Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2002-08-19 to 2003-03-24
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
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 (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: nominal 120 mg test item/L

- Sampling method: Duplicate samples from the prepared test media of the only
test concentration (after stirring for 3 days) and the control
were taken at the start of the test and at test end.

- Sample storage conditions before analysis: All samples were analysed directly after sampling

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION

- Method: Since the test item hydrolyses in water very quickly, in the present test the hydrolysis products of the test item were tested, according to the draft guidance document on aquatic toxicity testing of difficult substances. According to results of preliminary experiments the test item concentration decreased
during the test.period of 96 hours. Therefore, a limit test with nominal 120 mg test item/L was chosen to keep the mean measured concentration during the test period up to 100 mg/L ±20%.
The test item was mixed into test water at a concentration of 120 mg/L and was stirred for 24 hours. Thus, the main part of the test item at the start of the test were hydrolysis products.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM

- Common name: Rainbow trout

- Source: Forellenzuchtbetrieb Tautenhahn, 98646 Trostadt, Germany.

- Length at study initiation (length definition, mean, range and SD): 5.13 +/-0.39 cm

- Weight at study initiation (mean and range, SD): 1.26 +/-0.23 g

- Feeding during test: none

ACCLIMATION

- Acclimation period: 4 weeks

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

- Type and amount of food: not reported

- Feeding frequency: not reported

- Health during acclimation (any mortality observed): not reported

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
250 mg/l as CaCO3
Test temperature:
15-18ºC
pH:
7.7-7.9
Dissolved oxygen:
≥9.0 mg/l
Salinity:
not applicable
Nominal and measured concentrations:
Nominal loading rates: 0(Control) and 120 mg/l.
Measured concentrations: 96.2 mg test item/L (mean) representing 80% of the nominal
Details on test conditions:
TEST SYSTEM

- Test vessel: Aquaria

- Type: open

- Material, size, headspace, fill volume: 20 litre with 12 litre test medium volume

- Aeration: yes

- Renewal rate of test solution (frequency/flow rate): Static procedure

- No. of organisms per vessel: 7

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

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

TEST MEDIUM / WATER PARAMETERS

- Source/preparation of dilution water: In deionised water (conductivity < 5 uScm-l) analytical grade salts were added.

- Alkalinity: 0.8 mmol/l

- Ca/Mg ratio: 4:1

- Culture medium different from test medium: no

- Intervals of water quality measurement: Daily

OTHER TEST CONDITIONS

- Adjustment of pH: no

- Photoperiod: 16 h light, 8 h dark

- Light intensity: 410-440 lux

EFFECT PARAMETERS MEASURED: mortality after 2, 24, 48, 72 and 96 hours

TEST CONCENTRATIONS

- Spacing factor for test concentrations: limit test
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 96.2 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
> 96.2 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality of control: 0

Reported statistics and error estimates:
Not applicable

Any other information on results incl. tables

In the control and in the test medium of nominal 120 mg/L all fish survived until the end of the test and no signs of

intoxication were observed.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 96-hour NOEC (highest concentration tested without toxic effects after the exposure period of 96 hours), and the 96-hour LC 0 to Rainbow trout were detennined to be at least 96.2 mg/L. The NOEC and the LC 0 might even be higher than this concentration. The 96-hour LOEC (lowest concentration with toxic effects), the 96-hour LC 50 and the 96-hour LC 100 are clearly higher than 96.2 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 highest test concentration.
Executive summary:

A Limit test was performed to demonstrate whether the test item has a toxic effect on the test fish up to the concentration of nominal 120 mg test item/L. Since the test item hydrolyses in water very quickly, in the present test the hydrolysis products of the test item were tested.

In the control and in the test medium of nominal 120 mg/L all fish survived until the end of the test and no signs of intoxication were observed. At the start of the test just before introduction of the fish a concentration of 102.6 mg test item/L was determined

via DOC analysis. After 96 hours test duration 89.9 mg test item/L were determined. Thus, during the test period of 96 hours the fish were exposed to the hydrolysis products of a mean of 96.2 mg test item/L. Therefore, the reported results are related to the mean

measured concentration of 96.2 mg test item/L.

In this test the 96-hour LC 50 is clearly higher than 96.2 mg/L.