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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:
28 October - 1 November 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study according to guideline and under GLP. No data on actual concentrations.
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
No chemical analysis
Principles of method if other than guideline:
No measurement of actual concentrations. No preliminary test. Statistics different from guideline.
GLP compliance:
yes (incl. certificate)
Remarks:
although study director page can not be read
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
Direct dispersion in water. 0.2, 0.36, 0.64, 1.12 and 2.00 g of test material were each dispensed directly into 20 litres of diluent 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 17 October 1991 and was acclimatised to test conditions from 17 - 28 October 1991.
The stock fish were maintained in a glass fibre tank with a single-pass water renewal system.
Fish were fed dailey with commercial trout pellets, but feeding was discontinued 24h prior to the test.
Mean standard length = 4.1 cm (SD = 0.3 cm), mean weight = 0.97 g (SD = 0.20 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:
None
Hardness:
Approximately 50 mg/L as CaCO3
Test temperature:
14.0 C
pH:
7.4 - 7.6
Dissolved oxygen:
10.0 - 10.2 mgO2/L
Nominal and measured concentrations:
Nominal concentrations:
10, 18, 32, 56, 100 mg/L test substance
3, 5.4, 9.6, 16.8 and 30 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 concentrations plus 1 control (10 animals per test concentration).
Fish were placed at random in prepared test media, loading 0.49 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.:
4 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 95% CL: 3 - 5.4 mg/L
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
13 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL: 10 - 18 mg/L
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
13 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL: 10 - 18 mg/L
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
24 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL: 18 - 32 mg/L
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
28 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL: 24 - 34 mg/L
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Details on results:
The highest concentration resulting in 0% mortality = 10 mg/L and the lowest test concentration resulting in 100% mortality = 18 mg/L.
At 100 mg/L all fish died within 3 h after exposure. Apart from mortality, only loss of equilibrium was observed at concentrations >= 32 mg/L.
The LC50 (96h) was concluded at 13 mg/L , the NOEC (96h) was concluded at 10 mg/L on a nominal basis.
Reported statistics and error estimates:
Analysis of mortality was carried out by the method of Thompson (1947)

Number of surviving animals

Conc (mg/L)

0h

3h

6h

24h

48h

72h

96h

Control

10

10

10

10

10

10

10

10

10

10

10

10

10

10

10

18

10

10

10

10

10

0

0

32

10

10

10

3

0

0

0

56

10

10

0

0

0

0

0

100

10

0

0

0

0

0

0

Validity criteria fulfilled:
yes
Conclusions:
The study was performed according to GLP and guideline. Based on the available data, the highest concentration resulting in 0% mortality = 10 mg/L and the lowest test concentration resulting in 100% mortality = 18 mg/L. At 100 mg/L all fish died within 3 h after exposure. Apart from mortality, only loss of equilibrium was observed at concentrations >= 32 mg/L. The LC50 (96h) was concluded at 13 mg/L , the NOEC (96h) was concluded at 10 mg/L on a nominal basis.
Executive summary:

The acute toxicity of Ampholak YCE to rainbow trout (Oncorhynchus mykiss) was evaluated according to OECD203 and was performed under GLP. It was carried out as a semi-static test, with dose levels of nominally 10, 18, 32, 56 and 100 mg/L. The LC50 (96h) was observed to be 13 mg/L of test substance or 4 mg a.i./L, the NOEC (96h) was concluded at 10 mg/L (or 3 mg a.i./L) on a nominal basis. Loss of equilibrium was observed in animals exposed to concentrations of >= 32 mg/L (or 9.6 mg a.i./L).

Description of key information

The acute fish study from Sewell & Wetton (1992) resulted in a 96h LC50 for rainbow trout of 4.0 mg a.i./L based on nominal test concentrations

Key value for chemical safety assessment

LC50 for freshwater fish:
4 mg/L

Additional information

There is one acute fish study with Sodium cocopropylenediamine propionate available. The study lacks 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 acute fish study from Sewell & Wetton (1992) resulted in a 96h LC50 for rainbow trout of 4.0 mg a.i./L based on nominal test concentrations.