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
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant study conducted according to OECD Guidelines, with no or minor deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Analytical purity: 99.4 %
- Lot/batch No.: SC00011071
- Expiration date of the lot/batch: 01 February 2015

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

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

Nominal and measured concentrations:
Nominal concentrations of 10, 18, 32, 56 and 100 mg/L
Geometric mean measured concentrations of 9.2, 17, 28, 48 and 66 mg/L.

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
37 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 36-39
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
24 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: 22-27
Duration:
24 h
Dose descriptor:
LOEC
Effect conc.:
28 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
28 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
17 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
17 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
Analysis of the freshly prepared test media at 0 hours showed measured concentrations to range from 87% to 119% of nominal. Analysis of the old media at 48 hours showed measured concentrations to range from 71% to 76% of nominal with the exception of the 100 mg/L test concentration which showed a measured concentration of 49% of nominal. It was unclear as to why this result was considerably lower than the remaining concentrations. However, as 100% immobilisation was also observed at 56 mg/L it was considered that the results for the 100 mg/L would not affect the calculation of the 48-hour EC50 value and hence the integrity of the test.
Given that a slight decline in measured concentration was observed over the 48-hour test period, it was considered justifiable to base the results on geometric mean measured test concentrations.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Based on the geometric mean measured concentrations, the 48 hour EC50 of the test material in Daphnia magna in an immobilisation test was determined to be 24 mg/L. The No Observed Effect Concentration (NOEC) was determined to be 17 mg/L.