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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
11 May - 15 August 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
according to OECD 203 (1992), China guideline 203 (2013) and GLP
Qualifier:
according to guideline
Guideline:
other: China guideline 203
Version / remarks:
2013
Deviations:
no
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: 10 mg/L
- Sampling at 24-hour intervals
Vehicle:
no
Details on test solutions:
Test item was weighed and dissolved with test water to make up test solution of 10 mg/L. The solution was mixed with magnetic stirrer using a stirring rate about 420 rpm about 24 hour at room temperature and filtrated with 0.45 µm micro membrane filter before exposure.
Test organisms (species):
other: Gobiocypris rarus
Details on test organisms:
TEST ORGANISM
- Common name: Rare minnow (Gobiocypris rarus)
- Strain: Rare minnow20150826
- Source: Shanghai Academy of Public Measurement
- Age: about 1 year old
- Length at study initiation: 3.6 - 3.9 cm
- Weight at study initiation: 0.4314 - 0.7142 g

ACCLIMATION
- Acclimation conditions: same as test
- Type food during acclimation: brine shrimp
- Feeding frequency during acclimation: twice on workday and one on weekend
- Health during acclimation: healthy, no mortality observed

FEEDING DURING TEST: none
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
none
Hardness:
140 mg/L (as CaCO3)
Test temperature:
23.12 - 24.61 °C
pH:
7.90 - 8.08
Dissolved oxygen:
64.2 - 95.9 %
Nominal and measured concentrations:
Nominal: 10 mg/L
Geometric mean measured: 0.0943 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 10 L rectangle glass tanks (length 30 cm, width 20 cm height 30 cm)
- Type: not specified
- Aeration: before usage
- Renewal rate of test solution: 48 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: < 1.0 g fish/L water

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ground water treated with Aquapro pure water system
- Culture medium different from test medium: no
- Intervals of water quality measurement: measured at the beginning, at the end and every 24 h throughout the exposure

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12 hours light : 12 hours dark
- Light intensity: not specified

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentration (definitive test): 10 mg/L (nominal)
- Results used to determine the conditions for the definitive study: results of range finding test
Reference substance (positive control):
yes
Remarks:
Potassium dichromate, LC50 (24 h) = 464.31 mg/L (95 % confidence limits: 407.28 - 529.32 mg/L)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 0.094 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Other biological observations: none, fish showed no poisoning signs or deaths in control vessels and test vessels
- Mortality of control: 0
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: not reported
Results with reference substance (positive control):
Potassium dichromate, LC50 (24 h) = 464.31 mg/L (95 % confidence limits: 407.28 - 529.32 mg/L), test performed in a separate study
Reported statistics and error estimates:
The effects of the limit concentration was determined directly from the test results.
Sublethal observations / clinical signs:

Table 1: Cumulative mortality




































Nominal concentration [mg/L]



Cumulative mortality [%]



3 h



6 h



24 h



48 h



72 h



96 h



0



0



0



0



0



0



0



10



0



0



0



0



0



0



The results are based on geometric mean measured results, i.e., 0.0943 mg/L.

Validity criteria fulfilled:
yes
Remarks:
No fish died in the control group. The dissolved oxygen concentration was 64.2 to 95.9 % of ASV during the test period.
Conclusions:
The 96-hour LC50 on rare minnow (Gobiocypris rarus) was greater than the limit of solubility (> 0.0943 mg/L).
Executive summary:

An experimental study was conducted according to OECD 203 and GLP under semi-static conditions as limit test. The limit test was performed with saturated test solution  (nominal 10 mg/L). The test concentration was analysed by UPLC/UV from fresh and aged test solutions. The effect concentrations were based on the geometric mean measured values (0.0943 mg/L). After 96 h no mortality was observed. Thus, the LC50 (96 h) was estimated to be > 0.0943 mg/L (mean measured), the limit of solubility.

Description of key information

LC50 (96 h): > 0.0943 mg/L based on mortality of Gobiocypros rarus.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
> 0.094 mg/L

Additional information

One experimental study was conducted according to OECD 203 and GLP under semi-static conditions as limit test. The limit test was performed with saturated test solution  (nominal 10 mg/L). The test concentration was analysed by UPLC/UV from fresh and aged test solutions. The effect concentrations were based on the geometric mean measured values (0.0943 mg/L). After 96 h no mortality was observed. Thus, the LC50 (96 h) was estimated to be > 0.0943 mg/L (mean measured), the limit of solubility.