Reaction mass of 2-{[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and 2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-[2-(benzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-benzyl-2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-benzyl-N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride.

Toxicity to terrestrial arthropods

Administrative data

Endpoint:

toxicity to terrestrial arthropods: long-term

Data waiving:

other justification

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Hazard assessment conclusion:

PNEC aqua (freshwater)

PNEC value:

0.032 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

PNEC freshwater (intermittent releases):

0.69 mg/L

Hazard assessment conclusion:

PNEC aqua (marine water)

PNEC value:

0.003 mg/L

Assessment factor:

100

Extrapolation method:

assessment factor

PNEC marine water (intermittent releases):

0.69 mg/L

Hazard assessment conclusion:

PNEC STP

PNEC value:

13 mg/L

Assessment factor:

10

Extrapolation method:

assessment factor

Hazard assessment conclusion:

PNEC sediment (freshwater)

PNEC value:

0.12 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Hazard assessment conclusion:

PNEC sediment (marine water)

PNEC value:

0.012 mg/kg sediment dw

Extrapolation method:

equilibrium partitioning method

Hazard assessment conclusion:

no hazard identified

Hazard assessment conclusion:

PNEC soil

PNEC value:

0.004 mg/kg soil dw

Extrapolation method:

equilibrium partitioning method

Hazard assessment conclusion:

no potential for bioaccumulation

Classification relevant information for environmental hazard:

Degradation

Biodegradation: not readily biodegradable (29% and 17% biodegradation at 10 mg/L and 20 mg/L substance respectively, OECD 301B)

Hydrolysis: half-life: t1/2 < 16 min

 

Bioaccumulation

Log Kow:

Reaction mass containing six benzylated amine silanes: Log Kow: between -0.3 and 5.7 for the individual constituents (QSAR)

Silanol hydrolysis products: Log Kow: between -3.4 and 2.6 for the individual constituents (QSAR)

 

Aquatic acute toxicity

Fish: LC50 (96 h) = 75 mg/L (nominal, OECD 203)

Aquatic invertebrates: EC50 (48 h) = 74 mg/L (nominal, OECD 202)

Algae/aquatic plant: ErC50 (72 h) = 69 mg/L (nominal, OECD 201) 

 

Aquatic chronic toxicity:

Fish: NOEC (28 d) = 5 mg/L (nominal, OECD 215)

Aquatic invertebrates: NOEC (21 d) = 0.32 mg/L (nominal, OECD 211)

Algae/aquatic plant: and NOErC (72 h) = 10 mg/L (nominal, OECD 201) 

 

Classification according to CLP

Reaction mass containing six benzylated amine silanes (EC 700-961-2) is not considered rapidly biodegradable. Experimental data are available covering the potential acute and chronic toxicity of three trophic levels (fish, aquatic invertebrates and algae). The lowest acute effect values were indicated for algae and are clearly > 1 mg/L (ErC50 = 69 mg/L). Therefore, the substance is not classified for acute effects. The lowest chronic effect values were indicated for aquatic invertebrates (NOEC (21 d) = 0.32 mg/L). Thus, the test substance needs to be classified and labeled as “chronic category 2” (H411) according to the consolidated version of Regulation (EC) No 1272/2008 and further amendments (ATPs).

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Short-term toxicity data for reaction mass containing six benzylated amine silanes were available for fish, invertebrates and algae. All studies were performed according to OECD guidelines and GLP standards. In the acute fish toxicity test the 96 h LC50 was found to be 75 mg/L (nominal). A 48 h EC50 value of 74 mg/L (nominal) was determined for the effects of the substance on the mobility of Daphnia magna. A study testing the effects of the substance on the growth rate of the algae Scenedesmus subspicatus resulted in a 72 h EC50 value of 69 mg/L and a NOEC of 10 mg/L.

Long-term toxicity data for the substance were available for fish and aquatic invertebrates. Both studies were conducted based on OECD guidelines and GLP principles. A 28 d juvenile test using Oncorhynchus mykiss as the test organism revealed a NOEC of 5 mg/L (nominal) while a 21 d EC50 of 4.6 mg/L and a NOEC of 0.32 mg/L were determined for the effects of the substance on the reproduction rate of Daphnia magna.

The test item is a complex substance, which degrades quickly in water into monomeric (benzyl substituted aminoalkylsilane triols) or oligomeric (di-, tri-, or higher benzyl substituted aminoalkylsiloxanes) silicon-based substances and methanol. The tests were performed parent compound, which was supposed to display the principal aquatic hazard. The results of each of these studies refer to nominal concentrations of the test substance. However, since the substance hydrolyses rapidly it is assumed that the tested organisms were exposed to both the parent substance and the hydrolysis products.

Finally the influence of the test item reaction mass containing six benzylated amine silanes on the respiration rate of activated sludge was tested according to OECD guidance and GLP and the 3 h EC50 was found to amount 569 mg/L while the NOEC was found to be 130 mg/L.

