Triethoxy(vinyl)silane

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:

13 Feb - 17 Feb 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: Circular on Test Methods of New Chemical Substances (Japan), Fish acute toxicity test

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Remarks:

according to the Japanese GLP Standard

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Melting point: < 0°C
- Boiling point: 123°C
- Vapour pressure: < 2.7 kPa at 25 °C
- Water solubility (under test conditions): low
- Stability in water: Test item is hydrolyzed (half-life: within 30 min)

Analytical monitoring:

yes

Details on sampling:

- Sampling method: sampled directly by each vessel and pre-treatment was not performed
- Sample storage conditions before analysis: no strage before analysis
- Methanol concentration was measured, since the test item was quickly hydrolyzed

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: test item was measured and diluted in dilution water by stirring for 120 min

Test organisms (species):

Oryzias latipes

Details on test organisms:

TEST ORGANISM
- Common name: Medaka fish
- Source: Amishima Fishing, Yokohama, Japan
- Age at study initiation (mean and range, SD): within 1 year old
- Length at study initiation (mean and range): 2.19 (2.00 - 2.40) cm
- Weight at study initiation (mean and range): 0.068 (0.053 - 0.082) g
- Feeding during test: no food

ACCLIMATION
- Acclimation period: 19 Jan - 13 Feb 2006
- Acclimation conditions (same as test or not): similar to the test condition (acclimation condition: flow through, test condition: semi-static)
- Type and amount of food: Tetramin, 2% of body weight
- Health during acclimation (any mortality observed): mortaliy was < 5% during 7days before exposure

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

52 mg/L

Test temperature:

23.3 - 24.3 (24 ± 1 °C), measured at0, 24, 48, 72 and 96 hours after exposure.

pH:

6.8 - 7.4, measured at0, 24, 48, 72 and 96 hours after exposure.

Dissolved oxygen:

6.3 - 8.4 mg/L, measured at0, 24, 48, 72 and 96 hours after exposure.

Nominal and measured concentrations:

Nominal concentration: 100 mg/L
Measured concentration: 92.2 mg/L (time weighted mean)
The measured concentration was calculated based on the concentration of methanol yielded on hydrolysis

Details on test conditions:

TEST SYSTEM
- Test vessel: 5 L aquarium
- Type: closed with a teflon sheet
- Fill volume: 5 L
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): every 24 hours
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates):1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Charcoal-treated, dechlorinated, treated with sodium thiosulfateand to get rid of chlor perfectly, aerated tap water in Yokohama, Japan
- Alkalinity: 42 mg/L
- Ca/mg ratio: 14/3.9
- Culture medium different from test medium: same medium
- Intervals of water quality measurement: 6 months

OTHER TEST CONDITIONS
- Adjustment of pH: no adjustment of pH
- Photoperiod: 16 hours in the dark, 8 hours in the light
- Light intensity: < 1000 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
mortality and general condition (abnormal behavior and swim ability) were observed after 24, 48, 72 hours exposure and at the end of the study.

TEST CONCENTRATIONS
- Range finding studies were performed twice.
- Test concentrations: 1) 1, 10 and 100 mg/L, 2) 100 mg/L
- Results used to determine the conditions for the definitive study:
1) No mortality was observed in 1 and 10 mg/L. The mortality in 100 mg/L was 20%. No other toxicity was observed in all group.
2) No toxicity and mortality was observed in 100 mg/L.

Reference substance (positive control):

yes

Remarks:

copper sulfate pentahydrate (analytical grade)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 92.2 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Measured concentration is based on concentration of methanol

Duration:

96

Dose descriptor:

NOEC

Effect conc.:

>= 92.2 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Remarks on result:

other: Measured concentration is based on concentration of methanol

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Details on results:

- Behavioural abnormalities: No toxicological symptom was observed
- Mortality of control: 0%
- Other adverse effects control: No adverse effect in control

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- LC50: 0.77 mg/L

Sublethal observations / clinical signs:

Table 1. Mesured concentration of methanol

Nominal concentration (mg/L)	Mean measured concentration, mg/L (Percent of nominal)				Mean (a) measured Concentration, mg/L
	0 hour new	24 hours old	72 hours new	96 hours old
Control	< 0.03	< 0.03	< 0.03	< 0.03
64.8 (b)	56.5 (87)	54.6 (84)	67.1 (104)	61.3 (95)	59.8 (92)

(a): time weighted mean

(b): theoretical concentration as methanol

new: freshly prepared test solutions

old: test solutions on 24 hours after preparation of new solutions

Table 2. Caluculated concentration of the test substance using methanol concentration

