Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study initiation date - 16 August 1990; Experiment start date - 12 September 1990; Experiment end date - 14 September 1990; Study completion date - 25 February 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EEC Directive 84/449, L 251, Part C 2., pp. 155 - 159: "Acute Toxicity for Daphnia".
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: U.S. Environmental Protection Agency, Pesticide Assessment Guidelines, Subdivision E. Hazard Evaluation: Wildlife and Aquatic Organisms : Acute Toxicity Test for Freshwater Invertebrates, EPA- 540/9-85-005, June, 1985
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Name: FAT 20004/H
Batch no: EN 317
Expiration: June 1995.
Analytical monitoring:
yes
Details on sampling:
Analytical measurements of the test article were performed in the stock solution and in test media of the nominal concentrations 0.65, 2.5 and 10.0 mg/l at the start and the end of the test by sampling a part of the stock solution and freshly prepared test media and media, which were incubated during test duration under the same conditions as in the test itself.
Vehicle:
no
Details on test solutions:
A stock solution was prepared by dissolving the test article in Dimethylformamide p.A. (100 g/l). The stock solution was diluted in a series of sequential dilutions with the solvent to add the same volumes of solvent (0.1 ml/l) to each test solution.
Test organisms (species):
Daphnia magna
Details on test organisms:
The study was performed with young Daphnia magna Straus (6-24 hours old), bred in the laboratories of RCC under standardized conditions. The parental Daphnia were maintained in the same reconstituted water as in the test for at least 24 hours prior to the start of the test.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
2.5 mmol/l as CaC03
Test temperature:
19.5 - 19.8 °C (measured at the start and the end of the test)
pH:
8.0 - 8.3
Dissolved oxygen:
>9.8 mg/L
Nominal and measured concentrations:
The nominal concentrations tested were 0.65, 1.25, 2.5, 5.0 and 10.0 mg test article/l, a solvent control group and a control without any additions.
Details on test conditions:
Test procedure: static
Duration: 48 hours
Temperature: 19.5-19.8 °C
Oxygen concentration: >9.8 mg/L
pH-value: 8.0 - 8.3
Exposure to light: 16 hours/day, about 200 - 600 Lux
Reference substance (positive control):
not specified
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 10 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
After 24 and 48 hours of exposure no immobilisation was observed in the control and at 100 mg/L.
Results with reference substance (positive control):
EC50(24 h) between 1.0 and 2.0 mg/L
Reference substance: potassium dichromate
Reported statistics and error estimates:
The 24 h and 48 h EC50 are the estimated concentrations where 50 % of the daphnids were immobilised after 24 and 48 hours, respectively.
No statistical evaluation was indicated since no immobilisation occurred at the limit test concentration of 100 mg/L.
The NOEC was established based on the highest concentration at which the immobilisation is not higher than the allowed control immobilisation (≥10 % immobilisation).

Influence of FAT 20004/H on immobilization of Daphnia magna:

Nominal Conc. Of test material (mg/l) No. of Daphnia tested No. of immobilixzed Daphnia after: % of immobilized Daphnia after:
24 h 48 h 24 h 48 h
Control 20 0 0 0 0
Solvent control 20 0 0 0 0
0.65 20 0 0 0 0
1.25 20 0 0 0 0
2.5 20 0 0 0 0
5 20 0 0 0 0
10 20 1 1 5 5
Validity criteria fulfilled:
not specified
Conclusions:
The NOEC (highest concentration tested without toxic effect) of FAT20004/H was determined to be 10.0 mg test article/L. The 48 hour EC 50 could not be specified.
Executive summary:

The acute toxicity of FAT 20004/H to Daphnia magna was determined in a 48-hour static test according to the OECD Guideline for Testing of Chemicals, Section 2, No. 202, adopted 4 April 84, the EEC Directive 84/449, L 251, Part C 2, and to the Guideline of the U.S. Environmental Protection Agency, Pesticide. Assessment Guidelines, Subdivision E, EPA-540/9-85-005, June, 1985. The test was performed in compliance with the Good Laboratory Practice Regulations. The nominal concentrations tested were 0.65, 1.25, 2.5, 5.0 and 10.0 mg test article, a solvent control group and a control without any additions. In the control, the solvent control group and in the test concentrations of nominal 0.65 to 5.0 mg test article, no immobility or mortality was observed during test duration. In the highest concentration tested of 10.0 mg test article (as the highest concentration as possible to dissolve in dimethylformamid at room temperature and an addition of 100 ul solvent stock solution to 1 litre test medium) the immobility rate was 5 % after 24 and 48 hours test duration. Because of this low immobilization rate, the NOEC (highest concentration tested without toxic effect) of FAT 20004/H was determined to be 10.0 mg test article. The 48 hour EC 50 could not be specified.

Description of key information

The NOEC (highest concentration tested without toxic effect) of FAT20004/H was determined to be 10.0 mg test article/l. The 48 hour EC50 could not be specified. Hence LC50 is concluded to be greater than 100 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information

The acute toxicity of FAT 20004/H to Daphnia magna was determined in a 48-hour static test according to the OECD Guideline for Testing of Chemicals, Section 2, No. 202, adopted 4 April 84, the EEC Directive 84/449, L 251, Part C 2, and to the Guideline of the U.S. Environmental Protection Agency, Pesticide. Assessment Guidelines, Subdivision E, EPA-540/9-85-005, June, 1985. The test was performed in compliance with the Good Laboratory Practice Regulations. The nominal concentrations tested were 0.65, 1.25, 2.5, 5.0 and 10.0 mg test article/l, a solvent control group and a control without any additions. In the control, the solvent control group and in the test concentrations of nominal 0.65 to 5.0 mg test article, no immobility or mortality was observed during test duration. In the highest concentration tested of 10.0 mg test article (as the highest concentration as possible to dissolve in dimethylformamide at room temperature and an addition of 100 µl solvent stock solution to 1 litre test medium) the immobility rate was 5 % after 24 and 48 hours test duration. Because of this low immobilization rate, the NOEC (highest concentration tested without toxic effect) of FAT 20004/H was determined to be 10.0 mg test article. The 48-hour EC 50 could not be specified.