2006.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Identity: FAT 40827/A
Batch: T2 5572 BOP 01/06
Purity: determined in this study
Appearance: black sticky powder
Expiration date: 28.02.2011
Storage: at room temperature

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, non-adapted

Details on inoculum:

The sludge was washed three times with tap water by centrifugation and the supernatant liquid phase was decanted. A homogenized aliquot of the final sludge suspension was weighed, thereafter dried and the ratio of wet to dry weight was calculated. The final concentration of inoculum was 30 mg dry material per litre.

Duration of test (contact time):

28 d

Initial conc.:

100 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

Apparatus: The test flask (500-ml Erlenmeyer flasks) were incubated under continuous stirring in a SAPROMAT D12, oxygen consumption was recorded manually by taking a daily reading at least on each working day.
Test duration: 28 days
Light conditions: darkness
Temperature: 22 °C, maintained with a built-in thermostat and checked once per week.
pH: Prior to test start and at the end of the test, pH value in each flask was determined.

Reference substance:

benzoic acid, sodium salt

Remarks:

sodium benzoate

Parameter:

% degradation (O2 consumption)

Value:

3

Sampling time:

28 d

Remarks on result:

other: without nitrification

Parameter:

% degradation (O2 consumption)

Value:

2

Sampling time:

28 d

Remarks on result:

other: with nitrification

Parameter:

BOD5

Value:

0 mg O2/g test mat.

Results with reference substance:

day 14: 88 %
day 28: 90 %

In the toxicity control, biodegradation amounted to 53 % and 41 % without nitrification and with nitrification, respectively. Thus, the test item had no inhibitory effect on activated sludge microorganisms at the tested concentration of 100 mg/l, because biodegradation in the toxicity control was >25 % within 14 days.

Validity criteria fulfilled:

yes

Interpretation of results:

under test conditions no biodegradation observed

Conclusions:

The test substance is not ready biodegradable under valid test conditions.

Executive summary:

The test item was investigated for its ready biodegradability in a manometric respirometry test over 28 days according to EU Commission Directive 92/69/EEC, C.4 -D (1992) and OECD Guideline for Testing of Chemicals No. 301 F (1992). The test item and reference substance concentrations were 100 mg/l. The test temperature was 22 °C, maintained with a built-in thermostat and checked once per week, and pH was determined prior to test start and at the end of the test in each flask. The result of abiotic control showed that no degradation of test item occurred under the test conditions within 28 days. There was no inhibitory effect on the activity of activated sludge microorganisms from the result of toxicity control. The biochemical oxygen demand (BOD) of the test item in the test media was in the range of the inoculum controls throughout the entire 28-day exposure period. The biodegradation of reference substance was 88 % on day 14 and reached 90 % on day 28. Consequently, test item is not ready biodegradable under the valid test conditions within 28 days.

Reference 2

Endpoint:

biodegradation in water: inherent biodegradability

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Experiment start date - 28 August 2006; Experiment completion date - 29 September 2006; Study completion date - 28 November 2006.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: OECD guidance test in compliance with GLP, but the inoculum was collected only from one source, the test water was different from the requirement of OECD 302C and the test temperature was also not the required temperature according to OECD 302C.

Qualifier:

according to guideline

Guideline:

OECD Guideline 302 C (Inherent Biodegradability: Modified MITI Test (II))

Deviations:

yes

Remarks:

activated sludge from only one source; the test water was prepared according to OECD 301F; the temperature was 22 °C; the inoculum was not fed during the holding period; the holding period was maximum seven days; no test item specific analysis

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Identity: FAT 40827/A
Batch: T2 5572 BOP 01/06
Purity: determined in this study
Appearance: black sticky powder
Expiration date: 28.02.2011
Storage: at room temperature

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, non-adapted

Details on inoculum:

The sludge was washed twice with tap water by centrifugation and the supernatant liquid phase was decanted. A homogenized aliquot of the final sludge suspension was weighed, thereafter dried and the ratio of wet to dry weight was calculated. The final concentration of inoculum was 100 mg dry material per litre.

Duration of test (contact time):

28 d

Initial conc.:

50 mg/L

Based on:

test mat.

Initial conc.:

51 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

Apparatus: the test flask (500-ml Erlenmeyer flasks) were incubated under continuous stirring in a SAPROMAT D12, oxygen consumption was recorded manually by taking a daily reading at least on each working day
Test duration: 28 days light conditions: darkness temperature: 22 °C, maintained with a built-in thermostat and checked once per week
pH: prior to test start and at the end of the test, pH value in each flask was determined.

Reference substance:

benzoic acid, sodium salt

Remarks:

sodium benzoate

Parameter:

% degradation (O2 consumption)

Value:

13

Sampling time:

28 d

Remarks on result:

other: without nitrification

Parameter:

% degradation (O2 consumption)

Value:

8

Sampling time:

28 d

Remarks on result:

other: with nitrification

Results with reference substance:

Day 14: 78 %
Day 28: 86 %

In the toxicity control, biodegradation amounted to 62 % and 53 % without nitrification and with nitrification, respectively. Thus, the test item had no inhibitory effect on activated sludge microorganisms at the tested concentration of 50 mg/l, because biodegradation in the toxicity control was >25 % within 14 days.

Validity criteria fulfilled:

yes

Interpretation of results:

not inherently biodegradable

Conclusions:

At the end of the 28-day test period, the mean biodegradation of test item amounted to 13 % without nitrification and 8 % with nitrification. In conclusion, test item is not inherently biodegradable under the valid test conditions within 28 days.

Executive summary:

The test item was investigated for its inherent biodegradability in a manometric respirometry test over 28 days based on the OECD Guideline for Testing of Chemicals No. 302 C (1981). The test temperature was 22 °C, maintained with a built-in thermostat and checked once per week, and pH was determined prior to test start and at the end of the test in each flask. The result of abiotic control showed that no degradation of test item occurred under the test conditions within 28 days. There was no inhibitory effect on the activity of activated sludge microorganisms from the result of toxicity control. The biochemical oxygen demand (BOD) of the test item in the test media was in the range of the inoculum controls in one of the two replicates and slightly above the range of the inoculum controls in the other replicate throughout the entire 28-day exposure period. At the end of the 28-day test period, the mean biodegradation of test item amounted to 13 % without nitrification and 8 % with nitrification. The biodegradation of reference substance was 78 % on day 14 and reached 86 % on day 28. Consequently, test item is not biodegradable under the valid test conditions within 28 days.

Description of key information

The test substance is not readily or inherently biodegradable.

Key value for chemical safety assessment

Biodegradation in water:

under test conditions no biodegradation observed

Additional information

Two biodegradability tests are available for this substance, one investigating ready biodegradability according to OECD 301F and one inherent biodegradability according to OECD302C. The results are summarized as below. The ready biodegradability test was performed over 28 days according to EU Commission Directive 92/69/EEC, C.4 -D (1992) and OECD Guideline for Testing of Chemicals No. 301 F (1992). There was no inhibitory effect on the activity of activated sludge microorganisms from the result of toxicity control. The biochemical oxygen demand (BOD) of the test item in the test media was in the range of the inoculum controls throughout the entire 28-day exposure period. Consequently, test item is not ready biodegradable under the valid test conditions within 28 days.

Additionally, the test item was investigated for its inherent biodegradability in a manometric respirometry test over 28 days based on the OECD Guideline for Testing of Chemicals No. 302 C (1981). The test temperature was 22 °C, maintained with a built-in thermostat and checked once per week, and pH was determined prior to test start and at the end of the test in each flask. The result of abiotic control showed that no significant degradation of test item occurred under the test conditions within 28 days. There was no inhibitory effect on the activity of activated sludge microorganisms from the result of toxicity control. The biochemical oxygen demand (BOD) of the test item in the test media was in the range of the inoculum controls in one of the two replicates and slightly above the range of the inoculum controls in the other replicate throughout the entire 28-day exposure period. At the end of the 28-day test period, the mean biodegradation of test item amounted to 13 % without nitrification and 8 % with nitrification. The biodegradation of reference substance was 78 % on day 14 and reached 86 % on day 28. Consequently, test item is not inherently biodegradable under the valid test conditions within 28 days.