Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Purity : 96.8%

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Details on test solutions:
The test concentrations were analytically measured at the beginning of the test, after 48 h and at the test.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions: same as test

Study design

Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
The test organisms were checked for mortality after 2, 24, 48, 72 and 96 h from test initiation.

Test conditions

Test temperature:
18.4-21.3°C
pH:
7.02-7.82
Dissolved oxygen:
> 6.6 mg/l
Nominal and measured concentrations:
Five nominal concentration in a geometric series, namely 5.0, 8.9, 15.8, 28.1 and 50.0 microg/l.
Test item concentrated solution flow: 1.5 ml/min
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
< 5 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
5 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
8.6 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
At the lowest test concentrations the test item level was below the LOQ nad/or Detection; in the remaining two upper test concentrations the test item was found to be less than 17.8% to 47.4% of the nominal value. Therefore the biological results are not referred to the nominal concentration but to the geometric mean of the measured concentration.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of test item has been tested on zebra fish under flow-through conditions. The NOEC, LOEC and LC50 values after 96 hours, calculated based on the median of the measured exposure concentrations, were <5.0 micog/l, 5.0 ug/l and 8.8 microg/l (95% confidence range 6.7-11 microg/l) respectively.