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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 March - 4 June 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The study was carried out according to OECD guideline 203 and GLP. However, the concentrations were not confirmed by a specific analytical method, but by DOC determinations. Analytical measurements from the chronic Daphnia study (Migchielsen, 2013) indicated a significant decrease of the test substance concentration after two days. Nevertheless, the results can be used to conclude that the daphnia is the most sensitive species and the chronic Daphnia study is critical for the dossier. Therefore, the present study can be used with restrictions and a reliability 2 was assigned.
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
1) The water temperature was partly over 25°C (maximum 25.2°C). 2) The O2 concentration during holding of the fish is ≥ 60% of air saturation value (should be ≥80%). These deviations are considered to have no impact on quality and integrity of the study.
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on sampling:
Duplicate samples were taken from all concentrations at the start and the end of the test.
Vehicle:
no
Details on test solutions:
A blank control and 5 test substance concentrations were prepared: 25, 50, 100, 200 and 400 mg/L (nominal)
The test substance was dosed via directly weighing. The test medium was mixed with an ultraturrax (1 min, 17000 rpm).
The test item showed concentration related turbidity and sedimentation in the tested concentrations 100 to 400 mg/L during the course of the test. The concentration of 25 and 50 mg/L were clearly dissolved (visual observation).
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
All fish used in the test were gained at Dr. Noack Laboratorien from a single brood stock (supplier: Niedersächsischer Landesbetrieb für Wasserwirtschaft, Küsten- und Naturschutz, An der Scharlake 39, D-31135, Hildesheim, Germany)
Holding was performed at the test facility at 23 ± 2 degrees Celsius 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 test. No disease treatments were administered throughout holding and testing.
Food was provided 3 times per week. The amount of food was 4% of the fish body weight per feeding day. The test fish were not fed 24 h before the test started. There was no feeding during the test.
Average body length at the test start: 2.40 cm
Average body weight at the test start: 0.097 g
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
61 mg CaCO3/L
Test temperature:
22.8 - 25.2 degrees Celsius..
pH:
7.29 - 7.85
Dissolved oxygen:
≥60 % of air saturation value (95 - 100 %).
Nominal and measured concentrations:
Nominal concentrations: 0 (blank control), 25, 50, 100, 200 and 400 mg/L
Measured concentrations: (mean DOC concentration of duplicate measurements) at t = 0h: 3.5 (blank control), 14, 26, 47, 89 and 177 mg DOC/L
Measured concentrations: (mean DOC concentration of duplicate measurements) at t = 96h: 5.9 (blank control), 17, 26, 48, 92 and 178 mg DOC/L
TOC content of the substance taken from the study report of the ready biodegradability test (Brunswik-Titze, 2004): 48.85% (measurement by IFU Gewerbliches Institut für Fragen des Umweltschutzes GmbH, Grießheimer Weg 7a, D-79423 Heitersheim, Germany)
The DOC measurements correspond with a recovery rate of >80%.
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass-aquaria loosely covered by glass tops, with a test volume of 10 L were used.
- Aeration: Yes
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: < 1 g/L

TEST MEDIUM / WATER PARAMETERS
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 possible chlorine.

OTHER TEST CONDITIONS
- Photoperiod: Natural photoperiod
- Light intensity: 0.1 - 10µmol photons · m·^-2· s^-1

EFFECT PARAMETERS MEASURED:
Observations were made after 24, 48, 72 and 96 h.
Fish were considered dead if there was no visible movement (e.g. gill covers movement) and if touching of the caudal peduncle produced no reaction. Records were kept of visible abnormalities (e.g. loss of equilibrium, swimming behaviour, respiratory function, pigmentation, etc.).

TEST CONCENTRATIONS
- Spacing factor for test concentrations:2.0
- Range finding study: Yes
- Test concentrations: 0 (blank control), 100 mg/L
- No. of organisms per vessel: 5
- Results used to determine the conditions for the definitive study: One fish died at 100 mg/L (20%)
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
87 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CL 65 - 117 mg/L

Table 1: Observations in test vessels

Nominal concentration (mg/L)

Effect*

Test duration (h)

24

48

72

96

400

(E)

7/7

-

-

-

200

(E)

4/7

2/3

 

-

(2.6)

3/7

1/3

1/1

-

(2.3)

3/7

1/3

1/1

-

(1)

-

-

-

-

100

(E)

5/7

-

-

-

(2.6)

2/7

2/2

2/2

-

(2.3)

2/7

2/2

2/2

-

(1)

-

-

-

2/2

50

(1)

7/7

7/7

7/7

7/7

25

(1)

7/7

7/7

7/7

7/7

Control

(1)

7/7

7/7

7/7

7/7

 *The number corresponds to the following observation

(E) Exit letalis

(1) Normal behaviour

(2.3) Staggering

(2.6) Changed swimming motions

- No observations due to 100% mortality

Validity criteria fulfilled:
yes
Remarks:
1) O2 - saturation was >60 % 2) Mortality in the control was 0 % 3) Recovery rate > 80 % at test end of the study (via DOC analysis)
Conclusions:
The nominal 96h-LC50 value to fish was 87 mg/L
Executive summary:

The acute toxicity of the test substance to Danio rerio was investigated according to OECD guideline 203 and GLP.

The nominal 96h-LC50 value to fish was 87 mg/L

The DOC at the end of the study was > 80% compared to initial.

The validity criteria were fulfilled.

The concentrations were not confirmed by a specific analytical method, but by DOC determinations. Analytical measurements from the chronic Daphnia study (Migchielsen, 2013) indicated a significant decrease of the test substance concentration after two days. Nevertheless, the results can be used to conclude that the daphnia is the most sensitive species and the chronic Daphnia study is critical for the dossier. Therefore, the present study can be used with restrictions and a reliability 2 was assigned.

Description of key information

The nominal 96h-LC50 value to fish was 87 mg/L.

Key value for chemical safety assessment

LC50 for freshwater fish:
87 mg/L

Additional information

The acute toxicity of the test substance to Danio rerio was investigated according to OECD guideline 203 and GLP.

The nominal 96h-LC50 value to fish was 87 mg/L.

The DOC at the end of the study was > 80% compared to initial.

The validity criteria were fulfilled.

The concentrations were not confirmed by a specific analytical method, but by DOC determinations. Analytical measurements from the chronic Daphnia study (Migchielsen, 2013) indicated a significant decrease of the test substance concentration after two days. Nevertheless, the results can be used to conclude that the daphnia is the most sensitive species and the chronic Daphnia study is critical for the dossier. Therefore, the present study can be used with restrictions and a reliability 2 was assigned.