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:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Analysis of the test media samples was conducted on fresh media at 0 hours and on
corresponding old media at 96 hours. Measured test concentrations were determined
from samples of control and test solution.

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Healthy Danio rerio (zebrafish) were supplied by London University College, United
Kingdom, details of which are maintained in Smithers Viscient (ESG) Ltd. records.
The fish supplied came from the same batch of stock fish and were approximately
2 months old when used for the test.
The fish were acclimatised to the test conditions for at least 12 days prior to testing.
The mortality
rate of the stock batch of fish was 0 % in the seven days prior to the definitive test.
Fish were selected, at random, from the holding tank and allocated to the test vessels at
the start of each phase of testing. The fish were not fed for at least 24 hours before the
start of the definitive test and were not fed throughout the test.
At the end of the test, the total length and wet weight of a sub-sample of ten fish were
determined, selected at random from those used in the test.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
Total hardness as CaCO3 (mg/L) 63
Test temperature:
23.9-24.5 °C
pH:
7.18-7.61
Dissolved oxygen:
87-104%
Salinity:
Alkalinity as CaCO3 (mg/L) 119
Conductivity:
235-262 (μS/cm)
Nominal and measured concentrations:
measured concentrations remained
within ± 20 % (109 – 90.2 %) of the nominal concentration

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 123 mg/L
Nominal / measured:
meas. (not specified)
Basis for effect:
mortality (fish)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes