Bis(acetato-O)hydroxyaluminium

Biodegradation in water: screening tests

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Studies were not performed with the target chemical. However, aluminium hydroxide diacetate dissolves easily to acetic acid and aluminum hydroxide in water. Reliable experimental data and QSAR data are available for acetic acid, which is considered to be a suitable read across substance.

2. SOURCE AND TARGET CHEMICAL(S)
No further information.

3. ANALOGUE APPROACH JUSTIFICATION
Three experimental studies and one QSAR approach are available indicating the biodegradation of acetic acid. As aluminium hydroxide diacetate dissolves entirely to acetic acid and aluminium hydroxide it is considered suitable to use endpoints obtained from the studies conducted with the source chemical, acetic acid, for the evaluation of the biodegradability of the target chemical aluminium hydroxide diacetate.
The studies were not performed under GLP compliance, however they follow standard procedures or are well described in previous papers. Therefore, the studies are suitable for the read across approach.

For further information please refer to the statement under IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Key result

Parameter:

% degradation (O2 consumption)

Value:

96

Sampling time:

20 d

Reference 2

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, guideline, experimental study, notable limitations in design but contributing to weight of evidence

Principles of method if other than guideline:

not specified

GLP compliance:

no

Specific details on test material used for the study:

not reported

Oxygen conditions:

anaerobic

Inoculum or test system:

other: synthetic sewage

Remarks:

glucose, peptone and com steap liquor (carbon ratio = 1:1:2)

Details on inoculum:

Concentration of seeding bacteria was 100mg-C/L.

Duration of test (contact time):

28 d

Initial conc.:

30 mg/L

Details on study design:

TEST CONDITIONS
- Test temperature: 37±0.5 °C
- pH: 7
- pH adjusted: yes, with NaHCO

TEST SYSTEM
- Number of culture flasks: 10 vials
- Method used to create anaerobic conditions: Test procedures are cairied out in a glove box with N2 atmosphere. Oxygen-free water is used.

SAMPLING
- Sampling frequency: day 7, 14, 21 and 28
- Sampling method: decrease of DOC

Reference substance:

benzoic acid, sodium salt

Key result

Parameter:

% degradation (DOC removal)

Value:

99

Sampling time:

7 d

Details on results:

Under the test conditions the percentage biodegradation of the test item reached 99% after 7 days, indicating that the test item is readily biodegradable.

Results with reference substance:

The reference item benzoic acid was sufficiently degraded to > 78% after 14 days.

Validity criteria fulfilled:

not specified

Interpretation of results:

readily biodegradable

Conclusions:

The test item is considered to be ready biodegradable. The biodegradation percentage at day 7 was 99%.

Executive summary:

The ready biodegradability of the test item was determined with a synthetic sewage over a test period of 28 days.The test item 30 mg/L. The reference item benzoic acic was sufficiently degraded to > 78% after 14 days. The biodegradation of the test item reached 99% after 7 days. In conclusion, the test item is readily biodegradable.

The study varies considerably from current standard guidelines but is acceptable for the weight of evidence approach

Reference 3

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, non-standard, published in peer-reviewed literature, notable limitations in design and reporting but contributing to a weight of evidence assessment

Principles of method if other than guideline:

The Warburg technique was used to investigate the ability of activated sludges from wastewater treatment plants.

GLP compliance:

no

Specific details on test material used for the study:

No data reported

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, non-adapted

Details on inoculum:

Activated sludge from three municipal waste treatment plants.

Duration of test (contact time):

24 h

Initial conc.:

500 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

other: theoretical oxygen demand (TOD)

Details on study design:

Warburg respirometer technique

Parameter:

other: theoretical oxygen demand (TOD)

Value:

30

Sampling time:

6 h

Parameter:

other: theoretical oxygen demand (TOD)

Value:

34.9

Sampling time:

12 h

Key result

Parameter:

other: theoretical oxygen demand (TOD)

Value:

40.2

Sampling time:

24 h

Details on results:

Under the test conditions the percentage biodegradation of the test item reached 30.0, 34.9 and 40.2% after 6, 12 and 24 h, respectively. These findings indicate that the test item is readily biodegradable, if incubated for a longer time.

Validity criteria fulfilled:

not applicable

Interpretation of results:

readily biodegradable

Conclusions:

The test item is considered to be ready biodegradable. The biodegradation percentage after 24 hours was 40.2%.

Executive summary:

The ready biodegradability of the test item was determined with a domestic activated sludge over a test period of 24 h. The biodegradation of the test item reached 40.2% after 24 h. In conclusion, the test item is readily biodegradable.

This study is not GLP compliant and does not follow a standard guideline. The full methods are presented in a previous paper. This study is suitable for use as part of a weight of evidence approach.

