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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 2018-12-12 to 2018-12-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
2004
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Batch No.: B893504
Purity: 99.87%
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/L and control
- Sampling method: Samples of about 10 mL were taken from test group and control group in 0 hour fresh solution and 48 hour old solution. 10 mL of the sample was diluted for 50 folds by acetone before analysis.
Vehicle:
no
Details on test solutions:
0.05020 g test item was added into glass bottle filled with 500 mL test water. The solution was stirred completely.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna Straus
- Age at study initiation: less than 24 hours old and not first brood progeny
- Method of breeding:
- Source: Applying Chemistry Department Pesticide Environmental Evaluation Lab of the China Agricultural University
- Feeding during test : no feeding

ACCLIMATION
The test Daphnia magna was derived from a same healthy stock (i.e. showing no signs of stress such as high mortality, presence of males and ephippia, delay in the production of the first brood, discoloured animals, etc.). There were no difference between culture conditions of stock animals and test animals, the culture water had been exposed to oxygen for over 24 hours.

CULTURE
- Temperature: 18-22 °C
- Photoperiod:16 hours photoperiod daily, 8 hours dark
- Feeding: Concentrated alga suspension
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
170 mg/L (calculated as CaCO3)
Test temperature:
19.6 - 19.9°C
pH:
7.89 - 8.16
Dissolved oxygen:
9.21 - 9.73 mg/L
Nominal and measured concentrations:
Nominal: 100 mg/L
Measured: 92.9 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 250 mL glass beakers
- Test solution volume: 100 mL
- Replicates: 4 replicates for the test concentration and the control.
- Number of animals/vessel: 5
- Control: 5 daphnia in dilution water (without test item) were tested under the same test conditions as the test replicate.
- Test temperature: 18-22°C and the difference ±1°C
- Photoperiod: 16 hours photoperiod daily, 8 hours dark
- Dissolved oxygen concentration (target): not less than 3 mg/L during the test period
- pH value: within 6 - 9
- Note: no aerating to vessels, pH regulating or feeding.

TEST MEDIUM / WATER PARAMETERS
- Origin: the water treated with AquaproPure Water System
- Water hardness: 140 to 250 mg/L(as CaCO3)
- pH: 6.0 to 9.0 pH units
- TOC content: < 2 mg/L
- Aeration: Before usage, the water was aerated for more than 24 hours to attain dissolved oxygen saturation.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Biological observation:
Observation intervals: 24 and 48 hours after exposure
Method:Animals not able to swim within 15 seconds, after gentle agitation of the test vessel is considered to be immobilised (even if they can still move their antennae).In addition to immobility, any abnormal behaviour orappearance wasrecorded.
- Water quality and physicochemical measurements:
Water total hardness: at thebeginning of the test.
Dissolved oxygen and pH: measured in each replicate vessel for both control and test solution at thebeginning of the test and the end of the test.
Temperature:monitored continuously by automatic temperature monitoring system and recorded.

RANGE-FINDING STUDY
- Test concentrations: 0.01, 0.1, 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: The 48-hour EC50 was greater than 100 mg/L (nominal concentration). The test solution can be thought to be stable for at least 48 hours.
Reference substance (positive control):
yes
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
During the 48-hour exposure period, no immobilised and visible toxic signs were observed in the control group and 100 mg/L test group.
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- 24-hour EC50: 1.34 mg/L
- 95% confidence limits: 1.16 mg/L - 1.53 mg/L
Reported statistics and error estimates:
The test is a limit test and the toxic effect is derived from the results directly.
Validity criteria fulfilled:
yes
Conclusions:
According to the results and based on the nominal concentration,the 48-hours median effect concentration (EC50) of the test item to Daphnia magna was greater than 100 mg/L.
Executive summary:

A Daphnia magna acute immobilization test was conducted with Daphnia magna over a48-hour exposure period based on OECD 202.

Based on the results of the preliminary test, the definitive test was carried out at a nominal concentration of 100 mg/L. A concurrent blank control was performed in parallel. 4 replicates were used with 5 daphnia for each replicate. The test was performed with a static system over48 hours.

During the 48-hour exposure period, no immobilised and visible toxic signs were observed in the control group and 100 mg/L test group.

The overall arithmetic mean determined concentration was 92.9 mg/L, which is 92.9% of the nominal concentration.

According to the results and based on the nominal concentration,the 48-hours median effect concentration (EC50) of the test item to Daphnia magna was greater than 100 mg/L.

 

Description of key information

The 48-hours median effect concentration (EC50) of the test item to Daphnia magna was greater than 100 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC50
Effect concentration:
100 mg/L

Additional information