Reaction mass of [3-(trimethoxysilyl) propyl]urea, [3-(dimethoxyethoxysilyl) propyl]urea, [3-(methoxydiethoxysilyl) propyl]urea and [3-(triethoxysilyl) propyl]urea.

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:

1999-09-06 to 1999-12-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study. The study was conducted according to the appropriate OECD test guideline and in compliance with GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Control and 100 mg/l
- Sampling method: 10 ml samples were taken from the approximate centre of the test vessels at the start of the test and again after 48 and 96 hours.
- Sample storage conditions before analysis: Samples were analysed on the day of collection.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance was added directly to dilution water. A short period of magnetic stirring was applied to accelerate the dissolving of the substance. The resulting test medium was clear and colourless
- Controls: Dilution water

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Common carp
- Source: Zodiac, proefacc, 'De Haar Vissen', Wageningen, The Netherlands

- Length at study initiation (length definition, mean, range and SD): 2.4 cm (+/-0.13)
- Weight at study initiation (mean and range, SD): 0.36 g (+/-0.03)
- Method of breeding: F1 from a single parent pair
- Feeding during test: none

ACCLIMATION
- Acclimation period: at least 12 days from delivery
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: Trouvit
- Feeding frequency: Daily
- Health during acclimation (any mortality observed): <5% mortality in the 7 days prior to the start of the test.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

250 mg/l as CaCO3

Test temperature:

20.1 - 20.7ºC

pH:

7.7 - 8.1

Dissolved oxygen:

6.1 - 9.1 mg/l

Nominal and measured concentrations:

Nominal concentrations: 0 (Control) and 100 mg/l
Analysis of samples taken at the start of the test showed that the concentration based on component M2 was in agreement with nominal (93%). The concentrations of components M3 and M4 were 89 and 79% of nominal. After 48 hours the concentrations of components M2 and M3 had declined by 78 and 97% and component M4 could not be detected. At the end of the test the concentrations of components M2 and M3 were below 10% of their intitial concentrations and component M4 was not detectable.

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: glass, 8 litre with 5 litres of test medium
- Aeration: gently aerated on days 2 and 3
- Renewal rate of test solution: static
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.50 g/l

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO medium
- Culture medium different from test medium: no
- Intervals of water quality measurement: Daily

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light, 8 hours dark
- Light intensity: no data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality observed daily

TEST CONCENTRATIONS
- Spacing factor for test concentrations: limit test
- Justification for using less concentrations than requested by guideline: range finding test showing no effects at a concentration of 100 mg/l
- Range finding study
- Test concentrations: 100 mg/l
- Results used to determine the conditions for the definitive study: no effects

Reference substance (positive control):

yes

Remarks:

pentachlorophenol

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: 0

Results with reference substance (positive control):

- Results with reference substance valid? yes
- 96-h LC50: 0.06-0.15 mg/l

Reported statistics and error estimates:

Limit test and therefore no statistical analysis required

Sublethal observations / clinical signs:

Testing in a semi-static or flow-through system was considered to have little relevance due to the observed high rate of hydrolytical degradation of the three components. Instead, the assessment of the toxic potential of exposure of fish to A-1160 (methanol stripped) was considered to be more realistic in a static system which includes exposure to degradation products. Exposure to 100 mg/l in the final limit test induced no effect on survival. The swimming capacity of one fish was affected at the end of the test period. No mortality was observed in the control group. The 96h-LC₅₀for carp exposed to A-1160 (methanol stripped) was > 100 mg/l in a static system. Considering the high rate of hydrolytical degradation of the three major components of A-1160 (methanol stripped), exposure to possible degradation products did not induce additional effects on survival.

Validity criteria fulfilled:

yes

Conclusions:

A test medium prepared at a nominal concentration of 100 mg/l of ureudopropyltrialkoxysilane, mixed methoxy and ethoxy esters (CAS No. 119612-64-2) was not acutely toxic to Cyprinus carpio over 96 hours. The result is considered to be reliable. The test organisms were exposed primarily to the hydrolysis products of the substance.

Executive summary:

In a fish acute toxicity study in which carp were exposed to A-1160 (methanol stripped), no mortality occured at the limit concentration of 100 mg/L. The result is considered to be reliable. The test organisms were exposed primarily to the hydrolysis products of the substance.

Description of key information

LC50 (96h) > 100 mg/l (limit test), mortality, Cyprinus carpio (OECD 203), RL1

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

mg/L

Additional information

In an acute fish toxicity test according OECD 203 and GLP (NOTOX, 2000e), the 96h LC₅₀ for carp Cyprinus carpio exposed to

Ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters (116912-64-2) was >100 mg/l in a static system. Testing in a semi-static or flow-through system was considered to have little relevance due to the observed high rate of hydrolytical degradation of the three components. The data were predominantly generated on the parent compound, which was supposed to display the principal aquatic hazard and the assessment of the toxic potential of exposure of fish to Ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters was considered to be more realistic in a static system which includes exposure to degradation products. Therefore, the test organisms were exposed primarily to the hydrolysis products of the substance and exposure to the possible degradation products did not induce additional effects on survival. The result is considered to be reliable.