Cross-reference 3

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 - 16 March 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Version / remarks:

1984

GLP compliance:

yes (incl. QA statement)

Remarks:

Federal Office of Public Health, Swiss Agency for Therapeutic Products and Swiss Agency for the Environment, Forests and Landscape (2003)

Analytical monitoring:

no

Vehicle:

no

Remarks:

chloroform was used to prepare the test item dilutions but was evaporated prior to test start

Details on preparation and application of test substrate:

- Preparation of test item solution: the test item was dissolved and diluted in chloroform and applied to a portion of sand. For the highest test item concentration, 13.900 g of the test item were dissolved completely in 50 mL chloroform, resulting in a test item concentration of 278 mg/mL chloroform. The highest test concentration was diluted with chloroform to obtain the lower test concentrations. Aliquots of 1.5, 2.67, 4.74, and 8.43 mL of the application solution of the highest test concentration were
made up to 15 mL with chloroform to obtain the application solutions of the nominal test concentrations of 100, 178, 316, and 562 mg/kg dry soil, respectively.
- Preparation of artificial soil: the artificial soil (air dry components, without calcium carbonate) was prepared in a batch of 20 kg by intensely mixing 2 kg sphagnum peat, 4 kg kaolinite clay, and 14 kg sand (dry weights) in a cement mixer. For each test vessel, 554 g of the prepared substrate (air dry, corresponding to 546 dry weight (dw)) was thoroughly mixed with 10 g sand/test item mixture, 3.0 g calcium carbonate, and 186 mL purified water in a laboratory mixer.
- Method of mixing into soil: 10 mL of the corresponding application solution was applied to 50 g sand in a mortar. The solvent was completely evaporated at room temperature under a hood for 30 min. The sand/test item mixture was mixed with a pestle and then mixed on a roller mixer for 30 min. The mixture was then divided into aliquots of 10 g (corrected for the amount of test item applied to 10 g of sand) and filled into vials. Immediately before the start of the test, aliquots of 10 g sand/test item mixture were incorporated into the four replicates of 546 g artificial soil (dw) per test concentration by intense mixing in a laboratory mixer. The moisture content was brought to 35% by adding 186 mL of purified water.
- Controls: the control substrate was prepared analogous to the test substrates. A 50 g sand portion was treated with 10 mL chloroform (but without test item) identical to the application of the test item in the treatment groups.

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: earthworm
- Source: laboratory stock held in temperature-controlled room
- Feeding: during breeding the test species were fed with suitable food (e.g. horse manure and potatoes).
- Age at test initiation: adults with a clitellum, approximately four to five months old
- Weight at test initiation: 338 - 382 mg

ACCLIMATION
- Acclimation period: 1 day prior to test start
- Acclimation conditions (same as test or not): acclimatized to the artificial soil and test temperature

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

14 d

Test temperature:

18.9 - 20.4 °C

pH:

6.2 (untreated soil, test start)
5.5 - 6.3 (test end)

Moisture:

35% (at test start)
33 - 34% (at test end)

Details on test conditions:

TEST SYSTEM
- Test container (material, size): 1 L cylindrical glass vessels (diameter 10 cm, height 14 cm), vessels were covered by glass lids to limit evaporation, air exchange was sufficient
- Amount of soil or substrate: 556 g artificial soil dw (corresponding to about 750 g wet weight)
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 1

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate):
% sand: 70%
% Sphagnum peat: 10% (shredded, sieved through 2 mm sieve)
% kaolinite clay: 20%
% calcium carbonate: 0.5%

OTHER TEST CONDITIONS
- Photoperiod: continuous illumination
- Light intensity: 490 - 550 Lux

EFFECT PARAMETERS MEASURED: surviving worms were counted and inspected for abnormal behavior or other symptoms of toxicity after 7 and 14 d. Weight of worms was checked prior to exposure (individually) and at the end of the test (worms washed with water and gently dried on filter paper).

OTHER PARAMETERS MEASURED:
- pH: pH was measured in the untreated artificial soil. At the end the pH was checked in all test vessels. Replicates of each concentration were mixed. An aliquot of about 10 g was shaken with 25 mL KCI solution (1 M) for 30 min and the pH was measured in this suspension.
- temperature: continuously monitored

TEST CONCENTRATIONS
- Range finding study: yes
- Test concentrations: not reported
- Results used to determine the conditions for the definitive study: yes, but not reported

Nominal and measured concentrations:

Nominal concentrations: control, 100, 178, 316, 562 and 1000 mg/kg dw

Reference substance (positive control):

yes

Remarks:

2-chloroacetamide

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

>= 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Details on results:

- Mortality at end of exposure period: no
- Mortality of control: no mortalities
- Mean body wet weight per worm: 362 mg at test start and 342 mg at test end
- Changes in body weight of live adults (% of initial weight) at end of exposure period: 6% reduction of the weight in the control and 5-9% reduction in the treatments (for more details see field "any other information on results incl. tables")
- Morphological abnormalities: no
- Behavioural abnormalities: no
- Other biological observations: no

Results with reference substance (positive control):

- Results with reference substance valid: not stated in the report

Reported statistics and error estimates:

The changes in mean body weight of the surviving worms were compared to the control, and were statistically evaluated by means of a multiple Dunnett-test. Compared to the control, the losses in mean body wet weight of the worms were not statistically significantly different up to and including the highest nominal test concentration of 1000 mg/kg dry soil (results of a Dunnett-test, one-sided, a = 0.05).

The mean body wet weight per worm in the control vessels was 362 mg at the beginning of the test and 342 mg at the end of the study. Thus, the mean body wet weight of the surviving worms in the control had, on average, decreased slightly by 6% due to starvation during the exposure period of 14 days. The average reduction of the mean wet weight of the surviving test organisms in the treated soil was in the same range (5 to 9%). Compared to the control, the losses in mean body wet weight of the worms were not statistically significantly different up to and including the highest nominal test concentration of 1000 mg/kg dry soil.

Validity criteria fulfilled:

yes

Conclusions:

The tested substance was not toxic to the earthworm Eisenia fetida up to and including the highest tested concentration of 1000 mg/kg dw within 14 d. Therefore the LC50 was > 1000 mg/kg dw and the NOEC >= 1000 mg/kg dw (both nominal).

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2-{[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and 2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-[2-(benzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-benzyl-2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-benzyl-N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride.

Molecular formula:

Not applicable

IUPAC Name:

Reaction mass of 2-{[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and 2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-[2-(benzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-benzyl-2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-benzyl-N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride.