Esterification products of Guerbet alcohols, C24-26, branched and cyclic with benzene-1,2,4-tricarboxylic acid 1,2-anhydride (3:1)

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

Study period:

2019-02-01 to 2019-02-07

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:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 05347/MA
- Expiration date of the lot/batch: 2022-06-30

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, protected from frost, heat and direct sunlight

Analytical monitoring:

yes

Details on sampling:

The TOC was measured in the fresh media at the start of the exposure and at the renewal of the test solutions (0 and 24 hours) as well as in the old media at the renewal and at the end of the exposure (48 hours) in the limit loading and in the control. The measured concentrations in the limit loading were below the LOQ (2 mg C/L) in the fresh medium (0 and 24 hours) and below the LOQ (2 mg C/L) in the old medium (24 and 48 hours).

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: One water accommodated fraction (WAF) at 100 mg/L was prepared in a glass flask with an appropriate amount of demineralized water. The procedure according to OECD guidance document No. 23 (2018) was carried out. For the loading rate, an appropriate amount of the test item was placed by pipette onto the surface of an appropriate amount of demineralized water. A slow stirring procedure was applied. Gentle stirring (to avoid formation of emulsion) was carried out for 72 ± 1 hour with a magnetic stirrer at 30 ± 1 °C. After completion of stirring, the stock solution was allowed to stand for 24 ± 1 hour at 20 ± 1 °C. Then, the WAF was removed by siphoning from the approximate center of the water body.
- Other relevant information: The limit loading was colorless and visually clear throughout the exposure period.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Waterflea
- Strain/clone: Daphnia magna STRAUS
- Justification for species other than prescribed by test guideline: Not applicable
- Age at study initiation: < 24h
- Source: Inhouse culture
- Feeding during test : No

ACCLIMATION
Acclimatization of the daphnids was not necessary, because the dilution water was equivalent to the culture medium.

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES, INCLUDING CULTURING CONDITIONS:
- Culture: At test facility, in glass vessels (2 - 3 L capacity) with approximately 1.8 L M4 medium, at 20 ± 2 °C, in an incubator, 16 hours illumination; light intensity of max. 1500 lx.
- Feeding: The daphnids are fed at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

~300 mg CaCO3/L

Test temperature:

19-20 °C

pH:

7.5-7.9

Dissolved oxygen:

≥ 7.70 mg/L

Conductivity:

600-637 µS/cm

Nominal and measured concentrations:

Nominal: 100 mg/l
Measured: < LOQ

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers (4 (ID) x 7 (H) cm), 50 mL capacity, loosely covered with watch glasses
- Volume of solution: 20 ml (in each test replicate)
- Aeration: No
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency): 24h
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4 medium, freshly prepared
- Culture medium different from test medium: No
- Intervals of water quality measurement: 24 h

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

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Immobilization was determined in all groups after 24 and 48 hours. Determination of other adverse, sub-lethal effects (e.g. discoloration, abnormal behavior etc.) was done.

VEHICLE CONTROL PERFORMED: No

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

LOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: No
- Other biological observations: No
- Mortality of control: No
- Other adverse effects control: No
- Immobilisation of control: No
- Abnormal responses: No
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No

Results with reference substance (positive control):

- Results with reference substance valid? : Yes
- Limit test: No
- Dose-response test: Yes
- EC50: 2.0 mg/l

Immobilization rates [%] after 24 and 48 hours of exposure.

Nominal test item loading [mg/l]	Immobilization [%]
	24 hours					48 hours
	Replicates					Replicates
	1	2	3	4	MV	1	2	3	4	MV
100	0	0	0	0	0	0	0	0	0	0
Control	0	0	0	0	0	0	0	0	0	0

Validity criteria fulfilled:

yes

Conclusions:

In the limit test (loading 100 mg/L) with the test item, no effects on Daphnia magna were observed.

Executive summary:

In the acute immobilization test with Daphnia magna (STRAUS), the effects of the limit loading of 100 mg/L of the test item Esterification products of Guerbet alcohols, C24-26, branched and cyclic with benzene-1,2,4-tricarboxylic acid 1,2-anhydride were determined according to OECD 202 (2004) from 2019-02-01 to 2019-02-07.

The limit test was conducted under semi-static conditions over a period of 48 hours. The limit loading was colorless and visually clear throughout the exposure period. Twenty daphnids, divided into 4 replicates with 5 daphnids each, were exposed to the limit concentration and the control.

The total organic carbon concentration of the test item was measured in the fresh media at the start of the exposure and at the renewal of the test solutions (0 and 24 hours) as well as in the old media at the renewal and at the end of the exposure (48 hours) in the limit concentration and in the control.

The measured concentrations in the limit loading were < LOQ (2 mg C/L) in the fresh medium (0 and 24 hours) and < LOQ (2 mg C/L) in the old medium (24 and 48 hours).

Due to the unspecific analytical method, all effect loadings (EL10/50/100) were given based on the nominal loading of the test item.

Effect loadings	Test duration [h]	Nominal test item loading [mg/l]
EL10/50/100	24	> 100
	48	> 100

The validity criteria of the test guideline were fulfilled.

Description of key information

The test substance Esterification products of Guerbet alcohols, C24-26, branched and cyclic with benzene-1,2,4-tricarboxylic acid 1,2-anhydridewas not toxic under test conditions in the range of water solubility.

Additional information

Also for the analogue substance 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters no toxicity was observed up to the limit of water solubility.