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:
2015
Report Date:
2015

Materials and methods

Test guideline
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
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test organisms

Test organisms (species):
Daphnia magna

Study design

Test type:
semi-static
Water media type:
freshwater
Total exposure duration:
48 h

Test conditions

Test temperature:
20°C (max. deviation of 2°C) with variation of 1°C at aach individual test
pH:
7.7 (should be 7.8 with max. deviation of 0.2 for semistatic test)
Dissolved oxygen:
8.0 mg/L
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
51.5 mg/L
Nominal / measured:
meas. (TWA)
Basis for effect:
mobility
Remarks on result:
other: 50.0-53.0 mg/L
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
26.4 mg/L
Nominal / measured:
meas. (TWA)
Basis for effect:
mobility
Remarks on result:
other: 20.5-32.3 mg/L
Duration:
24 h
Dose descriptor:
EC0
Effect conc.:
7.3 mg/L
Nominal / measured:
meas. (TWA)
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
4.9 mg/L
Nominal / measured:
meas. (TWA)
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC100
Effect conc.:
73.9 mg/L
Nominal / measured:
meas. (TWA)
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
73.9 mg/L
Nominal / measured:
meas. (TWA)
Basis for effect:
mobility
Results with reference substance (positive control):
The results of the verification test with K2Cr2O7, are the following:
24 hour – EC50 = 1.95 mg·L-1(95% confidence limit: 1.75 – 2.15 mg·L-1)
48 hour – EC50 = 0.86 mg·L-1(95% confidence limit: 0.70 – 1.02 mg·L-1)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Executive summary:

The test substance, 2-methoxy-5-nitrophenyl acetate, was tested in acute immobilisation test on Daphnia magna.

The test was performed according to method C.2 – Daphnia sp. Acute Immobilisation Test, Council Regulation (EC) No. 440/2008, published in O.J.L 142, 2008.

The preliminary test was performed in range of the test substance nominal concentrations 1 – 100 mg·L-1. The analytical results showed, that the test substance 2-methoxy-5-nitrophenyl acetate was not stable in dilution water in the conditions of the test. Based on toxicity and instability of the test substance found in preliminary test, the definitive test was performed in appropriate concentration range and as semistatic.

The semistatic definitive test was performed in range of the test substance nominal concentrations 9 - 100 mg·L-1. The test solutions were renewed after 24 hours. The test substance concentrations was measured at the beginning, after 24 hours (before and after renewal) and at the end of the test.

There is stated in the guideline that, if evidence is available to demonstrate that the concentration of the test substance has been satisfactorily maintained within ± 20 percent of the nominal or measured initial concentration throughout the test, the results can be based on nominal or measured initial values.

Because concentrations of the test substance have not been satisfactorily maintained within ± 20 percent of the nominal or measured initial concentration throughout the test, time-weighted mean concentrations were used for all evaluations and results.