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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:
22 November 1999 - 26 November 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: control and 100 mg/L
- Sampling method: at t=0, 24, 48, 72 and 96 h
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: the test item was directly added to the test medium at a concentration of 100 mg/L. The solution was stirred on a magnetic stirrer for 2 hours before the start of the test.
- Controls: yes, medium without additives was used as a conrol.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebrafish
- Strain: Hamilton Buchanan
- Source: Bio International B.V. (The Netherlands)
- Age at study initiation (mean and range, SD): approx. 6 months old
- Length at delivery: 2.5 - 3.5 cm
- Delivery date: 1999-09-09
- Mortality: <2% mortality was observed during the period between delivery of the fish and the experimental start date.
- Acclimation conditions: synthetic freshwater according to ISO


FEEDING DURING TEST : not indicated
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
244.52 CaCO3/L (13.7 deutscher Härtegrad)
Test temperature:
Control and 100 mg/L: 21.1 - 21.9 °C throughout the test
pH:
Control and 100 mg/L: 7.6-7.9 throughout the test
Dissolved oxygen:
Control: 8.5 - 8.9 mg O2/L throughout the test
100 mg/L: 8.6 - 8.9 mg O2/L throughout the test
Nominal and measured concentrations:
Nominal concentration: 100 mg/L
Measured concentrations: 71, 68, 68, 68 and 68 mg/L at t=0, 24, 48, 72 and 96 h, respectively.
Details on test conditions:
TEST SYSTEM
- Test vessel: aquaria with a size of 300 x 135 x 200 mm, fill volume: 5 L
- Aeration: yes
- No. of organisms: 10 for the test solution and 10 for the control

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic freshwater according to ISO

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light/8 hours dark

EFFECT PARAMETERS MEASURED: mortality at t=2, 24, 48, 72 and 96 h

RANGE-FINDING STUDY: no range-finding study was conducted
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 68.6 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
other: Based on TOC measurements
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 102 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Remarks:
Calculated test item concentration from TOC measurements
Basis for effect:
mortality
Details on results:
- No mortality was observed in control and at the tested concentration of 100 mg/L
- No behavioural abnormalities were observed throughout the test for both control and test item concentration 100 mg/L
- The report indicated a 96h-LC0 of > 102.9 mg/L. However, based on the measured concentrations, an arithmetic mean exposure concentration of 68.6 mg/L was calculated by the applicant.
- Length at study end: 2.7 - 3.5 cm (control and 100 mg/L)
- Weight at study end, average of 10 fish: 0.364 g (control) and 0.325 g (100 mg/L)
Validity criteria fulfilled:
yes
Remarks:
See 'Overall Remarks'
Conclusions:
The 96h-LC50 of N,N-Bis-(hydroxyethyl)-m-toluidin was determined in a limit test according to EU method C.1 to exceed the tested concentration (i.e. >68.6 mg/L, mean measured exposure concentration based on TOC measurement).
Executive summary:

An acute fish toxicity test was performed according to EU method C.1. A concentration of 100 mg/L of the test item was directly applied to the test medium, the test solution was stirred for 2 hours on a magnetic stirrer and this solution was used as the test solution. Ten zebrafish were exposed to the limit concentration and a control for 96 hours. Observations for mortality were made at t=2, 24, 48, 72 and 96 h. Samples taken from the test solution and the control at t=0, 24, 48, 72 and 96 h were analysed by TOC analysis. Measured concentrations were 71 -68 mg/L. During the exposure period, no mortality occurred and no abnormalities were observed. Therefore, the LC50 was determined to exceed the limit concentration tested, i.e. >68.6 mg/L based on the mean measured exposure TOC concentration, corresponding to >102 mg/L test item.

Description of key information

In a limit study according to EU method C.1, the 96h-LC50 for freshwater fish was determined to be >102 mg/L based on mean measured concentration.

Key value for chemical safety assessment

LC50 for freshwater fish:
102 mg/L

Additional information

An acute fish toxicity test was performed according to EU method C.1. A concentration of 100 mg/L of the test item was directly applied to the test medium, the test solution was stirred for 2 hours on a magnetic stirrer and this solution was used as the test solution. Ten zebrafish were exposed to the limit concentration and a control for 96 hours. Observations for mortality were made at t=2, 24, 48, 72 and 96 h. Samples taken from the test solution and the control at t=0, 24, 48, 72 and 96 h were analysed by TOC analysis. Measured concentrations were 71 -68 mg/L. During the exposure period, no mortality occurred and no abnormalities were observed. Therefore, the LC50 was determined to exceed the limit concentration tested, i.e. >68.6 mg/L based on the mean measured exposure TOC concentration, corresponding to >102 mg/L test item.