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:
2002

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
Water: Tap water of local origin was used for holding and testing. The water was filtered on activated charcoal and aerated for at least 24 h to remove chlorine.
Nominal water parameters:
Total hardness: 40- 180 mg CaC03/L
pH-value: 6.0 - 8.5
The water is analysed once a year acc. to German tap water regulation.

Test concentration, Stock solution, Dispersion Treatment: A saturated solution was prepared. 200 mg were applied to 2 L test medium and shaken with 20 rpm for 24 h (Rotaling Shaker 3040, GFL). Thereafter the suspension was treated in a centrifuge (20 min, 3000 rpm). The clear solutionwas used in the test.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Danio rerio (zebrafish), Gnathostoma, Pisces, Osteichthyes, Teleostei, Clupeiformes, Cyprinidae
Origin: AQUARIUM AM AEGI, Feldstraße 7, 30159 Hannover, Germany. All fish used in the lest originated from the same delivery of the supplier.

Holding: Holding was performed at the test facility at 23 ± 2°C and diffuse light (0.1-10 µmol/m^2 s, natural photoperiod). The water was changed at least once per week. The dissolved oxygen concentration was more than 80 % of the air saturation value.
Only zebrafish with at least 12 days of acclimatisation and mortality < 5 % within the last 7 days before the study starts were used in the test. No disease treatments were administered throughout holding and testing.

Feeding: Food was provided 3 Iimes per week. The amount of food was 4 % of the fish body weight per feeding day. The test fish were not fed until 24 h before the test started.

Number of test fish: 7 zebrafish were used per lest concentration and control

Loading, length of fish: Fish density in the tanks was less than 1 g fish per Iiter test solution. Average body length at the test start: 2.90 cm. Average body weight at the test start: 0.27 g

Study design

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

Test conditions

Hardness:
58 mg/L as CaCO3
Test temperature:
21-21.9°C
pH:
6.71-7.33
Dissolved oxygen:
85-100% saturation
Nominal and measured concentrations:
0 + 1.3mg/l (corrected DOC saturated solution)
Details on test conditions:
Test vessel: Glass-aquaria loosely covered by glass tops were used.
Test volume: The test volume was 2 L per vessel
Aeration: Gentle aeration was provided
Dilution water: Same as for holding
Replicates: One replicate perlest concentration and control
lntroduction of fish: Fish were added to test chambers within 30 min after centrifugation of the lest item solution. Fish were introduced randomly to individual replicates.
Feeding of lest fish: The fish were not fed during the test
Light intensity: 0.1- 10 µmol/m^2s
Photoperiod: A natural photoperiod was provided du ring the lest.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
1.3 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
other: DOC
Basis for effect:
mortality
Remarks on result:
other: saturated solution
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1.3 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
other: DOC
Basis for effect:
mortality
Remarks on result:
other: saturated solution
Details on results:
No mortality and no sub-lethal effects occured.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
In an OECD203 limit test no toxicity to fish (Danio rerio) could be determined up to the concetration of the saturated solution (1.3 mg/L (corrected DOC) (96h)).
Executive summary:

In an OECD203 limit test no toxicity to fish (Danio rerio) could be determined up to the concetration of the saturated solution (1.3 mg/L (corrected DOC) (96h)).