Registration Dossier

Diss Factsheets

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:
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:
yes
Remarks:
(only three concentrations were tested)
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
yes
Remarks:
(only three concentrations were tested)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Code number: FAT-36-014/F
EN/Batch: 292347.26
Purity: 90.7 %
Appearance: solid
Solubility: <1g/L (in water)
Storage: Room temperature
Expiration date: 04/98
Analytical monitoring:
yes
Details on sampling:
All test medium samples for the analytical determinations were taken of the test solutions from the approximate center of the test vessels ( without mixing the medium) and kept at -18 °C to - 25 °C until analysis.
Vehicle:
no
Details on test solutions:
Stock solution: 0.5 g test substance were mixed with 200 mL test medium and fill up to 500 mL with test medium. The stock solution was homogenized for 10 minutes in the ultrasonic bath. Test concentrations: Based on a pretest, the test concentrations were chosen as 58, 100 and 180 mg/L nominal. At the end of the exposure in all test concentrations a slightly to clearly deposit on the bottom of the test vessels was observed.
Test organisms (species):
Daphnia magna
Details on test organisms:
Test organism: The Daphnia were bred in the testing facility of the Product Ecology TF, Textile Dyes Division under standardized conditions.
Breeding: Cultures of Daphnia magna are maintained in glass vessels containing aprox. 3 L of reconstituted water at 18-22 °C. The water was renewed partially three times weekly. The daphnids were feed with a suspension of green algae (Scenedesmus subspicatus) supplemented by a suspension of Tetramin-extract in such quantities that the food was consumed within 24 h.

Pretreatment: 24 h before the start of the exposure reproductive Daphnia were separated from the young Daphnia by sieving all individuals through a 710 µm sieve. The quality of the Daphnia is checked at least every 3 months by determining the EC50 values (24 h) for potassium dichromate (range: 0.8 -1.5 mg/L). For each concentration, of test substance, 20 Daphnia divided in two groups of 10 animals are used.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Remarks on exposure duration:
None
Post exposure observation period:
No data
Hardness:
136 mg/L CaCO3
Test temperature:
21 ⁰C
pH:
7.8-8.2
Dissolved oxygen:
Saturated
Salinity:
No data
Nominal and measured concentrations:
Nominal: 0, 58, 100 and 180 mg/L
Measured: 0, 66, 79 and 148 mg/L
Details on test conditions:
Experimental conditions: 48 h at 21 °C, 16 h light/8 h dark
The Daphnia were exposed to the test substance in 250 mL beakers containing 100-200 mL test medium with 10 animals per beaker. All tests are run in duplicate. During exposure the animals were kept at 21±1 °C with 16 h illumination.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 180 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 148 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
act. ingr.
Basis for effect:
mobility
Details on results:
In the control and in all test concentrations no immobilization of the Daphnia was observed after 48 h.

Analytical results of the test substance:

Concentration start

Concentration end

Nominal

concentration mg/L

mg/L

% of

nominal

mg/L

% of

nominal

Average

concentration

mg/L

58

72

124.1

59

101.7

66

100

86

86

71

71

79

180

161

89.4

135

75

148

Validity criteria fulfilled:
yes
Conclusions:
Under the test conditions, the measured 48 h EC50 of the test substance to Daphnia magna for immobilisation could not be identified and must be >148 mg/L (i.e., ca. >180 mg a.i./L).
Executive summary:

The acute toxicity of the test substance (of 90.7 % purity) to Daphnia magna was determined in a 48 h static test according to OECD Guideline 202 and EU Method C.2 in compliance with GLP. Daphnids were exposed to nominal concentrations of 0, 58, 100 and 180 mg/L for 48 h under static test conditions. Animals were observed for immobilization after 0, 24 and 48 h. Potassium dichromate was used as positive control. Test substance concentrations were verified analytically at study start and end. Measured test substance concentrations were in the range of 71 -124 % of nominal values, corresponded to 66, 79 and 148 mg a.i./L. Under the study conditions, the 48 h EC50 was higher than the highest dose tested, i.e. >180 mg/L (nominal) or >148 mg/L (mean measured).

Description of key information

The test item FAT 36014  had no acute toxic effects on Daphnia magna with a 48-hour EC50  >180 mg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
180 mg/L

Additional information

The study performed in 1994 describes acute toxicity of the test item 36014 to Daphnia magna determined in a 48-hour semi-static test with daily test medium renewal according to OECD TG 202. At the loading rate of 180 mg/L (mean concentration of 148 mg/L), no immobilized daphnids were observed during the test period of 48 hours. The summary of the biological results is as follows:

– 48-hour EC50 > 180 mg/L (mean concentration of > 148 mg/L)

– 48-hour EC0 and 48-hour NOEC ≥ 180 mg/L (mean concentration of > 148 mg/L)

Another similar study performed in 1994 reported 48-hour EC50 >148 mg/L for Daphnia magna. In conclusion, the test item FAT 36014 had no acute toxic effects on Daphnia magna under the present test conditions.