Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 - 24 Jul 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes (incl. certificate)
Remarks:
Gewerbeaufsicht in Niedersachsen, Staatliches Gewerbeaufsichtsamt Hildesheim, Germany
Analytical monitoring:
yes
Details on sampling:
- Concentrations: control, 100 mg/L
- Sampling method: Samples were taken at 0 and 96 h.
- Sample storage conditions before analysis: All original samples were stored at 6 ± 2 °C. Prepared samples were stored at room temperature in the autosampler until analysis.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test item amount was weighed and applied to the test media in the aquaria. The test media were mixed with an ultraturrax (3 min, 17000 rpm) and aerated for 30 min.
- Eluate: no
- Differential loading: yes
- Controls: yes, test medium control
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebrafish
- Source: Originally supplied from Umweltbundesamt, Berlin, Germany.
- Length at study initiation (length definition, mean, range and SD): 2.24 cm (2.2 - 2.3 cm)
- Weight at study initiation (mean and range, SD): 0.183 g (measurement of all fish together)
- Feeding during test: none

ACCLIMATION
- Acclimation period: 12 d
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: Sera vipan, SERA GmbH, Heinsberg, Germany; 4% of fish body weight
- Feeding frequency: 3 times per week; fish were not fed 24 h before start
- Health during acclimation (any mortality observed): Mortality < 5%
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
56.1 mg CaCO3/L (control)
Test temperature:
22.6 - 23.2 °C
pH:
7.31 - 7.57
Dissolved oxygen:
97 - 100%
Nominal and measured concentrations:
nominal: control, 100 mg/L
measured (0 h): < LOQ, 89.7 mg/L
measured (96 h): < LOQ, 91.1 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass aquaria
- Material, size, headspace, fill volume: glass, 25.5/18/28 cm (13 L), headspace: 3 L, fill volume: 10 mL
- Aeration: yes
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.128 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
- Culture medium different from test medium: no
- Intervals of water quality measurement: The pH-value, temperature and oxygen saturation were measured in all test vessels at the start of the exposure and every 24 hours. Total hardness was determined at the start of the exposure out of the control. During the test the water temperature was recorded continuously (once per hour) with a data logger. The light intensity on the surface of the test aquaria was measured at the start of the exposure.

OTHER TEST CONDITIONS
- Photoperiod: 16 h light/8 h dark
- Light intensity: 7-750 lux

EFFECT PARAMETERS MEASURED
- Mortality: Mortality was recorded after 2, 24, 48, 72 and 96 h.

TEST CONCENTRATIONS
- Range finding study: no
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality of control: 0%

All effect concentrations were based on the nominal concentrations since the measured concentrations were in the range of > 80 - < 120% of nominal (90 and 91%).

Validity criteria fulfilled:
yes
Conclusions:
No mortality of Danio rerio was observed at the limit concentration of 100 mg/L in a guideline study according to OECD 203 (GLP). Hence, the LC50 (96 h) was derived to be > 100 mg/L (nominal).
Executive summary:

The study was performed according to OECD 203 (GLP). Danio rerio was exposed to a limit concentration of 100 mg/L (nominal) under static conditions. The exposure concentrations were verified by HPLC-DAD analysis and resulted in 90% (0 h) and 91% (96 h) of nominal. Thus, the effect concentrations were based on the nominal concentrations. After a period of 96 h no mortality was recorded in the control and exposure vessels. Hence, the LC50 (96 h) was derived to be > 100 mg/L. All validity criteria were met.

Description of key information

No mortality of Danio rerio was observed at a nominal concentration of 100 mg/L in a guideline study according to OECD 203 (GLP). Hence, the LC50 (96 h) was derived to be > 100 mg/L (nominal).

Key value for chemical safety assessment

LC50 for freshwater fish:
100 mg/L

Additional information

One experimental study is available investigating the short-term toxicity of the test substance to fish (2015). The study was performed according to OECD 203 (GLP). Danio rerio was exposed to a limit concentration of 100 mg/L (nominal) under static conditions. The exposure concentrations were verified by HPLC-DAD analysis and resulted in 90% (0 h) and 91% (96 h) of nominal. Thus, the effect concentrations were based on the nominal concentrations. After a period of 96 h no mortality was recorded in the control and exposure vessels. Hence, the LC50 (96 h) was derived to be > 100 mg/L. All validity criteria were met.