Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1996-03-11 to 1996-03-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed acc. to the Guideline and under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrabärbling
The body length of 7 representative fish from each batch was measured.
Batch=3/96/L1; date=12-March-1996; n=7; variation range = 2.5-2.8 cm; mean = 2.6 cm; SD = 0.1;

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
2.3 mMol Ca(II) and Mg(II)
Test temperature:
21.4 - 22.3 °C (concentration groups)
21.4 - 22.4 °C (controls)
pH:
7.8 - 8.1 (concentration groups)
7.8 - 8.1 (controls)
Dissolved oxygen:
7.8 - 9.9 mg/L (concentration groups)
7.9 - 9.8 mg/L (controls)
Salinity:
not indicated
Nominal and measured concentrations:
Nominal concentrations: 0 - 1 - 2.5 - 5 - 10 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
Glass-aquaria
- Material, size, headspace, fill volume:
about 10 L per vessel (30 cm x 22cm x 24 cm) placed in a water bath made of Hostalit ZR with a glass pane made of perspex
- Aeration:
none during testing

- 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:
reconstituted water acc. to ISO/DIS 7346/1
preparation in two steel tanks with Hostalen lining
capacity of steel tanks 1000L
OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod:
12 hrs with approx. 700 Lux

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
6.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
9.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
The fish showed changes in appearance and behavior, swimming behavior and respiration rate in the 2.2 - 10 mg/L groups during the entire exposure time. Effects in the 1 mg/L group were reversible within 72 hours of exposure.
Dead fish showed dark colored integument and red opercula.
The individual symptoms are given in the appendix of the study report

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
LC50 (96h) is 6.1 mg/L based on mean measured concentrations.
Executive summary:

The test material was tested in zebra fish (Brachydanio rerio) over 96 hours in a static system. The nominal concentrations tested were 1 ; 2.2; 5; 10 mg/L and a negative control (0 mg/L). All tested concentrations were present as clear solutions. All test batches were homogeneous. No particulate matter was observed. The substance concentration was determined in the 5 and 10 mg/L groups. The values determined were in a range of 77 - 98 % of the theoretical value and reveiled a slight decreasing tendency over the study period. The lethality values given in this report are based on mean measured concentrations. In this 96-hour acute toxicity study of the test material the following lethality values were determined based on mean measured concentrations:

24 h 48 h 72 h 96 h
LC0 [mg/L]

4.1

4.1

4.1

4.1

LC50 [mg/L] 6.1 6.1 6.1 6.1
LC100 [mg/L] 9.2 9.2 9.2 9.2

Symptoms and lethality were observed at 10 mg/L. The 1 - 5 mg/L groups exhibited symptoms but no lethality.