Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988-04-11 to 1988-04-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented GLP and guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes
Remarks:
GLP compliance statement attached to full study report.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Sampling at start of study and after 48 and 96 hrs
- Amount: approx. 100 ml

Test solutions

Vehicle:
no
Details on test solutions:
- Preparation of stock solution of 3 g/l
- After filtration test substance concentration 15.4 mg/l
- This solution served as basis for subsequent concentrations

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
- Source: Hoechst AG, own breed of Department of Gewerbetoxikologie
- Age: hatched 1988-01-15
- Temperature: 22 +/- 1 °C

ACCLIMATISATION
- Oxygen contents: >= 80% of saturation value
- Lighting conditions: 12 hrs daily
- Population density: >= 1 g Fish per L water
- Feedings: twice daily, ad libitum
- Diet: Tetra Min

Study design

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

Test conditions

Test temperature:
Mean over study period: (°C)
Concentration groups: 21.4 - 22.1
control groups: 21.5 - 21.9
pH:
Mean over study period:
Concentration groups: 7.4 - 8.0
control groups: 7.2 - 8.0
Dissolved oxygen:
Mean over study period: (mg/l)
Concentration groups: 7.9 - 9.1
control groups: 7.5 - 9.0
Nominal and measured concentrations:
Nominal (mg/l) Measured mean (mg/l)
1.93 1.85 96.0 %
3.85 3.37 87.5 %
7.70 6.43 83.5 %
15.40 12.5 81.4 %
Details on test conditions:
- 10 fish per testing or control basin.
- Fasting of fish during entire study period
- Examination of fish at 2-4, 24, 48 and 72 hrs: Signs of lethality, obvious changes in appearance or behaviour
- Dead fish where removed from basins
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
LC0
Effect conc.:
7.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
10.9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LC100
Effect conc.:
15.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
7.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
10.9 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
15.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: swimming and lying on water surface, reduced activity, balance put on tails during swimming, elevated or reduced respiratory frequencey, gill covers sticking out, tumbling.
Reported statistics and error estimates:
Analysis of lethality results by probit analysis not possible. Since factor of concentration levels SQRT(2), no further concentrations tested. Geometric mean of LC0 and LC100 reported.

Any other information on results incl. tables

Conditions over the test period

testconcentration        controls

pH:              7.4 - 8.0                     7.2 - 8.0

O2 [mg/L]:   7.9 - 9.1                     7.5 - 9.0

Temp (°C): 21.4 - 22.1               21.5 - 21.9

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Executive summary:

The test of acute toxicity of nitrochlorhydrochinondimethylether in zebra danio (Brachydanio rerio) over a period of 96 hours resulted in the following lethal concentrations:

 

48 hours

[mg/l]

96 hours

[mg/l]

LC0

7.7

7.7

LC50

10.9

10.9

LC100

15.4

15.4

Concentrations tested: 0 / 1.93 / 3.85 / 7.7 and 15.4 mg/l.

At a concentration of 15.4 mg/l symptoms and lethality could be observed. However, the 1.93 up to 7.7 mg/l-groups showed symptoms but no lethalities.

Water samples were taken at the start of the study, after 48 and 96 hours from the middle of the basin to determine the test substance concentration. The mean values are at 81.4 - 96.0 % of the nominal value.