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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:
1995-02-09 to 1995-08-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
change of study monitor in april 1995
GLP compliance:
yes (incl. certificate)
Remarks:
Certificate included in study report
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0 and 100 mg test substance/L
- Sampling method: Duplicate samples from freshly prepared test media of the control and from the test concentration of 100 mg test substance/L were taken at the start of the test, after 24h just after the first test medium renewal and at the end of the test at 96h.
- Sample storage conditions before analysis: Samples were stored deep-frozen at -20°C
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:The test medium was prepared by dissolving a weighed amount of the test substance directly in the test water in the aquarium. The test media was prepared just before introduction of fish.
- Controls: test water
Test organisms (species):
other: Oncorhynchus mykiss Walbaum
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Strain: Oncorhynchus mykiss Walbaum
- Source: Forellenhof Fredelsloh, Moringen, Germany
- Length at study initiation (length definition, mean, range and SD): 5.5 ± 0.11 cm
- Weight at study initiation (mean and range, SD): 2.0 ± 0.15 g

ACCLIMATION
- Acclimation period: 12 weeks
- Type and amount of food: commercial trout diet (Alleinfutter für Forellenbrut, Aminostart (extr.), Kraftfutterwerk Wesel GmbH, Wesel, Germany)
- Health during acclimation (any mortality observed): At least during the last three weeks prior to the start of the test no fish diet in the test fish batch

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
2.10 mmol/L (= 210 mg/L as CaCO3)
Test temperature:
13.1 - 14.6 °C
pH:
7.7 - 8.8
Dissolved oxygen:
8.1-10.4 mg/L
Nominal and measured concentrations:
nominal: 0 and 100 mg/L
measured: fresh samples were between 95.2 and 107.9% of the nominal value
test media taken at the end of the 24 hour renewal periods were between 90.2 and 91.2 % of the nominal value
Details on test conditions:
TEST SYSTEM
- Test vessel: aquarium
- Fill volume: 30 L test medium
- Aeration: slightly
- Renewal rate of test solution (frequency/flow rate): 24 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water of the community Rossdorf; before use the total hardness was reduced in the laboratories of RCC and the water filtered through an activated carbon filter.
- Alkalinity: 4.60 mmol/L


OTHER TEST CONDITIONS
- Photoperiod: 16 hours light per day,
- Light intensity: appr. 50 - 300 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fish were observed after 2, 24, 48, 72 and 96 hours test duration for symptoms of intoxication and mortality.

TEST CONCENTRATIONS
- Range finding study
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
58.3 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Remarks:
active enzyme protein
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: no
- Mortality of control: 0
- Other adverse effects control: no
- Abnormal responses: no
Validity criteria fulfilled:
not specified
Conclusions:
The No-observed-effect concentration was the highest exposure concentration of 100 mg test material/L corresponding to 58.3 mg active enzyme protein/L.
Executive summary:

The acute toxicity of alpha-amylase to Rainbow Trout (Oncorhynchus mykiss) was determined in a 96‑hour semi-static test with a daily test medium renewal according to the OECD Guideline No. 203 and in compliance with GLP. 

A limit test was performed to demonstrate that the test substance has no toxic effect on the test animals up to the concentration of nominal 100 mg test substance/L corresponding to 58.3 mg active enzyme protein (aep)/L. The analysis of the exposure concentrations revealed that the test substance concentrations were within the range of 80 to 120% of the nominal value and thus the biological results are based on the nominal concentration of the test substance.

The 96h NOEC was determined to be 100 mg/L corresponding to 58.3 mg aep/L. The 96h LC50 value could not be determined due to the absence of toxicity of the test substance but is clearly higher than 100 mg/L (58.3 mg aep/L).

Description of key information

Alpha-amylase was not toxic at the the tested concentration of 100 mg/L (58.3 mg aep/L) and thus the NOEC was determined to be 100 mg/L (58.3 mg aep/L).The LC50 value could not be determnined due to the absence of toxicity of the test compound at the tested concentration.

Key value for chemical safety assessment

Additional information

The acute toxicity of alpha-amylase to Rainbow Trout (Oncorhynchus mykiss) was determined in a 96 hour semistatic test with a daily test medium renewal according to the OECD Guideline No. 203 and in compliance with GLP. 

A limit test was performed to demonstrate that the test substance has no toxic effect on the test animals up to the concentration of nominal 100 mg test substance/L corresponding to 58.3 mg active enzyme protein (aep)/L. The analysis of the exposure concentrations revealed that the test substance concentrations were within the range of 80 to 120% of the nominal value and thus the biological results are based on the nominal concentration of the test substance.

The 96h NOEC was determined to be 100 mg/L corresponding to 58.3 mg aep/L. The 96h LC50 value could not be determined due to the absence of toxicity of the test substance but is clearly higher than 100 mg/L (58.3 mg aep/L).