Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23/11/2015-4/12/2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

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
Specific details on test material used for the study:
Maderal (reference ZA1076)
Batch n° 100026324
Recieved the 08/07/2015 from the sponsor
Presented as a colourless translucent liquid
Stored at at room temperature and protected from direct sun light

Sampling and analysis

Analytical monitoring:
yes
Remarks:
daily, in the old and new medium used

Test solutions

Vehicle:
yes
Remarks:
acetone

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Received on 10/11/2015 and previously validated
Source : Elevage de la Grande Rivière, 69490 Saint-Forgeux, France
Adaptation : maintained at 23 +/- 2°C, with a 16/8h light/dark cycle, in the same reconstitued water as used for testing
Mean lenght : measured out from 15% of the total population, taken at random : 2.6 +/- 0.2 cm

Study design

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

Test conditions

Test temperature:
Range-finding test
Water control: between 21.2-22.3 °C
Solvent control: between 21.2-22.4 °C
Maderal: between: 21.1-22.6 °C
Definitive test:
Water control: between 20.1-22.1°C
Solvent control: between 20.3-22 °C
Maderal: between: 20.1-22.4 °C
pH:
Range finding-test :
Water control : between 6.9-7.2
Solvent control : between 6.9-7.2
Maderal : between 6.9-7.2 in all tests
Definitive test :
Water control : between 7.2-7.7
Solvent control : between 7.3-7.7
Maderal : between 7.2-7.9 in all tests
Dissolved oxygen:
Range finding-test:
Water control : between 56.8-99.7%
Solvent control : between 51.2-99.6%
Maderal : between 51.5-99.7% in all tests
Definitive test :
Water control : between 84.5-98.7%
Solvent control : between 85.9-98.7%
Maderal : between 79.6-98.7% in all tests
Nominal and measured concentrations:
Range-finding test : 0.01 ; 0.1 ; 1.0 ; 10.0 mg a.i./L
Definitive test:
Nominal concentrations: 4.5 ; 6.3 ; 9.0 ; 12.6 ; 18.0 mg a.i/L
Measured concentrations: 2.3 ; 3.0 ; 4.1 ; 5.4 ; 5.3 mg a.i/L
Details on test conditions:
Use of a Water control and solvent control (acetone)
Medium : ISO test water (according to ISO 6341) freshly reconstitued by dilution of mineral stock solution in pure water
Light : 16h of artificial light / d (< 500 lux)
Food : not fed during the exposure period
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
5.4 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 5.4 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Basis for effect:
mortality
Details on results:
No mortality observed in water/solvent control / No mortality observed in the test item treatments, even at the highest concentration
Results with reference substance (positive control):
LC50-96h between 50 and 250 mg/L

Any other information on results incl. tables

The test item treatments did not remain within 80 -120% of the nominal value because of high instabiliy of the test item in water, even if the test media were alternatively renewed/adjusted twice a day. Decrease of the material was reproducible for each given concentration.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Executive summary:

The short-term toxicity to fish was performed according to the OECD Guideline 203 (Fish, Acute Toxicity Test).

The results are the following:

NOEC-96h = 5.4 mg a.i./L

LC50-96h > 5.4 mg a.i./L