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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
June-October 2021
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
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Remarks:
A HPLC-Method
Details on sampling:
The samples were diluted with an equal amount of methanol (dilution factor 2) and acidified immediately after sampling with 1 % 2 M hydrochloric acid (final content).
Vehicle:
yes
Remarks:
Acetone The concentration of the solvent was 5000-fold higher than the nominal concentration in the treatment. For the solvent control, only acetone in a concentration of 0.2 mL/L was used.
Details on test solutions:
a stock solution containing 3 g/L in acetone was prepared. 1.4 mL of this stock solution was mixed with 7 L drinking water for preparation of the test solution.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
sexually immature young fish of the same age,
length 1 – 2 cm
Test type:
static
Water media type:
freshwater
Remarks:
Tap water was used in the test.
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
4 days
Hardness:
124.6 mg CaCO3/L
Test temperature:
24.1-23.6 oC
pH:
8.4-7.9
Dissolved oxygen:
100-94%
Conductivity:
233 μS/cm
Nominal and measured concentrations:
nominal 0.6 mg/L
measured 0.27 mg/L
Details on test conditions:
Date: 28. Jun – 02. Jul. 2020
Treatment: 0.6 mg/L nominal concentration Test Design: static
Medium renewal: none
Duration: 96 hours
Loading: 1 fish/L
Aeration: accomplished with glass tubes
Feeding: none
Photo period: 12/12 hours using LED’s
Light intensity: 540 lux
Temperature: 23.5 – 24.5 °C
within one test, temperature did not vary more than 2 °C
between test vessels and between successive days
Test vessels: Glass aquaria total volume 12 L
Replicate (Treatment): 1 vessel, each containing 7 L test solution and 7 fish
Replicate (Solvent control): one test vessel containing 7 L test medium, 0.2 mL/L ace-tone and 7 fish
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
0.11 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Remarks:
At the start and at the end of the test, the content of the test item in the test solutions was determined using HPLC-UV-determination. The concentration determined at the start of the test was 44 % of the nominal concentration. At the end of the test (af
Basis for effect:
mortality (fish)
Details on results:
At the start and at the end of the test, the content of the test item in the test solutions was determined using HPLC-UV-determination. The concentration determined at the start of the test was 44 % of the nominal concentration. At the end of the test (after 96 h), the measured concentration was 7 % of the nominal concentration. The low measured concentration was caused by the poor solubility in test medium and instability of the test item in aqueous me-dium, which was already shown during the validation of the analytical method (LAUS study 20011702G926). However, a low test item concentration was still detectable at the end of the test.
Validity criteria fulfilled:
yes
Remarks:
The mortality in the blank control may not exceed 1 fish at the end of the test. No mortality occurred in the blank control. The dissolved oxygen concentration must be at least 60% throughout the test.
Conclusions:
96h LC50
> 0.11 mg/L
Executive summary:

96h LC50
> 0.11 mg/L

Description of key information

The concentration determined at the start of the test was 44 % of the nominal concentration. At the end of the test (after 96 h), the measured concentration was 7 % of the nominal concentration. The low measured concentration was caused by the poor solubility in test medium and instability of the test item in aqueous me-dium, which was already shown during the validation of the analytical method (LAUS study 20011702G926). However, a low test item concentration was still detectable at the end of the test.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
0.11 mg/L

Additional information