N,N-Bis(2-hydroxyethyl)-C12-18(even numbered, C18 unsaturated) alkyl-1-amine oxides

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:

2008-06-11 to 2008-07-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study with no defiencies

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
n.a.

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, non-adapted

Details on inoculum:

Source: Municipal sewage treatment plant Frankfurt-Niederrad
Inoculum: activated sludge suspension, 0.8 g/L dry substance
Inoculum concentration: 33 ml/L
Bacteria count in test vessel: 1E+5 cfu/ml

Duration of test (contact time):

28 d

Initial conc.:

39.1 - 42.7 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

CO2 evolution

Details on study design:

OECD 301B Guideline conform

Reference substance:

benzoic acid, sodium salt

Parameter:

% degradation (CO2 evolution)

Value:

67

Sampling time:

28 d

Remarks on result:

other: Degradation after 28d: Sample 1 62%, Sample 2: 72%, average 67%

Results with reference substance:

Degradation after 28d: 83%

Validity criteria fulfilled:

yes

Interpretation of results:

readily biodegradable

Conclusions:

As the registration substance is a homologue mixture which has surfactant properties the 10d criteria for readily biodegradable substances is not applicable (see Detergent Regulation 2012/259/EU).

Reference 2

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Analysis certificate was provided allong with GLP accreditation this substance can therefore be considered reliable without restrictions.

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)

Deviations:

yes

Remarks:

This test has been performed according to slightly modified EEC/OECD test guidelines and in conformity with the OECD Principles of Good Laboratory Practice (GLP). Ammonium chloride was omitted from the medium to prevent nitrification.

Principles of method if other than guideline:

This test has been performed according to slightly modified EEC/OECD test guidelines and in conformity with the OECD Principles of Good
Laboratory Practice (GLP). Ammonium chloride was omitted from the medium to prevent nitrification. The closed bottle test was prolonged by
measuring the course of the oxygen decrease in the bottles after day 28 using a special funnel.The sludge was diluted to a concentration in the BOD
bottles of 2 mg DWl/itre.

GLP compliance:

yes

Oxygen conditions:

aerobic

Inoculum or test system:

other: Secondary Activated Sludge.

Details on inoculum:

Instead of an effluent / extract / mixture, activated sludge was used as an inoculum.The inoculum was taken from an activated
sludge plant. The sludge was preconditioned to reduce the endogenous respiration rates.Secondary activated sludge was obtained from the
RWZI Nieuwgraaf in Duiven (1990.02.07). The RWZI Nieuwgraaf is an activated sludge plant treating predominantly domestic wastewater.

Duration of test (contact time):

35 d

Initial conc.:

0.6 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

The test was performed in 280 ml BOD (Biological Oxygen Demand) bottles. (Data minimal)

Reference substance:

other: Sodium Acetate

Preliminary study:

No Data

Test performance:

The validity of the test is shown by the oxygen consumption in the control bottle with sodium acetate and an endogenous respiration of 0.3 mg/litre. The pH of the medium at the end of the test period was 6.8.

Parameter:

% degradation (O2 consumption)

Value:

57

Sampling time:

28 d

Parameter:

% degradation (O2 consumption)

Value:

69

Sampling time:

35 d

Details on results:

The test fulfills the criteria for an Enhanced Biodegradation Screening Test with prolonged duration up to 60d (see REACH Guidance Document Endpoint specific guidance R.7b) . After 35d 69% Degradation was reached and the substance can therefore be classified as readily biodegradable. In addition the test substance is a surfactant (see IUC Chapter 4.10) in detergents and therefore the 10d criteria need not to be fulfilled (see Detergents Regulation 2012/259/EU).

Results with reference substance:

Satisfactory See table Below.

Calculation of Biodegredation

The biodegradation was calculated as the ratio of the biochemical oxygen demand (BOD) to the theoretical oxygen demand (ThOD). The ThOD of the pure active ingredient is '2.9 O2/g test substance. The BOD of the test substance and sodium acetate were calculated from the oxygen concentrations in the bottles with and without test substance and the bottles with and without sodium acetate respectively.

Validity criteria fulfilled:

yes

Interpretation of results:

readily biodegradable

Conclusions:

This study was reliably conducted with all critical quality criteria met. The test fulfills the criteria for an Enhanced Biodegradation Screening Test with prolonged duration up to 60d (see REACH Guidance Document Endpoint specific guidance R.7b) . After 35d 69% Degradation was reached and the substance can therefore be classified as readily biodegradable. In addition the test substance is a surfactant (see IUC Chapter 4.10) in detergents and therefore the 10d criteria need not to be fulfilled (see Detergents Regulation 2012/259/EU).

Description of key information

The registration substance is readily biodegradable in an 28d OECD 301B CO2 Evolution test (67% CO2 evolution). The 10d window is not fulfilled but the registration substance is a surfactant in detergents and accordinng the Detergent Regulation 2012/259/EU the 10d window criteria does not apply.

Key value for chemical safety assessment

Biodegradation in water:

readily biodegradable