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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:
2017-05-29 to 2017-06-02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
30 May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
17 July 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
Version / remarks:
1996
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
TOXI-COOP Toxicological Research Center Zrt.
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test item is poorly water soluble material. In order to achieve the maximum solubility level, the test solution was prepared as follows: a supersaturated solution (100 mg/L nominal loading) was prepared by dispersing/dissolving an amount of 0.3 g test item in 3000 mL test medium (ISO medium). This solution was agitated by orbital shaker (~350 rpm) for approx. three days and then the non-dissolved test material was separated by filtration through a membrane filter (0.2 µm) in order to obtain the saturated test solution (corresponding to 100 mg/L nominal concentration).
- Controls: The dilution water (ISO medium, without addition of the test item) was used as a control solution.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish (Brachydanio rerio)
- Source: Akvárium magazin Kft. (Pasaréti Gyula) 1222 Budapest, Dévény u. 36.
- Age at study initiation: Juveniles were used
- Length at study initiation (range): 2 +/- 1 cm

ACCLIMATION
- Acclimation period: Fish were held for at least 12 days before test initiation in the fish laboratory of TOXI-COOP ZRT. under the same conditions as used during the exposure period
- Type and amount of food during acclimation: Fish were fed with appropriate, commercial diet for fish.
- Feeding frequency during acclimation: at least three times per week until one day before the test start.
- Health during acclimation:Apparently healthy animals were used in the test

FEEDING DURING TEST:
The fish were not fed during the test.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
249 mg/L (as CaCO3)
Test temperature:
21.5 – 22.0 °C
pH:
7.30 – 7.82
Dissolved oxygen:
79.2 – 95.2 % of the air saturation value at the temperature used.
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass aquariums with 3 litre test liquid.
- Aeration: No
- No. of organisms per vessel: 10 (no replicates were used)
- Biomass loading rate: The loading rate did not exceed 1.0 g/L (g fish/ liter test solution). The loading of the test-aquariums was calculated and was 0.90 g/L in the control and 0.66 g/L in the test item treated group.

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Rreconstituted water was used (ISO medium, prepared according to recommendation of Annex 2 of the OECD 203 guideline).

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

EFFECT PARAMETERS MEASURED: Fish were observed at approximately 5, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality.

TEST CONCENTRATIONS
- Preliminary test: A non-GLP preliminary experiment was carried out at saturation (100 mg/L nominal loading) concentration to determine the approximate toxicity of the test item.
- Results used to determine the conditions for the definitive study: Toxic effects were not observed during the preliminary test therefore only one test concentration at saturation (equivalent to 100 mg/L nominal concentration) and one control group was tested in a limit test.
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 (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Validity criteria fulfilled:
yes
Conclusions:
In this 96-hour static acute toxicity test on Zebrafish (Brachydanio rerio) the test item Reaction product of Hexamethylene diisocyanate, oligomers with Mercaptopropyltrimethoxysilane had no toxic effect on fish at aquatic saturation (equivalent to 100 mg/L nominal concentration). Accordingly, the 96-h LC50 value was determined to be > 100 mg/L. The 96-h NOEC was determined to be 100 mg/L.
The results are based on nominal test item concentration.
Executive summary:

A 96-h acute toxicity test with Brachydanio rerio was performed according to OECD guideline 203. The test item is a poorly water soluble material and therefore a saturated solution (100 mg/L nominal loading) was prepared and the fish were exposed unter static conditions to the test media containing the test item plus a control group for 96 hours. In this 96-hour static acute toxicity test on Zebrafish (Brachydanio rerio) the test item had no toxic effect on fish at aquatic saturation (equivalent to 100 mg/L nominal concentration). Accordingly, the 96-h LC50value was determined to be > 100 mg/L. The 96-h NOEC was determined to be 100 mg/L. All validity criteria were met. The results are based on nominal test item concentration.

Description of key information

In a 96-hour static acute toxicity test on Zebrafish (Brachydanio rerio) an LC50 value of > 100 mg/L and a NOEC of 100 mg/L were determined.

Key value for chemical safety assessment

Additional information

A 96-h acute toxicity test with Brachydanio rerio was performed according to OECD guideline 203. The test item is a poorly water soluble material and therefore a saturated solution (100 mg/L nominal loading) was prepared and the fish were exposed unter static conditions to the test media containing the test item plus a control group for 96 hours. In this 96-hour static acute toxicity test on Zebrafish (Brachydanio rerio) the test item had no toxic effect on fish at aquatic saturation (equivalent to 100 mg/L nominal concentration). Accordingly, the 96-h LC50 value was determined to be > 100 mg/L. The 96-h NOEC was determined to be 100 mg/L. All validity criteria were met. The results are based on nominal test item concentration.