pentasodium 3,7,11-tris(carboxylatomethyl)-15-(C12-18)-alkyl-3,7,11,15-tetraazaheptadecane-1,17-dioate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

24-26 November 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Good quality study under GLP, however no chemical analyses and no certificate of analysis. Description of the test substance is limit but consider sufficient.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation 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

Details on test solutions:

Direct dispersion in water. 200 mg of test material was dissolved in aged and dechlorinated tap water and the volume adjusted to 2 litres to give a 100 mg/L stock solution from which dilutions were made to give the test series.

tested concentrations: 1.0, 1.8, 3.2, 5.6, 10, 18, .32, 56 and 100 mg/L test substance

Test organisms (species):

Daphnia magna

Details on test organisms:

Laboratory culture originating from a strain supplied by the Institut National de Recherche Chimique Appliquée (I.R.CH.A), France Gravid adults were isolated 24 hours prior to intiation of the test. Young daphnids produced overnight were used for testing.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

no

Hardness:

Approximately 50 mg/L as CaCO3

Test temperature:

20-21 ºC

pH:

7.7-7.8

Dissolved oxygen:

7.9-8.4 mgO2/L

Nominal and measured concentrations:

nominal concentrations: 1.0, 1.8, 3.2, 5.6, 10, 18, .32, 56 and 100 mg/L test substance

Details on test conditions:

The test material was suspected to adsorb to glassware and so saturation of the adsorption sites was achieved by soaking the test vessels overnight pr.ior to the start of the test with the test solutions. At 0 hours the test vessels were emptied, rinsed with the solution to be tested and then refilled with the fresh. solution.

Test vessels were Glass jars each containing 200 mL test solution and covered to reduce evaporation. 9 test concentrations plus 1 control each in duplicate were tested with 20 animals per concentration.

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

14 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Remarks on result:

other: 95% CL (12-16 mg/L)

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

35 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95%CL (31-39 mg/L)

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

18 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

no reference substance

Reported statistics and error estimates:

48 h EC50= 35 mg/L 95%CL (31-39 mg/L) test substance

Concentration (mg/L)	Cumulative immobilized Daphnia (initial population : 10 per concentration)
	24 hours				48 hours
	R1	R2	Total	%	R1	R2	Total	%
Control	0	0	0	0	0	0	0	0
1.0	0	0	0	0	0	0	0	0
1.8	0	0	0	0	0	0	0	0
3.2	0	0	0	0	0	0	0	0
5.6	0	0	0	0	0	0	0	0
10	0	0	0	0	0	0	0	0
18	0	0	0	0	0	0	0	0
32	1	0	1	5	4	3	7	35
56	5	5	10	50	10	10	20	100
100	10	10	20	100	10	10	20	100

Validity criteria fulfilled:

yes

Conclusions:

Good quality study, however no chemical analyses therefore concentrations nominal. furtheremore the is no certifcate of analysis and description of test substance is limited but considered sufficient.

Executive summary:

STUDY SPONSOR: Berol Nobel AB

PROJECT NUMBER: 116/128

TEST MATERIAL: Ampholak 7CX

TEST SPECIES: Daphnia mama Straus tested in the 1st instar.

TEST TYPE: Acute toxicity. 48h EC50 (immobilisation)

TEST CONDITIONS: Static test conditions according to OECD Guideline No. 202,. referenced as Method C.2 of Commission Directive 84/449/EEC (which constitutes Annex V of.Council Directive 67/548/EEC).

RESULTS

These results are based on nominal test concentrations:

24h EC50= 55 mg/L       95% CL 48 - 63 mg/L

48h EC50= 35 mg/L                         95% CL 31 - 39 mg/L

"No Observed Effect Concentration" (NOEC) at 24 h = 18 mg/l (7.2 mg a i / l )

"No Observed Effect Concentratio'n" (NOEC) at 48 h = 18 mg/l (7.2 mg a i / l )

ai = active ingredient

Description of key information

One acute daphnia study with Sodium cocoamphopolycarboxy glycinate is available from Sewell & Wetton (1992). The study lacks like other studies from this period, the quantification of the test substance during the test. When this study was performed no suitable sensitive analytical method was available for the quantification of this test substance. The study from Sewell & Wetton resulted in a 48h EC50 for daphnia of 14 mg a.i./L based on nominal test concentrations.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

14 mg/L

Additional information

One acute daphnia study with Sodium cocoamphopolycarboxy glycinate is available from Sewell & Wetton (1992). The study lacks like other studies from this period, the quantification of the test substance during the test.

When this study was performed no suitable sensitive analytical method was available for the quantification of this type of test substances. The substance is however very soluble (575 g/L) and is therefore expected to be completely bioavailable during the acute fish and daphnia ecotoxicity tests. During algae tests however a decrease of the dissolved test substance concentration is anticipated due to some sorption of the substance to the large surface area of the algae. Where for the acute fish and daphnia the use of nominal concentrations is considered appropriate a geometric mean should if possible be applied to the algae test results.

The study from Sewell & Wetton resulted in a 48h EC50 for daphnia of 14 mg a.i./L based on nominal test concentrations.

The algae study from Sodium oleylamphopolycarboxy glycinate is read across to Sodium cocoamphopolycarboxy glycinate and for bridging reasons the acute daphnia study with sodium oleylamphopoly carboxy glycinate added to this dossier.

The study from Handley and Wetton (1992) with Sodium oleylamphopolycarboxy glycinate resulted in a 48h EC50 for daphnia magna of 2.4 mg a.i./L based on nominal test concentrations indicating a higher toxicity of the oleyl version of this substance when compared to the coco version.