N-[3-(trimethoxysilyl)propyl]aniline

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:

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

Adequacy of study:

key study

Study period:

May 28 to July 06 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 and nominal 100 mg/L

- Sampling method: Duplicate samples were taken from the freshly prepared test medium of the single test concentration and the control just before the start of the test. Additional duplicate samples were taken from the test medium and control at the test end (48 hours) of the test. For this, the contents of the two test test beakers of the single test concentration and the control were combined. The silicon concentrations were measured in the duplicate test medium samples from the start and the end of the test.

- Sample storage conditions before analysis: All samples were deep frozen (at about -20 °C) immediately after sampling.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test medium prepared by dissolving 32 mg test item completely in 300 ml test water by intense stirring for 5 minutes at room temperature.
The pH of the test medium was 9.5 and was adjusted to pH 8.0 with a concentrated hydrochloric acid solution and sodium hydrochloride solution. The test medium was prepared just before introduction of the daphnids.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna

- Strain: Straus

- Source: Originally from the University of Sheffield/UK in 1992 defined from supplier as clone 5

- Age at study initiation (mean and range, SD): 6-24 hours old

- Feeding during test: None

ACCLIMATION
- Acclimation period: No

- Acclimation conditions (same as test or not): Conditions prior to test are same as test conditions

- Type and amount of food: Not stated
- Feeding frequency: Not stated
- Health during acclimation (any mortality observed): Not stated

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

2.5 mmol/L test water

Test temperature:

21-22 °C

pH:

7.8 - 8

Dissolved oxygen:

8.0 - 8.3 mg/L

Nominal and measured concentrations:

Nominal: 0 and 100 mg/L
Measured: 126 and 115 mg/L at start and end of test respectively

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 ml glass beaker

- Type (delete if not applicable): open / closed: Covered with glass plates

- Material, size, fill volume: Glass, 100 ml, 60 ml

- Aeration: None

- Type of flow-through (e.g. peristaltic or proportional diluter): Static

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

- No. of organisms per vessel: 10

- No. of vessels per concentration (replicates): 2

- No. of vessels per control (replicates): 2

- Biomass loading rate: Lower than one daphnia per 2 ml of test solution

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

- Alkalinity: 0.8 mmol/L

- Ca/mg ratio: 4:1


- Culture medium different from test medium: No

- Intervals of water quality measurement: 0 and 48 hours

OTHER TEST CONDITIONS
- Adjustment of pH: Yes

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

- Light intensity: 200 - 1200 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality or Immobility at 24 and 48 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:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Mortality of control: No mortality
- Effect concentrations exceeding solubility of substance in test medium: No
- The analytically determined test item concentration in the test medium (based on analysis of Si) at the start and the end of the test was 126 and 115% of the nominal values, respectively. Therefore the results are expressed in nominal values

Table 1: Influence of Y-15167 on the mobility of Daphnia magna

Nominal test item concentration (mg/L)	Number of Daphnids tested	Immobilized Daphnids after 24 hours		Immobilized Daphnids after 24 hours
		No.	%	No.	%
Control	20	0	0	0	0
100	20	0	0	0	0

Table 2: Dissolved oxygen concentrations, pH values and temperature in the test medium and the control

Nominal test item concentration (mg/L)	Start (0 hours)			End (48 hours)
	pH	Oxygen (mg/L)	Temperature (°C)	pH	Oxygen (mg/L)	Temperature (°C)
Control	7.8	8.3	22	7.8	8.2	21
100	9.5*/8.0	8.3	22	7.8	8.0	21

* before/after pH adjustment

Validity criteria fulfilled:

yes

Remarks:

Immobilisation in controls and maintenance of steady test conditions (including test substance concentration >80% of nominal) were all fulfilled.

Conclusions:

A 48-h EC50 >100 mg/l in Daphnia magna was determined in a guideline test and in accordance with GLP. The result is taken to be reliable.

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

Reason / purpose for cross-reference:

read-across source

GLP compliance:

yes

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: RCC Ltd, 2001

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 25 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Smithers Viscient, 2013

Validity criteria fulfilled:

yes

Conclusions:

Based on reliable and appropriate read across data no toxicity to aquatic invertebrates is expected (48-h EC50 >100 mg/l in Daphnia magna) from the target substance.

Description of key information

EC50 (48 h) > 100 mg/L (nominal, OECD 202) based on read across from CAS 227085-51-0

Additional information

No studies on the short-term toxicity to invertebrates are available for N-[3-(trimethoxysilyl)propyl]aniline (CAS 3068-76-6). Therefore, this endpoint is covered by read-across to the analogous substances N-ethyl-3-trimethoxysilyl-2-methylpropanamine (CAS 227085-51-0) and N-[3-(trimethoxysilyl)propyl]butylamine (CAS 31024-56-3). Details on read across justifications 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.

In the key study a limit test with 100 mg/L N-ethyl-3-trimethoxysilyl-2-methylpropanamine (CAS 227085-51-0) and Daphnia magna as the test organism was performed in a static system according to OECD guidance 202 and GLP standards. Samples for analysis of the actual exposure concentrations were taken at the start and at the end of the limit test.The recovery of the test item was found to range between 115 and 126% of the nominal values.No toxic effects were observed during the 48-hour test period. Hence, the EC50 (48 h) was > 100 mg/L. As the substance hydrolyses rapidly, it is very likely that the test organisms were mainly exposed to the hydrolysis products retained in the test media.

In the supporting study the toxicity of the read across substance N-[3-(trimethoxysilyl)propyl]butylamine (CAS 31024-56-3) to aquatic invertebrates was tested according to OECD 202 and GLP standards. Daphnia magna as the test organism was exposed for 48 h in a static test regime to the nominal test substance concentrations of 0 (control), 1.6, 3.1, 6.3, 13 and 25 mg/L. 0.1 ml/L tetrahydrofuran was used as a vehicle. The corresponding mean measured concentration of the substance in the treated test medium over the course of the test could not be determined. However, no toxic effects on Daphnia magna was identified up to the highest tested concentration resulting in an EC50 (48 h) > 25 mg/L (nominal).

No toxic effects to aquatic invertebrates is expected by the target substance N-[3-(trimethoxysilyl)propyl]aniline (CAS 3068-76-6) based on the results of the read across substances N-ethyl-3-trimethoxysilyl-2-methylpropanamine (CAS 227085-51-0) and N-[3-(trimethoxysilyl)propyl]butylamine (CAS 31024-56-3).