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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:
2018 -03-08 to 2018-09-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on sampling:
Concentration: 100 mg/L
Samples for analytical confirmation of exposure concentrations were taken at the start and at the end of the test.
sampling volume : 5 mL
Storage: Samples were stored in a freezer (<= -15 °C) until analysis at the analytical laboratory of the test facility.
Vehicle:
no
Details on test solutions:
A limit test with a nominal concentration of 100 mg/L based on the results of a preceeding range-finding test.
Controls: Test medium without test item or other additives.
Test organisms (species):
Cyprinus carpio
Details on test organisms:
Species Carp (Cyprinus carpio, Teleostei, Cyprinidae) Linnaeus, 1758
Source Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands.
Mean length Range-finding test: 2.9 ± 0.2 cm
Limit test: 3.4 ± 0.3 cm
Mean weight Range-finding test: 0.34 ± 0.09 g
Limit test: 0.47 ± 0.12 g
Characteristics F1 from a single parent-pair bred in UV-treated water.
Reason for selection This system has been selected as an internationally accepted species.
Total fish used 26
Holding
Quarantine/Acclimatisation At least 12 days after delivery
Temperature of culture medium 23°C
pH of culture medium 7.8
Feeding during acclimatisation Daily with pelleted fish food (Essence (300-500 um), Coppens International bv, Helmond, The Netherlands)
Validity of batch In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%.
Feeding during test: No feeding from 24 hours prior to the test and during the total test period
Test type:
static
Water media type:
other: Adjusted ISO medium, formulated using RO-water (tap-water purified by reverse osmosis; GEON Waterbehandeling, Berkel-Enschot, The Netherlands)
Limit test:
yes
Total exposure duration:
96 h
Hardness:
180 mg CaCO3 per litre
Test temperature:
20-24°C, constant within 2°C
pH:
7.7 ± 0.3
Dissolved oxygen:
>5 mg/L at 22°C throughout the test.
Nominal and measured concentrations:
Nominal: 100 mg/L
Measured concentrations: 90% of nominal throughout the exposure period.
Details on test conditions:
TEST SYSTEM
- Test vessel: all-glass
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 10 litres, containing 9 litres of test solution
- Aeration: no during the test
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.37 g fish/Litre, i.e. 7 fish per 9 litres of test medium

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium
- Total organic carbon: 180 mg CaCO3 per litre
- Alkalinity: pH of 7.7 ± 0.3
- Culture medium different from test medium: no
- Intervals of water quality measurement: daily in all vessels with surviving fish

OTHER TEST CONDITIONS
- Adjustment of pH: yes i.The pH of the test solution was adjusted using a 1M HCl solution (Merck, Darmstadt, Germany) from 9.8 to 8.4 in the range-finding test and from 9.7 to 7.9 and 8.0 in the limit test.
- Photoperiod: 16 hour’s photoperiod daily
- Light intensity: not specified.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortality and other behavioral effects at 2½, 24, 48, 72 and 96 hours following the start of exposure. In addition, every afternoon from day 0 to observe for any dead or severely distressed fish.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: no (limit test)
- Justification for using less concentrations than requested by guideline: limit test
- Range finding study: yes
- Test concentrations: A range of 0.10 to 100 mg/L increasing by a factor of 10
- Results used to determine the conditions for the definitive study: yes
Reference substance (positive control):
yes
Remarks:
Pentachlorophenol (PCP).
Key result
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: No mortality observed: test item not toxic to fish.
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: No mortality observed.
Details on results:
No LC50 could be calculated because the test item proved to be non-toxic (LC50 > regulatory limit concentration of 100 mg/L).
Results with reference substance (positive control):
Results with reference substance valid: yes
- Mortality: yes
- LC50: 0.15 mg/L
- Other: Study according to OECD guideline No.203 (1992) as a static method.
Under the conditions of the test, PCP induced no lethal effects in carp at 0.10 mg/L. The 96h-LC50 for carp exposed to PCP was 0.15 mg/L (95 % confidence interval between 0.10 and 0.22 mg/L). This effect was already reached within 24 hours of exposure.

pH-values and dissolved oxygen concentrations (mg/L) during the limit test

Nominal concentration (mg/L)

Day 0

Day 1

Day 2

Day 3

Day 4

pH

O2

pH

O2

pH

O2

pH

O2

pH

O2

Control

8.0

9.3

7.9

7.4

7.6

7.1

7.5

6.8

8.1

6.8

100

7.9

8.9

7.8

7.3

7.8

7.0

7.8

7.2

8.1

6.7

Temperatures (°C) measured during the limit test

Nominal concentration (mg/L)

Day 0

Day 1

Day 2

Day 3

Day 4

 

 

 

 

 

Control

22

21

21

21

21

100

23

21

21

21

21

Validity criteria fulfilled:
yes
Conclusions:
In conclusion, the 96h-LC50 for Cyprinus carpio exposed to test item exceeded an analytically confirmed nominal concentration of 100 mg/L, i.e. the regulatory limit concentration. No mortality or other clinical effects were observed in this study.
Executive summary:

The ability of the test item to generate acute toxic effects inCyprinus carpio was examined according to OECD guideline No. 203 (1992).

A limit test was performed based on the results of a preceding range-finding test. Seven fish per group were exposed in a static procedure to an untreated control and to the nominal concentration of 100 mg/L during an exposure period of 96 hours. Samples for analytical confirmation of exposure concentrations were taken at the start and at the end of the test.

The initial measured concentration was 90 mg/L and remained stable during the test period (100% of the initially measured concentration at the end of the test). Based on these results, the effect parameters were expressed as analytically confirmed nominal concentrations.

No mortality or other clinical effects were observed in this study.

In conclusion, the 96h-LC50 for Cyprinus carpio exposed to the test item exceeded an analytically confirmed nominal concentration of 100 mg/L, i.e. the regulatory limit concentration. The test item is not toxic to fish.

The validity criteria according to the OECD203 was fulfilled.

Description of key information

A short-term toxicity testing on fish according to standard guideline as a standard requirement in Annex VIII was required within a CCH decision.

Accordingly, the ability of the test item to generate acute toxic effects in Cyprinus carpio was examined according to OECD guideline No. 203 (1992).

A limit test was performed based on the results of a preceding range-finding test. Seven fish per group were exposed in a static procedure to an untreated control and to the nominal concentration of 100 mg/L during an exposure period of 96 hours. Samples for analytical confirmation of exposure concentrations were taken at the start and at the end of the test.

The initial measured concentration was 90 mg/L and remained stable during the test period (100% of the initially measured concentration at the end of the test). Based on these results, the effect parameters were expressed as analytically confirmed nominal concentrations.

No mortality of fish or other clinical effects were observed in this study.

In conclusion, the 96h-LC50 for Cyprinus carpio exposed to the test item exceeded an analytically confirmed nominal concentration of 100 mg/L, i.e. the regulatory limit concentration. The test item is not toxic to fish.

The validity criteria according to the OECD203 was fulfilled.

Key value for chemical safety assessment

Additional information

No LC50 could be calculated because the test item proved to be non-toxic in the limit test conducted at an analytically confirmed nominal concentration of 100 mg/L.