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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Referenceopen allclose all

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
August 2008
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
Analytical monitoring:
not specified
Details on sampling:
Samples of the stock solution and the highest tested concentration at 0 hand 48 h were collected and stored in the freezer until analysed by the sponsor.
Vehicle:
no
Details on test solutions:
Method: 5000.3 mg test item dissolved in 1000 mL reconstituted test water to provide stock solution (5000 mg/L). Test solutions prepared by dilution of the stock solution using reconstituted test water.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Source: Taken from Toxicon's on going culture of Daphnia magna. The culture originates from DHI, Denmark.
- Age at study initiation (mean and range, SD): 6 to 24 hours old.
- Feeding during test
- Food type: Green algae - Pseudokirchneriella subcapita.
- Amount: 50-75 mL.
- Frequency: Fed on working days.


Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
Not applicable
Hardness:
Nominal 250 ± 25 mg/L.
Test temperature:
21 ± 1ºC.
pH:
Measured values 7.40 - 8.10
Dissolved oxygen:
Measured values 95.2 - 102.3%
Salinity:
Not applicable
Nominal and measured concentrations:
Nominal concentrations: 0, 500, 1000, 2000, 3000, and 4000 mg/L.
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: Glass petri dishes, 50 mL with 25 mL fill volume.
- No. of organisms per vessel: Five
- No. of vessels per concentration (replicates): four
- No. of vessels per control (replicates): four


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted test water prepared according to OECD test guideline 202.


OTHER TEST CONDITIONS
- Photoperiod: 16 hours light, 8 hours darkness.
- Light intensity: Subdued light.


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobilisation recorded at 24 and 48 hours.


Reference substance (positive control):
no
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
2 530 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
2 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
2 230 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Results with reference substance (positive control):
The report states the following: A qualification test on the Daphnia magna culture was made on 15 May 2008 to assure the quality of the test animals. EC50 was 1.3 mg/L.which confirmed that the culture was suitable as a test organism according to OECD TG no. 202.
Reported statistics and error estimates:
The EC50 values were calculated by means of graphic interpolation. The NOEC value is defined as the highest test concentration where the percent immobilisation is ≤10%

Cumulative % immobility over the 48 hour observation period

Nominal concentration (mg/L)

Cumulative % immobility

24 hours

48 hours

Control

0

0

500

0

0

1000

0

0

2000

10

35

3000

85

100

4000

100

100

Validity criteria fulfilled:
yes
Conclusions:
A static 48 hour definitive test was performed exposing Daphnia magna to a range of concentrations (500 - 4000 mg/L) of Polyol PX. The study was performed in accordance with the OECD guideline 202 and according to GLP. The 48 hour EC50 was calculated to be 2230 mg/L (based on nominal concentrations), the corresponding no-observed effect concentration was observed to be 1000 mg/L.
Executive summary:

The 48–hr-acute toxicity of Polyol PX to Daphnia magna was studied under static conditions. Test species were exposed to control and test chemical at nominal concentration of 500, 1000, 2000, 3000 and 4000 mg/L for 48 hr. Immobilisation was observed daily. The 48 – hour EC50 was 2230 mg /L. The 48 – hr NOEC based on immobilization was 1000 mg/L. Sublethal effects were not observed.


 


Based on the results of this study, Polyol PX would be classified as practically nontoxic to Daphnia magna, in accordance with the classification system of the U.S. EPA.


 


This study is classified as supplementary and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.


 


Results Synopsis


Test Organism Age: newly hatched animals (6 to 24 hr)


Test Type: Static


 


NOEC: 1000 mg/L


EC50: 2230 mg a.i./L


Endpoint Effected: Immobilisation

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 16 DEC 2021 to 18 DEC 2021
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)
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Before usage, the test item was melted at 60°C to guarantee that the substance is homogeneous.
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 4.6, 10, 22, 46, 100, 500 (QC) mg/L
- Sampling method: For the calibration, a dilution series in water was prepared, using a derivatized stock solution. The quantification was performed as an area sum of two signals: CPF and Pentaerythritol. The identification of two signals was performed using the reference items by measurement of solutions via GC/FID and GC/MSD.
10 mL of the test item solution or blank control solution was evaporated via nitrogen evaporation system. The residue was silylated by dissolving in 0.8 mL pyridine and 0.2 mL BSTFA via ultrasonic bath and heating at 104.4 – 109.9 °C for 15 minutes.
- Sample storage conditions before analysis: The test item was stored in a closed vessel at room temperature (20 ± 5 °C), in a dry area protected from direct sunlight and the elements
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain: Berlin
- Age at study initiation: between 0 and 24 hours
- Sex: female
- Method of breeding: Daphnia magna is bred in the LAUS GmbH throughout the year. The animals are kept for the use in toxicity tests. They multiply by parthenogenesis, thus being genetically identical.
- Source: Umweltbundesamt Berlin
- The keeping was performed similar to the method described in the OECD guideline, following SOP 115 002 01 (“Zucht und Hälterung von Daphnia magna STRAUS“), version 14 from 26.
Jul. 2021.