Nominal concentration (mg/L)	Mean measured concentration, mg/L (Percent of nominal)				Mean (a) measured Concentration, mg/L
	0 hour new	24 hours old	72 hours new	96 hours old
Control	< 0.04	< 0.04	< 0.04	< 0.04
100	87.1 (87)	84 (84)	103 (104)	94.5 (95)	92.2 (92)

(a): time weighted mean

Table 3. Mortality of the Medaka (Oryzias latipes)

Nominal concentration (mg/L)	Mean measured concentration (mg/L)	Cumulative Number of Dead (Percent Mortality)
		24 Hour	48 Hours	72 Hours	96 Hours
Control	-	0 (0)	0 (0)	0 (0)	0 (0)
100	92.2	0 (0)	0 (0)	0 (0)	0 (0)

Validity criteria fulfilled:

yes

Conclusions:

The LC50 of 2768-02-7 was measured to be > 92.2 mg/l. Due to the rapid rate of hydrolysis, the measured concentration was based on the hydrolysis product, methanol.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1993-10-11 to 1993-10-15

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 100 mg/l

- Concentrations measured in fresh test medium at the start of the test and then again prior to renewal after 24 hours exposure. Concentrations also determined in fresh test media prepared for renewals at 24, 48 and 72 hours.

Vehicle:

no

Details on test solutions:

Limit test at a nominal concentration of 100 mg/l. Test media prepared by dilution of a 10000 mg/l stock solution.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM

- Common name: Zebrafish

- Source: West aquarium, Bad Lauterberg, Germany

- Length at study initiation (length definition, mean, range and SD): 3.0 cm ±0.5 cm

- Feeding during test: none


ACCLIMATION

- Acclimation period: at least 14 days

- Acclimation conditions (same as test or not): yes

- Type and amount of food: TetraMin® at 1% of body weight

- Feeding frequency: Daily

- Health during acclimation (any mortality observed): The fish exhibit normal behaviour and are free from visible signs of disease at the start of the test.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

10.7 ºdH

Test temperature:

20 ±1ºC

pH:

7.7 - 8.8

Dissolved oxygen:

7.7 - 8.9 mg/l

Nominal and measured concentrations:

Nominal: 100 mg/l

Measured concentrations in fresh media at start of test and at 24, 48 and 72 h: 120, 108, 93 and 96 mg/l

Measured concentration in old test media prior to renewal at 24 h: 92 mg/l

Details on test conditions:

TEST SYSTEM

- Test vessel:

- Type: open aquarium

- Material, size, headspace, fill volume: 20 litre

- Aeration: Continuous

- Renewal rate of test solution (frequency/flow rate): Daily

- No. of organisms per vessel: 10

- No. of vessels per concentration (replicates): 1

- No. of vessels per control (replicates): 1

- Biomass loading rate: 0.4 g/l


TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: Potable water from Gelsenwasser AG


OTHER TEST CONDITIONS

- Adjustment of pH: None

- Photoperiod: 16 h light/8 h dark


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality after 24, 48, 72 and 96 h

Reference substance (positive control):

no

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:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: 0

Validity criteria fulfilled:

yes

Conclusions:

A 96-hour LC50 value of >100 mg/l and NOEC of ≥100 mg/l have been determined for the effects of the test substance on mortality of Brachydanio rerio. It is likely that the test organisms were primarily exposed to the hydrolysis products of the substance.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Not reported

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Secondary literature

Principles of method if other than guideline:

Not described

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

no

Test organisms (species):

Pimephales promelas

Test type:

not specified

Water media type:

not specified

Dose descriptor:

LC50

Effect conc.:

> 2 000 mg/L

Nominal / measured:

not specified

Conc. based on:

not specified

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

not specified

Conclusions:

An LC50 value of >2000 mg/l has been reported for the effects of the test substance on mortality of Pimephales promelas. The result is reported in secondary literature and its reliability cannot be assessed.

Reference 4

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions. No GLP or analysis of exposure media and no description of the test substance.

