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Ecotoxicological information

Short-term toxicity to fish

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Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study meets requirements of OECD Guideline 203 and GLP requirements

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
Test item analysis was technically not possible.
GLP compliance:
yes (incl. certificate)
Remarks:
GLP according to German "Chemikaliengesetz"

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Pigment Yellow 74
- Physical state: solid
- Stability under test conditions: stable in water
- Storage condition of test material: 7 +- 2°C and dry

Sampling and analysis

Analytical monitoring:
no

Test solutions

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 48 h and centrifugated with 3000 upm for 20 minutes.

Test organisms

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): 2.21 cm
- Weight at study initiation (mean): 0.4 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.

- 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.

Study design

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

Test conditions

Hardness:
Total hardness: 100 mg CaCO3/L (control & treatment)
Test temperature:
21.2°C - 22.0°C (control), 21.9°C - 22.7°C (treatment)
pH:
7.33 - 7.67 (control), 7.44 - 7.74 (treatment)
Dissolved oxygen:
97-100% Saturation
Nominal and measured concentrations:
Nominal concentration: 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Glass-aquaria, about 3 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

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
other: > saturation level
Nominal / measured:
nominal
Basis for effect:
mortality
Remarks on result:
other: NOEC > 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 other information on results incl. tables

- 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.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
In this study Pigment Yellow 74 did not cause any effects to zebrafish after 96 h when tested with the saturated solution. The NOEC (0 ¿ 96 h) is laid down as > concentration of the saturated solution.
Executive summary:

The acute toxicity of the test item Pigment Yellow 74 to fish (zebrafish) was determined according to OECD-Guideline for Testing of Chemicals No. 203 (1992) and EC Commission Directive 92/69/EC Method C.1 (1992) from 2006-05-15 to 2006-05 -19 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 Pigment Yellow 74 didn´t show any signs of toxicity nor lethality at all observation time points up to 96 hours. Therefore, the NOEC was laid down as > the concentration of the saturated solution.