[No public or meaningful name is available]

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Sampling and analysis

Analytical monitoring:

no

Test solutions

Vehicle:

yes

Remarks:

water

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
2 x 2 L with 100 mg/L were shaken with 20 rpm for 24 h and transferred to the gals aquarium.
- Controls:
dilution water
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): water
- Concentration of vehicle in test medium (stock solution and final test solution(s) or suspension(s) including control(s)): n.a.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.):
the test item sedimented and showed turbidity throughout the test

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Strain: Danio rerio
- Source:
a. Origin of parental fish: Aquarium Am Aegi, Hannover, Germany
b. fish used for the study: in house breed Dr. Noack Laboratorium, Sarstedt, Germany
- Length at study initiation (mean): 2.02 cm
- Weight at study initiation (mean): 0.07 g
- Method of breeding/maintenance:
Holding: was performed at the test facility at 23 +/- 2°C and diffuse light (0.1-10 µmol/m2s, natural photoperiod). The water was changed at least once per week. The dissolved oxygen concentration was more than 80% of the air saturation value. Only fish from a population with mortality < 5% within the last 7 days before start of the study were used in the test. No disease treatments were administered throughout holding and testing.
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.
Feeding: Food was provided 3 times per week. The amount of food was 4% of the fish body weight per feeding.


ACCLIMATION
none

FEEDING DURING TEST
The test fish were not fed until 24 h before the test started
Fish were not fed during the test

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

none

Test conditions

Hardness:

63 mg/L as CaCO3

Test temperature:

mean of 4 days: 21.6°C

pH:

mean of 4 days: 7.46

Dissolved oxygen:

mean of 4 days: 99%

Nominal and measured concentrations:

nominal: 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel/Type:
Glass-aquaria loosely covered by glass tops
- fill volume:
approx. 4 L
- Aeration:
Gentle aeration provided
- Type of flow-through (e.g. peristaltic or proportional diluter):
static
- Renewal rate of test solution (frequency/flow rate):
one applicatin of test item at test initiation
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin, filtered on activated charcoal and aerated for at least 24 h to remove chlorine
- Intervals of water quality measurement: every 24 h

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: natural photoperiod
- Light intensity: 0.1 - 10 µE/m2 x s

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
every 24 h: mortality, behaviour

TEST CONCENTRATIONS
- Range finding study : no mortality at 100 mg/L (nominal)

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 4

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 5

Key result

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 6

Key result

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 7

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

The test item sedimented and showed turbidity throughout the test. The nominal test item concentration of 100 mg/L caused no mortality or non-lethal effects.
The study met the validity criteria of the guideline:
- O2-saturation was >/= 60%
mortality in the control was 0%

Results with reference substance (positive control):

n.a.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In this study the test substance did not cause any effects to zebrafish after 96 h when tested with a nominal concentration of 100 mg/L. The NOEC (0-96 h) is laid down as 100 mg/L.

Executive summary:

The acute toxicity of the test substance to fish (zebrafrish) was determined according to OECD guideline 203.

A static limit test with a single test item concentration of 100 mg/L was conducted. Duration of the test was 96 h. 7 test organisms were exposed to the test concentration and control. Water quality parameters of pH-value and oxygen-saturation measured after 0, 24, 48, 72, and 96 h were determined to be within the acceptable limits. All effect values are based on the nominal concentration of the test item. No analysis was performed. Due to insolubility of the test item no specific analytical method was available.

The acute toxicity of the test substance is summarised as:

LC50 (96 h) > 100 mg/L

LC100 (96 h) > 100 mg/L

LC0 (96 h): 100 mg/L

NOEC (96 h): 100 mg/L