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Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
CAS No.:388606-32-4
Batch No.: YH00701
Chemical name: 1-[(3-Aminopropyl)dimethylsilyl]-2,2dimethyl-1-aza-2-silacyc1opentan
Purpose: industrial chemical
Colour: colourless to yellowish
Physical state: liquid
Storage: at room temperature, protected from light and humidity
Safety precautions: Routine hygienic procedures were sufficient
to assure personnel health and safety

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
In order to measure DOC-content of the samples, an aliquot of the solutions was pressed through a filter (pore size 0.45 µm) to remove the non-dissolved part of the sample (test samples and also fortified samples). The filtered sample was transferred into a vial.

Test solutions

Vehicle:
no
Details on test solutions:
Stock Solution: 1.0623 g of potassium hydrogen phthalate that was previously dried at 120 °C for 1 hour and cooled in a silica gel desiccator were weighed, dissolved and filled up with HPLC-water to 500 mL to obtain TC standard solution. The carbon concentration of the solution was 1000 mg Carbon/L. Exact data were documented in the raw data.
1.7501 g of sodium hydrogen carbonate that was previously dried for 2 hours in a silica gel desiccator, and 2.2053 g of sodium carbonate previously dried for 1 hour at 180 °C were weighed, dissolved and filled up with HPLC-water to 500 mL to obtain IC standard solution. The carbon concentration of the solution was 1000 mg Carbon/L. Exact data were documented in the raw data.
Standard Solutions:Appropriate amounts of the stock solution were diluted with pure water to get TC and IC standard solutions with a concentration of 10 and 100 mg Carbon/L, respectively. Mixing appropriate volumes of this standard solutions with pure water (performed from the autosampler of the TOC) resulted in measurement of standard solutions in the range from 2 to 100 mg Carbon/L in case of TC and 1 to 25 mg Carbon/L in case of IC.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
Juvenile male and female Rainbow trouts (Oncorhynchus mykiss) were used;The mean body length of the fish in the test was 4.43 ± 0.18 cm (Mean ± SD), the mean body wet weight 0.65 ± 0.11 g (Mean ± SD).
The test fish were obtained from Forellenzuchtbetrieb Wagenhausen, 88348 Bad Saulgau, Germany.
In accordance with the test guidelines the fish were held in test water in the laboratories of the testing facility for at least 12 days prior to the start of the test without any medication. During holding until one day before test start the fish were fed with a commercial fish diet for Rainbow trout. During the last 12 days prior to the start of the test, 3 fish died (3 %) in the test fish batch but all other fish were healthy.
12 days before the start of the test the fish were acclimated to the test water and test temperature. The fish were held in a 16-Litre glass aquaria with 12 litre test medium.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
not reported

Test conditions

Hardness:
2.5 mmol/L (= 250.0 mg/L) as CaCO3
Test temperature:
15-16 °C
pH:
7.5 - 7.9
Dissolved oxygen:
9,2-12.1 mg/l
Salinity:
not reported
Nominal and measured concentrations:
100 mg/l nominal
Details on test conditions:
Pre-experiments were carried out to determine the solubility of the test item in test water. These pre-experiments to the solubility of the test item were not performed in compliance with GLPRegulations, but the raw data of these determinations will be archived under the project number of the present study. The test concentration was based on the results of a rangefinding test. However, according to the Commission Directive 92/69/EEC concentrations in excess of nominal 100 mg test item/L were not tested.
The test medium of the only test concentration of nominal 100 mg/L was prepared by dissolving 3-times 400 mg test item into 4000 mL test water using utrasonic treatment (2-times 15 min), respectively, by intense stirring for 24 hours. In addition to the stirring period, the pH of the test medium was adjusted from pH 8.6 to pH 7.9 using 0.1 M HCI.
Then, the test medium water filtered using a 0.45 µm cellulose nitrate filter. Subsequently, the filtrated test medium was used in the test. The test media was prepared just before introduction of the fish (= start of the test).
At the start of the test 7 fish were introduced into each aquarium in a random order.
The water temperature, pH-values and the dissolved oxygen concentrations were determined daily in the test media of all test concentrations and the control. The behaviour of the test item in all test concentrations was determined once every day during the test.
The test fish were observed after approximately 2, 24, 48, 72 and96 hours test duration for symptoms of intoxication and
mortality. Dead fish were removed at least once daily and discarded
Reference substance (positive control):
not specified

Results and discussion

Effect concentrationsopen allclose all
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:
LC0
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:
In the control and in the test medium of 100 mg test item/L, all fish survived until the end of the test.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The experiment is valid because no fish died in the control and oxygen saturation was always> 60 %
Executive summary:

The purpose of this study was to evaluate the acute toxicity of the hydrolysis products of test item to fish according to OECD Guideline 203. For this purpose, juvenile Rainbow trout were exposed in a static test to aqueous test media containing the hydrolysis products of the test item at 100 mg/L under defined conditions. The recorded effects were the mortality and symptoms of intoxication of the fish. Since the test item hydrolysis very quickly in the test medium, the hydrolysis products of the test item was measured. This limit-test was performed in order to demonstrate that the test item had no toxic effects on the test fish up to this test concentration. The 96-hour NOEC (highest concentration tested without toxic effects after the exposure period of 96 hours) and the 96-hour LC 0 of the test item to Rainbow trout were determined to be at least 100 mg/L. The NOEC and the LC 0 might even be higher than this concentration, but concentrations in excess of 100 mg/L have not been tested. The 96-hour LOEC, the 96-hour LC 50 and the 96-hour LC 100 were clearly higher than 100 mg/L. These values could not be quantified due to the absence of toxicity of the hydrolysis products of the test item up to the tested concentration.Since the test item undergoes hydrolysis with formation of different chemical species and since no specific analytical method is available, the analysis of test item concentrations in the test media was done by determination of DOC content as sum parameter. At the start of the test just before introduction of the fish 102 % of the nominal test concentration was found. After 96 hours test duration 101 % of the nominal value was determined. Thus, during the test period of 96 hours the fish were exposed to a mean of 101 % of nominal. Therefore, all reported results are related to nominal concentration of the test item.