N-methyl-3-(trimethoxysilyl)propylamine

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:

12 - 17 June 2016

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:

2008

GLP compliance:

yes (incl. QA statement)

Remarks:

Staatlisches Gewerbeaufsichtsamt Hildesheim, Germany

Analytical monitoring:

yes

Details on sampling:

- Concentrations and sampling method: the concentration of the test item was verified in the test vessel media, the pH control media and the control media when freshly prepared, after 0 and 72 h and from the corresponding 24 h aged test media after 24 and 96 h. Only the hydrolysis product of the test item was analytical verified, since the test substance hydrolysis very rapidly.
- Sample storage conditions before analysis: all samples were stored at room temperature until sample preparation and in an autosampler until start of analysis, if necessary

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 5 L stock solution of 100 mg/L were prepared with dilution water and stirred for 24 h (1100 rpm, room temperature: 23.0 °C ± 0.2 °C). The total volume of 5 L was separated into two individual replicates (2.5 L). For one replicate the pH value was adjusted to 8.00 ± 0.20 with HCI. This replicate served as pH control compared to the non-adjusted replicate.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish
- Source: Umweltbundesamt, Berlin, Germany
- Holding: at 23 ± 2 °C and diffuse light (7 - 750 lux, natural photoperiod). The water (tap water, filtered on activated charcoal and aerated for at least 24 h ) was changed at least once per week. The dissolved oxygen concentration was > 80% of the air saturation value. Zebrafish with at least 12 d of acclimatisation and mortality < 5% within these days prior to the start of exposure were used for testing. No disease treatments were administered throughout holding and testing. Fish were fed (Sera Vipan, SERA GMBH) 3 times per week (4% of their body weight per feeding day). The test fish were not fed 24 h before test start.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

57 mg/L CaCO3

Test temperature:

22.7 - 23.5°C

pH:

Control: 7.01 - 7.52
100 mg/L test item: 7.41 - 9.85
100 mg/L test item with pH adjustment: 7.42 - 8.14

Dissolved oxygen:

79 - 100%

Nominal and measured concentrations:

0 (control), 100 mg/L (nominal), 100 mg/L (nominal with pH adjustment)

Details on test conditions:

TEST SYSTEM
- Test vessel: 3 L glass aquaria (11.5/13/20 cm)
- Fill volume: 2.5 L
- Aeration: no
- Renewal rate of test solution: daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per concentration with pH adjustment (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.404 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH, temperature and oxygen saturation were measured in all test vessels every 24 h and after renewal of the test media. Total hardness was determined at the start of the exposure in the control. The water temperature was recorded once per hour with a data logger.

OTHER TEST CONDITIONS
- Adjustment of pH: yes, in one replicate
- Photoperiod: 16 h light/8 h dark
- Light intensity: 7 - 750 Lux

EFFECT PARAMETERS MEASURED : observations for death, abnormalities (e.g. loss of equilibrium, swimming behaviour, respiratory function, pigmentation) were made after 2, 24, 48, 72 h. Size and weight determinations of the control fish were made at the end of exposure

Reference substance (positive control):

no

Key result

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
- Observations on body length and weight: average body weight at the test end: 0.144 g/L test solution, average body length at the test end: 2.50 (2.4 to 2.6) cm
- Mortality of control: no
- Other adverse effects control: no

Sublethal observations / clinical signs:

- No sublethal effects were observed in any test vessel and observation time point (2, 24, 48, 72, 96 h).

- No mortalities occured in any of the test vessels after 2, 24, 48, 72, 96 h.

- The measured concentrations of the hydrolysis product of the test item were between 116 and 120 % in the fresh media and between 113 to 117 % of nominal values in the old media. Therefore, all effect values were based on the nominal concentration of the test item.

Validity criteria fulfilled:

yes

Conclusions:

In the limit test with a nominal concentration of 100 mg test item/L, no toxic effects on Danio rerio were observed.

Description of key information

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

Additional information

A reliable study is available for the toxicity of N-methyl-3-(trimethoxysilyl)propylamine (CAS 3069-25-8) to fish according to OECD 203 and GLP standards (Noack Laboratories, 2017a). The test organism, Danio rerio, was exposed in a semi-static test regime to a single test item concentration of 100 mg/L (nominal). An additional vessel with the same test item concentration was prepared, in which the pH was adjusted to 8 ± 0.2. Analytical monitoring was performed by LC-MS. The silanol hydrolysis product of the test substance was quantified since the substance hydrolyses very rapidly.

Recoveries were between 116 and 120% in the fresh media and between 113 to 117 % of nominal values in the old media. 

The test showed no lethal effects on fish resulting in an LC50 (96 h) > 100 mg/L (nominal).