Reference 4

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP, guideline, experimental study, notable limitations in design but contributing to weight of evidence

Principles of method if other than guideline:

Study followed published BOD procedure - "Standard Methods for the Examination of Waste and Wastewater" 13th Edition, Amer. Pub. Health Assn., New York (1971).

GLP compliance:

no

Specific details on test material used for the study:

not reported

Oxygen conditions:

aerobic

Inoculum or test system:

other: settled domestic wastewater

Details on inoculum:

no further informations reported

Duration of test (contact time):

20 d

Initial conc.:

3 mg/L

Based on:

test mat.

Initial conc.:

7 mg/L

Based on:

test mat.

Initial conc.:

10 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

Freshwater biodegradation:
Settled domestic wastewater was first filtered through glass wool and used as seed material to clean the BOD bottles. Small aliquots of the test item were added to the BOD bottels which were half filled with aerated dilution water containing the specified minerals and buffer. A 0.1% stock solutions was used and added to yield in concentrations of 3.7 and 10 mg/L. These concentrations gave a potential oxygen demand of 3-30 mg/L over the 20 day test duration.

Key result

Parameter:

% degradation (O2 consumption)

Value:

96

Sampling time:

20 d

Details on results:

Under the test conditions the percentage biodegradation of the test item reached 96% after 20 days, indicating that the test item is readily biodegradable.

Validity criteria fulfilled:

not applicable

Interpretation of results:

readily biodegradable

Conclusions:

The test item is considered ready biodegradable as 96% degradation is seen in the non-acclimated freshwater study.

Executive summary:

The test item is considered ready biodegradable as 96% degradation is seen in the non-acclimated freshwater study.

The study varies considerably from current standard guidelines but is acceptable for the weight of evidence approach.

Reference 5

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Studies were not performed with the target chemical. However, aluminium hydroxide diacetate dissolves easily to acetic acid and aluminum hydroxide in water. Reliable experimental data and QSAR data are available for acetic acid, which is considered to be a suitable read across substance.

2. SOURCE AND TARGET CHEMICAL(S)
No further information.

3. ANALOGUE APPROACH JUSTIFICATION
Three experimental studies and one QSAR approach are available indicating the biodegradation of acetic acid. As aluminium hydroxide diacetate dissolves entirely to acetic acid and aluminium hydroxide it is considered suitable to use endpoints obtained from the studies conducted with the source chemical, acetic acid, for the evaluation of the biodegradability of the target chemical aluminium hydroxide diacetate.
The studies were not performed under GLP compliance, however they follow standard procedures or are well described in previous papers. Therefore, the studies are suitable for the read across approach.

For further information please refer to the statement under IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Key result

Parameter:

% degradation (DOC removal)

Value:

99

Sampling time:

7 d

Reference 6

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Studies were not performed with the target chemical. However, aluminium hydroxide diacetate dissolves easily to acetic acid and aluminum hydroxide in water. Reliable experimental data and QSAR data are available for acetic acid, which is considered to be a suitable read across substance.

2. SOURCE AND TARGET CHEMICAL(S)
No further information.

3. ANALOGUE APPROACH JUSTIFICATION
Three experimental studies and one QSAR approach are available indicating the biodegradation of acetic acid. As aluminium hydroxide diacetate dissolves entirely to acetic acid and aluminium hydroxide it is considered suitable to use endpoints obtained from the studies conducted with the source chemical, acetic acid, for the evaluation of the biodegradability of the target chemical aluminium hydroxide diacetate.
The studies were not performed under GLP compliance, however they follow standard procedures or are well described in previous papers. Therefore, the studies are suitable for the read across approach.

For further information please refer to the statement under IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Key result

Parameter:

other: theoretical oxygen demand (TOD)

Value:

40.2

Sampling time:

24 h

Description of key information

The target chemical is considered to be ready biodegradable, since four publications conducted with the source chemical, acetic acid, indicate its biodegradability (reference 5.2.1-1 to 5.2.1 -3).

Key value for chemical safety assessment

Biodegradation in water:

readily biodegradable

Additional information

The ready biodegradability of the source chemical, acetic acid, was tested in three experimental studies. The source chemical was exposed to different test systems, like synthetic sewage, activated sludge and domestic wastewater for 24 h until up to 20 days. The percentage biodegradation of the source chemical ranged from 40.2% after 24 h to 99% after 7 days. Since the source chemical is considered to be a suitable read across substance it can be assumed that the target chemical is also ready biodegradable. In accordance with column 2 of REACH Annex VII, the evaluation of the biodegradation of Al as the inorganic part of the target substance is not considered relevant since the study for ready biodegradation does not need to be conducted for inorganic substances.