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

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:

23-27 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. Limited but sufficient description of the test substance.

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. 500 mg of test material was dissolved in water and the volume adjusted to 500 ml to give a 1000 mg/L stock soution. 20, 36, 64, 112 and 200 mL aliquots of this stock solution were each separately dispersed in 20 litres of dechlorinated tap water to give the test series.

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 10 September 1992 and was acclimatised to test conditions from 16 -23 November 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 = 4.2 cm (SD = 0.2 cm), mean weight = 0.63 g (SD = 0.07 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:

7.4 -7.5

Dissolved oxygen:

9.9 - 10.1 mg O2/L

Salinity:

no data

Nominal and measured concentrations:

nominal concentrations: 1.0, 1.8, 3.2, 5.6 and 10 mg/L test substance. Active ingredient content is about 40%

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 daily 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 0.32 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.:

1.1 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CL (0.92 - 1.2 mg/L)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

2.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CL (2.3-3.1 mg/L)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1.8 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 2.7 mg/L 95% CL (2.3-3.1 mg/L) based on test substance

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	0	0	0
3.2	0	0	0	3	8
5.6	0	0	10	10	10
10	0	10	10	10	10

Validity criteria fulfilled:

yes

Conclusions:

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

Executive summary:

STUDY SPONSOR: Berol Nobel Nacka AB

PROJECT NUMBER: 116/129

TEST MATERIAL: Ampholak 7CX

TEST SPECIES: Rainbow trout (Oncorhynchus mykiss)

TEST TYPE: Acute toxicity 96 h LC50

TEST CONDITIONS: Semi-static test conditions accordi ng to OECD Guideline No. 203 referenced as Method C. 1 of Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/584/EEC)

RESULTS:

LC50 (96h) 2.7 mg/L 1.1 mg/L ai

95% condidence limits: 2.3 -3.1 mg/L 0.92 -1.2 mg/L ai.

ai = active ingredient

"No Observed Effect Concentration" (NOEC) 1.8 mg/l (0.72 mg ai / l )

Description of key information

One acute fish 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 96h LC50 for rainbow trout of 1.1 mg a.i./L based on nominal test concentrations.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

1.1 mg/L

Additional information

One acute fish study with Sodium cocoamphopolycarboxy glycinate is available from Sewell & Wetton(1993). The study lacks like other studies from this period, the quantification of the test substance during the test. The test vessels were however presoaked overnight and daily refreshed. 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 96h LC50 for rainbow trout of 1.1 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 fish study with sodium oleylamphopoly carboxy glycinate added to this dossier.

The fish study with Sodium oleylamphopolycarboxy glycinate 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. Indicating a comparable to slightly higher toxicity of the oleyl version of this substance when compared to the coco version.