Registration Dossier

Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

Administrative data

Endpoint:
biodegradation in water and sediment: simulation tests
Type of information:
experimental study planned
Study period:
as soon as possible after decision from ECHA
Justification for type of information:
ESTING PROPOSAL ON VERTEBRATE ANIMALS
[Please provide information for all of the points below. The information should be specific to the endpoint for which testing is proposed. Note that for testing proposals addressing testing on vertebrate animals under the REACH Regulation this document will be published on the ECHA website along with the third party consultation on the testing proposal(s).]

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out
2,2’-azobis[2-methylpropionamidine] dihydrochloride
- Name of the substance for which the testing proposal will be used [if different from tested substance]
-/-
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies
No GLP studies regarding biodegradation in surface water of the substance itself or transformation products available

- Available non-GLP studies
No non-GLP studies regarding biodegradation in surface water of the substance itself or transformation products available

- Historical human data
Not relevant

- (Q)SAR
No (Q)SAR for the endpoint simulation of biodegradation in surface water available.


- In vitro methods
Not relevant

- Weight of evidence
No relevant information regarding biodegradation in surface water available.

- Grouping and read-across
No relevant information regarding biodegradation in surface water from similar substances or transformation products available.

- Substance-tailored exposure driven testing [if applicable]
-/-
- Approaches in addition to above [if applicable]
-/-
- Other reasons [if applicable]
-/-

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
The substance itself or its transformation products identified based in the findings in the publication of Werber can be considered as soluble in water. Additionally, findings in the screening tests for biodegradation showed limited degradation under test conditions only, and therefore neither the substance nor (all) transformation products can be considered as readily biodegradable. These conclusions are supported by estimations on biodegradation using the OECD QSAR Toolbox.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]
The study should be performed at 12 °C in line with the guidance documents. Based on the findings and estimations regarding the partition coefficient of the substance and its transformation products as well as the identified use pattern a relevant exposure of the sediment and/or soil is considered to be unlikely. Therefore, only simulation testing in surface water is proposed.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 309 (Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: granular

Study design

Details on study design:
TEST CONDITIONS
- Volume of test solution/treatment:
- Composition of medium:
- Additional substrate:
- Solubilising agent (type and concentration if used):
- Test temperature: 12 °C
- pH:
- pH adjusted: yes/no
- CEC (meq/100 g):
- Aeration of dilution water:
- Suspended solids concentration:
- Continuous darkness: yes/no
- Any indication of the test material adsorbing to the walls of the test apparatus:
- Other:

TEST SYSTEM
- Culturing apparatus:
- Number of culture flasks/concentration:
- Method used to create aerobic conditions:
- Method used to create anaerobic conditions:
- Method used to control oxygen conditions:
- Measuring equipment:

- Test performed in closed vessels due to significant volatility of test substance:
- Test performed in open system:
- Details of trap for CO2 and volatile organics if used:
- Other:

SAMPLING
- Sampling frequency:
- Sampling method used per analysis type:
- Sterility check if applicable:
- Sample storage before analysis:
- Other:

DESCRIPTION OF CONTROL AND/OR BLANK TREATMENT PREPARATION
CONTROL AND BLANK SYSTEM
- Inoculum blank:
- Abiotic sterile control:
- Toxicity control:
- Other:

STATISTICAL METHODS:

Results and discussion

Applicant's summary and conclusion