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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
minor, without any consequences
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Product no. B4429, Lot no. SLBK5235V
- Expiration date of the lot/batch: 30 April 2018
- Purity test date: na

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: mechanical dispersion (as water soluble)
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Source: Fish Laboratory of TOXI-COOP ZRT. (8237 Tihany, Klebelsberg K. u. 3., Hungary)
- Age at study initiation: juveniles
- Length at study initiation (length definition, mean, range and SD): 2.0 ± 1 cm
- Feeding during test: No

ACCLIMATION
- Acclimation period: not required as bred in laboratory
- Acclimation conditions (same as test or not): same
- Type and amount of food: appropriate, commercial food
- Health during acclimation (any mortality observed): no mortality occurred in seven days before the start of experiment
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
none
Hardness:
approximate theoretical total hardness of 249 mg/L (as CaCO3)
Test temperature:
21.4 – 22.1 °C
pH:
7.48 – 7.83 (without adjustment)
Dissolved oxygen:
72.8 – 86.4 %
Salinity:
no information
Conductivity:
no information
Nominal and measured concentrations:
nominal = measured (98-100% recovery)
Details on test conditions:
TEST SYSTEM
- Test vessel: aquarium
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: fill volume: 5l
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: <= 1.0 g / L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water (ISO medium, prepared according to Annex 2 of the OECD guideline 203)

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12-16h photoperiod per day

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Observations at approximately 4, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality.
The body length of each fish was measured at the end of the test in order to check their compliance with the size range recommended for the species by the test guideline (OECD No. 203). The measured values were within the range of 1.90-2.80 cm.

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: no mortality observed in a pre-experiment with 100 mg/L
- Range finding study: Yes
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: Yes
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: no information
- Observations on body length and weight: Observed, but normal development
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: 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 effects observed
Results with reference substance (positive control):
not applicable
Reported statistics and error estimates:
not applicable as no effects observed
Sublethal observations / clinical signs:

In a 96-hour static acute toxicity test (acc. to OECD TG 203) on Zebrafish (Brachydanio rerio) the test substance had no toxic effect on fish at a

concentration of 100 mg/L (limit concentration). Accordingly, the 96-h LC50 value was determined to be > 100 mg/L. The 96-h NOEC was determined to be 100 mg/L.

Cumulative mortality data in the definitive test

Test Group

Cumulative mortality
(initial population = 10 fish / test group)

3h

6h

24h

48h

72h

96h

Control

0

0

0

0

0

0

100 mg/L

0

0

0

0

0

0


Validity criteria fulfilled:
yes
Executive summary:

The purpose of this study was to evaluate the acute toxicity of the test substance on Zebrafish (Brachydanio rerio). Young fish were exposed to aqueous test media containing the test item for 96 hours. Based on results obtained in a preliminary experiment fish were exposed to a single concentration of 100 mg/L (limit test). A concurrent control group was run.

A static test was performed as the test item was previously shown to be stable in the test medium over the test period. The analytically measured test item concentration remained within ± 20 % of the nominal during the test period of 96 hours; therefore the biological results are based on the nominal concentration.

The fish were observed at approximately 4, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality. Measurements of pH, dissolved oxygen and temperature were carried out daily. The test medium was fully characterized (content, physico-chemical characteristics).

All validity criteria were met. Mortality and any sub-lethal effects were not observed during the 96-h exposure period either in the treated or in the control group. The 96-h NOEC and LC0values were determined to be 100 mg/L; the LC50the LOEC, and LC100values were determined to be > 100 mg/L.

Description of key information

In a 96-hour static acute toxicity test (acc. to OECD TG 203) on Zebrafish (Brachydanio rerio) the test substance had no toxic effect on fish at a

concentration of 100 mg/L (limit concentration). Accordingly, the 96-h LC50 value was determined to be > 100 mg/L. The 96-h NOEC was determined to be 100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information

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