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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Report with few details but sufficient for assessment
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
not specified
GLP compliance:
not specified
Analytical monitoring:
not specified
Vehicle:
yes
Details on test solutions:
The test substance was dissolved in drinking water, nominal concentration 125 mg / l.
Test organisms (species):
Leuciscus idus
Details on test organisms:
Supplier: farm Christmann, Oberarnbach, DE
Young animals of 5-8 cm body length
Test type:
flow-through
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
16-20 °C
pH:
startint point (0 h): test solution: 8.9
end of the study (96 h): test solution 8.0
Dissolved oxygen:
startint point (0 h): test solution: 9.7
end of the study (96 h): test solution 7.5
Nominal and measured concentrations:
125 mg/l
Details on test conditions:
7 fish in 7 liters of solution
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 125 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
No mortality wa observed during the test,
Validity criteria fulfilled:
yes
Conclusions:
Not toxic for fish
LC50 > 125 mg/l
Executive summary:

The test results show no moratility and no toxic effect on fish.

Endpoint:
short-term toxicity to fish
Type of information:
other: read across from similar substance
Adequacy of study:
key study
Study period:
2009
Reliability:
2 (reliable with restrictions)
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
No deviations from test guidelines or other incidents occurred during the course of the reported test which may have influenced the results.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
not specified
Vehicle:
yes
Details on test solutions:
Fresh test solutions were prepared for each renewal.The test substance was homogenized by shaking of the container before use. The test substance 1.2001 g (first intervai 16 Mar 2009) and 1.2003 g (second intervai 18 Mar 2009) was weighed into a beaker. The defined volume of test water (10 L) was filled into the test vessel and an aliquot was removed and mixed with the test substance in a beaker using an ultra turrax high shear mixer. The mixture was then poured into the test vessel and the entire volume of test solution was homogenized again with an ultra turrax.To maintain constant exposure conditions the study was carried out as a static-renewal exposure. While the test substance is stable over 96h (see 3.6.1) there was a decrease in concentration at 96 h. In order to assure constant test conditions over the entire exposure period, the test solutions were changed at 48 h.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
7 fish were hatched at the testing faciiity 0.38 g (0.31 - 0.47 g) and 3.4 cm (3.3 - 3.5 cm)Age of the animale: Approx. 6 monthsAcclimation >14 days to test water with photoperiod:16 hours tight, 8 hours dark.Oxygen content: > 80% saturationpH: Generally 7.5 - 8.5Temperature: ca 23 °C
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
22 °C
pH:
same as acclimation
Dissolved oxygen:
same ad acclimation
Nominal and measured concentrations:
0, 120 mg/l. According to test guidelines, this study was conducted as a limit test. The test concentrations of 0 (control) and 120 mg/L were selected on the basis of a range finding test (experimental conduct in accordance with GLP, but without a GLP status).Result of the range finding test: LC50 > 100 mg/L. The raw data of the range finding test will be archived together with the raw data of this study.
Details on test conditions:
Type: Non chlorinated charcoal filtered tap water (Frankenthal, Germany) mixed with deionized water, aeratedTotal hardness: Approx. 1 mmol/L = 100 mg/L CaCO3 Conductivity: Approx. 250 pS/cm (at 25°C)Ca content:Approx. 40 mg/LMg content:Approx. 5 mg/LAcid capacity: Approx. 2.5 mmol/LpH-value: Generally 7.5 - 8.5Temperature: Approx. 23°C
Reference substance (positive control):
not specified
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 120 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
The fish were observed for mortality and toxic signs (changes appearance and abnormal behaviour in comparison to the contro) group) within 1 hour after start of exposure and 6, 24, 48, 72 and 96 hours after start of exposure. Fish were considered dead if there was no visible movement and no reaction after touching. Dead fish were removed from the test vessels.Daily observation of the appearance of the test solutions and dissolution behaviour of the test substance.Temperature, oxygen content and pH-value were measured in each test vessel within 1 hour after start of exposure and after 24, 48, 72 and 96 hours.At the end of exposure the body weight and Iength of a representative sample of fish are determined. The representative sample consists of all surviving fish from the Iowest concentration and contro) group
Validity criteria fulfilled:
yes
Conclusions:
The tested susbtance show no toxicity on fish LC50 > 120 mg/l
Executive summary:

In conclusion the 96 hour LC50 values for the tested substance with the zebrafish (Danio rerio) were > 120 mg/L based on the nominai concentration of the test substance and > 109 mg/L based on the mean of analytically determined concentrations.Since the analytically determined concentrations of the test substance in the test solutions were within ±20% of the nominal concentrations, the effect concentration can be expressed relative to the nominai concentration for the evaluation of the test substance.

Description of key information

There are two available studies performed both on Acid Yellow 23 and on another form of this dye.

Key value for chemical safety assessment

LC50 for freshwater fish:
120 mg/L

Additional information

Based on the existing study performed both on Acid Yellow 23 and on another form of this dye, an EC50 (96h) value > 120 mg/l was defined.

Based on this value, the tested substance does not require any classification for the environment.