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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:
13 - 17 Feb 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Qualifier:
according to guideline
Guideline:
ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 1: Static Method)
GLP compliance:
yes (incl. QA statement)
Remarks:
Food and Consumer Product Safety Authority (VWA), Utrecht, The Netherlands
Analytical monitoring:
no
Remarks:
No suitable analytical method could be established to quantify the test substance in test medium.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Preparation of test solutions started with individually prepared loading rates of 1.0, 10 and 100 mg/L applying a 1 h period of magnetic stirring. The obtained mixtures containing undissolved material were allowed to settle for a period of 40 min after which the Water Accommodated Fractions were siphoned off and used as test solutions.
- Eluate: no
- Differential loading: yes
- Controls: yes, test medium control
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): No, test solutions were clear and colorless.
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: carp
- Source: Zodiac, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Length at study initiation: 2.5 ± 0.2 cm
- Weight at study initiation: 0.43 ± 0.08 g

ACCLIMATION
- Acclimation period: at least 12 d after delivery
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation: pelleted fish food (Cyprico Crumble Excellent (300-500 µm), Coppens International bv, Helmond, The Netherlands)
- Feeding frequency during acclimation: daily
- Health during acclimation (any mortality observed): mortality < 5%

FEEDING DURING TEST
- No feeding from 24 h prior to the test and during the total test period.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
180 mg CaCO3
Test temperature:
21.1 - 22.8 °C
pH:
7.6 - 7.8
Dissolved oxygen:
6.5 - 9.5 mg O2/L
Nominal and measured concentrations:
nominal: control, 0.1, 10, 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: all-glass, 10 L, headspace: 1 L, fill volume: 9 L (control and highest loading rate); all-glass, 6.5 L, headspace: 1.5 L, fill volume: 4 L (lower loading rates)
- Aeration: no
- No. of organisms per vessel: 7 (control and highest loading rate), 3 (lower loading rates)
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.32 g fish/L (control and highest loading rate), 0.33 g fish/L (lower loading rates)

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Aadjusted ISO medium
- Culture medium different from test medium: no, same as test
- Intervals of water quality measurement: Daily in the control and the highest concentration, beginning at the start of the test (day 0).

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light / 8 h dark

EFFECT PARAMETERS MEASURED
- Mortality was recorded after 2¼, 24, 48, 72 and 96 h following the start of exposure. In addition, every afternoon from day 0 and every morning from day 1 to observe for any dead or severely distressed fish.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
Reference substance (positive control):
yes
Remarks:
pentachlorophenol
Key result
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
WAF
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
NOELR
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
WAF
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: Not observed
- Mortality of control: 0%
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Mortality: 0% at 0.1 mg/L, 20% at 0.22 mg/L, 100% at 0.46 mg/L
- LC50: 0.25 mg/L (95% CI 0.20 - 0.41 mg/L)
- Other: Tested from 05 - 09 Jan 2012
Reported statistics and error estimates:
Not applicable since no mortality was recorded.
Sublethal observations / clinical signs:

No mortality was recorded in any of the treatments.

Analytical measurements

The test substance is an organic compound with the element tin (Sn) in its molecular structure. An ICP-MS method was developed for the determination of the test substance based on the element Sn. Validation of the analytical assay was carried out, however, it was found that the accuracies on test samples prepared with the test substance were inadequate. The ICP-MS method developed was considered to be the best possible for the determination of the test substance:

- Oxygen and helium gas were used to remove the organic and tetrahydrofuran (THF) content of the test substance and accuracy samples.

- The analytical sequence had a normal number of samples and the instrument was cleaned prior to use.

- The substance must be dissolved in THF since it was not directly soluble in (aqueous) strong acids such as HNO3.

According to the results obtained it was concluded that it is not possible to use the ICP-MS method for quantification of test samples to support physico-chemical- and (eco)toxicologal studies. Other analytical techniques such as GC, HPLC and UV-Vis were not suitable for the determination of the test substance due to its hydrophobic molecular structure.

Validity criteria fulfilled:
yes

Description of key information

LL50 (96 h) > 100 mg/L (nominal, OECD 203)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information

One experimental study is available investigating the effects of the substance to freshwater fish. The study was performed according to OECD 203 (GLP) with Cyprinus carpio under static conditions. Test solutions were prepared as loading rates of 1.0, 10.0 and 100 mg/L by adding appropriate amounts of the substance to test medium followed by 1 h stirring, 40 min settling and siphoning off the soluble fraction to be used for testing. All test solutions were clear and colorless throughout the test. Analytical measurements were not possible to be conducted since no suitable analytical method could be established (see also IUCLID section 5.1.2). No mortality was recorded after 96 h resulting in a LL50 (96 h) of > 100 mg/L (nominal). No behavioral abnormalities and sub-lethal effects were observed during testing.