trisodium ({3-[(carboxylatomethyl)amino]propyl}{3-[(carboxylatomethyl)(C16-18, C18 unsat alkyl)amino]propyl}amino)acetate

Toxicity to aquatic algae and cyanobacteria

Link to relevant study record(s)

Reference

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15-18 February 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Good quality study under GLP, however no chemical analyses. Therefore concentrations nominal.

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Deviations:

yes

Remarks:

No Chemical analysis

Principles of method if other than guideline:

no chemical analyses

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Details on sampling:

no chemical analyses

Vehicle:

no

Remarks:

Test substance has a high water solubility of 640 g/L at pH 6.4.

Details on test solutions:

Direct dispersion in culture medium. 200 mg of test material was dispersed in culture medium and the volume adjusted to 1 litre to give a 200 mg/L stock solution. This stock solution was diluted using culture medium to give a 20 mg/L stock solution from which serial dilutions were made to give 10, 5.0, 2.5 and 1.25 mg/L stock solutions. 250 mL of the 1.25, 2.5, 5.0, 10 and 20 mg/L stock solutions were each separately mixed with 250 mL algal suspension to give the test series 0.625, 1.25, 2.5, 5.0 and 10 mg/L.

Test organisms (species):

Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)

Details on test organisms:

Scenedesmus subspicatus (Chodat) (CCAP 276/20) Culture Centre of Algae and Protozoa (CCAP), Institute of Freshwater Ecology, Cumbria, U.K.
Sterile culture medium (Appendix 1) was inoculated from a master culture of Scenedesmus subspicatus and incubated under continuous illumination (approximately 7000 lux) and aeration at 21°C to give an algal suspension in log phase growth characterised by an absorbance of 0.845 (@ 665 nm).
The suspension was diluted to an absorbance of 0.030 prior to use. This suspension had a mean cell density of 3.39 x 10^4 cells/mL .

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Post exposure observation period:

no

Hardness:

no data

Test temperature:

24 ºC

pH:

8.0-10.2

Dissolved oxygen:

No data

Salinity:

no data; standard test media used

Nominal and measured concentrations:

nominal concentrations: 0.625, 1.25, 2.5, 5.0 and 10 mg/L.

Details on test conditions:

250 mL conical flasks containing 100 mL test solution and loosely stoppered to reduce evaporation. All flasks were incubated and shaken (approximately 100 rpm) in an orbital shaker. 5 test concentrations plus 1 control each in triplicate was tested.
Algea were continuous illuminated (approximately 7000 lux) at 24 ºC.

Reference substance (positive control):

no

Key result

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

2.1 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

growth rate

Remarks on result:

other: ErC50 recalculated from raw data

Key result

Duration:

72 h

Dose descriptor:

EC10

Effect conc.:

0.87 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

growth rate

Remarks on result:

other: ErC10 recalculated from raw data

Duration:

72 h

Dose descriptor:

other: EbC50

Effect conc.:

3.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

1.25 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Results with reference substance (positive control):

no positive control

Nominal Concentration (mg/L)	pH	Mean absorbance values				pH
	0 h	0 h	24 h	48 h	72 h	72 h
Control  R1              R2              R3	8.0 8.0 8.0	0.030	0.072	0.208	0.725	10.2 10.1 10.1
0.625    R1              R2              R3	8.0 8.0 8.0	0.030	0.074	0.212	0.731	10.2 10.2 10.1
1.25 R1              R2 R3	8.0 8.0 8.0	0.030	0.073	0.201	0.731	10.0 10.1 10.1
2.5    R1 R2 R3	8.0 8.0 8.0	0.030	0.055	0.192	0.335	10.0 9.8 9.7
5.0    R1 R2 R3	8.0 8.0 8.0	0.030	0.042	0.115	0.229	8.7 9.2 9.0
10         R1 R2 R3	8.0 8.0     8.0	0.030	0.031	0.038	0.040	8.3 8.5 8.4

Validity criteria fulfilled:

yes

Conclusions:

Good quality study. The study is considered as valid with restriction. The study was performed according to the required guidance and documents on good laboratory practice. The validity criteria according to the guidelines are fulfilled. Nevertheless no chemical analysis was performed but this does not invalidate the study.

Executive summary:

STUDY SPONSOR : Berol Nobel AB

PROJECT NUMBER : 116/142

TEST MATERIAL : Ampholak 7TX

TEST SPECIES : Scenedesrnus subspicatus (Chodat) (CCAP 276/20)

TEST TYPE : Algal inhibition test

TEST CONDITIONS : Cultured under continuous illumination on an orbital shaker at 24°C for 72 hours according to OECD

Guideline No. 201 referenced as Method C.3 o f Commission Directive 92/69/EEC (which constitutes

Annex V of Council Directive 67/548/EEC) .

RESULTS

These results are based on nominal test concentrations.

EbC50 (72h) value : 3.6 mg/l

ErC50 (0 -24h) value : 3.9 mg/l

"No Observed Effect Concentration" (NOEC) : 1.25 mg/l

Recalculated results: dd 28 -03 -2018 for registration purposes.

ErC50 (0 -72h) value: 2.1 mg a.i./L

ErC10 (0 - 72h) value: 0.87 mg a.i./L

Description of key information

One algae study with Sodium tallowamphopolycarboxy glycinate is available. The toxicity of Sodium tallowamphopolycarboxy glycinate to an exponentially growing culture of Selenastrum capricornutum (currently known as Pseudokirchneriella subcapitata was determined over an exposure period of 72 hours according to OECD TG 201.

The ErC50 based on active ingredient is 2.1 mg/L.

The ErC10 based on active ingredient is 0.87 mg/L.

Key value for chemical safety assessment

EC50 for freshwater algae:

2.1 mg/L

EC10 or NOEC for freshwater algae:

0.87 mg/L

Additional information

One algae study with Sodium tallowamphopolycarboxy glycinate is available. The toxicity of Sodium tallowamphopolycarboxy glycinate to an exponentially growing culture of Selenastrum capricornutum (currently known as Pseudokirchneriella subcapitata was determined over an exposure period of 72 hours according to OECD TG 201. All validity criteria of the algae test were fulfilled but no chemical analysis was performed as the study was performed at a time when there were no sensitive analytical methods available for the test substance under consideration.

The results of the study were recalculated and the results are added to the test report and RSS

The ErC50 based on active ingredient is 2.1 mg/L

The ErC10 based on active ingredient is 0.87 mg/L