Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study according to OECD Guideline No. 203 and GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. QA statement)
Remarks:
GLP according to OECD, EC and German principles of Good Laboratory Practice
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION OF TEST SOLUTION
Preparation of the saturated solution: A dispersion (100 mg/L test item was weighed out) was prepared with dilution water, shaken with 20 rpm for 24 h (rotating shaker 3040, GFL) and membrane filtrated with 0.45µm (cellulose nitrate).
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebrafish
- Source: Aquarium am Aegi, Volgersweg 6, D-30175 Hannover, Germany
- Length at study initiation (mean): 2.63 cm
- Weight at study initiation (mean): 0.27 g
- Method of breeding: Holding was performed at the testing facility at 23.2 °C and diffuse light (0.1-10 µmol photons * m-2 * s-1, natural photoperiod). The water was changed at least once per week. The dissolved oxygen concentration was more than 80 % of the air saturation value. Zebrafish with at least 12 days of acclimatisation and mortality < 5 % within these days before the study started were used in the teast. No desease treatments were administered throughout holding and testing.

- Feeding during test
No feeding during the test. The test fish were not fed 24 h before the test started.


ACCLIMATION
- Acclimation period: 12 days of acclimatisation
- Acclimation conditions (same as test or not): Same as test conditions, but fish were fed.
- Type and amount of food: Stör perlets; SERA GMBH, D-52518 Heinsberg, Germany. The amount of food was 4 % of the fish body weight per feeding day.
- Feeding frequency: Food was provided 3 times per week.
- Health during acclimation (any mortality observed): Mortality <5%, no disease treatments were administered.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
Observations were carried out during exposure at the beginning of the experiment and after 24, 48, 72 and 96 hours.
Hardness:
Total hardness: 66 mg CaCO3/L (control & treatment)
Test temperature:
21.1°C - 21.5°C (treatment), 21.0°C - 21.4°C (control)
pH:
7.10 - 7.56 (treatment), 7.07 - 7.31 (control)
Dissolved oxygen:
95-100% saturation (control & treatment)
Nominal and measured concentrations:
Nominal concentration: 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Glass-aquaria, about 4 L per vessel, loosely covered by glass tops;
- Aeration: Gentle aeration was provided.
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: fish density in the tanks was less than 1 g per litre test solution.



TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin was used for holding and testing. The water was filtered on activated charcoal and aerated for at least 24 h to remove chlorine. Nominal water parameters: pH-value: 6.0 - 8.5; The water is analysed biannually acc. to German tap water regulation (see above for actual data for control and treatment).
- Culture medium different from test medium: no
- Intervals of water quality measurement:
pH , temperature and oxygen saturation: at the beginning and every 24 h in all vessels;
Total hardness: at the beginning;


OTHER TEST CONDITIONS
- Photoperiod: natural photoperiod
- Light intensity: 0.1 - 10 µmol photons • m-2 • s-1


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and behavior of the test fish and control fish were observed at 2, 24, 48, 72, 96 h.


TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: solubility limit
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Basis for effect:
mortality (fish)
Remarks on result:
other: NOEC >= saturated solution
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Remarks on result:
other: LC0 >= saturated solution
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Remarks on result:
other: LC100 > saturated solution
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Remarks on result:
other: LC50 > saturated solution
Details on results:
- There was no mortality in control as well as in treated fish at any observation time point.
- Behavioural abnormalities: Neither in treated nor in control fish could any abnormalities be observed at any observation time points.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The test item solution was clearly dissolved from 0 to 48 h but turbid after 72 to 96 h.
Validity criteria fulfilled:
yes
Conclusions:
In this study Hostaperm-Violett RL spez. did not cause any effects to zebrafish after 96 h when tested with the saturated solution. The NOEC (0 – 96 h), LC0 (96 h) and LC100 (96 h) are based on the nominal concentration.
Executive summary:

The acute toxicity of the test item to fish (zebrafish) was determined according to OECD-Guideline for Testing of Chemicals No. 203 (1992) from 2005 -03 -01 to 2005 -03 -05 at DR.U.NOACK-LABORATORIEN, Sarstedt, Germany. A static limit test with a saturated solution was conducted. The preparation method has been chosen with regard to the test item properties and in accordance with the relevant OECD guidance document (2000). Duration of the test was 96 h. 7 test organisms were exposed to the saturated solution and the control. Water quality parameters pH-value, temperature and oxygen-saturation measured after 0, 24, 48, 72 and 96 h were determined to be within the acceptable limits. No test item analysis was carried according to the sponsor.

The saturated solution of the test item didn´t show any signs of toxicity nor lethality at all observation time points up to 96 hours. Therefore, the NOEC and LC0 were laid down as >= 100 mg/lL (based on the nominal concentration) and LC100 was laid down as > 100 mg/L (based on the nominal concentration).


Description of key information

The saturated solution of the test item didn´t show any signs of toxicity nor lethality at all observation time points up to 96 hours. Therefore, the NOEC and LC0were laid down as >= 100 mg/lL (based on the nominal concentration)

Key value for chemical safety assessment

Additional information

The acute toxicity of the test item to fish(zebrafish) was determined according to OECD-Guideline for Testing of Chemicals No. 203(1992). A static limit test with a saturatedsolution was conducted. The preparation method has been chosen with regard to the test itemproperties and in accordance with the relevant OECD guidance document (2000).

The saturated solution of the test item didn´t show any signs of toxicity nor lethality at all observation time points up to 96 hours. Therefore, the NOEC and LC0were laid down as >= 100 mg/lL (based on the nominal concentration) and LC100was laid down as > 100 mg/L (based on the nominal concentration.