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Ecotoxicological information

Short-term toxicity to fish

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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 the analogue approach justification provided in section 13.
Reason / purpose for cross-reference:
read-across source
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)
Conclusions:
A 96-h LC50 >100 mg/l in Danio rerio was obtained in a guideline test and in accordance with GLP. The result is taken to be reliable.
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 July - 06 July 2001
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)
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0 and Nominal 100 mg/L

- Sampling method: Verification of test item concentrations was performed by analysis of silicon at the start and the end of the test.
Duplicate samples were taken from the approximate centre of the aquaria, without stiring, from the freshly prepared test medium of the single test concentration and from the control, just before the start of the test. Additional duplicate samples were taken from the test medium and the control after 48 hours and at the end of the test (96 hours).

- Sample storage conditions before analysis: Samples were immediately deep frozen (at about -20 °C) after sampling.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test medium of the only test concentration of nominal 100 mg/L was freshly prepared by dissolving 501 mg of the test item completely in to 5000 ml test water by stiring for 5 mins at room temperature.
The pH of test medium was 9.4 therefore the pH was adjusted to pH 7.8 using a concentrated hydrochloric acid solution (2 M).

- Eluate:
- Differential loading:

- Controls: Test water without test medium

- Evidence of undissolved material (e.g. precipitate, surface film, etc): Not stated
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish

- Strain: Not stated

- Source: Zoohaus Schaub, CH-4410 Liestal, Switzerland

- Age at study initiation (mean and range, SD): Not stated

- Length at study initiation (length definition, mean, range and SD): 3.5 ± 0.2 cm (mean ± SD)

- Weight at study initiation (mean and range, SD): 0.4 ± 0.10 g (mean ± SD)

- Feeding during test: No


ACCLIMATION
- Acclimation period: 1 week in test water at test temperature

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

- Type and amount of food: Fed until one day before the start of the test with a commercial fish diet (TETRA MIN Hauptfutter, supplied by TETRA-Werke, D-49304 Melle, Germany). Amount not stated.

- Health during acclimation (any mortality observed): < 5 % mortality and all fish were healthy
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
2.5 mmol/l test water
Test temperature:
22-23 °C
pH:
7.8 - 8.0
Dissolved oxygen:
7.8-8.2 mg/L
Nominal and measured concentrations:
0 mg/L control and Nominal 100 mg/L

Measured and corrected by mean recovery of spiked samples (from Nominal concentration of 100 mg/L): mean of 115 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass aquarium

- Type (delete if not applicable): open / closed: Not stated

- Material, size, headspace, fill volume: One glass auarium with 5 litres of test medium for each treatment

- Aeration: Test water was aerated until oxygen saturation was reached anded during the test period slightly aerat

- Type of flow-through (e.g. peristaltic or proportional diluter): Not stated

- Renewal rate of test solution (frequency/flow rate): No renewal

- No. of organisms per vessel: 7

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

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

- Biomass loading rate: 0.56 g fish wet weight per litre test medium

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water. Analytical grade salts were dissolved in deionized water

- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:

- Alkalinity: 0.8 mmol/l

- Ca/mg ratio: 4:1

- Culture medium different from test medium: Not stated

- Intervals of water quality measurement:0, 24, 48, 72 and 96 h

OTHER TEST CONDITIONS
- Adjustment of pH: Yes. pH 9.4 adjusted to pH 7.8 using concentrated hydrochloric acid

- Photoperiod: 16-hour light to 8 hour darkness photoperiod, with a 30 minute transition period.

- Light intensity: 50 to 500 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality, Symptoms of intoxication: strongly extended gills, apathy, distended abdomen, fish mainly at bottom of the aquarium, exophthalmus, convultions, fish mainly at the water surface, mucus secretion, fish lying on side or back on the bottom, tumbling during swimming, changed body colour; observed at 2, 24, 48, 72 and 96 hours

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Limit test

- Justification for using less concentrations than requested by guideline: Based on the results of the range finding test, no mortalities or sub-lethal effects were obseved at maximum concentration, from the OECD/EC Test Guidelines, of 100mg/L.

- Range finding study: Yes

- Test concentrations: Not stated

- Results used to determine the conditions for the definitive study: No mortalities observed up to 100 mg/l at the end of the study
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:
- Behavioural abnormalities: None

- Observations on body length and weight: Not stated

- Other biological observations: No other effects

- Mortality of control: No mortality

- Other adverse effects control: None stated

- Abnormal responses: None stated

- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None stated

- Effect concentrations exceeding solubility of substance in test medium: No
Sublethal observations / clinical signs:

Table 1: Mortality and observed symptoms of intoxication

 Nominal Test Item Concentration (mg/L)        Number of Affected fish*/number of dead fish           
 Observation Time            
 2 hours 24 hours   48 hours  72 hours  96 hours
 Control  0/0  0/0  0/0  0/0  0/0
 100  0/0  0/0  0/0  0/0  0/0
 LC50  > 100 mg/L            

