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Short-term toxicity to aquatic invertebrates

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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:
other: GLP guideline study
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Principles of method if other than guideline:
None
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
None
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 100 mg/l of FAT 36038/F
- Sampling method: The quantification of FAT 36038/F was performed by measuring the UV-signal of samples at 252 nm after HPLC separation.
- Sample storage conditions before analysis: The samples were stored deep frozen and protected from light until analysis was performed.
Vehicle:
yes
Details on test solutions:
According to the results of pre-experiments to the solubility of the test substance, FAT 36038/F could be dissolved respectively suspended in water at a concentration of nominal 100 mg/1. However, after 24 hours a great part of the test substance had precipitated and settled at the bottom.
Therefore, the emulsifier Tween 80 was used for the preparation of a concentrated homogeneous stock suspension. This stock suspension could be mixed homogeneously into water up to a test concentration of nominal 100 mg test substance/1 and a lower part of the test substance precipitated and settled at the bottom than in the pre-experiment without emulgator.
These pre-experiments to the solubility and the dosage of the test substance were not performed in compliance with GLP-Regulations.
Test organisms (species):
Daphnia magna
Details on test organisms:
The study was performed with young Daphnia (at the start of the test 6 - 24 hours old) of a clone of the species Daphnia magna Straus. The clone is bred in the laboratories of RCC under standardized conditions. The cultivation of the parental Daphnia was performed in reconstituted water of a similar quality regarding to pH, components of the main ions and total hardness as the test water used in the test.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
None
Hardness:
2.5 mmol/l (=250 mg/l) as CaCO3
Test temperature:
20.6-20.9 °C during the test period
pH:
7.6-7.7 (start of experiment)
8.0 (end of experiment)
Dissolved oxygen:
8.6-8.7 mg/L (start of experiment)
9.2-9.5 (end of experiment)
Salinity:
Not applicable
Nominal and measured concentrations:
- nominal concentration: 100 mg/l
- measured concentrations: 84.2 mg/l (84.2 % of the nominal concentration)
Details on test conditions:
In the only test concentration (nominal 100 mg/L), in the control and in the solvent control 20 Daphnia were tested, divided into four groups of five animals, each group in 200 ml test medium in a glass-beaker (250 ml). The Daphnia were not fed during the test period. The test was performed in an air-conditioned room.
- Light: 16 hours per day, approximately 200 - 600 Lux.
The Daphnia have not been fed, and the test media have not been airated during the test period.
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks on result:
other: The 48-hour EC 50 of the test substance could not be determined due to the low toxicity of the test substance.
Details on results:
Analytical results:
The analytically determined test substance concentrations in the test media decreased from 89,1 % of the nominal value at the start of the test to 79.2 % at the end of the test. This decrease was obviously caused by the low solubility of the test substance in the test water, since in the biological test it was observed that after 24 and 48 hours test period a small part of the test substance had precipitated and was lying at the bottom of the test beakers. The mean value of the measured concentrations in the samples from the start and the end of the test amounted to 84.2 % of the nominal concentration of 100 mg/1. The reported biological results are related to the nominal test concentration as well to the mean measured test substance concentration of 84.2 mg/l

Biological results:
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/. Concentrations in excess of nominal 100 mg test substance/l have not been tested.

In the control, the solvent control and in the only test concentration of nominal 100 mg test substance/l no immobilized or dead test animal was observed during the test period of 48 hours.

Therefore, 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 36'038/F to Daphnia magna was determined to be at least nominal 100 mg test substance/l (mean measured concentration: 84.2 mg/l). Since concentrations in excess of nominal 100 mg test substance/1 have not been tested, the NOEC might even be higher than this concentra tion. The 48-hour EC 50 of the test substance could not be determined due to the low toxicity of the test substance.

During the test period the dissolved oxygen concentrations in the test media were always 8.6 mg/l or higher, the pH-values in the range from pH 7.6 to 8.0.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
None

Dossilved oxygen concentrations (mg/l) and pH-values in the media at the start and end of the test.

      Start (0 hour)     End (48 hours)
 Nominal conc. of test subst. (mg/L)  pH Oxygen  pH  Oxygen 
 Control  7.6  8.6  8.0  9.5
 Solvent control  7.6  8.6  8.0  9.2
 100  7.7  8.7  8.0  9.2

Influence of FAT 36038/F on the mobility of Daphnia magna.

        No of immobilized daphnia after:     % of immobilized daphnia after:
 Nominal conc. of test subst. (mg/l)  N° of Daphnia tested  24 hours 48 hours   24 hours  48 hours
 Control  20  0  0  0  0
 Solvent control  20  0  0  0
 100  20  0  0  0  0
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 36038/F to Daphnia magna was determined to be at least nominal 100 mg test substance/1 (mean measured concentration: 84.2 mg/1). 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 toxicity of the test substance.
Executive summary:

The acute toxicity of the test substance FAT 36038/F 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 I, 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. Concentrations in excess of nominal 100 mg test substance/1 have not been tested. The emulsifier Tween 80 was used (100 mg/L) for the preparation of a concentrated homogeneous stock suspension and to keep the test substance in suspension as far as possible.

The analytically determined test substance concentrations in the test media decreased from 89.1 % of the nominal value at the start of the test to 79.2 % at the end of the test, obviously caused by the low solubility of the test substance in the test water.

The reported biological results are related to the nominal test concentration as well to the mean measured test substance concentration of 84.2 mg/l (84.2 % 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 36038/F to Daphnia magna was determined to be at least nominal 100 mg test substance/l (mean measured concentration: 84.2 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 toxicity of the test substance.

 

 

Description of key information

48 hr EC50 of a similar substance FAT 36038/F to Daphia magna was concluded to be > 100 mg/l.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
100 mg/L

Additional information

The acute toxicity of a similar substance FAT 36038/F to Daphnia magna was determined in a 48-hour static test according the OECD 202 Guideline. 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. 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 36038/F to Daphnia magna was determined to be at least nominal 100 mg/l.