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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994-09-26 to 1994-09-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
Samples of test medium were taken at the start of the test and then after 24 hours in the old medium prior to renewal. Samples of freshly prepared medium were taken again when the tst medium was renewed after 24, 48 and 72 hours.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: A 1000 mg/l stock solution was prepared by mixing for 18 h followed by filtration. The other treatments were prepared by dilution of the stock solution.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM

- Common name: Zebrafish

- Source: West aquarium, Bad Lauterberg, Germany

- Length at study initiation (length definition, mean, range and SD): 3.0 cm +/-0.5 cm

- Feeding during test: none

ACCLIMATION

- Acclimation period: at least 14 days

- Acclimation conditions (same as test or not): yes

- Type and amount of food: TetraMin® at 1% of body weight

- Feeding frequency: Daily

- Health during acclimation (any mortality observed): The fish exhibit normal behaviour and are free from visible signs of disease at the start of the t
est. Mortalities in the 7 days pruior to the test were ≤5%
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
11.3 ºdH
Test temperature:
20 - 21ºC
pH:
7.7 - 9.6
Dissolved oxygen:
83 - 103% ASV
Nominal and measured concentrations:
Nominal concentrations: 0 (Control), 110, 190, 330, 580 and 1000 mg/l

Mean measured concentrations over test: 0 (Control), 116, 194, 344, 676 and 1130 mg/l

The results are interpreted with reference to mean measured concentrations.
Details on test conditions:
TEST SYSTEM

- Test vessel: 20 litre aquarium

- Type (delete if not applicable): open

- Aeration: Yes, continuous

- Renewal rate of test solution: daily

- No. of organisms per vessel: 10

- No. of vessels per concentration (replicates): 1

- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: Potable water from Gelsenwasser AG


OTHER TEST CONDITIONS

- Adjustment of pH: No

- Photoperiod: 16 hours light, 8 hours dark


EFFECT PARAMETERS MEASURED: Daily mortalities


TEST CONCENTRATIONS

- Spacing factor for test concentrations: 1.7
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
597 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
344 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Remarks:
but exposure is to hydrolysis products
Basis for effect:
mortality (fish)
Details on results:
- Mortality of control: 0
Reported statistics and error estimates:
The LC50 was determined by graphical interpolation. The NOEC was obtained directly from the raw data.
Sublethal observations / clinical signs:

Table 1. Test results

 

Nominal concentration (mg/l)

Mean measured concentration (mg/l)

Percentage mortality after 24 hours

Percentage mortality after 48 hours

Percentage mortality after 72 hours

Percentage mortality after 96 hours

0 (Control)

-

0

0

0

0

110

116

0

0

0

0

190

194

0

0

0

0

330

344

0

0

10

10

580

676

0

0

10

60

1000

1130

10

90

100

100

 

Validity criteria fulfilled:
yes
Conclusions:
A 96-h LC50 value of 597 mg/l and NOEC of 344 mg/l have been determined for the effects of the test substance on mortality of Brachydanio rerio. It is likely that the test organisms were exposed to the hydrolysis products of the substance.

Description of key information

LC50 (96 h): 597 mg/l mortality Danio rerio, (Huls 1994)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
597 mg/L

Additional information

A 96-hour LC50 value of 597 mg/l and NOEC of 344 mg/l have been determined for the effects of the test substance on mortality of Danio rerio. The results are expressed relative to geometric mean measured DOC 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).

The pH rose above 9 at the higher concentrations in this study. It is therefore not possible to tell whether the toxicity observed is due to the test substance or the pH. In addition, toxicity due to the amine increases with increasing pH. This is because the unionised form of the amine is the most toxic compared to the ionised form, and the fraction of the unionised form increases at higher pH.

Two other results are available indicating LC50 values in the range 200 to 213 ppm and the corresponding NOECs were in the range 56 to 100 mg/l. However the results of these studies are of unassignable reliability.