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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:
2000-06-19 to 2000-07-07
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 8T509 (batch no.) ; AH0209 (test substance no.)
- Purity test date: 15 july 1998
- Analytical purity: 90.1% w/w primary amine, as a percentage of the total amine

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored in the dark, at ambient temperature, in the container in which it was received until required for testing, when an appropriate subsample was provided for the test operator

OTHER SPECIFICS
API: Poly(oxy(methyl-l ,2-ethanediyl)),alpha-hydro-omega-(2aminomethylethoxy)-ether with 2-ethyl-2-(hydroxymethyl)-1,3propanediol (3: 1)
Analytical monitoring:
yes
Details on sampling:
- concentrations: 50mg standard/L in 50:50 methanol:dechlorinated water
- Sampling method: flow injection analysis using an evaporative light scattering detector.
Samples for analysis were taken from the centre of the test solutions and diluted with an equal volume of methanol
Vehicle:
no
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Source: Houghton Springs Fish Farm, Winterbourne Houghton, Blandford Forum, Dorset DT11 OPD
- test species batch ref 0/13
- Holding of fish: in stock tanks
- Temperature: 15 ± 1°C
- Weight and length of dilution water control fish at end of exposure period:
mean weight (range): 2.59 g (1.84 - 3.01); mean length (range): 53 mm (48-55)
- Length at study initiation (length definition, mean, range and SD):
- Weight at study initiation (mean and range, SD):
- Feeding during test : no


ACCLIMATION
- Acclimation period: at least 7d
- Acclimation conditions (same as test or not): not
- Type and amount of food: commercial fish food. Food was withheld from the fish for at least 24 hours prior to the commencement of the test
- Feeding frequency:
- Health during acclimation (any mortality observed): no evidence of disease during holding, less than 4% mortality


Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
total hardness: 41.3 mg CaCO3/L
Test temperature:
Temp: 15 ± 1°C
pH:
pH range: 7.24 - 9.84
Dissolved oxygen:
DO range: 8.96 - 9.86 mg/L
Nominal and measured concentrations:
nominal concentrations: dilution water control, 10, 18, 32, 56, 100 mg/L.
mean measured concentrations: <2.5, 7.9, 13, 29, 37, 85 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: single borosilicate glass vessels, external dimensions: 460mm x 305 mm x 310 mm; length x height x width, maximum capacity of 43L, working volume of 30 L
- Aeration: gently areated
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 0
- Biomass loading rate: 0.86 g/L


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water supplied from a 100 m3 reservoir with an average retention time of 24 hours.
- Chlorine: free residual: <2 µg Cl2/L; combined residual: <2 µg Cl2/L
- Alkalinity: 23.4 mg CaCO3/L
- Conductivity: 231 µS/cm at 25°C
- Culture medium different from test medium: no
- Intervals of water quality measurement: every week day


OTHER TEST CONDITIONS
- Photoperiod:16h flurescent light and 8h dark with 20 minute dawn and dusk transition periods commencing at 06:00 and 21:40 hours.


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
mortality and symptoms of toxicity (spiralling, loss of balance, sounding, dark discolouration) at 3h, 24h, 48h, 72h, 96h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10E0.25 (1.78)

Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: no 95%CI
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 18 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
behaviour
Remarks:
spiralling, loss of balance, sounding, dark colouration
Details on results:
- Behavioural abnormalities: spiraling, loss of balance, sounding, dark discolouration
* control group and nominal conc 10 and 18 mg/L: no behavioural abnormalities
* 32 mg/L: 1/10 dead at 96h, sounding and dark discolouration at 72h
* 56 mg/L: 2/10 dead at 96h, sounding and dark discolouration at 72h
* 100 mg/L: 2/0 dead at 96h, spiralling and loss of balance at 48h, sounding and dark discolouration at 72h
more details in table 2 (p14), table 3 (p15)

- Mortality of control: no mortality
- Other adverse effects control: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no
Reported statistics and error estimates:
calculation method not applicable

The results obtained (based on nominal concentrations of the test substance) were:

 Time LC50   95% confidence intervals  Calculation method
 24h >100mg l -1   N/A  N/A
 48h > 100mg l -1  N/A  N/A 
72h  >100mg l -1  N/A  N/A 
96h  >100mg l -1  N/A   N/A

There was no symptoms of toxicity observed in the fish at the nominal concentration of 18mg l -1 therefore,

96 hour no observed effect concentration (NOEC) =18 mg l -1

Validity criteria fulfilled:
yes
Conclusions:
Acute toxicity to rainbow trout, 96h study.
Symptoms of toxicity observed in this study: spiralling, loss of balance, sounding and dark discolouration at nominal concentrations of 32 mg/L and above. No symptoms of toxicity in control group nor at the nominal concentration of 18 mg/L and below.
96h NOEC = 18 mg /L.
96h LC50 > 100 mg/L.

Description of key information

LC50 (96h) > 100 mg/L for Oncorhynchus mykiss (OECD TG 203, EC Method C.1)

Key value for chemical safety assessment

LC50 for freshwater fish:
100 mg/L

Additional information

The Klimisch 2 study by Brixham Environmental Laboratory (2000) performed a short-term toxicity test at 10, 18, 32, 56 and 100 mg/L. Ten rainbow trouts were exposed per concentration and ten other fish functioned as controls. No mortality was observed during the 96-hour test period. The test was considered valid.