Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
fish embryo acute toxicity (FET)
Remarks:
exposure only 48 hours
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Results from the Inter-laboratory transferability of the zebrafish embryo toxicity test
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 236 (Fish embryo acute toxicity (FET) test)
Deviations:
no
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Test type:
static
Water media type:
freshwater
Limit test:
no
Details on test conditions:
Within a national inter-laboratory calibration exercise, the zebrafish embryo toxicity test protocol was validated with respect to it transferability between different laboratories (Nagel, 1997). After testing 21 substances from different classes of chemicals, results proved to be well comparable between laboratories for both lethal and sublethal endpoints (Tables 10, 11).
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
21 010 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (embryo)
Remarks on result:
other:
Remarks:
results from IGB, Berlin
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
19 280 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (embryo)
Remarks on result:
other:
Remarks:
Results from IUCT, Schmallenber
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
22 890 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (embryo)
Remarks on result:
other:
Remarks:
Results from Univ. of Mainz
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
21 060 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (embryo)
Remarks on result:
other:
Remarks:
Mean of the three laboratories
Validity criteria fulfilled:
not applicable
Conclusions:
96 -hour LC50 Danio rerio: 21060 mg urea/L (FET test)
Executive summary:

In the background paper prepared by Branbeck and Lammer (2006) for the German UBA, the results fom an Inter-laboratory transferability test of the zebrafish embryo toxicity test were presented. The 96 -hour LC50 results from the three laboratories were similar (21010, 19280 and 22890 mg urea/L) resulting in a mean of 21060 mg urea/L for the FET test.

The results from this test are considered relevant and reliable for the risk assessment.

Description of key information

96 -h LC50 Danio rerio FET: 21060 mg urea/L (result from and inter-laboratory ring test).

There are further acute fish studies with various freshwater fish species available. All relevant and reliable studies confirm that urea has a low toxicity to fish.

Data for marine species are not available.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
21 060 mg/L

Additional information