Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Details on sampling:
No analytical verification or sampling conducted
Vehicle:
no
Details on test solutions:
Since the test item is hardly soluble in water, the test solution was prepared through 96-h stirring followed by filtration. The test item stock solution in organic solvent was prepared by completely dissolving 499.9 mg test item in 50 ml ethanol. 15 ml of that test item stock solution was added to an
empty glass vessel. After complete evaporation of the solvent, 1500 ml of the natural water was added. This mixture was moderately stirred for 96 h, followed by filtration. The resulting solution was used as test solution in the toxicity test. In the blank control, 15 mL pure solvent (ethanol) was added and evaporated before addition of the natural water, followed by 96-h stirring and filtration.

At least 1 h before the start of the exposure (addition of fish to the test medium), the test vessels were filled with the test solutions to allow equilibration of pH, oxygen and temperature. The pH was adjusted to pH 6.5–7.0.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Strain: NA
- Source: Aquarium Stern, CH-4310 Rheinfelden).
- Age at study initiation (mean and range, SD): Not specified (detailed as young)
- Length at study initiation (length definition, mean, range and SD): Not specified (although at end of test all fish were 1 to 3 cm)
- Weight at study initiation (mean and range, SD): Not specified

ACCLIMATION
- Acclimation period: At least 12 days
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food during acclimation: Not specified
- Feeding frequency during acclimation: Daily except on weekends.
- Health during acclimation (any mortality observed): None noted
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
26.8 °f H
Test temperature:
21°C
pH:
6.5 to 7.7
Dissolved oxygen:
7 to 8 mg/L (above 60% of the air saturation value at 21°C).
Salinity:
Not specified
Conductivity:
616 μS/cm
Nominal and measured concentrations:
Nominal loading rates of 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass aquaria filled with 1.25 L of water
- Type (delete if not applicable): open
- Aeration: Continuously
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): NA
- Biomass loading rate: < 1 g fish weight/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Standard as per OECD guidelines (natural water with routine measurements for contaminants)

OTHER TEST CONDITIONS
- Adjustment of pH: pH of media adjusted to 6.5 to 7 where necessary.
- Photoperiod: 16 hour light cycle
- Light intensity: Not specified

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality at 2, 24, 48, 72 and 96 hours. Abnormal behaviour was also noted.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Limit test
- Justification for using less concentrations than requested by guideline: NA
- Range finding study: Not conducted (limit test conducted based on results of algae and daphnia magna tests using the same substance)
- Test concentrations: NA
- Results used to determine the conditions for the definitive study: Yes (minimal effects in the algae and Daphnia studies)
Reference substance (positive control):
not required
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities:
- Observations on body length and weight: These were all noted as normal
- Other biological observations: None noted
- Mortality of control: None
- Other adverse effects control: None noted
- Abnormal responses: None noted
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None noted
Results with reference substance (positive control):
Not required
Reported statistics and error estimates:
Not conducted (no effects observed)
Validity criteria fulfilled:
yes
Conclusions:
The 96 hour LL50 (based on loading rates) of the substance was determined to be > the highest concentration tested (100 mg/L).

Description of key information

The 96 hour LL50 (based on loading rates) of the substance was determined to be > the highest concentration tested (100 mg/L).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information