Registration Dossier

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From February 8, 2017 to March 10, 2017
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):
Oryzias latipes
Details on test organisms:
- Source: National Chiayi University Freshwater Biological Resource Center
- Length at study initiation: 2.0 ± 1.0 cm
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Nominal and measured concentrations:
For the range-finding test, the nominal concentrations were 0.08, 0.16, 4.00, 20.00 and 100.00 mg/L.
For the limit test, the nominal concentration was 100.00 mg/L.
Details on test conditions:
- Test volume: 2 L
- Photoperiod: 12-16 hours daily
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Sublethal observations / clinical signs:

Table 1. Mortality and LC50 in the range-finding test

Group

(mg/L)a

Mortality (%)b

LC50

(mg/L)

24 ± 1 hours

48 ± 2 hours

72 ± 3 hours

96 ± 3 hours

Control group

0.00

0.00

0.00

0.00

0.00

Test group

100.00

0.00

0.00

0.00

0.00

> 100.00

20.00

0.00

0.00

0.00

0.00

4.00

0.00

0.00

0.00

0.00

0.16

0.00

0.00

0.00

0.00

0.08

0.00

0.00

0.00

0.00

a All one replicate was conducted at the control group and test groups in range-find test.

b Mortality (%) = Death number / Total number × 100%

Table 2. Temperature, dissolved oxygen and pH value in the range-finding test

Group

(mg/L)a

Time

(hour)

Temperature

(°C)

Dissolved oxygen

(%)

pH value

Control group

0.00

0

22.0

99.0

6.58

24 ± 1

23.0

88.5

7.70

48 ± 2

23.0

86.2

7.65

72 ± 3

22.0

85.0

7.78

96 ± 3

21.5

86.2

6.00

Test group

100.00

0

22.0

98.7

6.75

24 ± 1

23.0

90.2

7.60

48 ± 2

23.0

88.2

6.97

72 ± 3

22.0

86.0

7.96

96 ± 3

21.5

84.4

6.13

a One replicate was only conducted at the control group and highest concentration test group (100.00 mg/L) in the range-find test.

 

Table 3. Mortality in the limit test

Group

(mg/L)a

Mortality (%)b

24 ± 1 hours

48 ± 2 hours

72 ± 3 hours

96 ± 3 hours

Control group

0.00

0.00

0.00

0.00

0.00

Test group

100.00

0.00

0.00

0.00

0.00

a All one replicate was conducted at the control group and test groups in the limit test.

b Mortality (%) = Death number / Total number × 100%

 

Table 4. Temperature, dissolved oxygen and pH value in the limit test

Group

(mg/L)a

Time

(hour)

Temperature

(°C)

Dissolved oxygen

(%)

pH value

Control group

0.00

0

21.5

99.9

6.59

24 ± 1

22.0

86.0

6.35

48 ± 2

22.0

79.4

6.21

72 ± 3

21.0

78.6

6.67

96 ± 3

21.0

74.4

7.06

Test group

100.00

0

21.5

99.8

6.78

24 ± 1

22.0

83.7

6.14

48 ± 2

22.0

85.3

6.32

72 ± 3

21.0

84.6

6.61

96 ± 3

21.0

76.9

6.82

a All one replicate was only conducted at the control group and test group in the limit test.

Validity criteria fulfilled:
yes
Conclusions:
According to OECD 203 test method, the 96-hr LC50 of CJ302 was greater than 100.00 mg/L.
Executive summary:

This test using the procedures outlined in the SuperLab Study Plan for M62-161200028001EN which is based on the SOP for the OECD203 (SOPE-509) and OECD203 (OECD, 1992). All test validity criteria were met. At the range-finding test, the mortality of 0.08-100.00 mg/L were all 0.00% 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 96-hr LC50 of CJ302 was greater than 100 mg/L.

Description of key information

The 96-hr LC50 of CJ302 was greater than100 mg/L for ricefish (Oryzias latipes) (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 0.08-100.00 mg/L were all 0.00% 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 96-hr LC50 of CJ302 was greater than 100 mg/L.