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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
February 25, 2013 - July 5, 2013
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No OECD GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0 mg/L and 100 mg/L
- Sampling method: For the analysis of the actual test substance concentrations, 2 ml of the test solution was taken from each vessel at the beginning and at the end of the test.
- Sample storage conditions before analysis: n/a
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)

A nominal concentration of 100 mg/L of the test substance was prepared and stirred (via magnetic stirrer) in the dark at 500 rpm follwed by filtration using a 0.45 µm nitrocellulose membrane to make a saturated solution.

Vehicle:

Tap water, dechlorinated by activated carbon and sterilized by UV lamp was used.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish (Danio rerio)
- Source: Shanghai Xiexing Aquarium (ID: RR-MKT-130201)
- Age at study initiation (mean and range, SD): no data
- Length at end of study (length definition, mean, range and SD): 2.4 ± 0.1 cm (Mean ± SD)
- Weight at end of study (mean and range, SD): 0.24 ± 0.05 (Mean ± SD)
- Method of breeding: no data
- Maintenance of the brood fish: no data


ACCLIMATION
- Acclimation period: > 14 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation: fish were fed daily until 24 hours before test was started
- Feeding frequency during acclimation: daily
- Health during acclimation (any mortality observed): no mortality observed


FEEDING DURING TEST
none
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
no
Hardness:
165 mg CaCO3/L
Test temperature:
22.2 - 23.9°C
pH:
7.78 to 8.14
Dissolved oxygen:
76.9 to 87.2%
Salinity:
no data
Conductivity:
no data
Nominal and measured concentrations:
Nominal Concentration: 100 mg/L
Mean measured concentration: < 108 ng/mL
Details on test conditions:
TEST SYSTEM
- Test vessel: 5L glass tank
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 5L glass tanks were used containing 4L test solution
- Aeration: none
- 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): n/a
- Biomass loading rate: about 0.6g fish/litre

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water, dechlorinated by activated carbon and sterilized by UV lamp
- Total organic carbon: no data
- Particulate matter: no data
- Metals: no data
- Pesticides: no data
- Chlorine: no data
- Alkalinity: no data
- Ca/mg ratio: no data
- Culture medium different from test medium: no
- Intervals of water quality measurement: daily

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: Light : Dark = 12h : 12h
- Light intensity: no data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: nominal 100 mg/L and Control
- Results used to determine the conditions for the definitive study: no mortality at nominal 100 mg/L
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)
Details on results:
- Behavioural abnormalities: no
- Observations on body length and weight: no
- 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: yes
Validity criteria fulfilled:
yes
Conclusions:
There was no acute toxicity of the saturated solution in the limit test. The 96h LC50 of the test substance to Danio rerio was higher than the concentration of the saturated solution (which measured concentration was below 108 ng/mL) under test conditions.

Description of key information

GLP OECD 203: EC50 (96 h) > 100 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information