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Ecotoxicological information

Short-term toxicity to fish

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Administrative data

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-compliant OECD guideline study; short report on results from a screening test (range finding study); deemed scientifically acceptable based on results.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
, version of 17.07.1992
Deviations:
not applicable
Remarks:
(range-finder was performed only)
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Before use, the test material was heated in a water bath at about 30-40°C. About 8.8 g were weighed and dissolved in 4 L of dilution water to receive a stock solution of 2.2 g/L.
- Controls: dilution water
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebra fish
- Strain: CRL / ZF1
- Source: Bio-International, The Netherlands
- Length at study initiation (length definition, mean, range and SD): 2.0±1.0 cm
- Feeding during test: none

ACCLIMATION
- Acclimation period: 30 days
- Type and amount of food: TetraMin fish food; no feeding during the 24 hours before exposure
- Health during acclimation (any mortality observed): no mortality observed
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
not indicated
Test temperature:
22±2 °C (air-conditioned laboratory
pH:
7.5-8.0
Dissolved oxygen:
7.2-8.5 mg/L (>60% of saturation concentration)
Salinity:
not applicable
Nominal and measured concentrations:
nominal: 0.0022, 0.022, 0.22 and 2.2 g/L (2.2, 22, 220 and 2200 mg/L)
Details on test conditions:
TEST SYSTEM
- Test vessel: not indicated
- Material, size, headspace, fill volume: 2 L
- Aeration: no
- No. of organisms per vessel: 3 (range-finder test)
- 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
- Culture medium different from test medium: no

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and sub-lethal effects; recorded at 0, 24, 48, 72 and 96 hours

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
- Justification for using less concentrations than requested by guideline: based on the results obtained during the range finding study the main study was not conducted (range finding study results are reported)
- Range finding study
- Test concentrations: undiluted stock solution (nominal 2.2 g/L) and dilutions 1:10 (nominal 220 mg/L), 1:100 (nominal 22 mg/L) and 1:1000 (nominal 2.2 mg/L);
- Results used to determine the conditions for the definitive study: the definitive study was not conducted (see Executive summary)
Reference substance (positive control):
not required
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
22 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 2.2 - < 22 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
< 2.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 1 out of 3 fish died
Details on results:
- Behavioural abnormalities: none
- Mortality of control: not reported
- Abnormal responses: none
- Effect concentrations exceeding solubility of substance in test medium: the stock solution (used as the highest concentration in this range-finding study) showed a hardly observable oily phase at the surface and was slightly turbid.
Reported statistics and error estimates:
not applicable
Sublethal observations / clinical signs:

Table 1 Mortality

 

Dilution

Nominal

concentration

Number of dead

Remarks

 

g/L

mg/L

fish after 96 h

 

undiluted

2.2

2200

3

the first fish died after ca. 10 min.

1:10

0.22

220

3

fish were dead after ca. 25 min. already

1:100

0.022

22

3

two fish were dead after 72 h

1:1000

0.0022

2.2

1

--

 

Initial population = 3 fish / concentration. First, one of the three fish was inserted into each vessel. After about 10 minutes the remaining fish were inserted if no damage was observed.

Validity criteria fulfilled:
not applicable
Executive summary:

The reported data are from a range finding study. Since a LC50 in the range of 2 mg/L was expected, the originally foreseen analytical method (TOC analysis) was regarded as not sensitive enough. In the course of the development of a new analytical method it appeared that the test material was not stable in the relevant concentration range. Thus, the study was cancelled since a completely new test-design (flow-through system) would have been needed.

The results obtained in this range study are sufficiently meaningful. The expected LC50 is above 1 mg/L and thus would not trigger classification of the substance since the test material is readily biodegradable with a Log Pow of 2.1.

In the light of animal welfare a new full acute toxicity study with fish is not needed.

Description of key information

96-h LC50 2.2-22 mg/L for Brachydanio rerio (OECD TG 203)

Key value for chemical safety assessment

Additional information