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Short-term toxicity to fish

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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:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to
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
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
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

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 ureidopropyltrialkoxysilane, 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.

Endpoint:
short-term toxicity to fish
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:
read-across source
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Description of key information

LC50 (96h) > 100 mg/L (nominal, OECD 203) based on read across from CAS 116912-64-2

Key value for chemical safety assessment

Additional information

No reliable data on the toxicity of [3-(trimethoxysilyl)propyl]urea (CAS 23843-64-3) to fish are available. Therefore, good quality data from the analogous substance, ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters (CAS 116912-64-2), have been read across. 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 a study (2000) according to the guideline OECD 203 and GLP standards, the short term toxicity of the read across substance ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters (CAS 116912-64-2) to fish was tested. Cyprinus carpio as the test organism was exposed under static conditions for 96 h to the single nominal test item concentration of 100 mg/L. The substance was tested in a static system due to its high rate of hydrolytical degradation. With a static system an exposure to both the parent and the hydrolysis products was achieved. The substance was analytically monitored at the time points 0, 48 and 96 h. No toxic effects were observed in the study resulting in an LC50 (96 h) of > 100 mg/L (nominal).