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Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Details on sampling:

Range finding test : a preliminary test performed to find the range of toxicity of the test item. 5 different concentrations have been prepared with ten-folds dilutions to 0.1 mg/L and then tested.
Definitive test : a test performed after a range finding test to calculate the toxicity of the test item (limit test or EC50 test). The test sample has been prepared at 100 mg/L in culture medium.

Vehicle:

yes

Details on test solutions:

Concentration tested :
Range finding test : 5 different concentrations have been prepared with ten-folds dilutions to 0.1 mg/L
Definitive test : 100 mg/L in culture medium

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna straus, Crustacean, Cladocero
Age : 6-24 hours
Origin : breeder in Eurofins Biolab Test Facility
N. of animals : 20 for each treated - 20 for control
N. of replications : 4 for control and 4 for all treated concentration for range finding test and for limit test
N. of concentrations : 5 for range finding test - 1 for limit test

Water media type:

saltwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

48 hours

Hardness:

between 140 and 250 mg CaCO3/L

Test temperature:

20°C ± 2°C

pH:

6 - 8

Dissolved oxygen:

5 - 6 mg/L

Nominal and measured concentrations:

Determination of analytical concentration of total organic carbon (TOC) using an automatic Sievers analyser.

Details on test conditions:

Range finding test :
120 Daphnies have been used : 100 of them treated with the test item (20 per concentration tested) and 20 used as control
The 120 daphnies were kept in the same assay conditions without adding the test item
Definitive test :
40 Daphnies have been used : 20 of them treated with the test item (100 mg/L) and 20 used as control
The 40 daphnies were kept in the same assay conditions without adding the test item

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Details on results:

Oxygen concentration : the results for definitive test satisfy validity criteria.
pH and temperature : the results for definitive test satisfy validity criteria.
Analytical verification of the concentration of the test item : The test item should be considered stable, because the TOC values and the end of the test remain in the required range (80-120%) respect to the initial values.
EC50 > 100 mg/L

Number of immobilised Daphnie at 24 and 48h in treated (test item) and control in definitive test :

Control	24 hours	48 hours
Replication n°1	0/5	0/5
Replication n°2	0/5	0/5
Replication n°3	0/5	0/5
Replication n°4	0/5	0/5
Replication n°5	0/5	0/5
Concentration 100 mg/L
Replication n°1	0/5	0/5
Replication n°2	0/5	0/5
Replication n°3	0/5	0/5
Replication n°4	0/5	0/5
Replication n°5	0/5	0/5

Concentration of the test item at the beginning and at the end of the test (48 hours) in treated sample in the definitive test

	t=0	t=48h	% stability
Concentration 100 mg/L	42.52 ppm	44.84 ppm	106

Validity criteria fulfilled:

yes

Conclusions:

The obtained results, in compliance with assay validity creteria, showed that the Daphnia magna EC50 after 48 hours of the test item KERASTIM is > 100 mg/L.

Executive summary:

The aim of the study is to determine the ecotoxicological effects of the test item "KERASTIM S" on biotic systems: in particular aquatic organism such as Daphnia magna was used as test system in order to perform an EC50 test or to define a limit not toxic threshold.

The toxicity of the test item, KERASTIM S, on the cladocero Daphnia magna has been evaluated according to OECD guideline N. 202.

During the range finding test the Daphnie have been exposed to 5 different dilutions of the test item for a total period of 48 hours.

After the results of the range finding test a limit test has been performed. The Daphnie have been exposed to 100 mg/l of the test item for 48 hours.

Daphnie have been kept under observations for a period of 48 hours and the number of immobilised organisms and/or possible abnormal behaviours both in control and in treatment group vessel have been observed.

At the beginning and at the end of the test (48 hours) dissolved oxygen and pH have been measured in the tested concentration and in the control group. Temperature of the assay environment have been recorded at the beginning and at the end of the test.

Organic carbon concentration (TOC) has been measured at the beginning and at the end of the test in a pool derived from vessels in control and in the tested concentration.

The obtained results, in compliance with test acceptability criteria, can be summarised as follow:

Test item "KERASTIM S": EC₅₀(48 h) >100 mg/I

Description of key information

The toxicity of the test item, KERASTIM S, on the cladocero Daphnia magna has been evaluated according to OECD guideline N. 202.

The obtained results, in compliance with test acceptability criteria, can be summarised as follow:

Test item "KERASTIM S": EC50(48 h) >100 mg/I

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L