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Ecotoxicological information

Short-term toxicity to fish

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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:
Please refer to the attached analogue justification provided in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: in neutralized test solution
Remarks:
Source: 6.1.1-1
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
130 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Source: Van Leeuwen et al., 1985
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Source: Tonogai et al., 1982
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 April - 14 April 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Remarks:
according to the GLP standard by the Japanese Ministry of Environment
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: B34683L

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at roome temperature in the dark


Analytical monitoring:
yes
Details on sampling:
- Concentrations: all concentrations were sampled at the beginning of the test and after 24 h exposure
Vehicle:
no
Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name: medaka fish
- Length at study initiation: 2.22 cm (1.99 - 2.38 cm)
- Weight at study initiation: 0.1524 g (0.1209 - 0.2059 g)

ACCLIMATION
- Acclimation period: more than 12 days
- Acclimation conditions: same as test
- Type and amount of food during acclimation: TetraMin
- Feeding: until 24 hours before exposure
- Health during acclimation: mortality was 1.0% 1 week before exposure

FEEDING DURING TEST
- Frequency: no feeding
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
23.6 - 24.2 °C (control)
23.6 - 24.1 °C (test item)
23.7 - 24.1 °C (100 mg/L with neutralized test solution)
pH:
6.9 - 7.0 (control)
7.2 - 10.6 (test item)
6.8 - 7.1 (100 mg/L with neutralized test solution)
Dissolved oxygen:
6.6 - 10.5 mg/L (control)
6.5 - 10.5 mg/L (test item)
6.2 - 10.1 mg/L (100 mg/L with neutralized test solution)
Nominal and measured concentrations:
Nominal concentration: 9.5, 17.1, 30.9, 55.6, 100.0 (without pH adjustment) and 100 mg/L (with pH adjustment)
Getometric mean of measured concentration: 8.8, 16.3, 30.2, 54.7, 98.8 and 98.3 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 3 L glass aquaria
- Fill volume: 3 L
- Renewal rate of test solution: every 24 h
- No. of organisms per vessel: 10 fish
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: purified dechlorinated tap water purification through filtration with charcoal
- Alkalinity: 41.0 mg/L (as CaCO3)
- Intervals of water quality measurement: pH, oxygen concentration and temperature were measured directly before adding the fish and afterwards once per day

OTHER TEST CONDITIONS
- Adjustment of pH: nominal concentrations 9.5, 17.1, 30.9, 55.6, and 100.0 mg/L (without pH adjustment) and 100 mg/L with pH adjustment.
- Photoperiod: light/dark: 16/8 h

EFFECT PARAMETERS MEASURED: mortality and abnormalities were recorded after 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Range finding study was performed but no detailed information was available in the report
- Results used to determine the conditions for the definitive study: LC50 = 55.9 mg/L
Reference substance (positive control):
yes
Remarks:
Copper(II) Sulfate Pentahydrate
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: in neutralized test solution
Details on results:
- Behavioural abnormalities: abnormal swimming behaviour was observed above 30.9 mg/L
- Mortality of control: 0%
- Other adverse effects control: no adverse effects observed in control
Results with reference substance (positive control):
- Results with reference substance valid? Yes, but this test was performed before the main test.
- LC50 for 96 h: 0.59 mg/L
Sublethal observations / clinical signs:

Table 1. Measured concentrations of test item

Nominal concentration (mg/L)

Measured concentration (mg/L)

Percent of nominal (%)

0 hour

new

24 hour

old

Geometric mean

0 hour

new

24 hour

old

Control

< 0.04

< 0.04

-

-

-

9.5

8.8

8.8

8.8

92.6

92.6

17.1

16.3

16.3

16.3

95.3

95.3

30.9

30.4

30.1

30.2

98.4

97.4

55.6

54.8

54.7

54.7

98.6

98.4

100.0

99.2

98.5

98.8

99.2

98.5

100.0*

98.3

98.4

98.3

98.3

98.4

*: neutralized test solution

New: freshly prepared test solutions

Old: test solutions after 24 hours exposure period

 

 

Table 2. Mortality of the test organism

Nominal concentration (mg/L)

Cumulative number of dead animals (% mortality)

0 hour

24 hour

72 hour

96 hour

Control

0 (0)

0 (0)

0 (0)

0 (0)

9.5

0 (0)

0 (0)

0 (0)

0 (0)

17.1

1 (10)

1 (10)

1 (10)

1 (10)

30.9

2 (20)

3 (30)

4 (40)

6 (60)

55.6

10 (100)

- a

- a

- a

100.0

10 (100)

- a

- a

- a

100.0*

0 (0)

0 (0)

0 (0)

0 (0)

 *: neutralized test solution

a: no observation was made because all fish were dead at this observation timepoint.

