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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:
16 Jan - 21 Apr 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Hessisches Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Control and highest test item concentration (100 mg ai./L or 111 mg test item/L)
- Sampling method: Samples were taken every 24 h
- Sample storage conditions before analysis: Samples from test start so freshly prepared test solutions were stored at 2 - 8 °C; samples from test end were analysed directly on the day of collection.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test item was introduced into the water by direct weighing into the different treatments to give the final nominal concentrations. Filtration of stock solutions with the test item were done using flass fibre filters from Whatman, GF6, Lot A10164904.
- Controls: Yes
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra Fish
- Strain: Brachydanio rerio (Zebra fish)
- Source: Aquahandel de. (Holtenser Weg 6a, 37186 Moringen)
- Length at study initiation (length definition, mean, range and SD): 1.7 to 2.1 cm
- Weight at study initiation (mean and range, SD): 0.30 to 0.32 g

Feeding during the test: No
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
21.3 to 23.2 °C (Control)
21.1 - 23.2 °C (100 mg ai/L, 111 1 mg test item/L)
pH:
8.20 - 8.37 (Control)
8.23 - 8.37 (100 mg ai/L, 111 1 mg test item/L)
Dissolved oxygen:
7.6 - 9.4 mg O2/L (Control)
7.4 - 8.8 mg O2/L (100 mg ai/L, 111 1 mg test item/L)
Nominal and measured concentrations:
Control and 111 mg test item/L (nominal)
Control and 100 mg a.i./L (nominal)
Details on test conditions:
TEST SYSTEM
Test vessel:
- Type: open
- Material, size, headspace, fill volume: 5 L glass aquarium
- Aeration: The test solutions were aerated during the incubation period (96 h) in order to verify an oxygen content of >60% of the saturation value during the study.
- Renewal rate of test solution (frequency/flow rate): Test solutions were prepared daily and the test animals were transferred into the new test solutions daily.
- 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: the municipal drinking water supply entering test facility
- Culture medium different from test medium: no
- Intervals of water quality measurement: controlled regularly (monthly)

EFFECT PARAMETERS MEASURED: Daily the test solutions were examined for dead animals, and any abnormal behaviour of the test animals was recorded.

TEST CONCENTRATIONS
Range finding study
- Test concentrations: 10 mg/L in tap water
- Results used to determine the conditions for the definitive study: LC 0, LC50 and LC 100 >10 mg test item/L
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr. (dissolved fraction)
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LL10
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr. (dissolved fraction)
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
other: LL20
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr. (dissolved fraction)
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: No
- Mortality of control: No
Reported statistics and error estimates:
Statistical procedures for calculation of EC-values, as indicated in the study plan, were done upon receipt of the final mortalities using the commercial computer program ToxRatPro, Version3.2.1.

Analytical Results:

Formula of the active Substance: C24H 54N20 4P2S2Zn

According to this formula the contents of the different elements in the molecule are distributed as

C:46.04%; H:8.69%; N:4.7%; O:10.22%; P:9.89%; S: 10.24% and Zn: 10.44%

 Table 1: Analytical Results of Basis P

 

Time

nom. conc. of active substance [mg/L]

Basis P

mg Test ltem/L

% Nominal Conc.

Recovery % of t0

t0 fresh

t0 fresh

Control

100

 

0.000

69.596

-

69.6

-

-

t24 h aged

t24 h aged

Control

100

0.000

68.625

-

68.6

-

98.6

t0’ fresh after 24 h

t0’ fresh after 24 h

Control

100

0.000

58.827

-

58.8

-

-

t24 h’ after 48 h

t24 h’ aged after 48h

Control

100

0.000

58.908

-

58.9

-

100.8

Table 2: Analytical Results of Basis S

 

Time

nom. Conc. of active Substance [mg/L]

Basis S

mg Test ltem/L

% Nominal Conc.

Recovery % of t0

t0 fresh

t0 fresh

Control

100

0.000

129.980

-

130.0

-

-

t24 h aged

t24 h aged

Control

100

0.000

141.895

-

141.9

-

109.2

t0’ fresh after 24 h

t0’ fresh after 24 h

Control

100

0.000

124.023

-

124.0

-

-

t24 h’ after 48 h

t24 h’ aged after 48h

Control

100

0.000

123.047

-

123.0

-

99.2

 

Table 3: Analytical Results of Basis Zn

 

 

Time

nom. Cone. of active Substance [mg/L]

Basis Zn

Mean Recoveriy,

% of t0, total [Basis P, S, Zn]

 

mg Test ltem/L

 

% Nominal Conc.

 

Recovery % of t0

t0 fresh

t0 fresh

Control

100

0.000

8.161

-

8.2

-

-

 

 

 

 

 

 

 

 

92.9

t24 h aged

t24 h aged

Control

100

0.000

5.795

-

5.8

-

71.0

t0’ fresh after 24 h

t0’ fresh after 24 h

Control 100

0.000

7.921

-

7.9

-

-

t24 h’ after 48 h

t24 h’ aged after 48h

Control

100

0.000

6.849

-

6.8

-

86.5

 

 Table 4: Validity criteria for OECD 203

Criterion from the guideline

Outcome

Validity criterion fulfilled

The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test

No dead animals were observed

Yes

The dissolved oxygen concentration must have been at least 60 per cent of the air

saturation value throughout the test

>60%

Yes

Validity criteria fulfilled:
yes
Conclusions:
As a conclusion of the analytical part of this study, it can be stated that the concentrations of the test item remained sufficiently stable during incubation. Based on this, the reported endpoints are evaluated using the nominal concentrations:
The LC50 (96h) was determined to be > 100 mg/L

Description of key information

LL50 (96 h) > 100 mg a.i./L (Danio rerio, nominal, OECD 203, key study)

Key value for chemical safety assessment

Additional information

One experimental study was conducted testing acute toxicity of the test item to fish according to OECD Guideline No. 203 (1992) using zebra fish (Lebertz, 2017a). In order to investigate the effect of the test item on fish, the animals were exposed in a semi-static test design to up to a nominal test substance concentration of 111 mg/L (equivalent to 100 mg a.i. /L). Under the conditions used for the test, no significant toxic effects of the test item on fish were observed at a nominal test substance concentration of 111 mg/L (equivalent to 100 mg a.i. /L) (main test, performed as a limit test). As a conclusion of the analytical part of this study, it can be stated that the concentrations of the test item remained sufficiently stable during incubation. Based on this, the reported effect concentrations should refer to the nominal concentrations tested. The LL50 was determined to be > 100 mg a.i./L and 111 mg test item/L.