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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:
From October 29, 2019 to January 02, 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
- Source: AZOO BIO CORPORATION
- Length at study initiation: 1.0-2.0 cm
- Acclimation period: 10 days
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Nominal and measured concentrations:
Nominal concentrations for the range-finding test are 0.16, 0.80, 4.00, 20.00 and 100.00 mg/L.
Nominal concentration for the limit test is 100.00 mg/L.
Details on test conditions:
- Test volume: 500 mL
- Photoperiod: 16-hours : 8-hours (Light : Dark)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Sublethal observations / clinical signs:

Table 1. The number of fish died at each observation time for the range-finding test

Group

Nominal conc. (mg/L)

Number of death (individual)

0 hour

2 hours

5 hours

24 hours

30 hours

48 hours

54 hours

72 hours

78 hours

96 hours

Control group

0.00

0

0

0

0

0

0

0

0

0

1

Test group

0.16

0

0

0

0

0

0

0

0

0

1

0.80

0

0

0

0

0

0

0

0

0

1

4.00

0

0

0

0

0

0

0

0

0

1

20.00

0

0

0

0

1

1

1

1

1

1

100.00

0

0

0

0

0

0

0

1

1

1

Table 2. The percentages mortality of fish at each observation time for the range-finding test

Group

Nominal conc. (mg/L)

Mortality (%)

0 hour

2 hours

5 hours

24 hours

30 hours

48 hours

54 hours

72 hours

78 hours

96 hours

Control group

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

14.29

Test group

0.16

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

14.29

0.80

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

14.29

4.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

14.29

20.00

0.00

0.00

0.00

0.00

14.29

14.29

14.29

14.29

14.29

14.29

100.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

14.29

14.29

14.29

Table 3. Light intensity, temperature, dissolved oxygen and pH value for the range-finding test

Group

Nominal conc. (mg/L)

Time (hour)

Light intensity (lux)

Temperature (°C)

Dissolved oxygen level (%)

pH

Control group

0.00

0

900

25.0

99.0

7.81

24

890

24.9

87.1

7.61

48

910

25.0

86.0

7.28

72

880

24.9

72.9

7.15

96

890

24.9

74.3

7.17

Test group

100.00

0

900

25.0

99.3

7.80

24

890

24.9

85.0

7.53

48

910

25.0

88.1

7.35

72

880

24.9

74.5

7.10

96

890

24.9

76.1

7.18

Table 4. The number of fish died at each observation time for the limit test

Group

Nominal conc. (mg/L)

Number of death (individual)

0 hour

2 hours

5 hours

24 hours

30 hours

48 hours

54 hours

72 hours

78 hours

96 hours

Control group

0.00

0

0

0

0

0

0

0

0

0

0

Test group

100.00

0

0

0

0

0

0

0

0

0

0

Table 5. The percentages mortality of fish at each observation time for the limit test

Group

Nominal conc. (mg/L)

Mortality (%)

0 hour

2 hours

5 hours

24 hours

30 hours

48 hours

54 hours

72 hours

78 hours

96 hours

Control group

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

Test group

100.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

0.00

Table 6. Light intensity, temperature, dissolved oxygen and pH value for the limit test

Group

Nominal conc. (mg/L)

Time (hour)

Light intensity (lux)

Temperature (°C)

Dissolved oxygen level (%)

pH

Control group

0.00

0

880

25.0

99.0

7.11

24

890

25.0

94.5

7.16

48

860

25.0

90.2

7.10

72

880

25.0

88.0

7.06

96

900

25.0

86.8

7.11

Test group

100.00

0

880

25.0

99.7

7.15

24

890

25.0

93.2

7.18

48

860

25.0

90.8

7.13

72

880

25.0

87.1

7.09

96

900

25.0

88.9

7.15

Validity criteria fulfilled:
yes
Conclusions:
According to OECD 203 test method, the NOEC of CJ306 was 100 mg/L.
Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-190900035001EN which is based on the OECD 203 (OECD, 2019).All test validity criteria were met. At the range-finding test, the mortality of 0.16-100.00 mg/L were all 14.29% and 96-hr LC50 was greater than 100.00 mg/L. Base on this result of range-finding test, the highest concentration of range-finding test (100.00 mg/L) was used to conduct the limit test. Therefore, the limit test was conducted and results showed that the mortality of 100.00 mg/L was 0.00% at the end of test. Under the conditions of this test, the NOEC of CJ306 was 100 mg/L.

Description of key information

The NOEC of CJ306 was 100 mg/L for Danio rerio (OECD TG203).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information

The mortalities of control group were smaller than 10% in both range-finding and limit test. The temperature deviation were within ± 2 °C and dissolved oxygen were ≥ 60 %. All test validity criteria were met. At the range-finding test, the mortality of 0.16-100.00 mg/L were all 14.29% and 96-hr LC50 was greater than 100.00 mg/L. Base on this result of range-finding test, the highest concentration of range-finding test (100.00 mg/L) was used to conduct the limit test. Therefore, the limit test was conducted and results showed that the mortality of 100.00 mg/L was 0.00% at the end of test. Under the conditions of this test, the NOEC of CJ306 was 100 mg/L.

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