Registration Dossier

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2016-11-18 to 2017-04-07
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
The read across justification is included as attachment to section 13 in the IUCLID dataset.
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
2008
GLP compliance:
yes (incl. certificate)
Test material information:
Composition 1
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0.00, 2.50, 5.00, 10.0, 20.0 and 40.0 mg/L (nominal)
- Sample storage conditions before analysis: in the refrigerator at 6 +/- 2°C
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Appropriate volumes of the test item were pipetted directly into the test vessels filled with appropriate volumes of dilution water. The test media were mixed with an ultraturrax (1 min, 12000 rpm). This procedure was repeated for every water renewal.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Source: single brood stock (supplier: Umweltbundesamt, Schichauweg 58, D-12307 Berlin)
- Length at study initiation (length definition, mean, range and SD): mean: 2.76 cm
- Weight at study initiation (mean and range, SD): mean: 0.19 g
- Feeding during test: no

ACCLIMATION
- Acclimation period: at least 12 d
- Acclimation conditions (same as test or not): Same as test.
- Type and amount of food: Sera Vipan, 4% of fish body weight per feeding day
- Feeding frequency: 3 times/week
- Health during acclimation (any mortality observed): No mortality observed.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
65 mg CaCO3/L
Test temperature:
22.6 - 23.0°C
pH:
7.14 - 7.77
Dissolved oxygen:
81 - 100%
Nominal and measured concentrations:
Nominal: 0, 2.50, 5.00, 10.0, 20.0 and 40.0 mg/L
Measured: < LOQ, 1.31, 2.84, 5.25, 8.66 and 18.9 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass aquaria of 13 L were used, filled with approximately 10 L of dilution water (dimensions: 25.5/18/28 cm, depth of water: 20 cm) and covered with a floating lid (e.g. with aluminium foil), to reduce the loss of the test item.
- Type (delete if not applicable): semi-static (covered with aluminium foil)
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: Fish density: 0.131 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin
- Chlorine: filtered on activated charcoal and aerated for at least 24 hours to remove chlorine
- Hardness: 10 - 250 mg CaCO3/L
- pH: 6.0 - 8.5
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours/light
- Light intensity: mean value: 116 Lux.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, visible abnormalities (e.g. loss of equilibrium, swimming behaviour, respiratory function, pigmentation, etc.) after 3, 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Test concentrations: threshold test with 16 mg/L (29 % mortality); complete response test. 0, 2.50, 5.00, 10.0, 20.0 and 40.0 mg/L (nominal)
- Results used to determine the conditions for the definitive study: yes, full test with 5 test concentrations.
Reference substance (positive control):
not required
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
6.74 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: calculated as mean from the values of LC0 and LC100
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
9.04 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
5.25 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
8.66 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: At a concentration level of 8.66 mg/L and 18.9 mg/L the fishes showed lethargy, took side positions, were staggering and were hyperventilating.
- Mortality of control: no
- Other adverse effects control: no

Table 1: Cumulative mortality (%) (n=7)

Geometric mean measured concentration (mg/L)

Cumulative mortality (%) after different exposure periods (hours)

 

3

24

48

72

96

18.9

0

100

100

100

100

8.66

0

0

14

100

100

5.25

0

0

0

0

0

2.84

0

0

0

0

0

1.31

0

0

0

0

0

Control

0

0

0

0

0

 

  Table 2: Environmental conditions

Exposure time (days)

Geometric mean measured concentration (mg/L)

Mean oxygen saturation (%)

pH value

Temperature (°C)

0

18.9

100

7.67

22.8

8.66

100

7.71

22.8

5.25

100

7.72

22.7

2.84

100

7.77

22.8

1.31

100

7.75

22.8

Control

100

7.70

22.7

1

18.9

90

7.61

22.9

8.66

94

7.64

22.9

5.25

93

7.63

23.0

2.84

94

7.60

23.0

1.31

92

7.58

22.9

Control

93

7.53

22.9

2

18.9

-

-

-

8.66

91

7.66

22.8

5.25

92

7.64

22.8

2.84

93

7.62

22.8

1.31

93

7.61

22.8

Control

94

7.51

22.9

3

18.9

-

-

-

8.66

87

7.40

22.8

5.25

93

7.48

22.8

2.84

93

7.45

22.9

1.31

93

7.43

22.7

Control

94

7.33

22.8

4

18.9

-

-

-

8.66

-

-

-

5.25

82

7.44

22.7

2.84

88

7.53

22.6

1.31

88

7.53

22.8

Control

88

7.55

22.7

- no measurements due to 100% mortality

Table 3: Measured Concentrations and Percent of the Nominal Concentrations of the Test Item 

Sampling date

2017-02-20

0 h

(Fresh medium)

2017-02-21

24 h

(Old medium)

2017-02-23

72 h

(Fresh medium)

2017-02-24

96 h

(Old medium)

 

Nominal concentration of the test item

[mg/L]

Meas. concentration

[mg/L]

%

Meas. concentration

[mg/L]

%

Meas. concentration

[mg/L]

%

Meas. concentration

[mg/L]

%

Geometric mean measured concentration

[mg/L]

