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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test item name: Fatty acid, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine
Batch number: TEE3316/22
Molecular weight: > 700
Declared purity: 97 %
Storage conditions: Room temperature/dark conditions
Stability under storage conditions: Stable

Sampling and analysis

Analytical monitoring:
not specified

Test solutions

Vehicle:
not specified

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
The study was performed on the freshwater crustacean Daphnia magna Straus. A strain of this species was originally supplied by the Italian Health Department (Istituto Superiore di Sanità) in September 2004. Since that time, the clone has been bred in ChemService laboratories in reconstituted water with the same characteristic to the water used in the tests (as for pH, main ions, and total hardness) and under temperature and light conditions identical to those of the tests.
The daphnia breeding was daily fed with a fixed amount of green algae Pseudokirchneriella subcapitata (formerly Selenastrum capricornutum) cultivated in the ChemService Laboratory and with a suspension of the yeast Saccharomyces cerevisiae.
At the start of the test, the organisms used in the test were 6-24 hours old and were not first brood progeny.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Hardness:
140 - 250 mg/L as CaCO3
Test temperature:
19.7 and 22.5 °C
pH:
Immediately after preparation, the pH value in test item solution was 8.17 and 8.36 in control. The pH did not vary by more than 0.33 unit during the test
Dissolved oxygen:
greater than 6.0 mg/L

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
IC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Any other information on results incl. tables

A limit test was performed to evaluate the effect of the test item onDaphnia magnaunder static conditions.

The daphnids were observed for immobility after 24 and 48 hours of exposure. The observed immobilization in the test concentrations and in the control is reported in Table 1.

Table 1           

Lethal effect of Fatty acid, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine toDaphnia magna.

Nominal test item concentration

[mg/L]

No. of
Daphnia
tested

No. of immobilized
Daphnia

% of immobilized
Daphnia

24 h

48 h

24 h

48 h

0 (control)

20

0

0

0

0

100.0

20

0

0

0

0

In the negative control 0% immobilization was observed at the end of the test period and no daphnid was found to be trapped on the surface water. These values comply with the validity criterion of the test, that provides a maximum immobilization and/or a maximum number of daphnids trapped in to water surface of 10% in the control medium at the end of the test.

 

The results were analyzed for significant differences from control with the Fisher’s Exact test (α = 0.05) by the mean of CETIS elaboration software v1.026D.

 

The NOEC (highest concentration tested without toxic effects after the exposure period) was determined was equal to the nominal tested concentration, 100 mg/L, at both the observation times.

Given the nature of limit test, the LOEC and the 48-h IC50could not be determined, but, according to the results, were determined to be greater than the nominal concentration tested (i.e., IC50> 100 mg/L).

 

No remarkable observations were made concerning the appearance of the test medium. The test medium was a clear solution throughout the whole test duration.

 

Light intensity was measured at the start of the test and it was equal to 385 Lux, according to the mentioned guideline (200 – 1500 Lux).

 

The incubation temperature was in the range 19.7 - 22.5°C, with a mean value ofand a standard deviation of, these values exceeded the OECD’s recommended range (±) only for a short period.

During the test period, the dissolved oxygen concentrations in the test medium and the control were always greater than 6.0 mg/L (Table 2) according to guideline that provided a minimum oxygen concentration of 3.0 mg/L.

Immediately after preparation, the pH value in test item solution was 8.17 andcontrol. The pH did not vary by more than 0.33 unit during the test, as required in the mentioned guidelines (Table 2).

 

Table 2 

Dissolved oxygen concentrations and pH values in the test media at 0 and after 48 hours from test start of the test period.

 

Nominal test item concentration (mg/L)

0 (control)

100.0

Dissolved

oxygen

(mg/L)

0 h

6.90

7.57

48 h

6.64

6.61

pH

0 h

8.36

8.17

48 h

8.29

8.50

Applicant's summary and conclusion

Conclusions:
The test item “Fatty acid, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine” caused no adverse effect to Daphnia magna after 48-hours exposure at a nominal product concentration of 100 mg/L under static conditions.
The NOEC, LOEC and IC50 values after 24 and 48 h, calculated based on nominal concentration tested, were as follows:

NOEC 100 mg/L
LOEC > 100 mg/L
IC50 > 100 mg/L.
Executive summary:

The acute toxicity of the test item “Fatty acid, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine” toDaphnia magnawas determined in a 48‑hour static test according tothe OECD Guideline for Testing of Chemicals, No. 202 (2004).

 

For this purpose, juvenile daphnids (<24 hours old at initiation of the test) were exposed to an aqueous test medium containing the test item at the only nominal concentration of 100.0 mg/L. The exposed organisms were checked for immobilization 24 and 48 hours after test initiation.

 

The room temperature was in the range 19.7 –during the test period, these values exceeded the OECD’s recommended range (20 ±) for a short period, however this deviation did not affect the results of the study as showed by the immobilization data in the control.

 

Light intensity at test initiation was 385 Lux, according to the mentioned guideline (200-1500 Lux).

At the end of test period, in the negative control 0% of immobilization was observed and no daphnid was found trapped on the test water surface. These values comply with the validity criterion of the test, that provide a maximum immobilization and/or a maximum number of daphnids trapped on water surface of 10% in the control medium at the end of the test.

 

No immobilization was observed in the test item medium after 24 and 48 hours, therefore the NOEC (highest concentration tested without toxic effects after the exposure period) of “Fatty acid, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine”toDaphnia magnawas determined to be equal to the nominal tested concentration of 100.0 mg/L.

 

Based on the observed effects, the LOEC and the 48-h IC50were determined to be greater than the tested concentration, 100.0 mg/L.