Registration Dossier

Diss Factsheets

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
yes
Remarks:
Preparation of the test solution following OECD T/D protocol, 7 day at pH 8 (ref GHS annex X) Test water ISO 6341 medium.
Principles of method if other than guideline:
According to the test guidelines (OECD 211/EU C.20) prerequisities for the long term test are the following.

Results of an acute water flea toxicity test (see Method C.2, Part I Daphnia sp. acute immobilisation test) performed with Daphnia magna should be available. The result may be useful in selecting an appropriate range of test concentrations in the reproduction tests. The water solubility and the vapour pressure of the test substance should be known and a reliable analytical method for the quantification of the substance in the test solutions with reported recovery efficiency and limit of determination should be available.

Existing information indicate that acute lethal effects are not very likely at the level of solubility e.g. at 100 mg/l nominal load or even at remarkably higher loads. Therefore long term test could be carried out without a prerequisite (range finding) short term test.

Long term Daphnia test:

Test material FeSi – grade(s) & particle size to be determined
Test organisms Daphnia magna
Test method long term OECD 211/EU C.20. Daphnia magna, reproduction test
Endpoint Reproduction EC50, EC10/NOEC
Test duration 21 days
Sample preparation poorly soluble metals/alloys: OECD T/D protocol (GHS annex X)
Test water ISO 6341 medium
Analytical monitoring analytical control of dissolved metals
Test concentrations method stipulates ≥ 5 concentrations
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ferrosilicon
EC Number:
912-631-7
Cas Number:
12022-95-6
Molecular formula:
FeSi; FeSi2; Fe2Si
IUPAC Name:
Ferrosilicon

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
The test concentrations of the test substance used for the study were prepared from a water soluble fraction (WSF) at an initial loading concentration of 100 mg/L. The FeSi high Ba test solution concentrations were 1.0, 3.2, 10, 32 and 100 % which equated to an initial loading of 1.0, 3.2, 10, 32 and 100 mg/L. An appropriate shared control was used using EPA media only, plus an additional M7 control was used for comparison with the minimal media. The WSFs were prepared the day before use.

Test organisms

Test organisms (species):
Daphnia magna

Study design

Test type:
semi-static
Total exposure duration:
21 d

Test conditions

Test temperature:
20 ± 2°C
Details on test conditions:
The test vessels and any other container used for preparation of the test solutions were restricted only to un-plasticised plastic. Each test vessels contained between 50 and 100 ml of test solution and had loose fitting lids. The tests were performed in a climate controlled room set to 20±2ºC with 16:8 light:dark photoperiod.

Results and discussion

Effect concentrations
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: mortality, reproduction, growth
Details on results:
.

Applicant's summary and conclusion

Conclusions:
The data generated during the study indicated that there were no effects on survival, growth (length) and reproduction of Daphnia magna exposed to an initial nominal loading concentration of 100 mg/L FeSi high Ba after 21 days exposure. Therefore the NOEC for Daphnia magna reproduction and growth (length) for FeSi high Ba is at an initial loading concentration of 100 mg/L.

Categories Display