Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-12-11 to 1996-01-19
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was conducted according to the currently available guideline and according to GLP. However, a dispersion of the test item and not the water accommodated fraction was tested. The test substance concentration was not verified by analytical determination.
Cross-reference
Reason / purpose:
reference to other study

Data source

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

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
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
A stock solution (dispersion) was prepared. Then, the stock solution was disolved in the test tanks.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Brachydanio rerio, HAMILTON-BUCHANAN from the Zentral Toxikologie Hoechst AG, Kastengrung, Germany

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
No post exposure period

Test conditions

Hardness:
Not indicated
Test temperature:
21 - 23°C
pH:
7.8 - -8.2
Dissolved oxygen:
5.7 - 9.9 mg/L
Salinity:
Not indicated
Nominal and measured concentrations:
Nominal test concentration: 10, 22, 50 and 100 mg/L.
Details on test conditions:
TEST SYSTEM:
- 10 L test tanks
- 7 fishs per tank
- daily irradiation with 700 Lux for 12 hours /day
- No. of test tanks per concentration (replicates): 2
- The nominal concentrations tested were not verified by analytical determination.

EFFECT PARAMETERS MEASURED :
- observation of the behaviour of the fishs and its appearance
- counting of the fish lethality
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
22 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
50 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
At all test concentrations an influence of the test substance on the behaviour of the fishs especially with respect to swimming and respiration was observed. In addition, an influence of the test substance concentration on the appearance of the fishs and behaviour was observed. No mortality was obsreved at 10 and 22 mg/L nominal concentration, whereas the mortality reached levels of 43% and 100 % at 50 and 100 mg/L. The effects are caused by the dissolved and undissolved parts of the test item in the test solutions. Undissolved test substance in the test solutions and a surface film was observed .
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
Not applicable

Any other information on results incl. tables

Undissolved test substance in the test solutions and a surface film was observed . Therefore, the effects are caused by the dissolved and undissolved parts of the test item in the test solutions.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
the effects are caused by the dissolved and undissolved parts of the test item in the test solutions
Conclusions:
1. 96h-LC0= 22 mg/L
2. 96h-LC50 = 50 mg/L
3. 96h-LC100 = 100 mg/L
Executive summary:

The study examined the effect of Montanol 800 on Zebrafish (Brachydanio rerio) for 96 hours. The fishs were exposed to nominal test concentrations of 10, 22, 50 and 100 mg/L. A dispersion of the test substance was tested and not the water accomodated fraction. The test substance concentration was not verified by analytical determination. Therefore, all results were related to the nominal concentration.

At all test concentrations an influence of the test substance on the behaviour of the fishs especially with respect to swimming and respiration was observed. In addition, an influence of the test substance concentration on the appearance of the fishs was observed. No mortality was observed at 10 and 22 mg/L nominal concentration, whereas the mortality reached levels of 43% and 100 % at 50 and 100 mg/L. The effects are caused by the dissolved and undissolved parts of the test item in the test solutions. Undissolved test substance in the test solutions and a surface film was observed .