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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
2010

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
Details on test material:
Physical state: white solid

Sampling and analysis

Analytical monitoring:
no
Details on sampling:
- Concentrations: The concentrations used were based on the results of a range finding study (LC50 after 96 hours between 100 and 1000 mg/l). Therefore the concentrations were spaced by a factor of 2.2 as follows: 0, 2340, 100, 220, 484, 1060, and 2340 mg/l.
- Sampling method: Randomization

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebra fish
- Strain:
- Source: Charles River Aquatics, Someren, Netherlands
- Age at study initiation (mean and range, SD): About 3 months
- Length at study initiation (length definition, mean, range and SD): 2.85 (2.6-3.2) cm
- Weight at study initiation (mean and range, SD): 0.24 (0.2 - 0.4)g
- Feeding during test: Tetra Min standard feed for aquarium fish ad libitum; and on workdays generally additionally live artemia

ACCLIMATION
- Acclimation period: test conditions correspond to housing conditions
- Type and amount of food: 1 day before and during exposure withdrawal of food

Study design

Test type:
semi-static
Total exposure duration:
96 h

Test conditions

Hardness:
About 2.5 mmol/l
Test temperature:
About 22 degrees Celsius
pH:
About 8.0
Dissolved oxygen:
>60%
Details on test conditions:
TEST SYSTEM
- Test vessel: all glass aquaria (30 x 22 x 24 cm)
- Aeration: Slight
- No. of organisms per vessel: 10

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light, 8 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Survival at 1, 4, 24, 48, 72, and 96 hrs

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
>= 1 023.8 - <= 2 439.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Any other information on results incl. tables

Nominal Concentration (mg/l)

Number of fish

1 h

4 h

2 4h

48 h

72 h

96 h

0

10

0

0

0

0

0

0

2340 (pH adjusted)

10

0

0

0

0

0

0

100

10

0

0

0

0

0

0

220

10

0

0

0

0

0

0

484

10

0

0

0

0

0

0

1060

10

1

1

1

2

2

2

2340

10

10

10

10

10

10

10

Applicant's summary and conclusion

Conclusions:
The average between the analytically detected and nominal concentrations give a LC50 between 1023.8 and 2439.8 mg/l and a NOEC after 96 hours of 471.85 mg/l.
Executive summary:

Based on the nominal concentrations, the median lethal concentration (LC50) is between 1060 and 2340 mg/l. Mortality first occurred at a concentration of 1060 mg/l. The no observed effect concentration (NOEC) at 96 hours is 484 mg/l. The analytically detected concentrations gave a median LC50 of >1029.6 and 2390.8 mg/l and a NOEC of 460.6 mg/l.

Thus, the average between the analytically detected and nominal concentrations give a LC50 between 1023.8 and 2439.8 mg/l and a NOEC after 96 hours of 471.85 mg/l.