N-Phenyl-diethanolamine, reaction products with formaldehyde

Biodegradation in water and sediment: simulation tests

Administrative data

Endpoint:

biodegradation in water: simulation testing on ultimate degradation in surface water

Type of information:

experimental study planned

Justification for type of information:

TESTING PROPOSAL
The applicant will need to perform a simulation testing on ultimate degradation in surface water study, to fulfil the REACH Regulation (EC) No 1907/2006 data requirement (Annex IX, Section 9.2.1.2). Further, as the substance is not readily biodegradable, the requirement to identify degradation products (Annex IX, Section 9.2.3) is triggered and should be performed in conjunction with the ultimate degradation in surface water simulation test.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 2,2'-phenyliminodiethanol and its oligomerization products with formaldehyde (EC 942-131-4; CAS 26952-14-7).
- Name of the substance for which the testing proposal will be used [if different from tested substance]: N/A

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: There are no available GLP studies on the substance or via read-across analogues suitable to fulfil the endpoint.

- Available non-GLP studies: There are no available non-GLP studies on the substance or via read-across analogues suitable to fulfil the endpoint.

- (Q)SAR: (Q)SAR analysis is not sufficient to fill the endpoint. There are no adequate models to address this endpoint.

- Weight of evidence: There are not enough sufficient data on the substance or read-across analogues to be able to establish a weight of evidence argument.

- Grouping and read-across approach: There are no suitable analogues identified that could be used to fulfil the data requirement.

- Approaches in addition to above: N/A

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:
It is a requirement of REACH Regulation Annex IX, Section 9.2.1.2; that an ultimate degradation study is performed unless the substance is readily biodegradable or highly insoluble in water (Column 2 adaptations). Neither of these Column 2 adaptations apply. The substance is not readily biodegradable and was determined to be soluble in water. There are no Annex IX Column 2 adaptations applicable for waiving the data requirements as per Section 9.2.1.2. The sole available Column 2 adaptation for Section 9.2.3 (identification of degradation products) states that the data requirement may be waived if the substance is readily biodegradable. As clarified, the substance is not readily biodegradable and therefore the data must be generated.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: It is anticipated that an OECD 309 will be conducted, incorporating identification of degradation products. Further details on study design/methodology are not available, the registrant awaits approval from ECHA before commissioning the study.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 309 (Aerobic Mineralisation in Surface Water - Simulation Biodegradation Test)

Test material

Test material information

Constituent 1

Test material form:

liquid

Details on test material:

Storage conditions: At room temperature protected from light
Physical description: Light orange liquid

Further details (e.g. batch no.) unknown until the study is commissioned.