1,3-Propanediamine, N1-(3-aminopropyl)-N3-[3-(C18, C18 unsat) alkylamino]propyl]-, N-(carboxymethyl) derivs., sodium salts

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:

10-12 September

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Good quality study under GLP with certificate of analysis, however no chemical analyses. Therefore all concentrations in this report are nominal.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

no chemical analyses

Principles of method if other than guideline:

no chemical analyses

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):
no

Analytical monitoring:

no

Details on sampling:

no chemical analyses

Details on test solutions:

Direct dispersion in water. 1.0 g of test material was dispersed in 1 litre of diluent to give a stock solution of 1.0 g/l. 200 ml of this stock solution
was dispersed in 2 litres of diluent to give a 100 mg/l stock solution from which serial dilutions were made to give the test series. The test material
was suspected to absorb to glassware and so saturation of the absorption sites was achieved by soaking the test vessels overnight prior to the
start of the test with the test solutions. At 0 hours the test vessels were emptied, rinsed with the solution to fresh test solution.

tested concnetrations: 1.0, 1.8, 3.2, 5.6, 10, 18, 32, 56 and 100 mg/l.

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia Magna Straus
Source: Laboratory culture originating from a strain supplied by the Institut National de Recherche Chimique Appliquée (I.R.CH.A), France
Culture: At 21 ºC in polypropylene vessels containing two litres of dechlorinated and aged tap-water. Cultures were fed daily with a suspension of
mixed algea (predominantly Chlorella spp.). Culture conditions ensure that reproduction is by parthenogenesis.
Selection: Gravid adults were isolated 24 hours prior to initiation 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:

22ºC

pH:

7.3-7.4

Dissolved oxygen:

8.3-8.4 mg O2/L

Salinity:

no data

Nominal and measured concentrations:

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

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

3.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95%CL (6.4-10 mg/L)

Results with reference substance (positive control):

no reference substance tested

Reported statistics and error estimates:

48 h EC50= 8 mg/L with 95% Condifence Limits of 6.4-10 mg/L

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	5	4	9	45
10	0	0	0	0	8	8	16	80
18	0	0	0	0	9	8	17	85
32	0	0	0	0	9	9	18	90
56	4	6	10	50	9	9	18	90
100	7	8	15	75	10	10	20	100

Validity criteria fulfilled:

yes

Conclusions:

Good quality study, however no chemical analyses therefore all concentrations nominal.

Executive summary:

Study Sponsor: Berol Nobel Nacka AB

Project Number: 116/95

Test Substance: Ampholak XO7

Test Spscies: Daphnia magna (Straus) tested in the 1st instar.

Test Type: Acute toxicity. 48 h EC50 (immobilisation).

Test Conditions: Static test conditions according to OECD Guideline No. 202, Part 1 referenced as Method C.2 of Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

Results

24 h EC50 = 62 mg/L (17 mg ai/l) 95 % confidence limits: 51 - 76 mg/L (15- 19 mg ai/l)

48 h EC50 = 8.0 mg/L (2.4 mg ai/l) 95 % confidence limits: 6.4 - 10 mg/L (1.9 - 3.0 mg ai/l)

ai= active ingredient

"No Observed Effect Concnetration" (NOEC) at 24 h = 32 mg/l ( 9.6 mg ai/l)

"No Observed Effect Concnetration" (NOEC) at 48 h = 3.2 mg/l ( 1.0 mg ai/l)

Description of key information

One acute daphnia study with Sodium oleylamphopolycarboxy glycinate is available. The study lacks the quantification of the test substance during the test. The study from Handley and Wetton (1992) resulted in a 48h EC50 for daphnia magna of 2.4 mg a.i./L based on nominal test concentrations.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

2.4 mg/L

Additional information

One acute daphnia study with Sodium oleylamphopolycarboxy glycinate is available. The study lacks similar to the two fish studies the quantification of the test substance during the test. When these studies were performed no suitable sensitive analytical method was available for the quantification of this test substance. The study from Handley and Wetton (1992) resulted in a 48h EC50 for daphnia magna of 2.4 mg a.i./L based on nominal test concentrations.