4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate

Biodegradation in water: screening tests

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

biodegradation in water: inherent biodegradability

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 302 B (Inherent biodegradability: Zahn-Wellens/EMPA Test)

Principles of method if other than guideline:

limited details provided

GLP compliance:

no

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, industrial, non-adapted

Details on inoculum:

- Source of inoculum/activated sludge: Bayer water treatment plant
- Concentration of sludge: 250 mg/L

Duration of test (contact time):

28 d

Initial conc.:

262 mg/L

Based on:

test mat.

Initial conc.:

100 mg/L

Based on:

DOC

Parameter followed for biodegradation estimation:

DOC removal

Reference substance:

aniline

Parameter:

% degradation (DOC removal)

Value:

>= 70

Sampling time:

28 d

Remarks on result:

other: day 7-27

Remarks:

see table

Time	Blanc	Reference substance			Test substance
	DOC (mg/L)	DOC (mg/L)	DOC corrected (mg/L)	% degradation	DOC (mg/L)	DOC corrected (mg/L)	% degradation
0 h	16	110	94	0	72	56	0
3 h	15	84	69	27	70	55	2
1	15	91	75	20	44	28	50
7	26	29	3	97	40	14	75
14	24	26	2	98	33	9	84
21	18	20	2	98	29	11	80
27	15	17	2	98	32	17	70
28	15	18	3	97	37	22	61

 

Validity criteria fulfilled:

not specified

Interpretation of results:

inherently biodegradable

Conclusions:

Under the conditions of the test the substance is considered inherently biodegradable

Executive summary:

In a Zahn-Wellens test the substance was inherently biodegradable over the 28 day exposure period.

Reference 2

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 July 2017 to 28 August 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 310 (Ready Biodegradability - CO2 in Sealed Vessels (Headspace Test)

GLP compliance:

yes (incl. QA statement)

Oxygen conditions:

aerobic

Inoculum or test system:

sewage, predominantly domestic, non-adapted

Remarks:

urban (about 66%) and industrial (about 34%) liquid sewage

Details on inoculum:

- Source of inoculum/activated sludge: urban (about 66%) and industrial (about 34%) liquid sewage situated at San Rocco - Monza (MB), Italia.
- Storage conditions: under aerobic conditions
- Storage length: no data
- Preparation of inoculum for exposure: centrifuged and washed
- Pretreatment: none
- Concentration of sludge: 4 mg/L SS

Duration of test (contact time):

28 d

Initial conc.:

10.41 mg/L

Based on:

TOC

Remarks:

determined by REDOX SnC using CHN analyser

Parameter followed for biodegradation estimation:

inorg. C analysis

Details on study design:

TEST CONDITIONS
- Composition of medium: according to OECD 310
- Test temperature: 20°C
- pH: not indicated
- pH adjusted: no
- Suspended solids concentration: 4 mg/L
- Continuous darkness: yes
- Other: contimuous stirring
TEST SYSTEM
- Culturing apparatus: 1000 mL volumteric flask
- Number of culture flasks: 3/sampling and 5 for the sampling after 28 days for test substance, blancs and reference substance
- Measuring equipment: TOC analyser
- Test performed in closed vessels: yes

SAMPLING
- Sampling frequency: on day 1, 7, 14, 21 and 28 in blanks, reference substance controls and test substance treated bottles (3 replicates per sampling time except at day 28 5 replicates)
- Sampling method: in individual bottles reaction stopped with the addition of 6 ml
of sodium hydroxide (1 M) (12 h before measuring)
- Sample storage before analysis: none

CONTROL AND BLANK SYSTEM
- Inoculum blank: yes
- Abiotic sterile control: yes
- Toxicity control: yes


STATISTICAL METHODS:

Reference substance:

benzoic acid, sodium salt

Remarks:

at 21.50 mg/L as C

Key result

Parameter:

% degradation (inorg. C analysis)

Value:

4

Sampling time:

1 d

Key result

Parameter:

% degradation (inorg. C analysis)

Value:

18

Sampling time:

7 d

Key result

Parameter:

% degradation (inorg. C analysis)

Value:

15

Sampling time:

14 d

Key result

Parameter:

% degradation (inorg. C analysis)

Value:

12

Sampling time:

21 d

Key result

Parameter:

% degradation (inorg. C analysis)

Value:

12

Sampling time:

28 d

Details on results:

The substance is biodegradable, but does not meet the 10-day window criterion

Results with reference substance:

see table

 

CHECK POINT (Days)	% OF BIODEGRADATION Reference substance	% OF BIODEGRADATION Test item	% OF BIODEGRADATION Reference substance+ Test item
0	0	0	0
1	20	4	3
7	82	18	-
14	86	15	-
21	82	12	-
28	89	12	64

Validity criteria fulfilled:

yes

Interpretation of results:

not readily biodegradable

Conclusions:

the substance is considered to be not biodegradable

Executive summary:

In a test according to OECD 310, the substance (10.41 mg C/L) degraded 12% over a period of 28 days. The substance is not readily biodegradable.

Description of key information

In a test according to OECD 310, the substance (10.41 mg C/L) degraded 12% over a period of 28 days. The substance is not readily biodegradable (Eurofins 2017). In a Zahn-Wellens test >70% degradation of a formulation of the substance was observed (Bayer 1987).

Key value for chemical safety assessment

Biodegradation in water:

inherently biodegradable, not fulfilling specific criteria

Type of water:

freshwater

Additional information

Based on the composition of the tested substance in this Zahn-Wellens test, which is similar to that of the substance subject to registration, the outcome of this test is considered representative for the substance subject to registration.