* number of dead fish plus number with intoxification symptoms

Validity criteria fulfilled:
yes
Remarks:
Mortality in controls and maintenance of steady test conditions (including test substance concentration >80% of nominal) were all fulfilled.
Conclusions:
A 96-h LC50 >100 mg/l in Danio rerio was obtained in a guideline test and in accordance with GLP. The result is taken to be reliable.
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
8 Feb 2012 - 20 Nov 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
yes
Details on test solutions:
- Method: A primary stock solution was prepared by solving the test substance in THF. Secondary stock solutions were prepared by diluting the primary stock solution with THF. For preparation of the required test concentrations the secondary stock solutions were diluted with well water. The test solutions were stirred overnight to allow a complete hydrolysis.
- Chemical name of vehicle: tetrahydrofuran (THF)
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 0.10 mL/L
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no visible undissolved test substance following preparation
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Strain: SMV Lot No. 12A121
- Source: TroutLodge, Inc., Sumner, Washington
- Age at study initiation (mean and range, SD):
- Length at study initiation (mean, range): 39 mm (35 - 42 mm)
- Weight at study initiation (mean and range): 0.69 g (0.50 - 0.87 g)
- Feeding during test: fish were inadvertently fed during the 24 hours prior to test initiation

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): same
- Type and amount of food: Trout Chow, ad libitum
- Feeding frequency: daily
- Health during acclimation: no mortalitiy observed 48 h prior to testing
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
64 mg/L (CaCO3)
Test temperature:
14 - 15 °C
pH:
6.9 - 7.5
Dissolved oxygen:
5.4 - 9.6 mg/L
Nominal and measured concentrations:
Nominal test substance concentrations:
3.1, 6.3, 13, 25 and 50 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: aquaria
- Type: open
- Material, size, fill volume: glass, 39 × 20 × 25 centimeters, 10 L fill volume
- Aeration:
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.46 g /L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory well water
- Total organic carbon: 0.10 - 0.66 mg/L
- Alkalinity: as CaCO3: 20 mg/L
- Conductivity: 330 μS/cm
- Intervals of water quality measurement: daily

OTHER TEST CONDITIONS
- Adjustment of pH: 25 and 50 mg/L solutions were adjusted from a pH of 8.4 to 7.5 and from 9.2 to 7.25, respectively, with 0.20 and 0.64 mL of 5.0 N hydrochloric acid
- Photoperiod: 16:8 h day-night regime
- Light intensity: 810 - 880 lux

EFFECT PARAMETERS MEASURED:
Mortaility and symptoms of intoxication after 0, 24, 48, 72 and 96 hours

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0.0010, 0.010, 0.10, 1.0 and 10 mg/L, a control and a solvent (THF) control
- Results used to determine the conditions for the definitive study: no mortaility observed in any of the test concentrations
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
50 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
parent material
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 50 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
parent material
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 50 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
parent material
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: none
- Mortality of control: no
The average measured TOC concentrations in solvent control and treatment solutions ranged from 20 to 30 mg C/L. A concentration gradient was not observed. The comparable TOC content in all treatments and the solvent control indicates that the measured organic carbon originated from the solubiliser THF. The concentration of the hydrolysis products of the test substance could not be determined.
Reported statistics and error estimates:
The LC50 was calculated using the computer program CETISTM (Ives, 2011)

Description of key information

LC50 (96 h) > 100 mg/L (OECD 203, B. rerio, read across from CAS No. 227085-51-0), equivalent to > 81 mg/L when expressed in terms of the silanol hydrolysis product of the source substance, N-ethyl-3-trihydroxysilyl-2-methylpropanamine

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Dose descriptor:
LC50
Effect concentration:
> 81 mg/L

Additional information

A 96 hour LC50 value of > 50 mg/l and NOEC of ≥ 50 mg/l have been determined for the effects of the test substance on mortality of Oncorhynchus mykiss (OECD 203). The corresponding mean measured concentration of the substance in the treated test medium over the course of the test could not be determinated. No effects could be detected up to the highest tested concentration but the maximum nominal concentration used (50 mg/L) was well below the predicted solubility of the substance (13000 mg/L) and so does not provide an accurate representation of the likely toxicity of the substance.

Therefore it was considered appropriate to read across from the structurally analogue substance N-ethyl-3-trimethoxysilyl-2-methylpropanamine (CAS No. 227085-51-0). A limit test was conducted at a test concentration of 100 mg/L (OECD 203).

No effects were observed at this concentration to Zebra Fish (Brachydanio rerio). As the substance is subject to rapid hydrolysis, it is therefore likely that the test organisms were also exposed to hydrolysis products retained in the test media.

The results may be expressed in terms of concentration of the silanol hydrolysis product, N-ethyl-3-trihydroxysilyl-2-methylpropanamine, by applying a molecular weight correction: (MW of silanol (source) = 179.29 / MW of parent (source) = 221.37) * 100 = 81 mg/L.