Registration Dossier

Ecotoxicological information

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:
toxicity to aquatic algae and cyanobacteria
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:
2014
Report Date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 201 (Alga, Growth Inhibition Test)
Qualifier:
according to
Guideline:
EU Method C.3 (Algal Inhibition test)
Qualifier:
according to
Guideline:
other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23, December 14, 2000.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Since the substance decomposes in water, aquatic toxicity from the substance itself is unlikely to occur. In accordance with Column 2 adaptation statement of REACH Annex VII, this study would not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur. This experimental determination has been performed to determine whether the decomposition products cause aquatic toxicity.

Test organisms

Test organisms (species):
Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
72 h

Test conditions

Hardness:
24 mg CaCO3/l
Test temperature:
22-23ºC
pH:
starting at 7.7 - 8.2 and ending at 7.7 - 7.8
Salinity:
NH4Cl 15 mg/l
MgCl2.6H2O 12 mg/l
CaCl2.2H2O 18 mg/l
MgSO4.7H2O 15 mg/l
KH2PO4 1.6 mg/l
FeCl3.6H2O 64 μg/l
Na2EDTA.2H2O 100 μg/l
H3BO3 185 μg/l
MnCl2.4H2O 415 μg/l
ZnCl2 3 μg/l
CoCl2.6H2O 1.5 μg/l
CuCl2.2H2O 0.01 μg/l
Na2MoO4.2H2O 7 μg/l
NaHCO3 50 mg/l
Nominal and measured concentrations:
Due to a mistake 100 instead of 140 mg test substance per litre was prepared as the highest concentration, therefore, after correction the highest concentration was 71 instead of 100 mg a.i./l
% water soluble fraction at a loading rate of 71mg act.ingr./l: 1, 3.2, 10, 32, 100
average exposure concentratin mg TOC/l: 0.08, 0.1, 1.22, 13.37, 27.50
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
23.09 mg/L
Nominal / measured:
nominal
Conc. based on:
other: % water soluble fraction prepared at a loading rate of 71mg act.ingr./l
Basis for effect:
growth rate
Remarks on result:
other: lower 95%-cl: EC50=17.08mg/l; upper 95%-cl: EC50=31.41mg/l
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
5.32 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
other: average exposure concentrations (mg TOC/l)
Basis for effect:
growth rate
Remarks on result:
other: lower 95%-cl: EC50=4.24mg/l; upper 95%-cl: EC50=6.58mg/l
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
7.78 mg/L
Nominal / measured:
nominal
Conc. based on:
other: % water soluble fraction prepared at a loading rate of 71mg act.ingr./l
Basis for effect:
biomass
Remarks on result:
other: lower 95%-cl: EC50=7.78mg/l; upper 95%-cl: EC50=8.56mg/l
Duration:
72 h
Dose descriptor:
EC50
Effect conc.:
0.65 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
other: average exposure concentrations (mg TOC/l)
Basis for effect:
biomass
Remarks on result:
other: lower 95%-cl: EC50=0.53mg/l; upper 95%-cl: EC50=0.77mg/l

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The substance and its decomposition products inhibit growth rate and biomass of Algae.