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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15-19 June 1992

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 203 (Fish, Acute Toxicity 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. 2.0 g of test material was dispersed in water and the volume adjusted to 1 litre to give a 2.0 g/L stock solution . 10, 18, 32, 56 and 100 mL aliquots of this stock solution were each separately dispersed in dechlorinated tap water and the volume adjusted to 20 litres to give
the test series. 1.0, 1.8, 3.2, 5.6 and 10 mg/L.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

Rainbow trout (Oncorhynchus mykiss)
Source: Parkwood trout farm, Wigmore, kent, United Kingdom.
The stock of fish was held since 16 April 1992 and was acclimatised to test conditions from 8 -15 June 1992.
The stock fish were maintained in a glass fibre tank with a single-pass water renewal system. The light was controlled to give a 16h light and 8h
darkness cycle. Fish were fed dailey with commercial trout pellets, but feeding was discontinued 24h prior to the test.
Mean standard length = 4.3 cm (SD = 0.4 cm), mean weight = 1.00 g (SD = 0.29 g), no data on age of fish.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

no

Hardness:

Approximately 50 mg/L as CaCO3

Test temperature:

14 ºC

pH:

7.2-7.3

Dissolved oxygen:

10.0-10.1 mgO2/L

Salinity:

no data

Nominal and measured concentrations:

nominal concentrations: 1.0, 1.8, 3.2, 5.6 and 10 mg/L (30% a.i.)
Concentration based on active ingredient: 0.3, 0.54, 0.96, 1.68 and 3 mg a.i./L

Details on test conditions:

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 be tested and then refilled
with the fresh test solution.
There was a dailey renewal of test media to ensure stability of the test concentrations.

The lightning was controlled at 16h light- 8 h darkness cycle.

Test vessels: Glass aquaria holding 20L of test media. 5 test concentration in duplicate, plus 1 control (20 animals per test concentration).
Fish were placed at random in prepared test media, loading 0.50 g bodyweight/L.
Aeration via narrow bore glass tubes.

Criteria of death: absence of (i) respiratory movement and (ii) response to a physical stimulation.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.39 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

30% active ingredient

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CL (0.3-0.54 mg/L)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CL (1.0-1.8 mg/L)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Results with reference substance (positive control):

no reference substance

Reported statistics and error estimates:

96 h LC50 1.3 mg/L 95% CL (1.0-1.8 mg/L)

Sublethal observations / clinical signs:

Nominal concentration (mg/L)	Cumulative Mortality (initial population: 10)
	6 h	24h	48h	72h	96 h
Control	0	0	0	0	0
1.0	0	0	0	0	0
1.8	0	0	10	10	10
3.2	0	9	10	10	10
5.6	8	10	10	10	10
10	10	10	10	10	10

Validity criteria fulfilled:

yes

Conclusions:

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

Executive summary:

The acute toxicity of Tallowamphotriaminopolycarboxyglycinate to rainbow trout (Oncorhynchus mykiss) was tested according to OECD guideline 203 (1984) and "Fish, Acute Toxicity Test" referenced as Method C.l of Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The test concentrations were 1, 1.8, 3.2, 5.6 and 10 mg/L test substance (30% active ingredient) and the test solution were refreshed daily.

Highest test concentration resulting in 0% mortality = 1.0 mg/L (0.30 mg a.i./L)

Lowest test concentration resulting in 100% mortality = 1.8 mg/L (0.54 mg a.i./L)

"No Observed Effect Concentration" (NOEC) = 1.0 mg/L (0.30 mg a.i./L)

The "No Observed Effect Concentration" is based upon zero mortalities and the absence of any behavioural reactions to exposure at this concentration.

Description of key information

Acute fish studies are available for Sodium tallowamphopolycarboxy glycinate (Sewell 1993), Tallowamphotriamino polycarboxy glycinate (Sewell 1992) and tallowamphopolycarboxy glycinate (Douglos 1988). The three substances are considered to be identical substances under environmental conditions and consequently for all three substances similar LC50 values were observed of respectively, 0.42 mg a.i./L (95% 0.32 -0.56), 0.39 mg a.i./L and 0.52 mg a.i./L.

The lowest LC50 is used here as a worst-case as also the geometric mean may be used in case of equal quality.

These results are in good agreement with the results observed for a strongly related substance Sodium oleylamphopolycarboxy glycinate (CAS no.: 2060541 -49 -1) for which two acute fish studies are available and which hamper from the same short commings i.e. lack the quantification of the test substance during the test. The first study with the Sodium oleylamphopolycarboxy glycinate from Sewell & Grant-Salmon(1993) resulted in a 96h LC50 for rainbow trout of 1.3 mg a.i./L based on nominal test concentrations. The second study from Handley and Mead (1992) resulted in a 96h LC50 for rainbow trout of 0.72 mg a.i./L based on nominal test concentrations.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.39 mg/L

Additional information

Acute fish studies are available for Sodium tallowamphopolycarboxy glycinate (Sewell 1993), Tallowamphotriamino polycarboxy glycinate (Sewell 1992) and tallowamphopolycarboxy glycinate (Douglos 1988). All three studies lack 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 type of test substances. The substance is however very soluble (640 g/L at pH 6.4) 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 be applied to the algae test results.

The lowest LC50 of 0.39 mg/L based on nominal active ingredient concentration is used here as a worst-case.