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:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Sampling and analysis

Analytical monitoring:
no
Details on sampling:
- Concentrations: 100 mg/L
- Sampling method: directly weighing

Test solutions

Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
test concentration: 100 mg/L
Stock solution: Directly weighing
The test medium was mixed with an ultraturrax (1 min, 20500 rpm)

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name:Danio reria (zebrafish)
Gnathostoma, Pisces, Osteichthyes, Teleostei, Clupeiformes, Cyprinidae
- Source: AQUARIUM AM AEGI, Volgersweg 6, 0-30175 Hannover, All fish used in the test originated from the same delivery of the supplier.
- Length at study initiation (length definition, mean, range and SD):
Average body length at the test start: 2.66 cm
- Weight at study initiation (mean and range, SD):
Average body weight at the test start: 0.29 g
- Feeding during test:
The fish were not fed during the test.

ACCLIMATION
Holding was performed at the test facility at 23 ± 2 °C and diffuse light (0.1-10 f,Jmol photons' m-2 . S-1, natural photoperiod). The water was changed at least once per week. The dissolved oxygen concentration was more than 80 % of the air saturation value. Zebrafish with at least 12 days of acclimatisation and mortality < 5 % within these days before the study starts were used in the test. No disease treatments were administered throughout holding and testing.

Study design

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

Test conditions

Hardness:
10 - 250 mg CaCO3/L
Test temperature:
23 ± 2 °C
pH:
pH-value: 6.0 - 8.5
Dissolved oxygen:
Not less than 60 % of air saturation value.
Nominal and measured concentrations:
100 mg/L limit test
Details on test conditions:
TEST SYSTEM
- Test vessel:
Glass-aquaria loosely covered by glass tops were used.
- Material, size, headspace, fill volume:
about 10 L per vessel
- Aeration:
gentle aeration was provided
- Renewal rate of test solution (frequency/flow rate):
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution 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: 10 - 250 mg CaCO3/L
pH-value: 6.0 - 8.5
The water is analysed biannual ace. to German tap water regulation.

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod:
A natural photoperiod occurred during the test.
- Light intensity:
0.1 - 10 µmol photons x m-2 x s-1
Reference substance (positive control):
not required

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: confidence intervals not applicable
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: confidence intervals not applicable
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 100
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: confidence intervals not applicable
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: confidence intervals not applicable
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: confidence intervals not applicable
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: confidence intervals not applicable
Details on results:
The nominal test item concentration of 100 mg/L caused no mortality or non-lethal effects.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
In this study the test substance did not cause any effects to zebrafish after 96 h when tested with a single test concentration of 100 mg/L.
Executive summary:

The acute toxicity of the test item to fish (zebrafish) was determined according to OECD-Guideline for Testing of Chemicals No. 203 (1992) from 2005-07-25 to 2005-07-29 at DR.U.NoACK-LABORATORIEN, 31157 Sarstedt, Germany. A static limit test with a single test item concentration of 100 mg/L was conducted. Duration of the test was 96 h. 7 test organisms were exposed to the test concentration and the control. Water quality parameters pH-value, temperature and oxygen-saturation measured after 0, 24, 48, 72 and 96 h were determined to be within the acceptable limits. All effect values are based on the nominal concentration of the test item. DOC-analysis was carried out at test start from the test item and the control vessel.