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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:
2020

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
ethyl (2S)-3-[3,5-diamino-4-(4-methoxyphenoxy)phenyl]-2-acetamidopropanoate
Cas Number:
440667-78-7
Molecular formula:
C20H25N3O5
IUPAC Name:
ethyl (2S)-3-[3,5-diamino-4-(4-methoxyphenoxy)phenyl]-2-acetamidopropanoate
Test material form:
solid: particulate/powder

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Species Daphnia magna
Authority STRAUS
Strain Berlin
Sex female
Age between 0 and 24 hours
Origin Umweltbundesamt Berlin
In-house breeding since 27. September 2007
Selection of the test system was made following the proposal of the guidelines.

Animal Husbandry
Daphnia magna is bred in the LAUS GmbH throughout the year. The animals are kept for the use in toxicity tests. They multiply by parthenogenesis, thus being genetically identical. The keeping is performed similar to the method described in the OECD guideline, following SOP 115 002 01 („Zucht und Hälterung von Daphnia magna STRAUS“), version 13 from 11. Nov. 2019.
Vessels preserving glasses, nominal volume 2 L
Medium M4-Medium (recipe of ELENDT)
Food green algae (Desmodesmus subspicatus)
Medium renewal twice a week
Photo period 16/8 hours, using neon LED’s
Temperature 20  2 °C

Study design

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

Test conditions

Test temperature:
20.2 – 20.7 °C
pH:
7.6-7.7
Dissolved oxygen:
8.5-8.7 mg/L
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
One valid experiment was performed.
The study was performed as a limit test with the nominal concentration of 100 mg/L. For the test concentration and the blank control, 20 daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised daphnia were counted.
None of the animals was immobilised in the blank control and the tested concentration.
Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a cur-rent reference study to assure that the test conditions are reliable.

At the start and at the end of the test, the content of the test item in the test solutions was determined using HPLC.
The measured concentration was 102 % of the nominal concentration at the beginning of the test and 103 % of the nominal concentration at the end of the test. Therefore, the de-termination of the biological results was based on the nominal concentration (see Guidance Doc. No.23 (§176)).

No observations were made which might cause doubts concerning the validity of the study outcome. All validity criteria were met.
The result of the test is considered valid.
Executive summary:

Findings and Results:


One valid experiment was performed.


The study was performed as a limit test with the nominal concentration of 100 mg/L. For the test concentration and the blank control, 20 daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours, the immobilised daphnia were counted.


None of the animals was immobilised in the blank control and the tested concentration.


Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a current reference study to assure that the test conditions are reliable.


 


At the start and at the end of the test, the content of the test item in the test solutions was determined using HPLC.


The measured concentration was 102 % of the nominal concentration at the beginning of the test and 103 % of the nominal concentration at the end of the test. Therefore, the determination of the biological results was based on the nominal concentration (see Guidance Doc. No.23 (§176)).



The following results were determined for the test item L-Tyrosine, N-acetyl-3,5-diamino-O-(4-methoxyphenyl)-, ethyl ester (species: Daphnia magna).


 


48h-NOEC 100 mg/L
48h-LOEC > 100 mg/L
24
h-EC50 > 100 mg/L
48h-EC50 > 100 mg/L