The pH increased up to 10 in the non-neutralized test solutions and therefore the results derived from these vessels were not considered reliable. The LC50 of > 100 mg/L when the pH was adjusted was considered as reliable and was used for further assessment.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
according to guideline
Guideline:
other: Japanese Industrial Standards Commitee, JIS K0102, p. 154
Version / remarks:
1971
GLP compliance:
not specified
Analytical monitoring:
yes
Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name: Himedaka
- Length at study initiation: 2 cm
- Weight at study initiation: 0.2 g

ACCLIMATION
- Acclimation period: 10 days
- Acclimation conditions: acclimated in tap water
Test type:
static
Water media type:
freshwater
Total exposure duration:
48 h
Test temperature:
25 °C
pH:
neutral
Details on test conditions:
TEST SYSTEM
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1

OTHER TEST CONDITIONS
- Adjustment of pH: test item dissolved in water and neutralised afterwards

EFFECT PARAMETERS MEASURED: mortality
Reference substance (positive control):
yes
Remarks:
mercury chloride
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
not specified
Analytical monitoring:
not specified
Details on test solutions:
The test solutions were renewed daily. Detailed information about the chemical composition of the media is given elsewhere (Van Leeuwen and Maas, 1985).
Van Leeuwen, C.J., and H. Maas. “The Aquatic Toxicity of 2,6-Dichlorobenzamide (BAM), a Degradation Product of the Herbicide Dichlobenil.” Environmental Pollution Series A, Ecological and Biological 37, no. 2 (January 1985): 105–15. doi:10.1016/0143-1471(85)90002-9.
Test organisms (species):
Poecilia reticulata
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Details on test conditions:
TEST SYSTEM
- Test vessel: sealed vessels
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
130 mg/L
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95 % CI: 100-180 mg/L
Reported statistics and error estimates:
LC50 values an their 95% confidence intervals were calculated according to the Litchfield and Wilcoxon (1949) method
Validity criteria fulfilled:
not specified
Conclusions:
The LC50 of diethylamine ammounts to 130 mg/L when tested under the conditions of this assay (OECD TG 203).

Description of key information

LC50 (96 h) > 100 mg/L (nominal, OECD 203) based on read across from CAS 109-89-7

Key value for chemical safety assessment

Additional information

Data on the toxicity of Diethylammonium chloride (CAS 660-68-4) to fish are not available. Therefore read across from the analogues substance N-ethylethanamine (CAS 109-89-7) was conducted.

A study (reference: 6.1.1-1) is available testing the toxicity of N-ethylethanamine (CAS 109-89-7) to fish according to the OECD guidance 203 and GLP standards. The test organism, Oryzias latipes, was exposed in a semi-static test regime to the nominal test item concentrations of 0 (control), 9.5, 17.1, 30.9, 55.6, 100.0 (without pH adjustment) and 100 mg/L (with pH adjustment). An analytical monitoring was performed via HPLC. The recoveries were between 92.6 and 99.2% of the nominal values in both the fresh and the old media. No mortalities were observed within 96 h in the 100 mg/L concentration when the solution was neutralized. Therefore, the LC50 (96) was > 100 mg/L.

Two further publications available for N-ethylethanamine gave similar results. The publication by Van Leeuwen et. al. (1985) reports an LC50 (96 h) of 130 mg/L. The test was conducted according to the OECD guideline 203 in a semi-static regime. Poecilia reticulate was the test organism. In a further publication by Tonogai et al. (1982) Oryzias latipes was exposed to the test substance for 48 h. The test was conducted according to a guidance of the Japanese Industrial Standards Committee. No mortality of the fish was observed in this study resulting in an LC50 (48 h) of > 1000 mg/L. The publications were used as supporting information since they were poorly documented.

Based on the experimental data of the read across substance, no effects are expected by Diethylammonium chloride (CAS 660-68-4) to fish up to a concentration of 100 mg/L.