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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
The actual concentrations of the dissolved ions of the test substance were determined in the surplus of the test media before the test and in the pooled test media of the replicates after 48 hours.
Sample preparation: To 9.5 ml sample 0.5 ml nitric acid (suprapur) were added.

Test solutions

Vehicle:
no
Details on test solutions:
A preparation with 100 mg/L loading rate was prepared by adding 50 mg test substance to 500 mL dilution water. This suspension was stirred for 24 hours in the dark by using magnetic stir plates and bars. A filtrate (two times filtration by a folded filter and once by a cellulose-acetate filter 0.2 µm) was then obtained to ensure that no undissolved test substance particles were in the medium.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Neonates of Daphnia magna less than 24 hours old, were obtained by hatching ephippia, from Creasel Co., Fazantenpark 9, 98000 Deinze, Belgium..
The ephippia were hatched in a petri dish containing reconstituted water in a temperature controlled room at approx. 20 °C under continuous illumination of approximately 6 000 Lux. According to Creasel hatching occurs between 72 and 96 hours after initiating hatching. Approximately 2 hours before the start of the test the neonates were fed with a suspension of Spirulina powder, as also in traditional cultures the neonates have the opportunity to take up some feed particles. The neonates were collected for this test at approximately 87 hours after initiation of hatching.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
No.

Test conditions

Hardness:
250 mg CaCO3/L.
Test temperature:
20 °C.
pH:
7.3 to 7.4 in the test substance media.
Dissolved oxygen:
At least 7.6 mg/L.
Salinity:
No.
Nominal and measured concentrations:
Nominal: Loading rate of 100 mg test substance per L water.
Measured, based on ions. The sum of the ions was calculated as an indicator of an upper limit of the dissolved test substance.
Details on test conditions:
Test vessels: Disposable multiwell test plates with 30 test wells with a transparent lid, provided with the testkit. Each plate has four wells each (replicates A,B,C,D) for the control and for the test concentration. Additionally, for each concentration the plates are provided with "rinsing wells" to prevent dilution of the test substance during the transfer of the daphnia from the hatching petri dish to the test wells (see below).
Water: Reconstituted water.
Aeration: No extra aeration, but slight circulation of air is still possible when the lid of the test plate is closed.
Temperature: Ca. 21 °C, monitored daily (temperature controlled room).
Light: Artificial light from 4 a.m. to 8 p.m.
Feed: No feed.
Transfer to the test wells: The "rinsing wells" and the wells for the replicates of each concentration and control respectively were filled with 10 mL medium each. For the test substance concentration and for the control at least 20 actively swimming neonates were transferred with a micropipette from the hatching petri dish to the "rinsing well". Then 5 neonates from the "rinsing wells" were transferred to each of the 4 wells of the appropriate concentration.
Reference substance (positive control):
yes
Remarks:
periodic check with potassium dichromate.

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 other: mg loading / L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 other: mg loading / L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
>= 100 other: mg loading / L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
other: constitutive elements
Basis for effect:
mobility
Remarks on result:
other: The EC50 is higher than the water solubility

Any other information on results incl. tables

Actual test substance concentrations

The solubility of the test substance was non-stoichiometric. The solubility of lithium and phosphate was much higher than that of the other components. This indicates that the substance does not dissolve as one substance but hydrolyses with releasing some elements to a greater extent than others. The sum of the dissolved ions of the substance was 4.33 mg/L before the test and 4.27 mg/L after the test.

 

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 48 h toxicity (EC50) of the substance to Daphnia is higher than the loading rate of 100 mg/L and higher than the water solubility of the substance.
Executive summary:

The acute toxicity of the substance to Daphnia magna was determined in a static test according to the EU method C.2. The solubility of the substance in water is very low and therefore an aqueous extract of 100 mg/L loading rate, obtained by filtration, was tested. The dissolved ions of the test substance were determined by ICP/AES-technique.

Results

- Immobilisation of control group and test group daphnids was 0 % at the end of the test.

- There were no daphnids trapped at the water surface. 

- Temperature was stable during the test period. 

- Dissolved oxygen concentrations in the test vessels were not lower than 7.6 mg/L at each time determined. 

- The amount of the dissolved ions was similar at the start and at the end of the test. 

The 48 h toxicity (EC50) of the substance to Daphnia is higher than the loading rate of 100 mg/L and higher than the water solubility of the substance. 

The sum of the measured dissolved constitutive ions of the substance was 4.3 mg/L.