Reaction mass of 2-octyldodecyl 2-hydroxypropanoate, 2-Octyldodecan-1-ol and 2-octyldodecyl 2-[(2-hydroxypropanoyl)oxy]propanoate

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:

28. July - 13. October 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-Octyldodecyl 2-hydroxypropanoate

Molecular formula:

C23H46O3

IUPAC Name:

2-Octyldodecyl 2-hydroxypropanoate

Constituent 2

Reference substance name:

2-octyldodecan-1-ol

EC Number:

226-242-9

EC Name:

2-octyldodecan-1-ol

Cas Number:

5333-42-6

Molecular formula:

C20H42O

IUPAC Name:

2-octyldodecan-1-ol

Constituent 3

Reference substance name:

2-octyldodecyl 2-[(2-hydroxypropanoyl)oxy]propanoate

Molecular formula:

C26H50O5

IUPAC Name:

2-octyldodecyl 2-[(2-hydroxypropanoyl)oxy]propanoate

Test material form:

liquid: viscous

Details on test material:

- State of aggregation: liquid
- Particle size distribution: not relevant

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 6-3-A
- Expiration date of the lot/batch: 03. March 2019
- Purity test date: not stated

RADIOLABELLING INFORMATION (if applicable)
not applicable

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: assumed stable
- Solubility and stability of the test substance in the solvent/vehicle: Water accommodated fraction used
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

the DOC of the test item in the test
vessels was measured at the beginning and at the end of the test

Test solutions

Vehicle:

no

Details on test solutions:

The water-accommodated fraction (WAF) was prepared for the test. This was done by
mixing the nominal load of 10 g/L resp. 11.2 mL/L test item (based on a density of
0.898 g/mL given by the sponsor) with the corresponding amount of dilution water and stirring
vigorously for 7 days. The lower unfiltered phase of this water-accommodated fraction
was used.
The lower treatments were prepared by dilution of this WAF with dilution water.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Specification
Species Daphnia magna
Variety STRAUS
Strain Berlin
Sex female
Age between 0 and 24 hours
Origin Umweltbundesamt Berlin
In-house breeding since 27. September 2007
Selection of the test system was made following the proposal of the guidelines.

Animal Husbandry
Daphnia magna is bred in the LAUS GmbH throughout the year. The animals are kept for
the use in toxicity tests. They multiply by parthenogenesis, thus being genetically identical.
The husbandry is performed similar to the method described in the OECD guideline, following
SOP 115 002 01 („Zucht und Hälterung von Daphnia magna Straus“), Version 12
from 02. Feb. 2015.
Vessels preserving glasses, nominal volume 2 L
Medium M4-Medium (recipe of ELENDT)
Food unicellular green algae (Desmodesmus subspicatus)
Medium renewal twice a week
Photo period 16/8 hours, using neon tubes
Temperature 20  2 °C

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

2.502 mmol/L

Test temperature:

20.9 – 22.6 °C

pH:

7.6 -7.9

Dissolved oxygen:

8.7 - 9.0 mg/L

Nominal and measured concentrations:

0.1 / 0.32 / 1.0 / 3.2 / 10 g/L nominal concentration
Because only in the highest concentrated treatment test item was detected whilst no immobility
was observed, the determination of the results was based on the mean of the
measured DOC concentrations in the treatment 10 g/L and the carbon content of the test
item of 74.48 %.
The geometric mean of measured concentration was 1.7 mg/L

Details on test conditions:

Date of performance 09. – 11. Aug. 2017
Treatments 0.1 / 0.32 / 1.0 / 3.2 / 10 g/L nominal concentration
Temperature 20.9 – 22.6 °C
Duration 48 hours
Observation times 24 and 48 hours
Medium renewal none
Test vessels glass beakers, nominal volume 50 mL, tall shape
Replicates (Treatments) 4 vessels, each containing 20 ± 5 mL test solution and 5
Daphnia
Replicates (Blank control) 4 vessels, each containing 20 ± 5 mL dilution water and 5
Daphnia

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 1.7 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

> 1.7 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 1.7 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 1.7 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

VALIDITY
 Immobilisation in the controls may not exceed 10 %.
Immobilisation in the controls was 0 %.
 The concentration of dissolved oxygen at the end of the test must be at least 3 mg/L.
The lowest concentration of dissolved oxygen at the end of the test was 8.7 mg/L.
 The pH-value in the test solutions should not vary by more than 1.5 units during the
test.
The highest variation was 0.3 units.

Results with reference substance (positive control):

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a
current reference study. The 24h-EC50 value was determined as 1.6 mg/L.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

No effect of Salacos 13 on Daphnia magna was detected up to limit of solubility.
The following results were determined for the test item Salacos 13
48h-NOEC ≥ 1.7 mg/L (limit of solubility)
48h-LOEC > 1.7 mg/L (limit of solubility)
24h-EC50 > 1.7 mg/L (limit of solubility)
48h-EC50 > 1.7 mg/L (limit of solubility)

Executive summary:

One valid experiment was performed.

The study was performed using 5 concentrations ranging from 0.1 to 10 g/L nominal concentration.

For each test concentration, 20 Daphnia were exposed to the test item for 48

hours in a static test system. After 24 and 48 hours, the immobilised Daphnia were counted.

The concentrations showed no significant toxicity. None of the animals were immobilised

in the blank control.

Potassium dichromate K2Cr2O7 (CAS No. 7778-50-9) was used as positive control in a

current reference study to assure that the test conditions are reliable.

At the start and at the end of the test, the content of the test item in the test solutions was

determined using measurement of dissolved organic carbon (DOC). Due to the low solubility

of the test item, the measured DOC concentration in the treatments was very low. Only

in the highest concentrated treatment, the measured DOC concentration demonstrates the

presence of dissolved test item in the test solution. The measured concentration in the

treatment of nominal 10 g/L can be stated as limit of solubility in test medium.

Because only in the highest concentrated treatment test item was detected whilst no immobility

was observed, the determination of the results was based on the mean of the

measured concentrations in this treatment (nominal 10 g/L).

The following results were determined for the test item Salacos 13 (species: Daphnia

magna).

48h-NOEC ≥ 1.7 mg/L (limit of solubility)

48h-LOEC > 1.7 mg/L (limit of solubility)

24h-EC50 > 1.7 mg/L (limit of solubility)

48h-EC50 > 1.7 mg/L (limit of solubility)