Tetravinylsilane

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2018-05-06 to 2018-05-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch No.: 707001
Purity: 98.6%

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/L
- Sampling method: in 0 and 72 hour fresh solution and 24 and 96 hour old solution. 3 samples were taken from the upper, middle and bottom of the test solution and about 30 mL was taken for each sample. A sample of about 30 mL was taken from the control solution.

Vehicle:

no

Details on test solutions:

Weigh 1.0001-1.0005 g test item and add into 10 L test water. The solution was stirred with magnetic stirrer using a stirring rate at 330-500 rpm about 24 hours. 5 L solution was taken from the middle layer of solution and used for the test exposure.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: reproduced in this facility, their parents' origin were from Hangzhou Hunter Biotechnology Inc.
- Length at study initiation: 2.5-2.9 cm
- Weight at study initiation: 0.2231 - 0.2692 g
- Method of breeding: Light condition: 12 hours light: 12 hours darkness (the light is cool white light); Temperature: 23±2 °C; Oxygen concentration: At least 80% of air saturation value (ASV)

ACCLIMATION
- Acclimation period: no data
- Acclimation conditions: same as test
- Feeding frequency during acclimation: Twice on weekday and one time on weekend until 24 hours before the test was started
- Health during acclimation: no any sign of disease or mortalities

FEEDING DURING TEST
Fish was not fed during the period of the test.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

200 mg/L (as CaCO3)

Test temperature:

21.9 - 22.4 °C

pH:

7.64-8.12

Dissolved oxygen:

80.5%-103.8% of the air saturation value (ASV)

Nominal and measured concentrations:

Nominal: 100 mg/L
Measured: 3.724 mg/L.

Details on test conditions:

TEST SYSTEM
- Test vessel: about 5 L glass bottle
- Test solution volume: 5L
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: <1.0 g fish/L water

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: the water treated with Aquapro Pure Water System
- Total organic carbon: < 2 mg/L
- Particulate matter:


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12 hours light: 12 hours darkness (the light is cool white light)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Biological observation: 2, 4, 24, 48, 72 and 96 h after exposure

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 10, 30 and 100 mg/L
- Results used to determine the conditions for the definitive study: no death and any visible toxic signs were observed at group of 10, 30 and 100 mg/L.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 3.724 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

There was no death and visible toxic sign observed in the vessels of control group and test group of 100 mg/L.
Verification of test concentration:
The mean measured concentration of fresh solution was 3.853 mg/L, and the mean measured concentration of old solution was 3.595 mg/L. And the mean concentration was 3.724 mg/L.

Results with reference substance (positive control):

- Results with reference substance valid?
- 24-hour LC50: 282.25 mg/L, 95% confidence limits: 247.38 mg/L - 322.02 mg/L

Reported statistics and error estimates:

This test was a limit test, so toxicity effect was derived directly from the test results.

Validity criteria fulfilled:

yes

Conclusions:

Basing on the measured concentration and test results, the 96-hour LC50 of test item to zebra fish was greater than 3. 724 mg/L.

Executive summary:

An acute toxicity study of test item was conducted with zebra fish (Dania rerio) over a 96-hour exposure period in compliance with OECD 203.

According to the preliminary test results, the definitive test was conducted with a semi-static water renewal system (solutions were replaced every 24 hours) at 100 mg/L (nominal concentration). A concurrent blank control was performed in parallel. 7 fish were used in each of the test groups and the control group.

During the 96-hour exposure period, there was no death and visible toxic sign observed in the vessels of control group and test group of 100 mg/L.

Basing on the measured concentration and test results, the 96-hour LC50 of test item to zebra fish was greater than 3.724 mg/L.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2019-07-01 to 2019-07-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

Batch No.: 707001
Purity: 98.6%

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 80, 40, 20, 10 and 5.0% as stock solution content
- Frequency of measurement: At the start of exposure, before and after the renewal, and at the end of exposure
- Sample for measurement: Another solution sampled separately from the preparation container (at the preparation). The test solution for analysis was taken out from the middle layer of the test vessel. (before the renewal and at the end of exposure)
- Volume of sample: Approximately 10 mL ( all test levels)

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The weighed test sample (0.50 g) was added into the Erlenmeyer flask mixed with dilution water (5 L) to produce 100 mg/L as the nominal concentration. The flask was scaled, and then stirred for 48 hours with a magnetic stirrer. After stopping the siring the middle layer taken after settlement an hour was prepared as stock solution. The required amount of the stock solution and dilution water were mixed in a preparation container and stirred to prepare the test solution, and after dispensing into the test container, a glass lid was installed so that there was no gas phase. The stock solution (prepared for two containers) and the test solution were prepared every renewal.
- Controls: Dilution water without the test item

