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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:
2018-03-26 to 2018-03-29
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)
Version / remarks:
2002
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations:
A limit test item concentration of 100 mg/L was prepared.
The limit concentration and the control were analytically verified via LC-MS/MS in fresh media at the start of the exposure and renewal and in 24 hours aged test media at the end of the renewal interval and exposure.

- Sampling method:
At the start of the exposure and at renewal (0 and 24 hours), three aliquots were taken as sampies of the limit concentration and analyzed.
At the end of the interval and exposure (24 and 48 hours), three aliquots of the old media were taken as sampies of the old media were taken directly from the test vessels and analyzed.

Vehicle:
no
Details on test solutions:
In view of the difficulties associated with the evaluation of aquatic toxicity of poorly water soluble test items and multi-component test items, a modification of the standard method for the preparation of aqueous media was performed.
An approach endorsed by several important regulatory authorities in the EU and elsewhere (ECETOC 1996 and OECD 2000) is to expose the organisms to a Water Aecommodated Fraction (WAF) of the test item in cases where the test item is a complex mixture and is poorly soluble in water and in the permitted solvents.

One water accommodated fraction (WAF) was prepared with nominal loading of the test item of 100 mg/L.
For the limit loading level an appropriate amount of the test item was weighed. The test item was applied onto the water surface inside a brown glass flask with an appropriate amount of dilution water.
A slow stirring proeedure was applied for 24 hours at room temperature. After aseparation period of 2 hours, the aqueous phase or WAF was removed by siphoning (from the approximate center of the glass flask). The resulting water accommodated fraction (WAF) was checked via laser beam (Tyndall effect) for undissolved test item and was used in the test. The Tyndall effect was positive.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: STRAUS
- Source: continuous laboratory cultures. (Origin: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu), 14195 Berlin, Germany
- Feeding during test: The daphnids were not fed during the study.


ACCLIMATION
- Acclimation period: Acclimatization was not necessary, because the composition of the dilution water was equivalent to the culture medium.
- Type and amount of food: Mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus.
- Feeding frequency: The daphnids were fed at least 5 times per week ad libitum
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
209 -210 mg CaCO3/L
Test temperature:
18-22 °C
pH:
7.57 - 8.62
Dissolved oxygen:
9.17 - 9.98 mg/L
Conductivity:
612 - 616 µS/cm
Nominal and measured concentrations:
100 mg/L (nominal; WAF)
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass beakers (4 (ID) x 7 (H) cm), 50 mL capacity, loosely covered with watch glasses
- Aeration: no
- Renewal rate of test solution: The test solutions were renewed after 24 hours.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4


TEST MEDIUM / WATER PARAMETERS
- Ca/mg ratio: (209 - 210 mg CaCo3/L)
- Conductivity: 612 - 616 µS/cm


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16/8 hours light/dark cycle
- Light intensity: max. 1500 lx

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobilization was determined in all groups after 24 and 48 hours.

RANGE-FINDING STUDY

A preliminary range finding test under semi-static conditions over aperiod of 48 hours was conducted at the test facility with three nominal test item concentrations 1, 10 and 100 mg/L prepared with dilution water.
Three WAFs with a nominal loading of 100 - 10.0 - 1.00 mg/L were prepared prior to the start of the exposure (0 hours) and prior to the renewal of the test solutions (24 hours).

No effects on immobilization rates were observed in the preliminary range finding test.

Reference substance (positive control):
not required
Remarks:
Results of the most recent of the monthly performed reference tests (potassium dichromate)
Key result
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mobility
Remarks on result:
other: WAF
Results with reference substance (positive control):
potassium dichromate
EC 50 24h = 2.00 mg/L (study performed: 2018 03-13 to 2018-03-14) (95 % conifidence limits 1.00 - 4.00 mg/L)

The concentration of the test item Octadecanoic Acid, reaction products with triethylenetetramine was analytically verified via LC-MS/MS in fresh media at the start of the exposure (0 hours and 24 hours) and in the corresponding old media at the end of the exposure (24 hours and 48 hours) in the limit test item concentration and the control. The measured concentration of the test item at the start of the exposure was 0.108 % of the nominal test item concentration and was 0.266 % at the end (highest concentration following lead substanee C16/18 or C18/18, whatever is higher).

