Registration Dossier

Administrative data

short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 203 (Fish, Acute Toxicity Test)

Test material

Constituent 1
Chemical structure
Reference substance name:
(2S)-2-{[(2S)-1-ethoxy-1-oxopentan-2-yl]amino}propanoic acid
EC Number:
Cas Number:
Molecular formula:
C10 H19 N O4
(2S)-2-{[(2S)-1-ethoxy-1-oxopentan-2-yl]amino}propanoic acid
Test material form:
solid: crystalline
Details on test material:
White powder
Specific details on test material used for the study:
Batch 537481-017

Test solutions

Details on test solutions:
A solution containing a maximum of 100 mg/L of the test item plus two other range-finding concentrations was prepared. Test vessels (aquariums) was filled directly from the test solution containers immediately after preparation. The same vessels was used throughout the test. The pH range
considered as appropriate for a normal life of test organisms is circa 6 to 9. Consequently, the test solution « with a pH < 5 R or > 0.2 was tested with pH adjustment.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Justification of this choice: the rainbow trout is a fish species generally accepted by regulatory authorities for this type of study and is recommended in OECD and EEC guidelines.
Origin: CIT, BP 563, 27005 Evreux, France; the eggs are obtained from Viviers de France, Pisciculture des Fontaines, 64490 Sarrance, France.
Allocation to study: animals was selected using a hand-net, without preference, and randomly assigned to test vessels.
Number of animals: four groups of seven fish.

Study design

Test type:
Water media type:
Total exposure duration:
96 h

Test conditions

154 to 155 mg/L of CaCO3 in the control
Test temperature:
14.1 to 14.7°C
7.27 (mini) to 7.76 (maxi)
Dissolved oxygen:
6.8 mg/L (min) to 10.0 (max)
Nominal and measured concentrations:
Nominal concentrations : 1, 10 & 100 mg/L
Details on test conditions:
Test solutions was not changed over the test period.
Light/dark cycle: 16/8 hours.
Duration of test: 96 hours.
Loading: up to 1g of fish per liter of test solution. The animals were between 4 and 6 cm in length.
Oxygen concentration: all attempts was made to maintain dissolved oxygen at or above 60% of the air saturation value at that temperature.

Results and discussion

Effect concentrations
Key result
96 h
Dose descriptor:
Effect conc.:
> 100 mg/L
Nominal / measured:
Conc. based on:
test mat.
Basis for effect:
mortality (fish)

Applicant's summary and conclusion

The highest loading rate without clinical effect and mortality at T96h was 100 mg/L. The lowest loading rate with 100% mortality at T96h was> 100 mg / L.
LC50s at 24h, 48h, 72h and 96h were> 100 mg / L
Executive summary:

Acute short-term toxicity test on fish (rainbow trout) under static conditions was conducted accorting to guidline OCDE.

The highest loading rate without clinical effect and mortality at T96h was 100 mg/L. The lowest loading rate with 100% mortality at T96h was> 100 mg / L.