Test organisms (species):

Oryzias latipes

Details on test organisms:

TEST ORGANISM
- Common name: Medaka
- Source: CERI Kurume (in-test facility production)
- Age at study initiation: Two-month-old
- Length at study initiation: Total length 2.0 ± 1.0 cm


ACCLIMATION
- Acclimation period: 24 days
- Acclimation conditions (same as test or not): No, Acclimation tyrpe: Flow-through regime
- Type of food during acclimation: Feed of Medaka fry for education (KYORIN)
- Feeding amount and frequency during acclimation: Amount corresponding to 3% of body weight was fed every day.
- Health during acclimation (any mortality observed): 0% (during 7 days before the start of exposure)


FEEDING DURING TEST
No feeding
Feed withdrawal: 24 hours before the start of exposure

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

42 mg/L

Test temperature:

23.8-24.2 °C

pH:

7.2-7.9

Dissolved oxygen:

6.3-8.6 mg/L

Nominal and measured concentrations:

Nominal: 80, 40, 20, 10 and 5.0% as the stock solution content
Measured: 3.25, 1.62, 0.727, 0.395 and 0.175 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 3 L glass tank ( diameter: 16 cm, depth: 17cm)
- Type: closed system without head space
- Volume: Approximately 3.4 L/test level
- Aeration: No
- Renewal rate of test solution (frequency): every 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water, aerated sufficiently and temperature-controlled. Chemical characteristics of dilution water measured regularly are listed in Appendix 1 in attached background material.
- Culture medium different from test medium: no


OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: Room light, 16-hour light/8-hour dark

EFFECT PARAMETERS MEASURED:
Observation of test organism:
Mortality and visible abnormality were observed at 3, 24, 48, 72 and 96 hours after the start of exposure.


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.0
- Range finding study
- Test concentrations: 80, 25, 8.0 % as the stock solution content
- Results used to determine the conditions for the definitive study:
Abnormalities seen at 25%, 100% mortality occurred at 80% test level.

Reference substance (positive control):

yes

Remarks:

Copper (II) sulfate pentahydrate

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

1.5 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities:
- Size of test organism at the end of exposure for control: Total length: 2.2 ± 0.2 cm, Body Weight: 0.11 ± 0.02 g
- Mortality:
All the mortality of test organisms were confirmed at 48 hours observation after the start of exposure in 3.25 mg/L.
Minimum concentration causing 100% mortality at 96 hours was estimated as 3.25 mg/L. Maximum concentration causing no mortality at 96 hours was 0.727 mg/L. Number of dead fish in the control at the end of exposure was 0, which met the criterion for the validity of the test (ie. Not exceed one fish).

- Abnormal responses: Observed abnormal responses during exposure were lethargic, at the surface, muscle spasm, partial loss of equilibrium and reduced activity for 10% or more groups. No abnormal response was observed in the control.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The test solutions in all test levels were colorless and clear at the start and before the renewal. The concentration maintenance rate of the test item was 69.9 to 103%.
- Solubility in dilution water (24±1°C): 6.30 mg/L (measured value in preliminary study)

Results with reference substance (positive control):

- Results with reference substance valid? yes
- LC50: 96-hour LC50 0.29 mg/L
- Other: This value was within the stipulated range (mean ± S.D.: 0.13-0.89 mg/L, n=64) to background data in this test facility.

Reported statistics and error estimates:

The LC50 of 48, 72 and 96 hours were calculated by Binomial test.
For 24hours, the LC50 was estimated as "> the highest test concentration" since the mortality over 50% was not observed.

Validity criteria fulfilled:

yes

Conclusions:

The 96-hour LC50 of the test item for Medaka was 1.50 mg/L.

Executive summary:

This study was conducted in order to estimate the 96 h LC50 of the test item on the test organisms (Medaka) at less than the solubility of the test item in dilution water based on OECD 203. The definitive study was conducted semi-static regime (renewal every 24 hours, closed system without headspace) with five test concentrations of 80, 40, 20, 10 and 5.0% as stock solution content (3.25, 1.62, 0.727, 0.395 and 0.175 mg/L as measured concentration),and a control.As a result, 96-hour LC50 was 1.50 mg/L. Minimum concentration causing 100% mortality at 96 hours was estimated as 3.25 mg/L. Maximum concentration causing no mortality at 96 hours was 0.727 mg/L.

Description of key information

Two short-term toxicity to fish test are available both were conducted in compliance with OECD 203 and GLP.

The 96-hour LC50 of test item to zebra fish was greater than 3.724 mg/L (measured concentration).

The 96-hour LC50 of test item to Medaka (Oryzias latipes) was 1.50 mg/L (measured concentration).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

1.5 mg/L