The study was performed according to OECD Guideline 202 (2004).

The validity criteria were fulfilled:

• In the control group, no daphnids were immobilized or showed any signs of disease or stress, e.g. discoloration or unusual behavior such as trapping on the surface of the water, during the 48-hour test period

(required: not more than 10% of the daphnids in the control).

• The dissolved O2 concentration in the old media at the end of the exposure was ≥ 8.62 mg/L.

(required: > 3 mg/L at the test end of the exposure) in all test vessels of the limit concentration and the control.

Validity criteria fulfilled:
yes
Conclusions:
Based on the nominal loading of the water accomodated fraction (WAF) of the test item Octadecanoic Acid, reaction products with triethylenetetramine, the 48 hour-EL50 for Daphnia magna was > 100 mg/L.
In the WAF 100 mg/L of the test item Octadecanoic Acid, reaction products with triethylenetetramine, no effects on Daphnia magna were observed.
Executive summary:

In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item Octadeeanoic Acid, reaction products with triethylenetetramine were determined at the test facility according to OECD 202 (2004), equivalent to the Commission Regulation (EC) No.440/2008 Method C2 (2008).

The test item is a eomplex mixture and poorly soluble in water and in solvents recommended by appropriate guidelines. Due to the complex nature of the test item for the purposes of the test, the test item was prepared following the protocol of water aecommodated fraction (WAF). Exposure are expressed in terms of the original coneentration of the test item in water at the start of the mixing period (loading rate) irrespective of the actual concentration of the test item in the WAF.

One Water Aceommodated Fraction (WAF) was prepared with a nominal loading level of 100 mg/L in a limit test. The study was performed over aperiod of 48 hours under semi-static conditions with renewal of test solution after 24 hours as a worst case exposure. The WAF was visually clear with white test item partieies as suspended matter and showed a positive Tyndall effect at the start of the exposure and renewal.

The effect levels (EL) given are based on the nominal loading level of the test item Octadecanoie Acid, reaction products with triethylenetetramine:

EL10 24h: > 100 mg/L

EL50 24h: > 100 mg/L

EL100 24h: > 100 mg/L

EL10 48h: > 100 mg/L

EL50 48h: > 100 mg/L

EL100 48h: > 100 mg/L

In the WAF 100 mg/L of the test item Octadecanoic Acid, reaction products with triethylenetetramine, no effects on Daphnia magna were observed.

The validity eriteria of the test guidelines were fulfilled.

Description of key information

In the WAF 100 mg/L of the test item Octadecanoic Acid, reaction products with triethylenetetramine, no effects on Daphnia magna were observed.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
100 mg/L

Additional information

In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item Octadeeanoic Acid, reaction products with triethylenetetramine were determined at the test facility according to OECD 202 (2004), equivalent to the Commission Regulation (EC) No.440/2008 Method C2 (2008).

The test item is a eomplex mixture and poorly soluble in water and in solvents recommended by appropriate guidelines. Due to the complex nature of the test item for the purposes of the test, the test item was prepared following the protocol of water aecommodated fraction (WAF). Exposure are expressed in terms of the original coneentration of the test item in water at the start of the mixing period (loading rate) irrespective of the actual concentration of the test item in the WAF.

One Water Aceommodated Fraction (WAF) was prepared with a nominal loading level of 100 mg/L in a limit test. The study was performed over aperiod of 48 hours under semi-static conditions with renewal of test solution after 24 hours as a worst case exposure. The WAF was visually clear with white test item partieies as suspended matter and showed a positive Tyndall effect at the start of the exposure and renewal.

The effect levels (EL) given are based on the nominal loading level of the test item Octadecanoie Acid, reaction products with triethylenetetramine:

EL10 24h: > 100 mg/L

EL50 24h: > 100 mg/L

EL100 24h: > 100 mg/L

EL10 48h: > 100 mg/L

EL50 48h: > 100 mg/L

EL100 48h: > 100 mg/L

In the WAF 100 mg/L of the test item Octadecanoic Acid, reaction products with triethylenetetramine, no effects on Daphnia magna were observed.

The validity eriteria of the test guidelines were fulfilled.