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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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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:
1994
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:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 9300102
- Expiration date of the lot/batch: July 1998

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Solubility and stability of the test substance in the solvent/vehicle: <0.1 g/l in water
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 µg/ml
- Sample storage conditions before analysis: Deep frozen and protected from light
Vehicle:
not specified
Details on test solutions:
None
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Source: RCC Ltd.
- Age at study initiation (mean and range, SD):6 - 24 hours old
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
Not available
Hardness:
2.5 mmol/L (= 250 mg/L) as CaCO3
Test temperature:
20 °C
Nominal and measured concentrations:
According to the results of the pre-experiments to the solubility and the dosage of the test substance, a stock "solution" was prepared by suspending the test substance in the emulsifier Tween 80: 100 mg test substance were homogeneously mixed into 100 mg Tween 80, and then this mixture was filled up with test water to 1000 ml. Thus, this solution contained 100 mg/L test substance and 100 mg/L Tween 80. The test medium was intensively mixed.
The only nominal concentration tested was 100 mg test substance/L with the auxiliary emulsifier concentration of 100 mg Tween 80 per litre. Additionally, a control (test water without any additions) and a solvent control (100 mg Tween 80 per litre test water) were tested.
Details on test conditions:
TEST MEDIUM / WATER PARAMETERS
- Alkalinity:0.8 mmol/L
- Ca/mg ratio:4 : 1

OTHER TEST CONDITIONS
- Photoperiod:16 hours per day, approximately 200 - 600 Lux
Reference substance (positive control):
not specified
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
The 48-hour NOEC (highest tested concentration without toxic effects after the exposure period of 48 hours), respectively the 48-hour EC 0 of FAT 36'034/D to Daphnia magna was determined to be at least nominal 100 mg test substance/L (mean measured concentration: 70 mg/L). Since concentrations in excess of nominal 100 mg test substance/L have not been tested, the NOEC might even be higher than this concentration. The 48-hour EC 50 of the test substance could not be determined due to the low water solubility and low toxicity of the test substance.
Validity criteria fulfilled:
yes
Conclusions:
The 48-hour NOEC (highest tested concentration without toxic effects after the exposure period of 48 hours), respectively the 48-hour EC 0 of FAT 36'034/D to Daphnia magna was determined to be at least nominal 100 mg test substance/L (mean measured concentration: 70 mg/L)
Executive summary:

The acute toxicity of the test substance FAT 36034/D to Daphnia magna was determined in a 48-hour static test according to the Commission Directive 92/69/EEC, Annex Part C.2, dated December 29, 1992 and the OECD Guideline for Testing of Chemicals, Section 2, No. 202, Part 1, adopted April 04, 1984. The test was performed in compliance with Good Laboratory Practice Regulations.

A limit test was performed in accordance with the EEC test guideline to demonstrate that the test substance has no toxic effect on the test animals up to the concentration of nominal 100 mg test substance/L. This was the maximum concentration far above the water solubility of the test substance which could be brought homogeneously into test water by means of dosing an auxiliary emulsifier stock solution (Tween 80, 100 mg per litre test medium) without observable separation of the test substance in the freshly prepared test solution. The analytically determined test substance concentrations in the test media decreased from 85.0 % of the nominal value at the start of the test to 55.0 % at the end of the test, obviously caused by the low water solubility of the test substance.

The reported biological results are related to the nominal test concentration as well as to the mean measured test substance concentration of 70 mg/L (A 70 % of the nominal concentration).

The 48-hour NOEC (highest tested concentration without toxic effects after the exposure period of 48 hours), respectively the 48-hour EC 0 of FAT 36034/D to Daphnia magna was determined to be at least nominal 100 mg test substance/L (mean measured concentration: 70 mg/L). Since concentrations in excess of nominal 100 mg test substance/L have not been tested, the NOEC might even be higher than this concentration.

The 48-hour EC 50 of the test substance could not be determined due to the low water solubility and low toxicity of the test substance.

Description of key information

The 48-hour NOEC (highest tested concentration without toxic effects after the exposure period of 48 hours), respectively the 48-hour EC 0 of FAT 36'034/D to Daphnia magna was determined to be at least nominal 100 mg test substance/L (mean measured concentration: 70 mg/L). Since concentrations in excess of nominal 100 mg test substance/L have not been tested, the NOEC might even be higher than this concentration.

Key value for chemical safety assessment

Additional information

A study was performed to determine the acute toxicity of FAT 36034/D to Daphnia magna in a 48-hour static test according to the Commission Directive 92/69/EEC, Annex Part C.2, dated December 29, 1992 and the OECD Guideline for Testing of Chemicals, Section 2, No. 202, Part 1, adopted April 04, 1984. The test was performed in compliance with Good Laboratory Practice Regulations.

A limit test was performed in accordance with the EEC test guideline to demonstrate that the test substance has no toxic effect on the test animals up to the concentration of nominal 100 mg test substance/L. This was the maximum concentration far above the water solubility of the test substance which could be brought homogeneously into test water by means of dosing an auxiliary emulsifier stock solution (Tween 80, 100 mg per litre test medium) without observable separation of the test substance in the freshly prepared test solution. The analytically determined test substance concentrations in the test media decreased from 85.0 % of the nominal value at the start of the test to 55.0 % at the end of the test, obviously caused by the low water solubility of the test substance.

The reported biological results are related to the nominal test concentration as well as to the mean measured test substance concentration of 70 mg/L (a 70 % of the nominal concentration was tested).

The 48-hour NOEC (highest tested concentration without toxic effects after the exposure period of 48 hours), respectively the 48-hour EC 0 of FAT 36034/D to Daphnia magna was determined to be at least nominal 100 mg test substance/L (mean measured concentration: 70 mg/L). Since concentrations in excess of nominal 100 mg test substance/L have not been tested, the NOEC might even be higher than this concentration. The 48-hour EC 50 of the test substance could not be determined due to the low water solubility and low toxicity of the test substance.