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

no data

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM

- Common name: Rainbow trout

- Source: Fender's Fish Hatchery

- Feeding during test: no data

ACCLIMATION

- Acclimation period: A minimum of two weeks

- Acclimation conditions: same as test

- Type and amount of food: not reported

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

reconstitiuted soft water

Test temperature:

12ºC

pH:

no data

Dissolved oxygen:

no data

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal concentrations: 0(Control), 100, 320 and 1000 mg/l

Details on test conditions:

TEST SYSTEM

- Test vessel:

- Type: open

- Material: Polyethylene lined

- Aeration: no data

- Renewal rate of test solution (frequency/flow rate): no data

- No. of organisms per vessel: 10

- No. of vessels per concentration (replicates): 1

- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: Reconstituted soft water (EPA 660/3-75-009)

- Culture medium different from test medium: no

- Intervals of water quality measurement: no data


OTHER TEST CONDITIONS

- Adjustment of pH: no data

- Photoperiod: no data

- Light intensity: no data


EFFECT PARAMETERS MEASURED (with observation intervals if applicable): daily mortality


TEST CONCENTRATIONS

- Spacing factor for test concentrations: 3.2

- Range finding study: no data

Reference substance (positive control):

no

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:

LC50

Effect conc.:

191 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 125-281

Details on results:

- Mortality of control: 10% (1 fish)

- Other adverse effects control: none

Reported statistics and error estimates:

The LC50 value was calculated by probit analysis based on Finney's Method (Statistical Methods in Biological Assay, 1952).

Sublethal observations / clinical signs:

Table 1. Test results

Nominal test concentration (mg/l)	Percentage mortality after 24 hours	Percentage mortality after 48 hours	Percentage mortality after 72 hours	Percentage mortality after 96 hours
0 (Control)	0	0	10	10
100	0	0	0	0
320	30	100	100	100
1000	90	100	100	100

Validity criteria fulfilled:

yes

Conclusions:

A 96-hour L50 value of 191 mg/l and NOEC of 100 mg/l have been determined for the effects of the test substance on mortality of Oncorhynchus mykiss. It is likely that the test organism were primarily exposed to the hydrolysis product of the test substance.

Reference 5

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Not reported

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment

Principles of method if other than guideline:

Not described

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

not specified

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Test type:

not specified

Water media type:

not specified

Hardness:

no data

Test temperature:

no data

pH:

no data

Dissolved oxygen:

no data

Salinity:

no data

Nominal and measured concentrations:

no data

Details on test conditions:

no data

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

not specified

Conc. based on:

not specified

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

not specified

Conclusions:

An LC50 value of >100 mg/l has been reported for the effects of the test substance on mortality of Oncorhynchus mykiss. There is insufficient information on the study to assess the reliability of the result.

Reference 6

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please refer to overall summary (IUCLID Section 6.1) and attached justification for grouping in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 92.2 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Measured concentration is based on concentration of methanol

Remarks:

MOE, 2006

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

191 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Dow Corning 1979

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

not specified

Conc. based on:

not specified

Basis for effect:

mortality (fish)

Remarks on result:

other: Bemment 2001

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Hüls AG 1995

Dose descriptor:

LC50

Effect conc.:

> 2 000 mg/L

Nominal / measured:

not specified

Conc. based on:

not specified

Basis for effect:

mortality (fish)

Remarks on result:

other: Chandra 1997

Description of key information

In a 96 h test no effects were observed at > 92.2 mg/L meas. (TWA) (> 100 mg/l nominal) to Oryzias latipes (OECD 203, RL2)

Additional information

Measured data were not available for triethoxy(vinyl)silane (CAS 78-08-0), therefore read across of data from the analogue substance trimethoxyvinylsilane (CAS 2768-02 -7) was deemed acceptable for assessment.

A limit test (OECD Guideline 203 Fish Acute Toxicity Test, Ministry of the Environment, Government of Japan, 2006) was conducted with a nominal test concentration of 100 mg/L corresponding to a 92 mg/L mean measured (based on analytical verification of the hydrolysis product methanol). No toxic effects were observed up to this concentration to the tested organism Oryzias latipes.

Several other studies verify this result. In the supporting study of Dow Corning, a 96 h LC50 value of 191 mg/l and a NOEC of 100 mg/l for the effects of the test substance on mortality of Oncorhynchus mykiss (1979) were determined. For the same test species an LC50 > 100 mg/l was calculated (Momentive, 2001). In a GLP study according to EU-Method C.1 (Hüls AG, 1995), the 96 h LC50 for Brachydanio rerio was found to be > 100 mg/l and the NOEC was ≥ 100 mg/l. In a secondary literature of Chandra (1997) the LC50 for Pimephales promelas was > 2000 mg/l.

As the substance is subject to rapid hydrolysis, it is very likely that the test organisms were primarily exposed to hydrolysis products retained in the test media.