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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
14 June 2019 - 11 October 2019
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)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Batch No.of test material:
120001168816
- Expiration date of the batch:
May 12, 2020
- Purity test date:
May 13, 2019

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Tightly closed in cool, dry, well ventilated area, refrigerator at 2-10°C
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Samples were taken from all test concentrations
- Sample storage conditions before analysis: Deep frozen (<= -18°C)
Vehicle:
no
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Water flea (Daphnia magna Straus)
- Strain/clone: Clone M10
- Age at study initiation: <24 hours :
- Source: inhouse culture, originally supplied by KU Leuven, Belgium
- Age of parental stock: > 35 days
- Feeding during test : Animals were not fed during the test
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Hardness:
250 mg/L CaCO3
Test temperature:
20.6 - 21.4°C
pH:
7.6 - 7.8
Dissolved oxygen:
98 - 104% of air saturation value
Conductivity:
652 µS
Nominal and measured concentrations:
Nominal: 4.27, 9.39, 20.7, 45.5 and 100 mg/L
Measured: 3.8, 8.4, 18.5, 40.6, and 89.2 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: open
- Material, size, headspace, fill volume: 100 mL glass vessels, covered with watch glasses; fill volume 50-60 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Test medium: Elendt M4
- Culture medium different from test medium: no
- Intervals of water quality measurement: Water quality parameters were measured at the start of the test, after temperature adaption of the test solutions, and at the end of the test.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light: 8 hours dark
- Light intensity: 50–1000 lx

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Immobility, determined daily

RANGE-FINDING STUDY
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 89.2 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities:
- Immobilisation of control: No immobile daphnids were observed in the control
- Effect concentrations exceeding solubility of substance in test medium: no
Validity criteria fulfilled:
yes
Conclusions:
A weak concentration-response relationship was observed with less than 50% immobility at the highest tested concentration. Thus, the EC50 was determined as higher than the highest test concentration of 100 mg/L (nominal). The test item concentrations were stable during the test with a mean recovery of 89.2%.

Description of key information

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information

A 48-hour acute toxicity study in Daphnia magna conducted under static conditions reported an EC50value of >100 mg/l (nominal concentrations) based on mobility.