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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:
November 2017 - March 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
yes
Remarks:
The analytical method used to determine the correct application of test item was not appropriate.
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
Analytical samples were analysed at t = 0 h fresh and t = 96 h aged from control and all test item concentrations.
Vehicle:
yes
Remarks:
test medium
Details on test solutions:
The test medium was water composed of reconstituted test water consisting of analytical grade salts dissolved in purified water with a ratio of Ca:Mg and Na:K of 4:1 and 10:1, respectively, based on molarity, and a conductivity of 685 µS/cm.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Danio rerio Hamilton (Cypriniformes: Cyprinidae), size between 1 and 3 cm

Fish from the own stock breeding of the test facility were used. The parent animals were originally purchased from the Karlsruhe Institute of Technology (KIT, Karlsruhe, Germany) in a healthy condition. According to the supplier they had been bred from wild strain (WIK) zebrafish before. Since they have been purchased, the zebrafish were continuously reared in the laboratory of the testing facility. Only fish in good health and free from any apparent malformation were used. The last feeding was performed two days prior test start.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Remarks on exposure duration:
N/A
Post exposure observation period:
N/A
Hardness:
12°dH corresponding to 214 mg CaCO3/L
Test temperature:
22.8 – 23.5 °C
pH:
7.38 – 7.76
Dissolved oxygen:
≥ 77 % of air saturation
Salinity:
N/A
Conductivity:
685 µS/cm
Nominal and measured concentrations:
Nominal: 1.11, 2.44, 5.37, 11.8 and 26.0 mg/L
Actual (measured): 0.88, 2.11, 5.36, 11.5 and 26.8 mg/L
The concentrations were adjusted per active ingredient content (90%), using conversion factor 1.1.
Details on test conditions:
Fish were observed at 0, 4, 24, 48, 72 and 96 hours after test start. Fish were considered dead if there was no visible movement (e.g. gill movement), and if touching of the caudal peduncle produced no reaction. Records were made on visible abnormalities as: difficulties with maintenance of equilibrium, swimming behaviour, respiratory function, pigmentation and all other observed effects. Dead fish were removed, weighted and measured if observed. At termination of the test, all fish were euthanized and all fish were weighed and measured.

Measurements of temperature, pH-value and oxygen saturation were performed in 24 hour intervals in fresh and aged test solutions. Water hardness of the untreated control was determined at the beginning of the test.
Reference substance (positive control):
not required
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
25.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
26.4 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
11.8 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
11.5 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
No mortality was observed within the period of the test in the control and at the test item concentration up to and including 11.8 mg/L. At 26.0 mg/L, two fish were found dead after 24 h and 4 fish were found dead after 48 h.

No sublethal effects were observed in the control and at concentrations 1.11 and 2.44 mg/L. At 5.37 mg/L all fish showed reduced activity after 4 h, from 24 h until the end of the test one fish showed reduced activity. At 11.8 mg/L all fish showed reduced activity at 4, 24 and 48 h. At 72 and 96 h five fish showed reduced activity. At 26.0 mg/L reduced activity was observed at 4 h for all fish, at 24 h for five fish and at 48, 72 and 96 h for three fish.

All fish were weighed and measured. The average weight of the test organisms was 0.1206 +/- 0.0326 g; the average length was 24.7 +/- 2.3 mm.
Reported statistics and error estimates:
The LC50-values were calculated using Weibull analysis with linear maximum likelihood regression and control compensation using the statistics program ToxRat Professional 3.2.1
The NOEC (mortality) was established based on the highest test concentration at which no mortality above the allowed control mortality was observed.
Sublethal observations / clinical signs:

LC50and NOEC-values of fish exposed to the test item evaluated using nominal and mean measured (actual) concentrations

Time

[h]

NOEC mortality

[mg/L]

LC501)

[mg/L]

95 % confidence limit of LC50
[mg/L]

 

nominal

actual2)

nominal

actual2)

 

4

26.0

26.8

-

-

-

24

11.8

11.5

-

-

-

48

11.8

11.5

25.7

26.4

-

72

11.8

11.5

25.7

26.4

-

96

11.8

11.5

25.7

26.4

-

- not applicable due to mathematical reasons or inappropriate data
1)evaluated using Weibull analysis
2)based on geometric mean of the measured content of substance in fresh and aged test solutions

Validity criteria fulfilled:
yes
Conclusions:
The LC50 (96 h) of the test item Strodex PK-90 was determined to be 25.7 mg/L (test item nominal) and 26.4 mg/L (test item actual). The corresponding NOEC (mortality) (96 h) was 11.8 mg/L test item (nominal) and 11.5 mg/L test item (actual), respectively.
No sublethal effects were observed in the control and up to and including the test concentration of 2.44 mg/L nominal (2.11 mg/L actual) after 96 h. At 5.37 mg/L nominal (5.36 mg/L actual) one fish, at 11.8 mg/L nominal (11.5 mg/L actual) five fish and at 26.0 mg/L nominal (26.8 mg/L actual) three fish showed reduced activity after 96 h.

Description of key information

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
26 mg/L

Additional information

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