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:
From June 19,2017 to September 22,2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Batch Number: VE00463145
Appearance: Colorless to pale yellow liquid
Expiration Date: April 06,2018
Purity: 99.9 % (sum of isomers)

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
For the determination of the actual test item concentrations, duplicate samples were taken from each test concentration and the control at the start and at the end of the two 24-hour test medium renewal periods.
For sampling from the aged test media, the contents of the respective replicates were combined prior to sampling.
Immediately after sampling, acetonitrile (1 mL acetonitrile per mL sample volume) was added to each sample to stabilize the latter during the storage period. Thereafter, all samples were frozen (at -20 ± 5 °C). Based on analytical pre-experiments for investigation of the storage stability, the test item was found to be stable in the test water under these storage conditions (see Appendix 1, Table 6 of the Study Report).
The concentrations of SINODOR CQ were analyzed in one of the duplicate test medium samples taken from all treatments and all sampling dates.

Test solutions

Vehicle:
no
Details on test solutions:
At the start of the test and at the start of the renewal period after 24 hours, the highest test medium (i.e: the undiluted equilibrated test medium with a loading rate of 100 mg/l) was prepared following the slow-stirring method.
The equilibrated aqueous phase with a loading rate of 100 mg/L, containing dissolved test item only, was used as highest test concentration and was diluted with the test water to obtain the test media with the lower test concentrations, i.e. the dilutions 1:2.2, 1:4.6, 1:10 and 1:22.
Additionally, a control (test water only) was run in parallel.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
The study was performed with young daphnids of the species Daphnia magna Straus.
At the start of the test, the organisms used in the test were 6-24 hours old and were not first brood progency.

Study design

Test type:
semi-static
Water media type:
other:
Remarks:
Reconstitued test water (ISO Test Water)
Limit test:
no
Total exposure duration:
48 h

Test conditions

Hardness:
250 mg/L as CaCO3
Test temperature:
The water test temperature was in the range of 21-22°C during the test
pH:
The pH values of the test media were between 7.9 and 8.2
Dissolved oxygen:
The dissolved oxygen concentrations in the test media and control were at least 8.1 mg/L
Nominal and measured concentrations:
The results demonstrate the correct preparation of the test media, i.e. the spacing factor of 2.2 between the different test concentrations was met. At the end of the test medium renewal periods, 43 to 67 % of the initially measured values were found demonstrating a decrease of test item concentrations during the 24-hour renewal periods.
Details on test conditions:
Based on the results of the stirring experiment and the range-finding test and in agreement with the Sponsor, the following concentrations of SINODOR CQ were selected for the main test: the equilibrated test medium with a loading rate of 100 mg/L and the dilutions 1:2.2, 1:4.6, 1:10 and 1:22.
Additionally, a control (test water without test item) was tested in parallel.
The main test was performed in a closed system to avoid losses of the test item by evaporation.
Based on the analytical results of the pre-experiments, a semi-static main test with test medium renewal after 24 hours was chosen to keep the concentration as constant as possible during the test period of 48 hours. After 24 hours, the test organisms were transferred by wide-bore pipette in to clean test vessels with freshly prepared test medium of the corresponding concentration.
Reference substance (positive control):
yes
Remarks:
Potassium Dichromate

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.076 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other:
Remarks:
95% Confidence
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
0.029 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
0.15 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
The biological results are based on the mean measured test item concentrations.
A clear dose-response effect was obeserved during the exposure period of 48 hours:
At the 3 lower test concentartions of 0.0062 to 0.029 mg/L, no toxic effects were observed until test end.
At the next higher concentration of 0.061 mg/L, 25% of the daphnids were found to be immobile following 48 hours of exposure.
At the highest concentration of 0.015 mg/L, all daphnids were found to be immobile after 48hours.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
During the first 24 hours of the test, no immobilized test organisms were determined in the control and up to and including the mean measured concentration of 0.061 mg/L. At the highest concentration of 0.15 mg/l, 100 % of the daphnids were found to be immobile.
The 24-hour EC50 of the test item was calculated to be 0.10 mg/L with 95% confidence limits of 0.061 and 0.15 mg/L.
The 24hour EC0 and NOEC were at the concentration of 0.061 mg/L.
The 24 hour EC100 was 0.15 mg/L.


After 48 hours of exposure, no immobolized test organisms were determined in the control and up to and including the test concentration of 0.029 mg/L.
At the next higher concentration of 0.061 mg/L, 25% of the daphnids were found to be immobile.
All other daphnids were mobile, but showed reduced swimming activity at this concentration.
At the highest concentration of 0.15 mg/L, 100% of the daphnids were found to be immobile.
The 48 hours EC50 was calculated to be 0.076 mg/L with 95% confidence limits of 0.060 and 0.095 mg/L.
The 48 hour EC0 and NOEC of SINODOR CQ were both at the mean mesured concentration of 0.029 mg/L, since no toxic effect was obeserved up to and including this test concentration.
The 48 hours EC 100 was at the mean measured concentration of 0.15 mg/L.
Executive summary:

The 48 hours EC50 was calculated to be 0.076 mg/L with 95% confidence limits of 0.060 and 0.095mg/L.