40.0

24.2

61

14.7

37

1)

18.9

20.0

11.8

59

6.37

32

1)

8.66

10.0

7.75

78

4.40

44

6.26

63

3.56

36

5.25

5.00

3.45

69

2.47

49

3.23

65

2.36

47

2.84

2.50

1.57

63

1.05

42

1.54

62

1.18

47

1.31

Control

< LOQ

< LOQ

< LOQ

< LOQ

< LOQ

Meas. concentration = Measured concentration of the test item, enrichment factor taken into account

% = Percent of nominal concentration of the test item

LOQ = Limit of Quantification (0.2 mg/L test item)

1) = Not analyzed due to 100% mortality after 24 hours

Validity criteria fulfilled:
yes
Conclusions:
LC50 (96 h): 6.74 mg/L based on mortality of Danio rerio (OECD 203).
The toxicity of Ethyl hexanoate to fish (Danio rerio, Zebrafish) was determined in a GLP study according to OECD 203. The LC50 of 6.74 mg/L was calculated from the geometric mean measured values of the LC0 and the LC100.
Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The read across justification is included as attachment to section 13 in the IUCLID dataset.
Reason / purpose:
read-across source
Related information:
Composition 1
Test material information:
Composition 1
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
6.74 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
other: Source substance
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
4.77 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
other: Target substance
Basis for effect:
mortality
Remarks on result:
other: recalculated value to correct differences in molecular weight between source (MW = 144.2114 g/mol) and target (MW = 102.132 g/mol).
Conclusions:
The toxicity of Ethyl propionate to fish (Danio rerio) was predicted from the source substance Ethyl hexanoate (CAS no. 123-66-0) (see read across justification). The effect value (mortality; LC50) was predicted to be 6.74 mg/L. The recalculated value to correct differences in molecular weight between source (MW = 144.2114 g/mol) and target (MW = 102.132 g/mol) was 4.77 mg/L.
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1978
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Test procedure in accordance with national standard methods but insufficient documented. Publication reports only 48 hour effect values for fish, which are not comparable to 96 hours effect values. Further, no details about the test design is reported.
Reference:
Composition 0
Composition 0
Composition 0
Qualifier:
according to
Guideline:
other: DIN 38412 L15
Deviations:
yes
Remarks:
48 h instead of 96 h tested
GLP compliance:
no
Test material information:
Composition 1
Analytical monitoring:
not specified
Vehicle:
not specified
Test organisms (species):
Leuciscus idus melanotus
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
125 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: Testing laboratory 1
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
113 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: Testing laboratory 2
Duration:
48 h
Dose descriptor:
LC0
Effect conc.:
89 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: Testing laboratory 1
Duration:
48 h
Dose descriptor:
LC0
Effect conc.:
89 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: Testing laboratory 2
Duration:
48 h
Dose descriptor:
LC100
Effect conc.:
160 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: Testing laboratory 1
Duration:
48 h
Dose descriptor:
LC100
Effect conc.:
125 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: Testing laboratory 2
Validity criteria fulfilled:
not specified
Conclusions:
The results of a short-term toxicity test with Leuciscus idus melanotus was described in the publication of Juhnke and Lüdemann (1978). In both laboratories the LC50 values were estimated to be 125 mg/L and 113 mg/L, respectively.

Description of key information

LC50 (96) = 4.77 mg/L (Danio rerio, OECD 203)

Key value for chemical safety assessment

LC50 for freshwater fish:
4.77 mg/L

Additional information

To assess the toxicity of the test substance to fish one study is available. Since this study is not reliable (the test duration was only 48 h) a read-across approach to Ethyl hexanoate (CAS no. 123 -66 -0) was used to cover this endpoint.

Both substances have a similar chemical structure and corresponding physicochemical properties. In addition they show similarity in their environmental fate such as biodegradability and in their ecotoxicity effects, whereby Ethyl hexanoate is more toxic to aquatic organisms than Ethyl propionate. This is especially reflected in the lower LC50 (48 h) value of 9.04 mg/L when Ethyl hexanoate is tested on Danio rerio compared with a higher LC50 (48 h) of > 100 mg/L when Ethyl propionate is tested on Leuciscus idus melanotus (see also supporting study). Ethyl hexanoate can therefore be considered as worst case and is proposed suitable to predict the short-term toxicity to fish of the target substance Ethyl propionate.

The toxicity of the read-across substance to fish was determined in a semi-static test performed according to OECD 203 and GLP. Individuals of Danio rerio were exposed to nominal test concentrations of 2.5, 5.0, 10, 20 and 40 mg/L, equivalent to geometric mean measured concentrations of 1.31, 2.84, 5.25, 8.66 and 18.9 mg/L. After 96 h 100% mortality was observed at 8.66 mg/L whereas 0% mortality was recorded at 5.25 mg/L. The LC50 (96 h) was determined to be 6.74 mg/L..

The determined LC50 valuer of 6.74 mg/L for the source substance was correct for the target substance by taking into account the difference in molecular weight between source (MW = 144.2114 g/mol) and target (MW = 102.132 g/mol) substance. For the target substance a LC50 (96 h) of 4.77 mg/L was calculated.