Reaction product of Hexamethylene diisocyanate, oligomers with Mercaptopropyltrimethoxysilane

Short-term toxicity to fish

Link to relevant study record(s)

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)

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)

Details on results:

There were no mortalities or any sub-lethal effects observed in 10 fishes in the control group or in 10 fishes exposed to the saturated test concentration (equivalent to 100 mg/L nominal concentration) during the 96-h test period.
Accordingly, the 96-h NOEC was determined to be 100 mg/L and the LOEC and the EC50 values were determined to be higher than 100 mg/L.

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 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.

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.

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.