N-[3-(trimethoxysilyl)propylcyclohexylamine]

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:

02 - 06 Nov 1998

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

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Hessisches Ministerium für Umwelt, Energie, Jugend, Familie und Gesundheit, Wiesbaden, Germany

Analytical monitoring:

yes

Remarks:

ICP - measurement of Si-concentration

Details on sampling:

- Concentrations: control and 100 mg/L
- Sampling method: Duplicates from the single test concentration of 100 mg/L and the control were taken from freshly prepared test medium and on Days 2 and 4 of exposure. All samples taken from the 100 mg/L concentration and only one replicate from the control samples were analyzed in the laboratories of Dr. Weßling Laboratorien GmbH, Darmstadt, Germany.
- Sample storage conditions before analysis: Samples were stored in a refrigerator until analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 500.4 mg test substance were suspended homogeneously in 5 L test water by intense stirring for 30 min.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Source: City Zoo, Darmstadt, Germany
- Age at study initiation: juveniles
- Length at study initiation (length definition, mean, range and SD): 3.5 ± 0.1 cm (10 fish from the test fish batch were measured at the start of the test)
- Weight at study initiation (mean and range, SD): 0.64 ± 0.17 g wet weight (10 fish from the test fish batch were measured at the start of the test)

ACCLIMATION
- Acclimation period: 4 weeks
- Acclimation conditions (same as test or not): acclimated to the test temperature in the laboratory, in test water
- Type and amount of food during acclimation: until one day before test start fish were fed with a commercial fish diet (TETRA MIN Hauptfutter)
- Health during acclimation (any mortality observed): During the last 4 weeks prior to the test start, one fish died (mortality rate 2%), all other fish were healthy

FEEDING DURING TEST : no

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

2.5 mmol/L (= 250 mg/L) as CaCO3

Test temperature:

22 - 23 °C

pH:

7.8 - 8.8

Dissolved oxygen:

7.2 - 8.7 mg/L

Salinity:

-

Conductivity:

-

Nominal and measured concentrations:

Nominal: control, 100 mg/L
Measured (based on Si): 96.2 - 100.3% of nominal

Details on test conditions:

TEST SYSTEM
- Test vessel: 9 L glass aquaria
- Fill volume: 5 L test medium, 4 L headspace
- Aeration: media slightly aerated during the test

- 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: according to the guideline
- Alkalinity: 0.8 mmol/L
- Ca/Mg ratio: 4/1
- Intervals of water quality measurement: Temperature, pH and dissolved oxygen concentrations were determined daily. The behaviour of the test substance in the test water was observed once every day.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light/ 8 h dark
- Light intensity: 248 - 255 lx

EFFECT PARAMETERS MEASURED: fish were observed after approx. 2, 24, 48, 72 and 96 h for symptoms of intoxication and mortality

TEST CONCENTRATIONS
- Range finding study : yes. Not according to GLP and data not reported.
- Results used to determine the conditions for the definitive study: yes, tested concentration is based on the results of the range finding test

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)

Details on results:

- Behavioural abnormalities: no
- Other biological observations: no
- Mortality of control: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no observations, test medium was clear

Sublethal observations / clinical signs:

ANALYTICAL RESULTS:

The measured substance concentrations during the test period were in the range between 96.2 and 100.3 % of the nominal values. Therefore the results are expressed as nominal values. A differentiation between test substance and hydrolysis product was not possible with the used analytical method.

BIOLOGICAL RESULTS:

Further effect values presented in the study report:

- NOEC (96 h) >= 100 mg/L

- LC0 (96 h) >= 100 mg/L

- LC100 (96 h) > 100 mg/L

VALIDITY CRITERIA:

Table 1: Validity criteria for OECD 203.

Criterion from the guideline	Outcome	Validity criterion fulfilled
The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test	No mortalities	yes
The dissolved oxygen concentration must have been at least 60 per cent of the air saturation value throughout the test	7.2 - 8.7 mg/L (>60%)	yes
There must be evidence that the concentration of the substance being tested has been satisfactorily maintained, and preferably it should be at least 80 per cent of the nominal concentration throughout the test. If the deviation from the nominal concentration is greater than 20 per cent, results should be based on the measured concentration.	The measured test item concentrations were between 96 and 100% of the nominal values.	yes

Validity criteria fulfilled:

yes

Conclusions:

The limit test performed according to the OECD guidance 203 under static conditions, showed no toxic effects to the tested organism Brachydanio rerio up to the highest tested concentration of 100 mg/L (nominal).

Description of key information

LC50 (96 h) > 100 mg/L (nominal, OECD 203)

Additional information

In an acute fish toxicity test (1999) according to the OECD guidance 203 and GLP standards, the test organism Brachydanio rerio was exposed to a single nominal concentrations of 100 mg /L. An analytical monitoring took place via ICP by measuring the Si-signal of the test substance in the medium. Samples were taken from the freshly prepared medium and from the aged medium on Day 2 and 4. The recovery of the measured samples was between 96 and 100% of the nominal values. However a differentiation between parent substance and hydrolysis product was not possible with the used analytical method. Since static conditions were used for the test and the hydrolysis of the substance at neutral pH is rapid (half-life = 4.1 min at pH 7), it is assumed that the tested organism was exposed to both the parent compound and the hydrolysis products. The study did not show any toxic effects to fish and resulted in a LC50 (96 h) of > 100 mg/L.