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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
Cited as Directive 84/449/EEC, C.1 ("Acute toxicity for fish")
Deviations:
yes
Remarks:
: initial test concentration > water solubility, followed by a decrease of >20 % during the time interval down to the maximum water solubility
Principles of method if other than guideline:
Limit test with the maximum concentration technically achievable, performed according to Safepharm Standard Protocol Number FT/12/1/89.
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance was dissolved in 10% Tween 80 in acetone to form a preliminary solution.
- Controls: 1 blank and 1 vehicle control
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): 10% Tween 80 in acetone
- Concentration of vehicle in test medium: 100 µL/L auxiliary solvent
Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: golden orfe
- Source: Midland Waterlife, Derbyx, U.K.
- Age at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD): 5.6 cm (S.D = 0.2 cm)
- Weight at study initiation (mean and range, SD): 1.75 g (S.D. = 0.12 g)
- Feeding during test
- Food type: Tetramin flake food
- Amount: no data
- Frequency: daily

ACCLIMATION
- Acclimation period: 7 days
- Acclimation conditions (same as test or not): yes
- Type and amount of food: Tetramin flake food
- Feeding frequency: daily, discontinued 48 h prior to the test
- Health during acclimation (any mortality observed): 2% in 7 days prior to the test
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
no
Hardness:
50 mg/L(as CaCO3)
Test temperature:
21 to 22°C
pH:
8.0 to 8.4
Dissolved oxygen:
8.3 to 8.7 mg/L
Nominal and measured concentrations:
nominal: 0.5 mg/L
measured: 0.55 mg/L (n=2) initial conc.; 0.135 mg/L (n=2) after 24 h (end of initial test period); 0.098 mg/L (n=2) after 96 h (end of 3rd renewal period), average 24h values = 0.12 mg/L (n =4), corresponding to ~23 % of nominal.
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): glas aquaria holding 20 L of test media
- Aeration: via narrow bore glass tubes
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of animals per concentration: 20
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.88 g/L

TEST MEDIUM / WATER PARAMETERS (mean parameters over three months)
- Source/preparation of dilution water: dechlorinated laboratory tap water
- Total organic carbon: 1.03 mg/L
- Alkalinity: 9.81 mg/L (CaCO3)
- Ca/mg ratio: 12/2.6
- Conductivity: 114 µS/cm

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light

TEST CONCENTRATIONS
- Spacing factor for test concentrations: only one test concentration used
- Justification for using less concentrations than requested by guideline: low solubility of test substance
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
ca. 0.24 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
other: mortality and behaviour
Remarks on result:
other: averaged geometric mean of initial and measured effect concentration at 24 and 96 h
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 0.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: no
- Observations on body length and weight: no data
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no data
Validity criteria fulfilled:
yes
Conclusions:
No acute toxicity towards fish within the range of water solubility: Solubility of test substance in water is too low to result in concentrations toxic to fish in a short term tests.
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Basic data given
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: Testing method for industrial waste water - Acute toxicity test by fish - JIS K 0102-1998, 71
Principles of method if other than guideline:
Japanese national standard JIS K 0102-1998, 71
GLP compliance:
yes
Analytical monitoring:
not specified
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance was mixed with a 10fold portion of Tween 80. This mixture was dissolved in deionized water to prepare a stock solution of 1000 mg/L.
- Controls: yes
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Tween 80
Test organisms (species):
Oryzias latipes
Details on test organisms:
TEST ORGANISM
- Common name: medaka, Japanese killifish
- Source: Nakajima Fish Farm, Kumamoto, Japan
- Length at study initiation: 3.2 cm on average
- Weight at study initiation: 0.31 g on average
- Feeding during test: no data

ACCLIMATION
- Acclimation period: at least 18 d
- Acclimation conditions (same as test or not): yes
- Type and amount of food: no data
- Health during acclimation (any mortality observed): no mortality
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
no
Hardness:
77.5 mg/L (Ca, Mg; analytical value of dilution water)
Test temperature:
23.9 - 24.4°C
pH:
7.5 - 7.9
Dissolved oxygen:
6.7 - 7.5 mg/L
Nominal and measured concentrations:
0.953, 1.71, 3.09, 5.56, and 10 mg/L (no information if nomimal or measured concentrations)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: glas gallon bottle
- Fill volume: 3.85 L
- Aeration: no data
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate): every 8 to 16 h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): no data
- Biomass loading rate: 0.4 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ground water from the site of the laboratory (water quality according to OECD TG 305)
- Particulate matter: < 1 mg/L
- Metals:
- Pesticides: < 0.0001 mg/L
- Chlorine: < 0.01 mg/L
- Alkalinity: 158 mg/L
- Ca/mg ratio:
- Conductance: 493 µS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: once every 6 month

OTHER TEST CONDITIONS
- Adjustment of pH: no

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
Reference substance (positive control):
yes
Remarks:
test substance: sodium pentachlorophenol
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
0.95 mg/L
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
2.44 mg/L
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
5.56 mg/L
Nominal / measured:
not specified
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Mortality of control: no mortality
Results with reference substance (positive control):
48 h LC50 of sodium pentacholorphenol for test fish of the same lot was 0.621 mg/L
Reported statistics and error estimates:
96h LC50 was calculated by the method of Doudoroff.
Validity criteria fulfilled:
no
Remarks:
no information on measured test substance concentration throughout the test
Conclusions:
No acute fish toxicity in the range of water solubility.

Description of key information

Within the range of water solubility of diisopropylnaphthalene (0.1 to 0.2 mg/L), no lethal effects on fish were observed in short-term toxicity tests.
In a 96 h short-term toxicity test using 5 graduated concentrations prepared with Tween 80 as vehicle, a LC50 of 2.44 mg/L was determined.

Key value for chemical safety assessment

Additional information

Five studies on short-term toxicity to fish have been identified. All of them have shortcomings. Only one reports a LC50 which can be considered to be reliable (Kikushima et al. 2003). But for this study also, validity criteria are not fulfilled (use of vehicle, no information on analytical test concentration measurements).

 

Study

Test concentration

Result

Shortcomings

Reliability

Handley/Safepharm 1989 (golden orfe)

nominal: 0.5 mg/L
measured:
0 h:  0.55  mg/L
24 h: 0.135 mg/L
96 h: 0.098 mg/L

LC0: ca. 0.24 mg/L (averaged geometric mean for 24 and 96 h)
LC50: > 0.5 mg/L (nominal)

only one test concentration;
test concentration strongly decreasing over time

2

Kikushima et al. 2003 (killifish)

0.953, 1.71, 3.09, 5.56, 10 mg/L

LC0: 0.95 mg/L
LC50: 2.44 mg/L

no information on analytical measurement of TS concentrations;

use of vehicle;

short renewal period (8 h)

2

CITI 1992b (killifish)

no data

LC50: 4.5 mg/L

exposure period only 48 h;
only data table;
no further information

3

Kureha 1981 (killifish)

12.5, 25, 50, 100, 200, 1000
ppm (= ca. mg/L)

LC0: 1000 ppm

no information on analytical measurement of TS concentrations;

use of vehicle;
TS concentration far above water solubility;
limited reporting;
results very different from others

3

Kureha 1981 (carp)

12.5, 25, 50, 100, 200, 1000
ppm (= ca. mg/L)

LC0: 1000 ppm

no information on analytical measurement of TS concentrations;

use of vehicle;
TS concentration far above water solubility;
limited reporting;
results very different from others

3

Ozaki and Ikeda 1976 (yellowtail)

i.p. injection
(no dose noted)

LC50: 1920 mg/kg

route of exposure not comparable with TG procedure;
only abstract available