ACCLIMATION
19 hours and 15 minutes before the start of the test, the adult animals were separated from
the young. 0.75 hours before test start, the adults were caught with the help of a glass tube,
and the newborn daphnia (age < 24h) were sieved from the medium and immediately placed
into a beaker containing M4-medium. After the settling-in period, animals which showed no
apparent damage were used for the test.
Test type:
static
Water media type:
freshwater
Remarks:
Deionized water with an enrichment of certain minerals was used in the test. The minerals which are added comply to the composition M4 (Annex 2: Composition of Test medium (M4 medium)) derived by ELENDT as stated in the OECD-Guideline.
Limit test:
no
Total exposure duration:
48 h
Test temperature:
19.0 – 20.2 °C, continuously measured with temperature
data logger
pH:
7.7 - 7.8
Dissolved oxygen:
8.7 - 9.0 mg/L
Nominal and measured concentrations:
4.6 / 10 / 22 / 46 / 100 mg/L (nominal)
Details on test conditions:
TEST SYSTEM
- Test vessel: Beakers, glass, nominal volume 50 mL
- Volume of solution: 20 ± 5 mL
- Renewal rate of test solution: none
- No. of organisms per vessel: 5
- No. of vessels per concentration: 4
- No. of vessels per control: 4

OTHER TEST CONDITIONS
- Photoperiod: 16/8 hours, using LED’s

EFFECT PARAMETERS MEASURED: Immobility (every 24 h)
Reference substance (positive control):
yes
Remarks:
Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study to assure that the test conditions are reliable.
Duration:
24 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.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
The tested concentrations showed no toxicity. None of the animals was immobilised in the blank control and in the treatments with the exception of the concentration 22 mg/L (one immobilised Daphnia).
Results with reference substance (positive control):
Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study to assure that the test conditions are reliable. The 24h-EC50 value lay within the range of the laboratory (1.20 – 2.82 mg/L).
Reported statistics and error estimates:
Because no toxicity was observed at the highest tested concentration 100 mg/L, no statistical evaluation was performed and the biological results are reported as a range.
Validity criteria fulfilled:
yes
Remarks:
Immobilisation in the controls may not exceed 10 %. Immobilisation in the control was 0 %. The concentration of dissolved oxygen at the end of the test must be at least 3 mg/L. The lowest concentration of dissolved oxygen at the end of the test was 8.7.
Conclusions:
One valid experiment was performed.
The study was performed using 5 concentrations ranging from 4.6 to 100 mg/L (nominal). For each test concentration and the blank control, 20 daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised daphnia were counted.
The tested concentrations showed no toxicity. None of the animals was immobilised in the blank control and in the treatments with the exception of the concentration 22 mg/L (one immobilised animal). Because no toxicity was observed, no statistical evaluation was performed and the biological results were reported as a range.
Executive summary:

The 48 –hr-acute toxicity of Polyol PX to Daphnia magna was studied under static conditions. Test species were exposed to control and test chemical at nominal concentration of 0 (control), 4.6, 10, 22, 46, 100 mg/L for 48 hr. Immobilisation was observed daily. The 48 – hour EC50 was >100 mg/L. No sublethal effect was observed.


 


Based on the results of this study, Polyol PX would be classified as practically nontoxic to Daphnia magna in accordance with the classification system of the U.S. EPA.


 


This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.

Description of key information

A reliable (Klimisch 1) static 48 hour definitive test was performed exposing Daphnia magna to a range of concentrations (10 - 100 mg/L) of Polyol PX. The study was performed in accordance with the OECD guideline 202 and according to GLP. The 48 hour EC50 was calculated to be >100 mg/L (based on nominal concentrations).

Key value for chemical safety assessment

Fresh water invertebrates

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

Additional information