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Ecotoxicological information

Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10-14 September 1991
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:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
no chemical analyses
Principles of method if other than guideline:
no chemical analyses
GLP compliance:
yes (incl. certificate)
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 1 litre of water to give a 2000 mg/l stock solution. 10 ml, 18 ml,
32 ml, 56 ml and 100 ml of this stock solution were dispersed in 20 litres of diluent 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 be tested and then refilled with the fresh solution.

Stability of the test concnetrations was ensured by daily renewel of test media.
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 July 1991 and was acclimatised to test conditions from 2 September 1991.
The stock fish were maintained in a glass fibre tank with a single-pass water renewal system at 14ºC. 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 at least 17 hours prior to the test.
Mean standard length = 4.9 cm (SD = 0.3 cm), mean weight = 1.55 mg (SD = 0.26 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:
14.0 ºC
pH:
7.3-7.4
Dissolved oxygen:
10.0 - 10.1 mg O2/L
Salinity:
no data
Nominal and measured concentrations:
nominal concentartions: 1.0, 1.8, 3.2, 5.6 and 10 mg/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.


Test vessels: Glass aquaria holding 20L of test media. 5 test concentration in duplicate, plus 1 control (10 animals per test concentration).
Fish were placed at random in prepared test media, loading 0.78 g bodyweight/L.
Aeration via narrow bore glass tubes.
Temperature: 14ºC
The lightning was controlled at 16h light- 8 h darkness cycle.
Criteria of death: absence of (i) respiratory movement and (ii) response to a physical stimulation.
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
1.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
2.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95%CL (1.8-3.2 mg/L)
Results with reference substance (positive control):
no reference substance tested
Reported statistics and error estimates:
96 h LC50= 2.4 mg/L with 95% Confidence Limit of 1.8-3.2 mg/L

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

3

10

10

5.6

0

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:

STUDY SPONSOR: Berol Nobel Nacka AB

PROJECT NUMBER: 116/96

TEST MATERIAL: Ampholak XO7

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) 2.4 mg/L 0.72 mg/L ai

95% condidence limits: 1.8 - 3.2 mg/L 0.54 - 0.96 mg/L ai.

ai = active ingredient

"No Observed Effect Concentration" (NOEC) 1.8 mg/l (0.54 mg ai/l)

Description of key information

The acute fish 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

LC50 for freshwater fish:
0.72 mg/L

Additional information

Two acute fish studies with Sodium oleylamphopolycarboxy glycinate are available. Both 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 test substance. The study 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 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.