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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:
21-25 October 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Good quality study under GLP, however no chemical analyses and no certificate of analysis or detailed description of the test substance. Therefore concentrations nominal.
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
no chemical analysis, fish slightly bigger than required
Principles of method if other than guideline:
no chemical analyses
fish were slightly bigger than recommended, however this was considered not to have influenced the final results.
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
no
Details on sampling:
no chemical analyses
Details on test solutions:
Direct dispersion in water. 4.0 g of test material were dispersed in 1 litre of diluent to give the stock solution of 4.0 g/l 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 be tested
and then refilled with the fresh test solution.
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 11 September 1991 and was acclimatised to test conditions from 14 -21 October 1991.
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 = 6.4 cm (SD = 0.5 cm), mean weight = 3.40 g (SD = 0.58 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:
aproximately 50mg/L as CaCO3
Test temperature:
14ºC
pH:
7.2-7.3
Dissolved oxygen:
10.0 -10.1 mg O2/L
Salinity:
no data
Nominal and measured concentrations:
Nominal concentrations: 1.0, 1.4, 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.

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

Test vessels: Glass aquaria holding 40L 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 0.85 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
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
3.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95%CL (3.2-4.4 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
Results with reference substance (positive control):
no reference substance tested
Reported statistics and error estimates:
96 h LC50=3.8 mg/L with 95% CL of 3.2-4.4 mg/L
Validity criteria fulfilled:
yes
Conclusions:
Good quality study, however no chemical analyses therefore concentrations nominal.
Executive summary:

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) 3.8 mg/L which equals 1.1 mg a.i./L

95% condidence limits: 3.2 - 4.4 mg/L which equals 0.93 - 1.3 mg a.i./L

ai = active ingredient

"No Observed Effect Concentration" (NOEC) 1.8 mg/l (0.51 mg ai/l)

Description of key information

In a s semi-static test conditions according to OECD Guideline No. 203 the LC50 (96h) was determined to 1.1 mg/L (Based on active active ingredient)

Key value for chemical safety assessment

LC50 for freshwater fish:
1.1 mg/L

Additional information

One acute fish study with Amines, N-C12 -18 -alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts is available. The study is performed semi-statically according to OECD 203. Similar to other studies from this period it lacks 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 & Wetton (1992) resulted in a 96h LC50 for rainbow trout of 1.1 mg a.i./L based on nominal test concentrations.