N-[3-(trimethoxysilyl)propylcyclohexylamine]

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 - 04 Jun 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

1992

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

1984

GLP compliance:

yes (incl. QA statement)

Remarks:

Hessisches Ministerium für Umwelt, Landwirtschaft und Forsten, Wiesbaden, Germany

Analytical monitoring:

yes

Remarks:

TOC

Details on sampling:

- Concentrations: All test concentrations and the control were sampled.
- Sampling method: Duplicate samples from freshly prepared and 48 h old test media were taken for analysis. Only one of the control duplicate samples was analysed for each time point.
- Sample storage conditions before analysis: Samples were analyzed directly after sampling.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test item was mixed into test water at a concentration of 210 mg/L and stirred for 24 h. This stock solution was diluted with test water to prepare the further test media.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: Supplied 1997 by the Umweltbundesamt, Institut für Wasser-Boden und Lufthygiene, Berlin Germany. Daphnia were since then bred in the laboratory under similar temperature and light conditions as in the test and in similar reconstituted water regarding the pH, components of the main ions and total hardness. Daphnia of the stock culture were fed at least each working day with green algae
- Age at test start: 7 h and 30 min - 23 h and 15 min, Daphnia were not first brood progeny
- Sex: female
- Feeding during test: no

ACCLIMATION
- Acclimation period: for 7 h and 30 min under test conditions
- Acclimation conditions (same as test or not): same as test

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

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

Test temperature:

20 °C

pH:

7.0 - 7.6

Dissolved oxygen:

8.2 - 9.5 mg O2/L

Nominal and measured concentrations:

Nominal: control, 11, 23, 48, 100, 210 mg test item/L
Analytically determined mean test item concentrations were between 81 and 87% of the nominal values

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL glass beakers
- Fill volume: 80 mL; Headspace 20 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline (Reconstituted water Elendt M4)
- Alkalinity: 0.9 mmol/L
- Intervals of water quality measurement: pH and dissolved oxygen concentrations were determined at test start and end in all test vessels. Water temperature was measured in one control beaker at the start and end of the test. The behavior of the test item in the test water was determined at the start of the test, after 24 and 48 h in all test concentrations.

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light/ 8 h dark
- Light intensity: 150 - 420 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): The immobility or mortality of Daphnia was determined by visual controls after 24 and 48 h. Animals not able to swim within 15 sec. after gentle agitation of the test beaker were considered immobile

RANGE-FINDING STUDY
- A range finding test was performed in order to determine the test concentrations. This test was not performed according to GLP regulations and data are excluded from the final report

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 210 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: no
- Mortality of control: no mortality
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no

ANALYTICAL RESULTS:

The analytically determined mean test item concentrations were between 81 and 87% of the nominal values. Therefore all reported biological results are expressed as nominal concentrations.

BIOLOGICAL RESULTS:

Table 1: Influence of test item on mobility of Daphnia magna.

Concentration of test item [mg/L]	No of Daphnia tested	No of immobilized Daphnia		% immobilized Daphnia
		24 h	48 h	24h	48h
control	20	0	0	0	0
11	20	0	0	0	0
23	20	0	0	0	0
48	20	0		0	0
100	20	0	2	0	10*
210	20	0	7	0	35*

* significant

Further reported effect values:

- EC0 (48 h) = 48 mg/L

- EC100 (48 h) > 210 mg/L

- NOEC (48 h) = 48 mg/L

- LOEC (48 h) = 100 mg/L

VALIDITY CRITERIA:

Table 2: Validity criteria for OECD 202

Criterion from the guideline	Outcome	Validity criterion fulfilled
In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized.	0% immobilization in control	yes
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels.	>= 8.2 mg O2/L	yes

Validity criteria fulfilled:

yes

Remarks:

For further details please refer to “Any other information on results incl. tables”.

Conclusions:

The study conducted according to OECD 202 and Daphnia magna as the test organism, resulted into an EC50 (48 h) of > 210 mg/L (nominal).

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

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 attached justification below and the overall justification for grouping of substances attached in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across source

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 210 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: no
- Mortality of control: no mortality
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no

Description of key information

EC50 (48 h) > 210 mg/L (nominal, OECD 202) based on read across from CAS 27445-54-1.

Additional information

Experimental data on the toxicity of N-[3-(trimethoxysilyl)propylcyclohexylamine] (CAS 3068-78-8) towards freshwater aquatic invertebrates are not available. Therefore, in accordance with the Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and the read across assessment framework (RAAF, ECHA 2017) a read across from the analogue substance N-{[Diethoxy(methyl)silyl]methyl}cyclohexanamine (CAS 27445-54-1) has been performed. Details on the read-across justification can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.

One study is available testing the short term toxicity of the analogue substance N-{[Diethoxy(methyl)silyl]methyl}cyclohexanamine (CAS 27445-54-1) to aquatic invertebrates according to the OECD guideline 202 and GLP (2004). The test organism Daphnia magna was exposed in a static testing regime for 48 h to nominal test item concentrations of 11, 23, 48, 100 and 210 mg test item/L as well as a control. The test item concentrations were analytically monitored at the beginning and at the end of the test via TOC measurements. The analytically determined mean test item concentrations were between 81 and 87% of the nominal values. 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 daphnids were exposed to both, the parent compound and the hydrolysis products. The test resulted in an EC50 (48 h) of > 210 mg/L (nominal).

Based on the results of the analogue substance and as explained in the attached read across justification (see IUCLID target entry) similar results are expected for 1 N-[3-(trimethoxysilyl)propylcyclohexylamine] (CAS 3068-78-8).