N-(3-(trimethoxysilyl)propyl)ethylenediamine

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Guideline study with acceptable restrictions. The study was not conducted under GLP and exposure concentrations were not measured.

Qualifier:

no guideline followed

Principles of method if other than guideline:

The study consisted of triplicate runs of a 21-day test. Each run consisted of duplicates for control and all test concentrations. Each duplicate started wlth five 24-48 hour old Daphnia magna. Concentrations of 0.01, 0.03, 0. 1 , 0.3 and 1.0 ppm were selected for the test. First generation Daphnia mortality was recorded throughout the test and their reproductive functlon was assessed by counting the total number of young produced through day 21.

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

The substance was added directly to 600 mL beakers, each containing 400 ml of hard reconstituted fresh water.

Test organisms (species):

Daphnia magna

Details on test organisms:

- Source: The test daphnlds were from a laboratory culturing. The origlnal colony of Daphnia magna was obtained through the Dow Chemical Company, which obtained thelr colony from the Duluth Laboratory of the Unlted States Envlronmental Protection Agency.

- Culture medium: The colonies were maintained under static conditions in reconstltuted hard water (EPA 660/3-75-009) made-up from glass-distilled water. Before culture inoculation, the reconstituted water was aerated for 2-4 hours.

- Culture conditions: The colonies were maintained in five-gallon glass aquaria under approximately 1000 foot-candle llluminatlon (18/6 hour light/dark) in an environmental chamber designed to maintain 22+/-1°C.

- Feeding: The food for the Daphnia. magna is prepared each week by blending 0.25 g alfalfa meal, 4.0 g trout chow and 400 mL dlstilled water. Thls solution is allowed to settle and the supernatant is used as food.

,- Test organisms; A number of egg-bearing daphnia were isolated prior to each test for a period of 24-48 hours. Five 24-48 hour old
Daphnia magna produced in the period prior to the test were introduced into each test concentration along with the untreated control group.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Hardness:

No data

Test temperature:

22+/-1°C

pH:

No data

Dissolved oxygen:

No data

Salinity:

Not applicable

Nominal and measured concentrations:

Nominal concentrations: 0 (Control), 0.01, 0.03, 0.1, 0.3 and 1.0 ppm

Details on test conditions:

Five 24-48 hour old Daphnia magna were introduced into each test concentration along with the untreated control group.

The test consisted of tripllcate runs of the 21-day test. Each run consisted of duplicates for control and all test concentrations, each duplicate started wlth five 24-48 hour old Daphnia magna.

The daphnia were fed 0.25 ml of daphnia food each day except weekends throughout the 21-day study.

0bservations were made each day for each of the test concentrations and control groups for mortalities and young produced.

The daphnia were transferred to fresh test and control vessels weekly throughout the 2l-day study.

Survival of the first generation daphnids was recorded throughout the test. The reproductive functlon of the flrst generation daphnia was assessed by counting the total number of young produced through day 21.

Comparlson between test vessels and controls were made for first generation survival, fecundity, and survlval of the second generatlons. General
observation of behavior and abnormalities were also made.

Reference substance (positive control):

no

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 1 other: ppm

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: reproduction and mortality

Details on results:

Control parental daphnia survival after 21 days: 96.7%

There were no statistically significant differences in survival and reproductive output between the Controls and any of the treatments.

Reported statistics and error estimates:

The levels of effect on survival and reproduction were insufficient to determine ECx values.

Differences in reproductive output were assessed by t test with p<0.05

Table 1. Test results

 

Nominal concentration (ppm)	Survival of parental daphnia (%)	Total young produced +/-Stand Dev	Young produced per female +/-Stand Dev	Initial survival of offspring (%)
0 (Control)	96.7	52.7+/-25.3	10.72+/-4.81	99.7
0.01	100	47.7+/-23.3	9.53+/-4.66	98.3
0.03	100	46.0+/-28.1	9.20+/-5.63	100
0.1	100	52.2+/-25.3	10.43+/-5.07	99.7
0.3	100	44.2+/-29.0	8.83+/-5.81	99.6
1.0	90	33.5+/-17.1	6.93+/-3.19	99.5

 

Validity criteria fulfilled:

yes

Conclusions:

A 21-day NOEC of ≥1 ppm has been determined for the effects of the test substance on survival and reproduction of Daphnia magna. The results are expressed relative to nominal concentrations of the test substance. However the substance is subject to rapid hydrolysis and under the test conditions it is therefore likely that exposure will have been to its hydrolysis products (methanol and N-(3-(trihydroxysilyl)propyl)ethylenediamine).

Description of key information

21-day NOEC ≥1ppm (≥1 mg/l, nominal) (no guideline followed), Daphnia magna. The NOEC is equivalent to ≥0.81 ppm (≥0.81 mg/l) when expressed in terms of the silanol hydrolysis product, N-(3-(trihydroxysilyl)propyl)ethylenediamine.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

NOEC

Effect concentration:

>= 0.81 mg/L

Additional information

A 21-day NOEC value of ≥1ppm (≥1 mg/l,nominal) has been determined for the effects of the registration substance, N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS 1760-24-3, EC 217-164-6), on survival and reproduction of Daphnia magna (Dow Corning, 1980). The results are expressed relative to nominal concentrations of the test substance. The test was not conducted according to a standardised test guideline, or in compliance with GLP, however the test was well documented, and the method used was comparable to OECD TG 211. In view of the test media preparation method and exposure regime, it is likely that the test organisms were exposed predominantly to the hydrolysis products of the tested substance (methanol and N-(3-(trihydroxysilyl)propyl)ethylenediamine).

The results may be expressed in terms of concentration of the silanol hydrolysis product, N-(3-(trihydroxysilyl)propyl)ethylenediamine, by applying a molecular weight correction: (MW of silanol = 180.28 / MW of parent = 222.36) * ≥1 = ≥0.81 mg/l.