Registration Dossier

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
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 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
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 solutions

Details on test solutions:
As the substance did not completely dissolve, solutions were siphoned via glass wool.

Test organisms

Test organisms (species):
Daphnia magna

Study design

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

Test conditions

Hardness:
180 mg/l expressed as CaCO3
Test temperature:
19-20°C
pH:
starting at 6.8 - 7.6 and ending at 7.1 - 8.0
Dissolved oxygen:
starting at 7.6 - 9.6mg/l and ending at 8.1 - 9.4mg/l
Salinity:
CaCl2.2H2O 211.5 mg/l
MgSO4.7H2O 88.8 mg/l
NaHCO3 46.7 mg/l
KCl 4.2 mg/l
Nominal and measured concentrations:
% water soluble fraction prepared at a loading rate of 100mg act.ingr./l: 1, 2.2, 4.6, 10, 22, 46 and 100
average exposure concentration mg TOC/l: 0.39, 0.86, 1.8, 4.2, 9.4, 20, 45
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
8.077 mg/L
Nominal / measured:
nominal
Conc. based on:
other: % water soluble fraction at 100mg act. ingr./l
Basis for effect:
mobility
Remarks on result:
other: lower 95%-cl: EC50=7.094mg/l; upper 95%-cl: EC50=9.070mg/l
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
3.325 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
other: average exposure concentration (mg TOC/l)
Basis for effect:
mobility
Remarks on result:
other: lower 95%-cl: EC50=2.9mg/l; upper 95%-cl: EC50=3.781mg/l

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The substance and its decomposition products cause aquatic toxicity to Daphnia magna.